FOI Request for Surgical Polymeric Surgical Mesh

USER: WEEKS, SUSAN M (smw)FOLDER: K052401 - 223 pages (FOI:07004171)

COMPANY: ETHICON, INC. (ETHICON)PRODUCT: MESH, SURGICAL, POLYMERIC (FTL)

SUMMARY: Product: GYNECARE TVT SECUR SYSTEM

DATE REQUESTED: Tue Jul 17 24:00:00 2007DATE PRINTED: Wed Aug 22 09:15:57 2007

Note: Releasable Version

FOI - Page 1 of 223

510K SUMMARY - 5 pages 1

CORRESPONDENCE - 11 pages 6

ORIGINAL - 87 pages 17

REVIEWER INFORMATION - 27 pages 104

SUPPLEMENT - 91 pages 131

FOI - Page 2 of 223

NOV 2 8 2005

Section 5

510(k) SUMMARY

Statement Information supporting claims of substantial equivalence, asdefined under the Federal Food, Drug, and Cosmetic Act,respecting safety and effectiveness is summarized below. For theconvenience of the Reviewer, this summary is formatted inaccordance with the Agency's final rule ".... 510(k) Summariesand 5 10(k) Statements . (21 CFR 807) and can be used toprovide a substantial equivalence summary to anyone requesting itfrom the Agency.

MODIFIED DEVICF NAME:

GYNECARE TVT SECUR* System

PREDICATE DEVICE NAME:

GYNECARE TVT System and GYNECARE TVT ObturatorSystem

Device Description The GYNECARE TVT SECUR* device is a sterile, single patientuse device, consisting of one piece of undyed or blue(Phtalocyanine blue, Color index Number 74160) PROLENE*polypropylene mesh (tape) approximately 1. 1 cm x 8.0cm(approximately '/2 x 4 inches). The ends of the device will besandwiched between pieces of fleece made of polyglactin910/polydioxanone coated with polydioxanone film. The coatedends arc added to facilitate passage (stiffens the ends) andplacement (tactile feel for the surgeon) of the mesh implant. Twocurved, stainless steel, single use introducers are used to deliver theimplant. The introducers are supplied fixed to the implant via awire through the coated ends and inserters. TVT SECUR isdesigned to accommodate two surgical techniques: the "Hammockapproach" and the "U approach". The GYNECARE TVTUniversal System is a less invasive 'exit less' device which willenable the physician to perform a suburethal sling procedureplacing the mesh under the mid urethra without either the deliverydevice or the implant exiting the skin.

GYNECARE TVT SECUR SvstemGYNECARE, a division of ETHICON, Inc.

000016

FOI - Page 3 of 223

/g-o Q3qo i-

Intended Use A pubourethral sling for treatment of stress urinary incontinence(SU1), for female urinary incontinence resulting from urethralhypermobility and/or intrinsic sphincter deficiency.

Indications Statement GYNECARE TVT SECUR* is indicated for the treatment of stressurinary incontinence (SUI), for female urinary incontinenceresulting from urethral hypermobility and/or intrinsic sphincterdeficiency.

Technological The modified device has the same technological characteristics asCharacteristics the predicate device. The form, fit, function and method of

operation are similar.

Performance Data Results of verification testing indicates that the product mcets theestablished performance requirements.

Conclusion Based upon the 510(k) summaries and 510(k) statements (21 CFR807) and the infornation provided herein, we conclude that thesubject device is substantially equivalent to the predicate devicesunder the Federal Food, Drug and Cosmetic Act.

Contact Patricia M. Hojnoski, M.S.Senior Project Manager, Regulatory AffairsETHICON, INC.Rt. 22 WestSomerville, NJ 08876-0151

Phone: (908) 218-2893Fax: (908) 218-2595

Date August 30, 2005

GYNECARE TVT SECUR SvstemGYNECARE, a division of I HICON, Inc.

U&D.i7

FOI - Page 4 of 223

DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service

Food and Drug Administration9200 Corporate BoulevardNOV 2 8 2005 Rockville MD 20850

Patricia M. Hojnoski, M.S.Senior Project Manager, Regulatory AffairsGynecare, A Division of Ethicon, Inc.P.O. Box 151, US Route 22 WestSomerville, New Jersey 08876

Re: K052401Trade/Device Name: GYNECARE TVT SECUR* SystemRegulation Number: 21 CFR 878.3300Regulation Name: Surgical meshRegulatory Class: IIProduct Code: FTLDated: October25, 2005Received: November 17, 2005

Dear Ms. Hojnoski:

We have reviewed your Section 5 10(k) premarket notification of intent to market the devicereferenced above and have determined the device is substantially equivalent (for the indicationsfor use stated in the enclosure) to legally marketed predicate devices marketed in interstatecommerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or todevices that have been reclassified in accordance with the provisions of the Federal Food, Drug,and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA).You may, therefore, market the device, subject to the general controls provisions of the Act. Thegeneral controls provisions of the Act include requirements for annual registration, listing ofdevices, good manufacturing practice, labeling, and prohibitions against misbranding andadulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), itmay be subject to such additional controls. Existing major regulations affecting your device canbe found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA maypublish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not meanthat FDA has made a determination that your device complies with other requirements of the Actor any Federal statutes and regulations administered by other Federal agencies. You mustcomply with all the Act's requirements, including, but not limited to: registration and listing (21CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as setforth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronicproduct radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

FOI - Page 5 of 223

Patricia M. Hojnoski, M.S.

This letter will allow you to begin marketing your device as described in your Section 510(k)premarket notification. The FDA finding of substantial equivalence of your device to a legallymarketed predicate device results in a classification for your device and thus, permits your deviceto proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), pleasecontact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled,"Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtainother general information on your responsibilities under the Act from the Division of SmallManufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or(301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industrv/support/index.html.

Sincerely yours,

Mark N. MelkersonActing DirectorDivision of General, Restorative

and Neurological DevicesOffice of Device EvaluationCenter for Devices and

Radiological Health

Enclosure

FOI - Page 6 of 223

INDICATIONS FOR USE

510(k) Number (if known):

Device Name: GyNECARE TVT SFFCTTR* System

Indications for Use: The GYNECARE TVT SECUR* device is intended for use inwomen as a sub-urethral sling for the treatment of stress urinaryincontinence (SUI) resulting from urethral hypermobility and/orintrinsic sphincter deficiency.

Prescription Use X AND/OR Over-The-Counter Use(Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IFNEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of General, Restorative,and Neurological Devices

510(k) Number 6S ' a)GYNECARE TVT SECUR System

GYNECARE, a division of ETHICON. Inc.

FOI - Page 7 of 223

DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service

Food and Drug Administration9200 Corporate Boulevard

NOV 2 8 2005 Rockville MD 20850

Patricia M. Hojnoski, M.S.Senior Project Manager, Regulatory AffairsGynecare, A Division of Ethicon, Inc.P.O. Box 151, US Route 22 WestSomerville, New Jersey 08876

Re: K052401Trade/Device Name: GYNECARE TVT SECUR* SystemRegulation Number: 21 CFR 878.3300Regulation Name: Surgical meshRegulatory Class: IIProduct Code: FTLDated: October25, 2005Received: November 17, 2005

Dear Ms. Hojnoski:

We have reviewed your Section 510(k) premarket notification of intent to market the devicereferenced above and have determined the device is substantially equivalent (for the indicationsfor use stated in the enclosure) to legally marketed predicate devices marketed in interstatecommerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or todevices that have been reclassified in accordance with the provisions of the Federal Food, Drug,and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA).You may, therefore, market the device, subject to the general controls provisions of the Act. Thegeneral controls provisions of the Act include requirements for annual registration, listing ofdevices, good manufacturing practice, labeling, and prohibitions against misbranding andadulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), itmaybe subject to such additional controls. Existing major regulations affecting your device canbe found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA maypublish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not meanthat FDA has made a determination that your device complies with other requirements of the Actor any Federal statutes and regulations administered by other Federal agencies. You mustcomply with all the Act's requirements, including, but not limited to: registration and listing (21CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as setforth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronicproduct radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

FOI - Page 8 of 223

Patricia M. Hojnoski, M.S.

This letter will allow you to begin marketing your device as described in your Section 510(k)premarket notification. The FDA finding of substantial equivalence of your device to a legallymarketed predicate device results in a classification for your device and thus, permits your deviceto proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), pleasecontact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled,"Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtainother general information on your responsibilities under the Act from the Division of SmallManufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or(301) 443-6597 or at its Internet address http://www.fda.wv/cdrh/industrV/support/index.html.

Sincerely yours,

ar kN. MelkersonActing DirectorDivision of General, Restorativeand Neurological Devices

Office of Device EvaluationCenter for Devices and

Radiological Health

Enclosure

2_

FOI - Page 9 of 223

I sr~so

INDICATIONS FOR USE


Device Name: GVNECARE TVT SECITR* Systemi

Indications for Use: The GYNECARE TVT SECUR* device is intended for use inwomen as a sub-urethral sling for the treatment of stress urinaryincontinence (SUI) resulting from urethral hypermobility and/orintrinsic sphincter deficiency.

Prescription Use X AND/OR Over-The-Counter Use ___(Part 21 CFR 801 Subpart 0) (21 CFR 801 Subpart C)



Division of General, Restorative,and Neurological Devices

510(k) Number 9 )(GYNECARET VT SECi. It SystermGYNECARE, a di vision of ETI-1ICON, Inc.

FOI - Page 10 of 223

Pages 11 through 18 have been removed.

KogDqu\TABLE OF CONTENTS

GYNECARE TVT SECUR SYSTEM 510(k)

Descriptinn: Page #

User Fee Cover Sheet .......................................................... 1CDRH Cover Sheet ............................................................ 45 10(k) Cover Letter ............................................................ 10Indications for Use Statement ................................................. 13510(k) Summary ................................................................. 15Truthful and Accuracy Statement ............................................. 18Class III Summary and Certification .......................................... 20Financial Certification or Disclosure .......................................... 21Declaration of Conformity and Summary Reports ........................... 22Executive Summary .............................................................. 23Device Description ............................................................... 25Substantial Equivalence Discussion ............................................ 33Proposed Labeling ................................................................ 37Sterilization and Shelf Life ...................................................... 67Biocompatibility .................................................................. 69Software ............................................................................ 73Electromagnetic Compatibility and Electrical Safety ........................ 74Bench Testing ...................................................................... 75Performance Testing - Animal and Human Cadaver ......................... 76Performance Testing - Clinical .................................................. 85Kit Certification .................................................................... 86

['7

GYNECARE TVT SECUR SystemGYNECARE, a division of ETHICON, Inc.


Section 1: Medical Device User Fee Cover Sheet (Form FDA 8601)


000001


Pages 21 and 22 have been removed.

Section 2: CDRH Premarket Review Submission Cover Sheet


000004


DEPARTMENT OF HEALTH AND HUMAN SERVICESFomApvaFOOD AND DRUG ADMINISTRATION OMB No. 9010-0120

Expiration Date: May 31, 2007.CDRH PREMARKET REVIEW SUBMISSION COVER SHEET See OMB Statement on page 5.

Date of Submission User Fee Payment ID Number FDA Submission Document Number (if known)

PMA PMA & HDE Supplement PDP S lg (k) Meeting5 Original Submission Regular (180 day) Original POP DOriginai Submission: Pre-510(K) Meeting

Premarket Report Special Notice of Completion []Traditional Pre-IDE MeetingModular Submission Panel Track (PMA Only) Amendment to POP 5 Special Pre-PMA Meeting

5 Amendment SO-day Supplement Abbreviated (Complete Pre-PDP MeetingReport 30-day Notice section 1, PageS) Day 100 MeetingReport Amendment [135-day Supplement LI Additional informaton Agreement Meeting

5 Licensing Agreement Me Real-time Review E] Third Party Determination MeetingAmendment to PMA & Other (specify):

]OtherIDE Humanitarian Device Class II Exemption Petition Evaluation of Automatic Other Submission

Exemption (HDE) Class III Designation5 Original Submission EOriginal Submission Original Submission (Dn S o n 513(g)

Amendment Amendment Additional Information Additional Information U Other(describe submission):

ReportReport Amendment

Have you used or cited Standards in your submission? El Yes [ No (if Yes, please complete Section I, Page 5)

Company / Institution Name Establishment Registration Number (if known)Ethicon, Inc. 2210968Division Name (if applicable) Phone Number (including area code)GYNECARE TVT SECUR System ( 908 ) 218-2893

Street Address FAX Number (including area code)P.O. Box 151; Route 22 West ( 908 ) 218-2595

City State / Province ZIP/Postal Code CountrySomerville NJ 08876 USA

Contact Name

--------- ---- -----------

Contact Title Contact E-mail AddressSr. Project Manager -----------------------------

Company / Institution Name

Division Name (if applicable) Phone Number (including area code)

( )Street Address FAX Number (including area code)

( )City State / Province ZIP/Postal Code Country

Contact Name

Contact Title Contact E-mail Address

FORM FDA 3514 (6/05) PAGE 1 OF 5 PAGESSt Mda Ar~ (301) 443 I BEr

000005


Withdrawal [] Change in design, component, or EJLocation change:Additional or Expanded Indications specification: Manufacturer5 Request for Extension Software/Hardware SterilizerPost-approval Study Protocol Color Additive Packager

Request for Applicant Hold MaterialRequest for Removal of Applicant Hold SpecificationsRequest to Remove or Add Manufacturing Site Other (specify below) DReport Submission:

Annual or PeriodicL]Process change: Post-approval Study

Manufacturing riLabeling change: Adverse ReactionSterilization Indications Device DefectPackaging Instructions AmendmentOther (specify below) Performance

Shelf LifeTrade Name 5 Change in OwnershipOther (specify below) Change in Correspondent

]Response to FDA correspondence: Change of Applicant Address

E Other Reason (specify):

5 New Device 5 Change in: 5 Repose to FDA Letter Concerning:5]New Indication Correspondent / Applicant Conditional Approval5] Addition of Institution Design/Device Deemed ApprovedrJ Expansion / Extension of Study Informed Consent Deficient Final Report

IRS Certification Manufacturer Deficient Progress ReportTermination of Study Manufacturing Process Deficient Investigator Report

5Withdrawal of Application Protocol - Feasibility Disapproval5 Unanticipated Adverse Effect Protocol - Other Request Extension ofNotification of Emergency Use Sponsor

5Compassionate Use Request Request Meeting5 Treatment IDE 5 Report submission: Request Headrng5'Continued Access Current Investigator

Annual Progress ReportSite Waiver ReportFinal

5 Other Reason (specify):

5 New Device 5 Additional or Expanded Indications []Change in Technology

r.1 Other Reason (specify):Modification of existing device.

FORM FDA 3514 (6/05) PAGE 2 OF 5 PAGES

000006


* a]eII La0iFimI* 6'eW f Sl I Lio S1II[II61111111Product codes of devices to which substantial equivalence is claimed Summary of, or statement concerning,

+K974098 2 K012628 K358safety and effectiveness information_ _ __d ~ ~ ~ ~ 31 K033568 11 4 1 MV ~~~~~~~~~510 (k) summary attached

5 510 (k) statement

Information on devices to which substantial equivalence is claimed (if known)N3 5IOQQk Number Trade or Proprietary or Model Name Manufacturer

1K974098 GYNEGARE TVT System 1ETHICON, Inc.

K012628 2 GYNECARE TVT System ETHICON, Inc.

3 K033568 3GYNECARE TVT Obturator System 3 ETHICON, Inc.

4 4 4

5 ~~~~~~~~~5 5

6 ~~~~~~~~~6 6

Common or usual name or classificationClass II; Mesh, Surgical, Polymeric (21 CFR 878.3300), common name: pubo-urethral sling

I Trade or Proprietary or Model Name for This Device Model Number

1GYNEGARE TVT SEGUR System

2 2

3 3

4 ~~~~~~~~~~~~~~~~~~~~~~~4

5 ~~~~~~~~~~~~~~~~~~~~~~5FDA document numbers of all pnor related submissions (regardless of outcome)

1 K974098 2 K012628 3K033568 45 6

7 81 19 10 1 11 12

Data Included in Submission

*' **** *~SProduct Code C.F.R. Section (lifapplicable) Device Class79FTL 21 GFR 878.3300 5l Ciass I 9Csass if

Classification PanelGeneral and Plastic Surgery Devices 5Class Ill 5UnclassifiedIndications (from labeling)The GYNECARE TVT SECUR* device is intended for use in women as a sub-urethral sling for the treatment of stress urinaryincontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency.


000007


FDA Document Number (if known)Note: Submission of this information does not affect the need to submit a 2891or 2891a Device Establishment Registration form.

&I ,~1[llI re Ij r_, 0 I M VA J,~[ to]. 1 1 letw r R. ,Y_7 e. f,1[tI ~ CF'MI M. I: tII IrL,-111 Il L0 Ik'tI 1 .1 ; F,11~[1[l~ :ILI SM Original FDA Establishment Registration Number [ Manufacturer [] Contract Sterilizer5] Add [] Delete 221 0968 5 Contract Manufacturer 1] Repackager / Relabeler

Company / Institution Name Establishment Registration Number

Ethicon, Inc. 2210968


GYNECARE ( 908 ) 218-2893Street Address FAX Number (including area code)

P.O. Box 151; Route 22 West ( 908 ) 218-2595City State / Province ZIP/Postal Code Country

Somerville NJ 08876 USA

Contact Name Contact Title Contact E-mail Address

--------- ---- ----------- Sr. Project Manager ----------------------------

7 Original [ DeleteFDA Establishment Registration Number 5 Manufacturer 5 Contract Sterilizer[] Add E[]elete Contract Manufacturer 5 Repackager / Relabeler

Company / Institution Name Establishment Registration Number


(Street Address FAX Number (including area code)

(City State / Province ZIP/Postal Code Country


FDA Establishment Registration Number Manufacturer Contract Sterilizer

[] Add n5Delete Contract Manufacturer 5 Repackager / RelabelerCompany / Institution Name Establishment Registration Number


(Street Address FAX Number (including area code)

City State / Province ZIP/Postal Code Country



000008


Note: Complete this section if your application or submission cites standards or includes a "Declaration of Conformity to a Recognized Standard"statement.

Standards No. Standards Standards Title Version DateOrganization


2


3


4


5


6


7

Please Include any additional standards to be cited on a separate page.

Public reporting burden for this collection of information is estimated to average 0.5 hour per response, including the time for reviewing instructions, searchingexisting data sources, gathering and maintaining the data needed, and completing reviewing the collection of information. Send comments regarding this burdenestimate or any other aspect of this collection of information, including suggestions for reducing Ihis burden to:

Food and Drug AdministrationCDRH (HFZ-342)9200 Corporate Blvd.Rockville, MD 20850

An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control


000009


Section 3: 510(k) Cover Letter



GynecaretA :vso;of ETH]CW , I~

P.O. Box 151US Route 22 WestSomerville, NJ 08876

August 30, 2005

Food and Drug Administration RE: 5 10(k) Notification:Center for Devices and Radiological Health (HFZ-401) GYNECARE TV?'Office of Device Evaluation SECUR* System9200 Corporate Blvd.Rockville, MD 20850

ATTENTION: Document Mail Clerk

To Whom It May Concern:

Modified Device GYNECARE, a Division of ETHICON, Inc. submits this Notification ofIntent to market a modification to the GYNECARE Tension-free VaginalTape (TVT) System as described within this Traditional 5 10(k) DeviceModification Premarket Notification (21 CFR 807.90(e)). The commonname for this device is: pubo-urethral sling. The currently marketedGYNECARE TVT System was cleared by the FDA under: K033568,K012628, and K974098. The modified device is referred to as theGYNECARE TVT SECUR* System.

This 510(k) submission has been formatted in accordance with thefollowing Guidance Document: "Format for Traditional and Abbreviated510(k)s" issued on August 12, 2005.

The modifications to the existing device are as follows:

- The GYNECARE TVT Universal System is less invasive 'exit less'device that will enable the physician to perform a suburethal slingprocedure placing the mesh under the mid urethra without either the

GYNECARE TVT SECUR SystemGYNECARE, a division of ETHICON, Inc. \L\_

0000o0


delivery device or the implant exiting the skin. The currently marketedTVT device exits through the abdomen or through the thigh. In addition,for TVT SECUR, the delivering device and mesh will have the flexibilityto be placed in either a "U" or "Hammock" direction. Both approaches aresimilar to existing validated techniques; however, the modified deviceoffers a less invasive approach. The "Hammock" approach affixes into theintemis muscle or into the internis muscle and membrane. The "U"approach affixes into the lower edge of the pubic synthesis in theconnective tissue of the endopelvic fascia. The placement will depend onsurgeon preference and individual requirements of the patient. Theplacement of the mesh (midurethra) remains unchanged.- The ends of the mesh will be sandwiched between layers of absorbablematerial made from polyglactin --- -- polydioxanone fleece material coatedwith polydioxanone film. The ------ d ends are added to facilitate passage(stiffens the ends) and placement (tactile feel for the surgeon) of the meshimplant, but are then absorbed leaving the ends ingrown into tissue. Twocurved, stainless steel, single use introducers are used to deliver theimplant. The introducers are supplied fixed to the implant via a wirethrough the coated ends and inserters.

The GYNECARE TVT SECUR System does not change the intended useor the application of the TVT tape.

Substantial A discussion of our substantial equivalence conclusion is enclosedEquivalence with this Notification. The conclusion is formatted in accordance with 21

CFR 807.81(a)(3) and the FDA guidance document entitled, "DecidingWhen to Submit a 510(k) for a Change to an Existing Device". Thisdiscussion format is convenient to use as a summary of substantialequivalence to anyone requesting it from the agency.

Design and Per the recommendation in the Guidance Document: "Format forUse of the Device Traditional and Abbreviated 510(k)s" the following table is being

provided:


000011


Question Yes NoIs the device intended for prescription use (21 CFR 801 Subpart XD)?Is the device intended for over-the-counter use (21 CFR 807 XSubpart C)?Does the device contain components derived from a tissue or other Xbiologic source?Is the device provided sterile? XIs the device intended for single use? XIs the device a reprocessed single use device? XDoes the device contain a drug? xDoes the device contain a biologic? xDoes the device use software? xDoes the submission include clinical information? XIs the device implanted? X

Summary of Safety Included in this 510(k) Device Modification Notification isEffectiveness a Summary of Safety and Effectiveness.

Confidentiality In accordance with the Premarket Notification Procedures regardingConfidentiality of Information (21 CFR 807.95), ETHICON, Inc. wishesto certify to the Food and Drug Administration that it has complied withall parts of that section, and considers the content of the submission and itsintention to market this device as confidential commercial information.

User Fee A copy of the Medical Device User Fee Cover Sheet is appended to thisletter. The user fee check has been sent to the FDA under separate cover.

Contact Please contact the undersigned at (908) 218-2893 or by fax at (908) 218-2595 for any questions regarding this notification.

Sincerely,

Paicia M. Hojnoski, M.S.Senior Project ManagerRegulatory AffairsGYNECARE, A Division of ETHICON, INC.Submitted in Duplicate*trademarkGYNECARE TVT SECUR System

GYNECARE, a division of ETHICON, Inc. /A

000012


Section 4: Indications for Use Statement

000013GYNECARE TVT SECUR SystemGYNECARE, a division of ETHICON, Inc.

\AY,)


INDICATIONS FOR USE


Device Name: GYNECARE TVT SECTJR* System

Indications for Use: The GYNECARE TVT SECUR* device is intended for use inwomen as a sub-urethral sling for the treatment of stress urinaryincontinence (SUL) resulting from urethral hypermobility and/orintrinsic sphincter deficiency.

Prescription Use _A AND/OR Over-The-Counter Use ___(Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)



GYNECARE TVT SECIJR SysteimGYNECARE. a division of ETHICON, Inc.


Section 5

510(k) SUMMARY

Statement Information supporting claims of substantial equivalence, asdefined under the Federal Food, Drug, and Cosmetic Act,respecting safety and effectiveness is summarized below. For theconvenience of the Reviewer, this summary is formatted inaccordance with the Agency's final rule ".... 510(k) Summariesand 5 10(k) Statements .... (21 CFR 807) and can be used toprovide a substantial equivalence summary to anyone requesting itfrom the Agency.

MODIFIED DEVTCE NAME:


PREDICATE DEVICE NAME:

GYNECARE TVT System and GYNECARE TVT ObturatorSystem

Device Description The GYNECARE TVT SECUR* device is a sterile, single patientuse device, consisting of one piece of undyed or blue(Phtalocyanine blue, Color index Number 74160) PROLENE*polypropylene mesh (tape) approximately 1.1 cm x 8.0cm(approximately 2 x 4 inches). The ends of the device will besandwiched between pieces of fleece made of polyglactin910/polydioxanone coated with polydioxanone film. The coatedends are added to facilitate passage (stiffens the ends) andplacement (tactile feel for the surgeon) of the mesh implant. Twocurved, stainless steel, single use introducers are used to deliver theimplant. The introducers are supplied fixed to the implant via awire through the coated ends and inserters. TVT SECUR isdesigned to accommodate two surgical techniques: the "Hammockapproach" and the "U approach". The GYNECARE TVTUniversal System is a less invasive 'exit less' device which willenable the physician to perform a suburethal sling procedureplacing the mesh under the mid urethra without either the deliverydevice or the implant exiting the skin.


000016


Intended Use A pubourethral sling for treatment of stress urinary incontinence(SUI), for female urinary incontinence resulting from urethralhypermobility and/or intrinsic sphincter deficiency.

Indications Statement GYNECARE TVT SECUR* is indicated for the treatment of stressurinary incontinence (SUI), for female urinary incontinenceresulting from urethral hypermobility and/or intrinsic sphincterdeficiency.

Technological The modified device has the same technological characteristics asCharacteristics the predicate device. The form, fit, function and method of

operation are similar.

Performance Data Results of verification testing indicates that the product meets theestablished performance requirements.

Conclusion Based upon the 510(k) summaries and 510(k) statements (21 CFR807) and the information provided herein, we conclude that thesubject device is substantially equivalent to the predicate devicesunder the Federal Food, Drug and Cosmetic Act.

Contact Patricia M. Hojnoski, M.S.Senior Project Manager, Regulatory AffairsETHICON, INC.Rt. 22 WestSomerville, NJ 08876-0151

Phone: (908) 218-2893Fax: (908) 218-2595

Date August 30, 2005


0OD017


Section 6: Truthful and Accuracy Statement


000018


Section 6

TRUTHFUL AND ACCURACY STATEMENT

(As Required by 21 CFR 807.87(k))

Pursuant to 21 CFR. 807.87(k), I, Patricia Hojnoski, certify that to the best of my knowledge andbelief and based upon the data and information submitted to me in the course of myresponsibilities as Senior Project Manager, Regulatory Affairs of ETHICON, Inc., a Johnson &Johnson company and in reliance thereupon, the data and information submitted in thispremarket notification are truthful and accurate and that no facts material to a review of thesubstantial equivalence of this device have been knowingly omitted from this submission.

Patricia M. Hojnoski, M.S.Senior Project ManagerGYNECARE, a division of ETHICON

Date


000019


Section 7: Class III Summary and Certification

GYNECARE TVT SECUR* device is not a Class III device; therefore a Class III certificationis not required.


00000


Section 8: Financial Certification or Disclosure Statement

This section is not applicable since clinical study information is not required as part of thissubmission.


000021


Section 9: Declarations of Conformity and Summary Reports

This section is not applicable since this 510(k) is a "Traditional" not an "Abbreviated" 510(k).


000022\Sts-


Section 10: Executive Summary


00002,3\stA


Section 10: Executive Summary

Description of Device:

The GYNECARE TVT SECUR* device is a sterile, ------- -------- ---- ---- ice, consisting of onepiece of undyed or blue ------------------

------ ------- ------- ---------- --------- PROLENE*polypropylene mesh (tape) approximately 1.1Icm x 8.0cm (approximately Y2 x 4 inches). The endsof the device will be sandwiched between pieces of fleece made of polyglactin--- -- polydioxanone coated with polydioxanone film. The coated ends are added to facilitatepassage (stiffens the ends) and placement (tactile feel for the surgeon) of the mesh implant. Twocurved, stainless steel, single use introducers are used to deliver the implant. The introducers aresupplied fixed to the implant via a wire through the coated ends and inserters. TVT SECUR isdesigned to accommodate two surgical techniques: the "Hammock approach" and the "Uapproach". The GYNECARE TVT Universal System is a less invasive 'exit less' device whichwill enable the physician to perform a suburethal sling procedure placing the mesh under the midurethra without either the delivery device or the implant exiting the skin.

Indications for Use:

The GYNECARE TVT SECUR* device is intended for use in women as a sub-urethral sling forthe treatment of stress urinary incontinence (SUI) resulting from urethral hypermobility and/orintrinsic sphincter deficiency.

Device Comparison Table:

Refer to Section 12.

Summary of Performance Testing:

Refer to Section 19.


000024


Section 11: Device Description


00002


SECTION 11

MODIFIED DEVICE AND DESCRIPTION

Name ofthe Device

CLASSIFICATION COMMON TRADE NAME!NAME NAME PROPRIETARY

NAMEMesh, Surgical, Pubo-urethral GYNECARE TVTPolyeric (2l CFR, Sling SECUR* System878.3300)

________

Establishment GYNECARE is a Division of ETHICON, Inc., a Johnson andRegistration Johnson Company. The establishment registration number forNumber GYNECARE, a Division of ETHICON, Inc. is #2210968.

Device Classification Surgical mesh is classified by the FDA as a Class II MedicalDevice, General and Plastic Surgery Devices (21CFR, 878.3300,Product Code 79FTL).

Predicate Device(s) GYNECARE TVT SECUR* device is a modification of thecurrently marketed GYNECARE TVT device covered under510(k) K033568, K012628, and K974098.

Change or Modificationto an Existing Device The changes to the device are:

- The ends of the mesh device will be sandwiched between twolayers of polyglactin --- -- polydioxanone fleece material coatedwith polydioxanone film. The coated ends are added to facilitatepassage (stiffens the ends) and placement (tactile feel for thesurgeon) of the mesh implant. Two curved, stainless steel, singleuse introducers are used to deliver the implant. The introducers aresupplied fixed to the implant via a wire through the coated endsand inserters.

GYNECARE TVT SECUR SystemGYNECARE, a division of ETHICON, Inc. 0 0 2


o The GYNECARE TVT Universal System is less invasive 'exitless' device that will enable the physician to perform asuburethal sling procedure placing the mesh under the midurethra without either the delivery device or the implant exitingthe skin. The currently marketed TVT device exits through theabdomen or through the thigh. In addition, for TVT SECUR,the delivering device and mesh will have the flexibility to beplaced in either a 'U' or 'Hammock' direction. Bothapproaches are similar to existing validated techniques;however, the modified device offers a less invasive approach.The "Hammock" approach affixes into the intemnis muscle orinto the internis muscle and membrane. The "U" approachaffixes into the lower edge of the pubic synthesis in theconnective tissue of the endopelvic fascia. The placement willdepend on surgeon preference and individual requirements ofthe patient. The placement of the mesh (miduretbra) remainsunchanged.

The GYNECARE TVT SECUR System does not change theintended use or the application of the TVT tape.

Physical Description GYNECARE TVT SECUR* System includes the device and itsaccessories. The device and accessories are sold as a set. Thesystem consists of the following:

Device:GYNECARE TVT SECUR* System (Sterile, Single-Use)

CosstffiImplantUn-Protected InserterProtected Inserter2 Finger PadsProtective Cover2 Release Wires

Refer to the photograph in this section for further detail.

GYNECARE TVT SECUR SystemGYNECARE, a division of ETHICON, hic. 0 0 2


GYNECARIF TVT SF.CIJR* Syvtem-

The Device (item A) is a sterile, single patient use Device,consisting --- --- e piece of blue ------------------

------ ------- ------

---------- --------- PROLENE* polypropylene mesh (tape)approximately 1. 1 cm x 8. 0cm (approx 1/2 -- -- inches) with piecesof fleece made from VICRYL*---------------

------ and PDS* ------- ---------------- undyed yarn whic-- sandwich the end sections of themesh. The sandwich is bonded ------- er in a thermal process usingtwo pieces of dyed ---------------------- film, this film is dyed violetwith D&C Violet No. 2 ------- ------- ----- ---------- This fleece is thesame material that is contained in the Codman ETHISORBDurapatch product K991413. Polyglactin ----- is also used tomanufacture VICRYL Suture (N17-482 and K946271).Polydioxanone dyed with D&C violet No. 2 is used to manufacturedyed PDS II suture (N418-331).

PROLENE polypropylene mesh is constructed of knitted filamentsof extruded polypropylene strands identical in composition to thatused in PROLENE polypropylene nonabsorbable surgical suture.This material, when used as a suture, has been reported to be non-reactive and to retain its strength indefinitely in clinical use.PROLENE mesh is knitted by a process that interlinks each fiberjunction and which provides for elasticity in both directions. Thisbi-directional elastic property allows adaptation to various stressesencountered in the body.The fleece sandwich is a synthetic absorbable composite materialmade from VICRYL and PDS yarn. The yarn is knitted, processedinto a fleece layer, the layers are then sandwiched to the mesh byusing two pieces of dyed ---------------------- film using a thermalprocess. The resultant fle---- ---------- is of sufficient pore size toallow continuing growth of cells and intrinsic body tissue. Thesandwiched fleece ends are mainly undyed, soft, expandable, andpliable. Absorption of sandwiched fleece ends is essentiallycomplete within approximately 90 days, the fleece layers arereplaced as connective tissue grows into the mesh. Portions of thePDS yarn/film can be detected up to 180 days post-implantation.

GYNECARE TVT SECUR SystemGYNECARE, a division of ETHICON, Inc. 0 0 2


Two curved stainless steel Inserters are provided to deliver theimplant that is secured to the Inserter by release wire. The releasewires are secured to the inserter by the finger pads. The protectivecover is used to cover the 2 nd inserter tip and is removed beforeinsertion. A standard needle holder attached to the Inserter deliversthe implant. The Inserter allows for common surgical instrumentsto aid in the smooth and consistent placement of the implant.

Packaging The GYNECARE TVT SECUR System will be packaged in aninjection molded polypropylene tray. This tray is then sealed in analuminum foil packet. The foil packet is the sterile barrier. Thetray is then placed in an outer carton, either in a 1-up or a 4-upconfiguration.


000029


PATIENT-CONTACTING MATERIAL IDENTIFICATION

Patient Contacting The patient contacting materials used for the ModifiedMaterials GYNECARE TVT SECUR* device and accessories are identified

in the table below:

PART MATERIALI PATIENTCONTACT

Devic(1) TVT SECUR* device:

(a) Mesh PROLENE* Implant-------------------- Mesh----------- ----- ----- ------------

---------

Ends of mesh Sandwiched by a fleece of Implantundyed polyglactin ----- andpolydioxanone filaments,and a film of polydioxanonedyed with D&C violet No. 2.(same material as inCodman ETHISORBDurapatch (K991413).Polyglactin ---- is also usedto manufacture VICRYLSuture (N 17-482 andK946271). Polydioxanonedyed with D&C violet No. 2is used to manufacture dyedPDS II suture (N18-331)

Finger pads ----------------- violet Nonepolypropylene anticipated

Protective cap ----------------- violet Nonepolypropylene anticipated

(b) Surgical steel Inserters ----- Stainless Steel (SS) Transient

with release wires


000030


All patient contacting materials with the exception of the mesh (1)(a) are considered to beexternally communicating, coming into contact with tissues for less than 24 hours. The mesh isclassified as an implant.

Refer to Section 15 for the Biocompatibility Assessment.

GYNECARE TVT SECUR SystemGYNECARE, a division of ETHICON, Inc. 000031


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Section 12: Substantial Equivalence Discussion


000 33


SECTION 12

SUBSTANTIAL EQUIVALENCE

Substantial The modified GYNECARE TVT SECUR* deviceEquivalence has the following similarities to the predicate device (GYNECARE

TVT device) which previously received 510(k) clearance.

Has the same indications for use

* Uses the same operating principle

Incorporates the same basic design

Patient contacting materials (are the same except for theends of the m---- -- hich are sandwiched between two layersof polyglactin ----- polydioxanone fleece material coatedwith polydioxanone film).

Sterilization method is unchanged

In summary, the GYNECARE TVT SECUR* System described inthis submission is substantially equivalent to the predicate device.See the table on the following page for further comparisons:



FEATURE Predicate Predicate ModifiedGYNECARE TVT GYNECARE GYNECARETVT

Device (K974098 and TVT Obturator SECUR* deviceK012628) Device(K033568)

A sub-urethral sling fortreatment of stressIntendedUse of urinary incontinence(SUI), for female urinary Same Sameincontinence resultingfrom urethralhypermobility and/orintrinsic sphincterdeficiency.Knitted filaments of Same Same, but the ends of thepolypropylene device (mesh) will be(unpigmented and sandwiched between two

Implant pigmented blue) ------ s of polyglactin

Device PROLENE* ----- polydioxanone fleecematerial coated withpolydioxanone film -dyedviolet with D&C VioletNo. 2 (same material as inCodman ETHISORBDurapatch K991413).Polyglactin 910 is alsoused to manufactureVICRYL Suture (N17-482 and K946271).Polydioxanone dyed withD&C violet No. 2 is usedto manufacture dyed PDSII suture (N18-331)

Stainless steel needles Plastic tubes Stainless steel needlesattached to each end of with receptacle attached to each end ofmesh ends attached to mesh

each end ofmesh

Tape Tension-free placement Same SamePlacement of tape under Midurethra


000035


Implant Nonabsorbable Same SamePROLENE mesh

Sterilization EtO Sterilization Same SameRe-Use Single Use Device Same Same

Thermoformed tray with Same Injection moldedPackage Tyvek lid. This is then polypropylene tray. This

placed in an outer carton. tray is then sealed in analuminum foil packet.This is then placed in anouter carton.

Accessories packaged Accessories Accessories packagedseparately packaged with with the device

the device

TVT Introducer Helical Passers, Stainless steel insertersAccessories TVT Rigid Catheter Winged Guide that are supplied attached,TVT Rigid Catheter te eoe nGuide ~~~~~~~~then removed andGuide discarded after placement

TVT Abdominal Guides of the implant.and Couplers

Length of -500mm** -450mm** -80mm

TapeSurgical "U" (transvaginal) "Hammock" "Hammock" (obturator)

Technique approach (obturator) approach and "U"and "abdominal" approach (transvaginal) approachapproach

** a portion is cut off and discarded after passage.

The GYNECARE TVT SECUR System does not change the intended use or the application ofthe TVT tape. The GYNECARE TVT Universal System is a less invasive 'exit less' device thatwill enable the physician to perform a suburethal sling procedure placing the mesh under the midurethra without either the delivery device or the implant exiting the skin. The currently marketedTVT devices exit through the abdomen or through the thigh. In addition, the delivering deviceand mesh will have the flexibility to be placed in either a 'U' or 'Hammock' direction. Theplacement will depend on surgeon preference and individual requirements of the patient. Theplacement of the mesh (midurethra) remains unchanged.


000036


Section 13: Proposed Labeling


000037


SECTION 13

PROPOSED DRAFT LABELING


Introduction The device labeling for the GYNECARE TVT SECUR* device iscomprised of the primary package label, box labels, patienttracking labels, and package insert

Primary Label The primary label is printed on Tyvek which is used as the sterilebarrier for the device primary package.

Box Labels Individual labeled boxes for 1-up and 4- up configurations

Patient Tracking Labels Provided with product for patient record purposes

Package Insert The text for the package insert has been updated to reflect themodified device.

GYNECARE TVT SECUR SystemGYNECARE, a division of ETHICON, Inc. 000038

005FOI - Page 57 of 223

Gynecare 0$ TTTVT SECUW system

Tensue-fr.. S.uppor for lncont...nc DisposituemeselleCon.tet: 1eIce 2 lsres perIncontieeSterileI. Do o uei if packagei Conetenuo 1 disposition 2 ~.inn wtrdamaged or"opend.. Podotto ster Ie. Noi .usaresSpen..oingeij eteebeadje I co.e.on state apertstegen i .... tineove 5 aniita.lnhoed: I -tuna deed S.Apat eIn teso per. tretaento2 a"dinbrevgnotureniA wede n tiolacieSnorkel. Niot gebrik~ennano de Coenteddo I ddsposimvo 2 nfrddtorvepakking geopord yf besnhadigd i.Enteniiaddo. NA.n odln so aSoceje A.n tension pear sAne. enibalagem etvrdet~rs dvd'in...ntinec.....n.ini. Os Aborts.Cotton :1I diopositt, 2 jotredunteurs SisentadeA sapn i In .in tenitnSeeril. No dasel tlivr si Ietl geb.. p..nee ornoheeiea~h.iot edndo~e9ins .,, stvM.Gotn dv: I d,.ispsiin,spenn....sfreie U.ndeorsijoen 2 insetsdor~ebMc MInkMnIoe Estdni. N. olior si el vovaseseIrihet 1I pinplatat rnnsabiento n detlado.2 Enl~fhninsnom..rteSteit. Nicht vswvewnndi. Pacluso geatnet oden FLO0TIbescdhadigtwnde.

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Primary Label

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Patient TrackingLabels

000042


Predicate Labeling

GYNECARE TVT Obturator System

GYNECARE TVT SECUR System 0OO0s9GYNECARE, a division of ETHICON, Inc.


GYNECARE TVT*Obturator System

Tension-free Support for Incontinence

GYNECARE TVT* obturatorsysteemSpanningsvrij steunbandje tegen incontinentieGYNECARE TVT* obturatorsystemSpaendingsfri ststte til inkontinens

GYNECARE TVT* -obturaattorijirjeste1mdJiinnityksetdn tuki inkontinenssin hoitoon

Systeme obturateur GYNECARE TVT*Dispositif sans tension contre les incontinences

GYNECARE TVT* Obturator SystemSpannungsfreie Unterstiitzung bei Inkontinenz

Sistema otturatorio GYNECARE TVT*Dispositivo tension-free per l'incontinenza

Sistema obturador GYNECARE TVT*Apoio sem tensio para incontin~ncia

Sistema obturador GYNECARE TVT*Protector sin tensi6n para la incontinencia

GYNECARE TVT* obturatoriabandsystemTensionsfritt st6d fir behandling av inkontinens

Ii(aga eitutcogaztwon GYNECARE TVT*ZW6"qILU UTOU'l4pL4fl r7 'v civfply imo TrgaKP&-tEta;, Vlopi; tdKMi

Legal ManufacturerETHICON, SariRue du Puits-Godet 20CH*2000 NeuchdtelSwitzerland

Manufactured for.

GYNECARE 'WORLDWIDE

Somer,le,. NewdeseoSS7-olS 000060Made in SwitzerlandETHICON, INC. 2003 'Trademark RMC P18070/C


GYNECARE TVT* Obturator SystemTension-free Support for Incontinence

GYNECARE TVT Obturator Device,Sterile Single Use

GYNECARE TVT Obturator Helical Passers,Sterile Single Use

GYNECARE TVT Obturator Atraumatic Winged Guide,Sterile Single Use

Please read all information carefully.Failure to properly follow instructions may result in improper functioning of the device and maylead to injury.Important:This package insert is designed to provide instructions for use of the GYNECARE TVT* ObturatorSystem, including the GYNECARE TVT Obturator device, Helical Passers and Atraumatic WingedGuide, It is not a comprehensive reference to surgical technique for correcting SUI (Stress UrinaryIncontinence), The device should be used only by physicians trained in the surgical treatment ofstress uninary incontinence and specifically in implanting the GYNECARE TVT Obturator device.These instructions are intended for general use of the device. Variations in use may occur inspecific procedures due to individual technique and patient anatomy.DESCRIPTIONThe GYNECARE TVT Obturator System is a sterile, single patient use procedure kit consisting of:GYNECARE TVT Obturator deviceThe GYNECARE TVT Obturator device is a sterile, single patient use device, consisting of one pieceof undyed or blue (Phtajocyanine blue, Color index Number 74160) PROLENE* polypropylenemesh (tape) approximately 1/2 x 18 inches (1.1 x 45 cm) covered by a plastic sheath overlappingin the middle. Plastic tube receptacles are attached at each end. PROLENE polypropylene meshis constructed of knitted filaments of extruded polypropylene strands identical in composition tothat used in PROLENE polypropylene non-absorbable surgical suture. This material, when usedas a suture, has been reported to be non-reactive and to retain its strength indefinitely in clinicaluse. PROLENE mesh is knitted by a process that interlinks each fiber junction and that providingelasticity in both directions. This bi-directional elastic property allows adaptation to variousstresses encountered in the body.GYNECARE TVT Helical PassersThe GYNECARE TVT Helical Passers are two stainless steel, curved wire passers with plastichandles that are designed to deliver the GYNECARE TVT Obturator device. Helical Passers areprovided as left and right units, pre-assembled to the GYNECARE TVT Obturator device. TheHelical Passer MUST not be bent or deformed in any way.GYNECARE TYT Atraumatic Winged GuideThe GYNECARE TVT Atraumatic Winged Guide is a stainless steel accessory instrument, whichfacilitates the passage of the GYNECARE TVT Helical Passers through the dissection tract.INDICATIONSThe GYNECARE TVT Obturator device is intended to be used in women as a sub-urethral sling forthe treatment of stress urinary incontinence (SUI) resulting from urethral hypermobility and/orintrinsic sphincter deficiency.INSTRUCTIONS FOR USE(Note: hand positions shown in illustrations may vary)1. Place the patient in the dorsal lithotoiy position with the hips hyperflexed over the

abdomen. The buttocks should be positioned flush with the edge of the table.2. The procedure can be carried out under local, regional or general anesthesia.3. If desired, retract the labia to provide additional exposure.4 Insert a urethral catheter into the bladder and empty the bladder,5. Mark the exit points of the plastic tubes by tracing a horizontal line at the level of the

urethral meatus, and a second line parallel and 2 cm above the first line. Locate the exitpoints on this line, 2 cm lateral to the folds of the thigh (the skin may be flattened bystretching), Mark the exit points, alternatively a 5-10 mm incision may be made at each exit 000061point or at a later stage of the procedure, (See Figure I)


FIG. 1

6. Using Allis clamps for traction, make a 1 cm mjdclne incision in the vaginal mucosa starting1 cm proximal to the urethral meatus.(Note: it is suggested that the device insertion be completed on one side beforebeginning dissecdon of the second side.)After initiating sharp dissection, continue by using a "push-spread technique", to performblunt dissection preferably using pointed, curved scissors. The path of the lateral dissectionshould be oriented at a 45 angle from the midline, with the scissors oriented on thehorizontal plane (See Figure 2). Continue dissection towards the junction between the bodyof the pubic bones and the inferior pubic ramus. (See Agure 2)

Palpable 'Junction'

FIG. 2When the junction between the body of the pubic bones and the inferior pubic ramus isreached, perforate the obturator membrane. A loss of resistance can be felt when themembrane is perforated. The channel should be approximately 5-7 mm in diameter and nodeeper than 5 cm. Dissection beyond 5 cm may allow unintended entry into the Space ofRetzius. If the bone is not reached after dissecting 5 cm, re-evaluate that the angle ofdissection is correct.

7. Remove the internal package workstation from the external package. Then remove theGYNECARE TVT Winged Guide from the package workstation, (See Agure 3)

Helical Pcssers/Device Assmbly

FIG. 38. Insert the GYNECARE TVT Winged Guide into the dissected tract until it passes the inferior

pubic ramus and enters the opening previously made in the obturator membrane. Loss ofresistance can be felt as the Winged Guide passes through the obturator membrane.If difficulty is encountered during insertion of the guide, reconfirm the direction of the tractwith the scissors.(Note: The open side of the guide must be facing the surgeon. The bendable tab canbe bent to increase the length of the guide if needed, See Fgur 5.) 000062.

2\~tN


9. Remove the GYNECARE TV` Helical Passers/Device Assembly and the GYNECARE TVTObturator device assembly from the sterile pack (See Fgure 3 for components).(Note: To ensure correct orientation of the Helical Passers and tape, verify that theG YNECARE logo and thumb indent on the plastic handle are facing the surgeon, andthat the points are on the outside facing the surgeon. The Helical Passer in thesurgeon's left hand must be used on the patient's right side; See Fiture 4.)

FIG. 4

10. Place one of the Helical Passers on the sterile drape or other suitable sterile location untilneeded. Assure that the tape is not twisted.

11. Insert the correct GYNECARE TVT Helical Passer into the dissected tract following the channelof the GYNECARE TVT Winged Guide. Push the device inward, traversing, and slightly passingthe obturator membrane. Make sure the device handle is oriented so the straight tip of theHelical Passer is aligned with the channel in the GYNECARE TVT Winged Guide and remainsin that orientation until the tip traverses the obturator membrane. (See Fgure 5)

Winged Guide

FIG. 5

12. Once in this position, remove the GYNECARE TVT Winged Guide and keep sterile for later useon the same patient.

FIG. 613. Once the GYNECARE TVT Winged Guide has been removed, rotate the handle of the Helical

Passer as you simultaneously move towards the midline until the handle is vertical to thefloor (See Figure 6) (Note: Never allow the handle to be oriented horizontal to the floor.)

000063a


FIG. 714. The point of the Helical Passer should exit neawthe previously determined exit points (See

Figure 7). However, slight skin manipulation may be required. If the skin incision has notbeen previously made, make it at the point where the tip of the helical passer tents the skin.When the tip of the plastic tube appears at the skin opening, grasp the pointed tip of theplastic tube with a clamp and, while stabilizing the tube near the urethra with the thumb,remove the Helical Passer by a reverse rotation of the handle. (See Figure 8)

\/

FIG. 8

15. Pull the plastic tube completely through the skin until the tape appears. (See Figure 9)

/

FIG. 9

16. Repeat the technique on the patient's other side ensuring that the tape lies flat under theurethra. (See Figure 10)(Note: ff a twist in the tape is discovered, ensure that the twist is not positioned underthe urethra after thM excess tape is pulled through.)

0000G4

4


Exit point.

FIG. 1017. When both plastic tubes have been extracted through the skin incisions, cut the plastic tubes

from the tape and plastic sheaths. Position the tape loosely e.g. without tension, and flatunder the midurethra. At this stage a cough test can be performed. This allows adjustment ofthe tape so that only a few drops of urine are lost during the cough. (See Figure 11)

FIG. 11When the tape is in position, remove the plastic sheath that covers the tapes.Place a blunt instrument (e.g., scissors or forceps) between the urethra and the tape duringremoval of the plastic sheaths, or use other suitable means during sheath removal, to avoidpositioning the tape with tension.(Note: Premature removal of the sheath may make subsequent adjustments diffiicult)

18. Following tape adjustment close the vaginal incision. Cut the tape ends at the exit points justbelow the skin of the inner thigh. Close the skin incisions with suture or surgical skin adhesive.

19. Cystoscopy can be performed at the discretion of the surgeon. It cystoscopy was performedfollowing the first passage, make sure the bladder is emptied prior to initiating passage ofthe second side. Post-operative indwelling catheterization is not typically required. Thepatient should be encouraged to try to empty the bladder 2-3 hours after the operation.

CONTRAINDICATIONSAs with any suspension surgery, this procedure should not be performed in pregnant patients.Additionally, because the PROLENE polypropylene mesh will not stretch significantly, it should notbe performed in patients with future growth potential including women with plans forfuture pregnancy.WARNINGS AND PRECAUTIONS* Do not use GYNECARE TVT Obturator procedure for patients who are on anti-coagulaton

therapy.* Do not use GYNECARE TVT Obturator procedure for patients who have a urinary tract

infection.* Users should be familiar with surgical technique for urethral suspensions and should be

adequately trained in the GYNECARE TVT Obturator procedure before employing theGYNECARE TVT Obturator device.

* Acceptable surgical practice should be followed for the GYNECARE TVT Obturator procedureas well as for the management of contaminated or infected wounds.

* The GYNECARE TVT Obturator procedure should be performed with care to avoid largevessels, nerves, bladder and bowel, Attention to patient anatomy and correct passage of thedevice will minimize risks.

* Bleeding may occur post-operatively. Observe for any symptoms or signs before releasingthe patient from hospital.

* Although bladder injury is unlikely to occur with this technique, cystoscopy may beperformed at the discretion of the surgeon.Do not remove the plastic sheaths until the tape has been properly positioned.Ensure that the tape is placed with no tension under the mid-urethra.Do not perform this procedure if you think the surgical site may be infected or contaminated.

000065


* Since no clinical information is available about pregnancy following sub-urethral slingprocedure with the GYNECARE TVT Obturator System, the patient should be counseled thatfuture pregnancies may negate the effects of the surgical procedure and the patient mayagain become incontinent.

* Since no clinical information is available about vaginal delivery following a sub-urethralsling procedure with the GYNECARE TVT Obturator System, in case of pregnancy deliveryvia cesarean section should be considered.

* Post-operatively, the patient should be advised to refrain from heavy lifting and/or exercise(e.g., cycling, jogging) for at least three to four weeks and intercourse for one month. Thepatient can usually return to other normal activity after one or two weeks.

* The patient should be instructed to contact the surgeon immediately if dysuria, bleeding orother problems occur.

* Transient leg pain lasting 24-48 hours may occur and can usually be managed with mildanalgesics.

* As with other incontinence procedures, de novo detrusor instability may occur following asub-urethral sling procedure utilizing the GYNECARE TVT Obturator System. To minimize thisrisk, make sure to place the tape as described above.

* Do not contact the PROLENE mesh with any staples, clips or clamps as mechanical damageto the mesh may occur.

* Do not resterilize GYNECARE TVT Obturator device or its components. Discard opened,unused devices.Prophylactic antibiotics can be administered according to the surgeon's usual practice.

ADVERSE REACTIONS* Punctures or lacerations of vessels, nerves, bladder, urethra or bowel may occur during

needle passage and may require surgical repair.* Transitory local irritation at the wound site and a transitory foreign body response may

occur. This response could result in extrusion, erosion, fistula formation or inflammation.* As with all foreign bodies, PROLENE mesh may potentiate an existing infection, The plastic

sheaths initially covering the PROLENE mesh are designed to minimize the riskof contamination.

* Over correction, i.e. too much tension applied to the tape, may cause temporary orpermanent lower urinary tract obstruction.

ACTIONSAnimal studies show that implantation of PROLENE mesh elicits a minimal inflammatory reactionin tissues, which is transient and is followed by the deposition of a thin fibrous layer of tissue,that can grow through the interstices of the mesh, thus incorporating the mesh into adjacenttissue. The material is not absorbed, nor is it subject to degradation or weakening by the actionof tissue enzymes.

HOW SUPPLIEDThe GYNECARE TVT Obturator System is provided sterile (ethylene oxide) for single use. Do notresterilize. Do not use if package is opened or damaged. Discard opened, unused devices.

STORAGERecommended storage conditions for the GYNECARE TVT Obturator System single use device arebelow 250. away from moisture and direct heat. Do not use after expiry date.CAUTION: Federal (USA) law restrict this device to sale by or on the order of a physician.

'Trademark

SYMBOLS USED ON LABELING

C E 00886STERIE Method of SterilizationCE mark and identification numberof Notified Body, Product conformsto the essential requirements of the Medical DeviceDbnectie 93/4fi/EECDirective 53142/EEC K5) ~~~~~~~Do not reuse/resterilize

LOOT] Batch numberX Use by- year and month See instructions for use 00001616

6


Section 14: Sterilization and Shelf Life



Section 14

Sterilization and Shelf Life

Sterilization The GYNECARE TVT SECUR* System will be sterilized byethylene oxide sterilization. The program used to validate thesterilization process complies with the requirements of ANSI /AAMI / ISO 11135:1995 Medical Devices - Validation androutine control of ethylene oxide sterilization.

The process will be validated to ensure that a sterility assurancelevel of 10-6 or better is achieved.

The levels of ethylene oxide sterilization residuals that remain onthe GYNECARE TVT SECUR System will comply with therequirements of ANSI / AAMI / ISO 10993-7: 1995 BiologicalEvaluation of Medical Devices - Part 7: Ethylene OxideSterilization Residuals.

There is no change to the sterilization method used to sterilize theGYNECARE TVT SECUR System as compared to the predicateTVT System.

Shelf Life A study is on-going to support a shelf-life of 6 months for productlaunch.

GYNECARE TVT SECUR System 000068GYNECARE, a division of ETHICON, Inc.


Section 15: Biocompatibility


2190


Section 16: Software

There are no software components in the modified device, therefore this section is not applicable.


MlFOI - Page 92 of 223

Section 17: Electromagnetic Compatibility and Electrical Safety

This device does not contain electrical components, therefore this section is not applicable.

000074GYNECARE TVT SECUR SystemGYNECARE, a division of ETHICON, Tnc.

2sP-5FOI - Page 93 of 223

Section 18: Performance Testing: Bench

Bench testing is not provided as part of this 5 10O(k) submission.

GYNECARE TVT SECZJR System ((j~GYNECARE, a division of ETHICON, Inc.

).& sQFOI - Page 94 of 223

Section 19: Performance Testing - Animal and Human Cadaver

Overall Summary of Sheep and Human Cadaver Labs for Development of the GYNECARE TVTSECUR* System

- Summary of: A 3 Month Pre-Clinical Trial to Assess the Fixation Force of a New TVT(TVTx) in the Sheep Model ----------- ------- ----- -------------- - Summary of: Evaluation of Fixation Force for the GYNECARE TVT SECUR ----- icein a Sheep Cadaver Pelvic Floor Model ------ -------------

---------- ----------- --------

---------- --------

- Summary of: Evaluation of the Pullout Force of GYNECARE TVT SECUR Implantedinto the Urogenital Diaphragm and Obturator Membrane of a Human Cadaver ------ -------------

---------- ----------- --------- ---------- --------

OOO(1icGYNECARE TVT SECUR SystemGYNECARE, a division of ETHICON, Inc.


Section 20: Performance Testing - Clinical

This section is not applicable, since clinical data was not required to support this submission.

GYNECARE TVT SECUR System ( 0GYNECARE, a division of ETHICON, Inc.


Section 21: Kit Certification

The GYNECARE TVT SECUR System will not be available as components of other customprocedural kits.


LI-I-FOI - Page 105 of 223

FOI Request for Surgical Polymeric Surgical Mesh

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Transcript of FOI Request for Surgical Polymeric Surgical Mesh