HertRT'..K123641 510(k) Summarypassed the USP class VI test for cytotoxicity, as well as 1-cell...

HertRT...'..K123641

510(k) Summary pg 1 of 8

COMPANY

Name: HertART ApSAddress: Korskildelund 6

Denmark Greve JUL 0 3 2013

Registration No.: 3008524469

Contact Person: Mr. Henrik DOrgeKorskildelund 6DK 2670 GreveDenmark

Office: +45 3651 9170Mobile: +45 2214 3822E-mail: [email protected]

Date of Summary: July 02, 2013

DEVICE NAME

Trade names: Vitrolife Culture Dish 40 mmVitrolife Culture Dish 60 mmVitrolife Micro-droplet Culture DishVitrolife 5-well Culture DishVitrolife Centre Well DishVitrolife ICSI Dish

Common name: IVF DishesClassification name: Assisted Reproduction LabwareClassification regulation: 21 CFR884.6160Product code: MQKClassification panel: Obstetrics/Gyn ecologyDevice class: ii

PREDICATE DEVICES

Falcon IVF Round Dish (K(991253) for Vitrolife Culture Dish 60 mm & Vitrolife Culture Dish 40 mm

Nunc IVE Multidish 4 Wells Nunclon (K040717) for Vitrolife 5 Well Culture Dish

Nunc IVF ICSI Dish (K0429) for Vitrolife ICSI Dish

Falcon IVF One Well Dish (K(991251) for Vitrolife Centre Well Dish

Genx Culture Dish (now marketed as Sun IVF Embryo Corral Dish) (K(993881) for Vitrolife MicroDroplet Culture Dish

HertART ApS of 8IVF Dishes

Ki123641HertAR 7,...,.. pg 2 of 8

510(k) Summary

DESCRIPTION OF DEVICE

The HertART disposable dishes are injection molded. The dishes are supplied with a lid.The polymers used for the dishes are virgin crystal grade polystyrene, which has successfullypassed the USP class VI test for cytotoxicity, as well as 1-cell embryotoxicity test. The HertARTdishes are packed in sleeves of x units in a box for a total of y units, as defined below:

Trade Name Configuration PackagingVitrolife Culture Dish 60 mm Round dish with lid: o63 x 15,15 mm 10 units per sleeve

One round well 60 mm in diameter 540 units per case______________________Well Volume: 24,00 mL

Vitrolife Culture Dish 40 mm Square dish with lid; 5 units per sleeve65,96 mm x 65,96 mm x 13,20 mm 400 units per caseOne round well: 40 mm in diameter, Well

______________________volume of 12,56 mLVitrolife S-well Culture Dish Square dish with lid: 5 units per sleeve

65,96 mm x 65,96 mm x. 13,20 mm 400 units per case_______________________5 round wells, Well Volume: 1,7 mL

Vitrolife Centre Well Dish Square dish with lid: 5 units per sleeve65,96 mm x 65,96 mm x 13,20 mm 400 units per case1 well, round bottom, oval opening.

Vitrolife ICSI Dish Square dish with lid: 5 units per sleeve65,96 mm x 65,96 mm x 11,70 mm 400 units per case1 square well with rounded corners

Vitrolife Micro-droplet Culture Square dish with lid: 5 units per sleeveDish 65,96 mm x 65,96 mm x 13,20 mm 400 units per case

12 round wells holds drops up to $0 pL________________________ Well Volume: 12.5 pL _ ________

The dishes are terminally sterilized by gamma irradiation to achieve a SAL of 10-6. The dishes arenon-pyrogenic as tested by LAL, and non-embryotoxic as tested by 1-cell Mouse Embryo Assay(MEA). The dishes are disposable and intended for single use.

INDICATIONS FOR USE

The Vitrolife Culture Dish 60 mm, Vitrolife Culture Dish 40 mm and Vitrolife Centre Well Dish areintended for fl/F, suitable for use in preparing, storing, manipulating, or transferring humangametes or embryos for in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), or otherreproduction procedures.

The Vitrolife 5 Well Culture Dish is intended for IVF, suitable for preparing, storing, manipulatingor transferring human gametes or embryos for in vitro fertilization (IVF), or other in vitrofertilization techniques.

The Vitrolife ICSI Dish is intended for IVF, suitable for holding oocytes and sperm duringfertilization via intracytoplasmic sperm injection (ICSI).

The Vitrolife Micro Droplet Culture Dish is intended for IVE. It may be used with sperm and for theculturing of embryos using drop culture.

H-ertART ApS of 8IVF Dishes

K123641HertRT..-"'.pg 3 of 8

510(k) Summary

PREDICATE DEVICE COMPARISON

Parameter Subject Device - Vitrolife Predicate Device - Falcon DifferencesCuiture.Dish 60 mm IVF Round Dish (K991253) __________

Device Round petri dish with diameter Round petri dish with diameter none60 mm 60 mm

Indication for Intended for IVF, suitable for Intended for use in preparing, noneUse use in preparing, storing, storing, manipulating, or

manipulating, or transferring transferring human gametes orhuman gametes or embryos for embryos for in vitro fertilizationin vitro fertilization (IVF), (IVF), gamete intrafallopiangamete intrafallopian transfer transfer (GIFT), or other(GIFT), or other reproduction reproduction proceduresprocedures

Material Virgin Polystyrene, tested for Virgin Polystyrene, tested for none____________USP Class VI cytotoxicity USP Class VI cytotoxicity ___________

Dimensions Diameter 60 mm Diameter 60 mm noneDesign Round dishes with vented lid. Round dishes with vented lid. Predicate device isfeatures Flat bottom, optically clear Flat bottom, optically clear surface treated for

surfaces. surfaces. Surfaces are treated increased wettabilitySurfaces are non-treated for improved wettability ___________

Well shape Well area of 24,07 cm' Well area of 24,07 cm' noneWell volume 23,00 mL 23,00 mL noneDiscussion Predicate device uses surface treatment, which is traditionally used for cell culture labware

for better cell adhesion. As gametes and embryos do not adhere to surfaces, and since mostculture within IVE nowadays is done in drops of media, improved wettability is not a desiredproduct feature for modern IVF procedures. The proposed device uses a more sensitive 1-cell ['EA assay compared to the predicate device using a 2-cell MEA in order to improve!ensure consistency of product performanceThe differences do not impact the use of the identified predicate device to support theproposed device, as they do not raise any new types of safety or effectiveness questions.

____________Therefore, the subject is substantially equivalent to the predicate device.

Parameter -Subject Device - Vitrolife Predicate Device - Falcon Differences__________ Culture Dish 40 mm IVF Round Dish (K991253)

Device Square dish with round inner Round petri dish with diameter Proposed device hasdiameter of 40 mm 60 mm square outer geometry

and smaller round wellIndication for Intended for IVF, suitable for Intended for use in preparing, Noneuse use in preparing, storing, storing, manipulating, or

manipulating, or transferring transferring human gametes orhuman gametes or embryos for embryos for in vitro fertilizationin vitro fertilization (IVF), (IVE), gamete intrafallopiangamete intrafallopian transfer transfer (GIFT), or other(GIFT), or other reproduction reproduction proceduresprocedures.

Material Virgin Polystyrene, tested for Virgin Polystyrene, tested for noneUSP Class VI cytotoxicity USP Class VI cytotoxicity


HertRT......K123641

510(k) Summary pg 4of 8

Dimensions Dish Size without lid: 65,96 Diameter 60 mm round dish Proposed device hasmm x 65,96 mm x 10,50 mm smaller round diameterDish Size with lid: 65,96 mm x65,96 mm x 13,20 mmWell diameter: 40 mm

Design Square dish with round well. Round dishes with vented lid Proposed device has anfeatures with vented lid. A patient ID coving all of the dish. Flat outer square geometry

area not covered by the lid, bottom, optically clear surfaces. with ID area. PredicateFlat bottom, optically clear Surfaces are treated for device is surfacesurfaces. improved wettability treated for increasedSurfaces are non-treated wettability.

Well shape Round well area of 12,56 cm 2 W:ell area of 24,07 m2 Proposed device hasWell volume 12,56 mE 23,00 mL smaller well area and

I less mL

Discussion Proposed device has a square outer geometry and a patient ID area. The square outergeometry facilitates the handling and stacking of dishes, while the patient ID area forwriting or barcode increases the safety in relation to mix-ups.Predicate device uses surface treatment, which is traditionally used for cell culture labwarefor better cell adhesion. As gametes and embryos do not adhere to surfaces, and since mostculture within IVF nowadays is done in drops of media, improved wettability is not a desiredproduct feature for modern IVF procedures.The proposed device uses a more sensitive 1-cell MEA assay compared to the predicatedevice using a 2-cell MEA in order to improve/ensure consistency of product performanceThe differences do not impact the use of the identified predicate device to support theproposed device, as they do not raise any new types of safety or effectiveness questions.Therefore, the subject is substantially equivalent to the predicate device.

Parameter Subject Device - Vitrolife 5 Predicate Device - Nunc IVF Differenceswell Culture Dish Multidish 4 Wells (K040717) __________

Device Square dish with 5 round wells Square dish with 4 round wells Proposed device has 5wells while predicate

_________________________ device has 4 wells.

Indications for Intended for IVF, suitable for Intended for preparing, storing,Use preparing, storing, manipulating or transferring

manipulating or transferring human gametes or embryos forhuman gametes or embryos for in vitro fertilization (IVF), or nonein vitro fertilization (lyE), or other in vitro fertilizationother in vitro fertilization techniques, and cell culturetechniques ________________

Material Virgin Polystyrene, tested for Virgin Polystyrene, tested for noneUSP Class VI cytotoxicity USP Class VI cytotoxicity ___________

Dimensions Base: 65,96 mm x 65,96 mm Base: 65,96 mm x 65,96 mm noneDish size with lid: 65,96 mm x

___________65,96 mm x 13,20 mmDesign Square dish with vented lid. A Square dish with vented lid Proposed dish has afeatures patient ID area not covered by coving all of the dish. Flat patient ID area.

the lid,. bottom, optically clear surfaces. Predicate device canFlat bottom, optically clear Product comes both with or come as surfacesurfaces. without surface treatment for treated for increasedSurfaces are non-treated improved wettability wettability


K123641H-ertART..,'. P9 5 of 8

510(k) Summary

Well shape well area of 1.9 CM2 well area of 1.9 cm' Proposed device has aWell Volume of 1,7 mL ramp along the innerWells having a ramp along the edge of the wellsedgeThe well diameter isapproximately 10.7 mnm at thebottom of the well and thenquickly expands to a 15,3 mmdiameter cylinder. The height isapproximately 9.4 mm fromthe bottom of the well to therim

Discussion Proposed device has a patient ID area. The square outer geometry facilitates the handlingand stacking of dishes, while the patient ID area for writing or barcode increases the safetyin relation to mix-ups.Proposed device has a ramp along the inner edge of the wells preventing the embryos fromgetting stuck in the corners and thereby facilitates the use of the product.Predicate device uses surface treatment, which is traditionally used for cell culture labwarefor better cell adhesion. As gametes and embryos do not adhere to surfaces, and since mostculture within IVF nowadays is done in drops of media, improved wettability is notconsidered a desired product feature for modern IVF procedures.The differences do not impact the use of the identified predicate device to support theproposed device, as they do not raise any new types of safety or effectiveness questions.

____________Therefore, the subject is substantially equivalent to the predicate device.

Parameter Subject Device - Vitrolife Predicate Device - Nunc IVF DifferencesICSI Dish ICSI Dish (K090429) __________

Device Square dish with 1 well with Round dish with 1 round well Proposed device hasrounded corners square outer geometry

and 1 well with roundedcorners, while predicatedevice has round outergeometry and roundwell

Indication for Intended for IVF, suitable for Intended for holding docytesUse holding oocytes and sperm and sperm during fertilization

during fertilization via via intracytoplasmic sperm noneintracytoplasmic sperm injection (ICSI).inj ection (ICSI). I_______________


Dimensions Dish Size without lid:65,96 mm Diameter: 55.77 mm Proposed device isx 65,96 mm x 9,00 mm Height without lid: 8.64 mm square and wider.Dish Size with lid: 65,96 mm x Height with lid: 9.75 mm Height is comparable.65,96 mm x 11,70 mmThe ICSI dish has one largecontinuous surface with thelength (at the bottom of thewell) of 50.5 mm and a widthof 34.8 mm. The corners arerounded and the total volume isapproximately 14.5 mL.


HertA T.,.",..K123641pg 6 of 8

510(k) Summary

Design The bottom of the dishes is The bottom of the dishes is Proposed device has afeatures clear and optimal clear, clear and optimal clear, patient ID area.

The lid can be handled with one The lid can be handled with onehand while other lab equipment hand while other lab equipmentcan be handled with the other can be handled with the otherhand. The dishes can be hand, The dishes can bestacked. stacked.A patient ID area not coveredby the lid. _______________ ___________

Discussion Proposed device has a patient ID area. The square outer geometry facilitates the handlingand stacking of dishes, while the patient ID area for writing or barcode increases the safetyin relation to mix-ups.

The differences do not impact the use of the identified predicate device to support theproposed device, as they do not raise any new types of safety or effectiveness questions.

_____________Therefore, the subject is substantially equivalent to the predicate device.

Parameter Subject Device - Vitrolife Predicate Device - Falcon DifferencesCentre Well Dish IVF One Well Dish

___________(K991251)

Device Square dish with 1 oval well Round dish with 1 round well Proposed device hassquare outer geometryand oval well. Predicatedevice has round outer

_______________________ ________________________ eometry and round well

Indication for Intended for IVF, suitable for Intended for use in preparing, NoneUse use in preparing, storing, storing, manipulating, or

manipulating, or transferring transferring human gametes orhuman gametes or embryos for embryos for in vitro fertilizationin vitro fertilization (IVF), (IVF), gamete intrafallopiangamete intrafallopian transfer transfer (GIFT), or other(GIFT), or other reproduction reproduction proceduresprocedures.


Dimensions Dish with lid: 65,96 mm x Diameter: 55.77 mm Height is comparable65,96 mm x 13,20 mm Height without lid: 8.64 mmHeight without lid: 10.50 mm Height With lid: 9.75 mm

Design The dishes have perfectly flat, The dishes have perfectly flat, Proposed device has anfeatures optically clear surfaces for optically clear surfaces for oval well while predicate

optimum manipulation and optimum manipulation and device has a round well.observation of the ova and observation of the ova and Predicate device is surfaceembryos. The oval well embryos, Surfaces are treated treated for increasedfacilitates the handling of the for improved wettability. wettability.ova and embryos by equipment The lids are designed for Proposed device has aduring microscopy. aseptic manipulation and patient ID areaThe lids are designed for consistent venting to maintainaseptic manipulation and proper humidificationconsistent venting to maintainproper humidification. Thedishes can be stacked.A patient ID area not covered

____________ by the lid


He rtART..". K123641pg 7 of 8

510(k) Summary

Well shape. Round bottom with diameter Roundapprox. 15.5 mm and a largeroval opening

Well volume Well Volume > 2.5 mE Well volume of 2.5 mDiscussion Proposed device has a patient ID area. The square outer geometry facilitates the handling and

stacking of dishes, while the patient ID area for writing or barcode increases the safety inrelation to mix-ups.The oval well in proposed device facilitates the handling of the ova and embryos by equipmentduring microscopy.Predicate device uses surface treatment, which is traditionally used for cell culture labware forbetter cell adhesion. As gametes and embryos do not adhere to surfaces, and since mostculture within IVF nowadays is done in drops of media, improved wettability is not a desiredproduct feature for modern IVF procedures.

Proposed device used 1-cell method for MEA testing while predicate device used 2-cell method.There is to day no established standard discriminating between 1-cell or 2-cell method.

The differences do not impact the use of the identified predicate device to support theproposed device, as they do not raise any new types of safety or effectiveness questions.Therefore, the subject is substantially equivalent to the predicate device.

Parameter Subject Device - Vitrolife Predicate Device - Genx DifferencesMicro Droplet Culture Dish Culture Dish (Sun IVF

_____________________Embryo Corral)_K993881)Device Square dish with 12 round Round dish with 11 round wells Proposed device has

wells square outer geometryand round walls, while

ipredicate device hasround outer geometry and

____________ ______________________ _______________________ picket-fenced walls

Indication for Intended for IVF. It may be Intended to be used when Predicate device allowsuse / used with sperm and for the culturing tissues and cells. It media to flow freelyintended use culturing of embryos using drop may be used with sperm and among culturing

culture, for the culturing of embryos. cells/embryos, howeverProposed device allowindividual cells/embryosto be cultures in

____________ ______________________ _______________________ separated drop cultures.

Material Virgin Polystyrene, tested for Polystyrene Proposed device uses USP_________ LI SP Class VI cytotoxicity ________________Class tested polystyrene

Dimensions Dish with lid: 65,96 mm x Outer Diameter: 60 mm Proposed device has65,96 mm x 13,20 mm square outer geometry

while predicate device has_____________ __________________________round

Design The basic design is a square The basic design is that of a Proposed device has afeatures culture dish with twelve small traditional culture dish. Approx square outer geometry

wells (volume 12.5 microliter, 60 mm round with areas of 1/2 and well areas defined byholding standing drops up to 50 inch side walls. This dish does small solid walls, whilemicroliter). The micro-wells are not have defined areas for the predicate device has aplaced with a-numerical ID in a cell to be confined within, round outer geometry andrectangular well format to allow These areas are squares of well areas defined byeasy identification during picket-fenced walls. small picket-fenced walls.microscopy. Proposed device hasThe height of a well is _______________micro-wells with a-

HertARApS of 8IVF Dishes

HertARTr,, -. Ki123641

510(k) Summarypg8o8

approximately 0.95 mm and numerical ID to allow easythe diameter is 3.3 mm at the identification duringbottom with sides sloping to microscopy, as well as aapproximately 4.3 mm at the separate patient ID area.top. There will typically be oneseparated media-drop in eachwell, this is however not linkedto if the customer decides toplace several embryos in eachwell (co-culture) or only oneembryo (single embryo cultureThe lids are designed foraseptic manipulation andconsistent venting to maintainproper humidification.A patient ID area not coveredby the lid.

Discussion The square outer geometry of the proposed device facilitates the handling and stacking ofdishes, while the patient ID area for writing or barcode increases the safety in relation to mix-UPS.

Predicate device allows media to flow freely among culturing cells/embryos, whileProposed device allow individual cells/embryos to be cultured in separated drop cultures, whichis a routine procedure in many IVF clinics.The alphanumerical ID at each microwell allows easy drop identification during microscopy.

The differences do not impact the use of theidentified predicate device to support theproposed device, as they do not raise any new types of safety or effectiveness questions.

_____________Therefore, the subject is substantially equivalent to the predicate device.

HertART ApS PageS8 of SIVIF Dishes

DEPARTMENT OF HEALTH & HUMAN SERVICES Publ~ic I leail Serv'ie

Food and Drug Administration,

Z4 ~10903 New IHiapshire AN enueIjoCUTTnn Control Center - \V066-G609

Silver Spring. IdD 20993-0002

July 3, 2013

* HertARTApS%/ Mr. Henrik DbrgeVP Business DevelopmentKorskildelund 6Greve 2670DENMARK

Re: K 123641trade/Device Name: Vitrolife Culture Dish 40 mm, Vitrolife Culture Dish 60 min,

Vitrolife Centre Well Dish, Vitrolife 5 Well Culture Dish,Vitrolife ICSI Dish, and Vitrolife Micro Droplet Culture Dish

Regulation Number: 21 CFR 884.6160Regulation Name: External uterine contraction monitor and accessoriesRegulatory Class: Class 11Product Code: MQKDated: May 6,2013Received: May 23. 2013

Dear Mr. Ddrge:

We have reviewed your Section 5 10(k) premarket nouification of intent to market the device

referenced above and have determined the device is Substantially equivalent (for the indications

for use stated in the enclosure) to legally marketed predicate devices marketed in interstate

commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to

devices that have been rcclassified in accordance with the provisions of the Federal Food, Drug,

and Cosmetic Act (Act) that do not require approval of a preniarket approval application (PMA).

You tray, therefore, market the device, subject to the general controls provisions of the Act. The

general controls provisions of thle Act include requirements for annual registration, listing of

devices, good manufacturing practice, labeling, and prohibitions against misbranding and

adulteration. Please note: CDRH does not evaluate information related to contract liability

warranties. We remind you, however, that device labeling must be truthful and not misleading'.

lfyour device is classified (see above) into either class 11 (Special Controls) or class Ill (PMA). it

may be subject to additional controls. Existing major regulations affecting your device can be

found in thle Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may

publish further announcements concerning Your device in the Federal Register.

Mr. Henrik D6rge

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(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medicaldevice-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), pleasecontact the Division of Small Manufacturers, International and Consumer Assistance at itstoll-free number (800) 638-2041 or (301) 796-7100 or at its Internet addresshttp://www.fdasgov/MedicalDevices/ResourcesforYou/ndustry/default.htm. Also, please notethe regulation entitled, "Misbranding by reference to premarket notification" (2ICFR Part807.97). For questions regarding the reporting of adverse events under the MDR regulation(21 CFR Part 803), please go tohttp)://www.fda.aov/MedicalDevices/Safetv/ReoortaProblem/default.htm for the CDRI-'s Officeof Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from theDivision of Small Manufacturers, International and Consumer Assistance at its toll-free number(800) 638-2041 or (301) 796-7 100 or at its Internet addresshttp)://www.fda-gov/MedicaDevices/ResourcesforYou/industrv/default.htm.

Sincerely yours,

Benja&, 44 he r-SUt -t =

Benjamin R. Fisher, Ph.D.DirectorDivision of Reproductive, Castro-Renal.

and Urological DevicesOffice of Device EvaluationCenter for Devices and Radiological Health

Enclosure

Indications for Use Statement

510(k) Number: K123641

Device Name: Vitrolife Culture Dish 40 mmVitrolife Culture Dish 60 mmVitrotife Centre Well Dish

Indications for Use:

The Vitrolife Culture Dishes are Intended for IVF, suitable for use in preparing, storing,manipulating, or transferring human gametes or embryos for in vitro fertilization (IVF),gamete intrafalloplan transfer (GIFT), or other reproduction procedures.

Prescription Use ___X__NDO Over-The-Counter Use ____

(Part 21 CFR 801 Subpart D) AN/R(21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTIN[UE ON ANOTHER PAGE OFNEEDED)

Concurrence of CDR-, Office of Device Evaluation (ODE)

Benjamin R. Fisher -S2013.07.031 2:45J9- -400

(Division Sign-Off)Division of Reproductive, Gastro-Renal, andUrologicul Devices510(k) Number K1 23641

Page 1 of 4


510(k) Number: K123641

Device Name: Vitrolife 5 Well Culture Dish


The Vltrolife 5 Well Culture Dish Is Intended for IVF, suitable for preparing, storing,manipulating or transferring human gametes or embryos for in vitro fertilization (IVF), orother in vitro fertilization techniques.

Prescription Use _ _/O Over-The-Counter Use ____

(Part 21 CFR 801 Subpart D) AN/R(21 CER 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LfNE-CONTINUE ON ANOTHER PAGE OFNEEDED)

Concurrence of CDRI-, Office of Device Evaluation (ODE)

Benjamin. R. Fisher -S2013.07.03 12:46:47 -041001

(Division Sign-Off)Division of Reproductive, Gastro-RenaI~ andUrological Devices510(k) Number K1 23641

Page 2 of 4


510(k) Number: K123641

Device Name: Vitrolife ICSI Dish


The Vitrolife ICSI Dish is intended for IVF, suitable for holding oocytes and sperm duringfertilization via intracytoplasmic sperm Injection (ICSI).

Prescription Use __X__D/l Over-The-Counter Use ___

(Part 21 CER 80f Subpart D) AN/R(21 CER 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Benjamin R. Fisher-S2013.07.03 12:47:427 -04'00'(Division Sign-Off)Division of Reproductive, Gastro-Renal, andUrological Devices510(k) Number Ki123641

Page 3 of 4


510(k) Number: K123641

Device Name: Vitrolife Micro Droplet Culture Dish


The Vitralife Micro Droplet Culture Dish Is Intended for IVF. It may be used with spermand for the culturing of embryos using drop culture.

Prescription Use _ _AN/ Over-The-Counter Use ___

(Part 21 CER 801 Subpart D) AN/R(21 CFR 801 Subpart C)

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

Concurrence of CDR.H, Office of Device Evaluation (ODE)

Benjamj m'"§U6ThIIJ hr -S201 3.O7O32:4 -04'00'(Division Sign-Off)Division of Reproductive, Gastro-Renal, andUrological Devices510(k) Number K123641

Page 4 of 4

HertRT'..K123641 510(k) Summarypassed the USP class VI test for cytotoxicity, as well as 1-cell...

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