Slide 1 of 19 Rob Packard, President [email protected] .

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Rob Packard, Presidentwww.MedicalDeviceAcademy.com

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http://bit.ly/Substantial-Equiv-Guidance

http://www.medicaldeviceacademy.com/




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Agenda

• New FDA guidance & flow chart• Intended Use• Technological Characteristics • Split Predicates • Multiple Predicates• Examples• Reference Device• Presentation of Equivalence Data



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Most Critical Sections

• 4 – Indications for Use (1st)• 5 - 510(k) Summary (4th)• 10 – Executive Summary (my last)• 11 - Device Description (2nd)• 12 – Substantial Equivalence (3rd)

• RTA Checklist is a great quality



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How FDA Evaluates SE?



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6 Questions

1. Is the predicate device legally marketed?

2. Do the devices have the same intended use?

3. Do the devices have the same technological characteristics?

4. Do the different technological characteristics raise different questions of safety and effectiveness?

5. Are the methods of evaluating new/different characteristics acceptable?

6. Does the data demonstrate substantial equivalence?



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Legally Marketed?

Registration and listing database

http://bit.ly/CDRH-Registration-Listing-Database

A 510(k) is not enough!





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Same Intended for Use?

• Compare with Applicable Regulation• Compare with Primary Predicate• Carefully Justify Differences with Subject Device

– More Narrow Scope

– Broader Scope



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Technological Characteristics?

• Materials• Design• Energy Source• Other Features• Same ≠ Equivalent

– Does not raise DIFFERENT issues of safety or effectiveness

– Must be as safe and effective as predicate



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Split Predicates

• 1st Predicate has same intended use• 2nd Predicate has same technological

characteristics

This is not allowed.



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Multiple Predicates Allowed…

• Option 1:– Two predicates with different technological

characteristics, but the same intended use• Option 2:

– A device with more than one intended use• Options 3:

– More than one indication under the same intended use



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Examples

• Example 1 – Hemodialysis catheter– Predicate A has same extension design– Predicate B has same tip design– Both A & B predicates have the same intended use

• Example 2 – Fracture fixation plate– Predicate A is indicated for middle bone fractures– Predicate B is indicated for bone tip fractures– Both A & B predicates are intended for long bone

fractures– New performance testing may be required



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Examples (continued)

• Example 3 – Laser hand piece– Predicate A Er:YAG laser hand piece – Predicate B Q-Switch Nd:YAG laser hand piece– Both A & B predicates have the same general intended use

of lasers: “incision, excision, ablation, vaporization of soft tissue.”

– New performance testing may be required– A single predicate could have been used, but the inclusion

of a second predicate is helpful in establishing substantial equivalence with regard to specific indications and technological characteristics.



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• Example 4 – Multi-parameter monitor– New monitor includes different technologies– Predicate for each parameter– Monitoring of each parameter cannot interfere with

the others– New performance testing may be required



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• Example 5 – Temperature measuring urinary catheter– Urinary catheter is primary predicate– Thermometer is secondary predicate added as a

convenience– Two predicates fall under different classifications– The additional feature cannot alter the risk profile of

the urinary catheter



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Use of Reference Device

• Must first pass decision point questions 1-4• Example of a knee implant with a new coating:

– Predicate is a legally marketed– Predicate has the same intended use– Predicate has different technological characteristics

(i.e., the coating)– Predicate and subject device have the same

questions of safety & effectiveness (i.e., biocompatability)



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Why Questions 1-4 first?Predicate = Metal-Ceramic Total Shoulder

Subject Device = Metal-Ceramic Total Knee

1. Yes legally marketed device N/A

2. Intended use for resurfacing joint 2. Intended use for resurfacing joint

3. Semi-constrained ceramic humeral ball on a cobalt chrome shaft wearing against a cobalt chrome glenoid articulating surface

3. Semi-constrained femoral head made of ceramic wearing against cobalt chrome tibial plateau

4. No weight bearing function of a total shoulder and metal shalt supporting ceramic ball; less likely to fracture ceramic

4. Weight bearing function of a total knee and no metal supporting ceramic femoral head; more likely to fracture ceramic requires greater loading during cyclic testing

The different risks associated with the different indications for use and the fact that the fixation of the two ceramic articulating surfaces is very different make it impossible to say that the devices do not present different risks. The conclusion would be NSE and a reference device for cyclic testing would be irrelevant.



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Equivalence Data

• Intended Use• Technological Characteristics

– Materials, Design, Energy Source, Other Features• Performance Data

– Biocompatibility– Electrical Safety & Electromagnetic compatibility (EMC)– Software verification and validation– Mechanical and acoustic testing– Animal Study– Clinical Study



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Q & A

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Need a quotation for a510(k) Submission?

Rob Packard

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+1.802.281.4381

rob13485



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Slide 1 of 19 Rob Packard, President [email protected] .

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