1. Slide 1 of 19 Rob Packard, President www.MedicalDeviceAcademy.com rob@13485cert.com http://bit.ly/Substantial-Equiv-Guidance

2. Slide 2 of 19 Rob Packard, President www.MedicalDeviceAcademy.com rob@13485cert.com Agenda New FDA guidance & flow chart Intended Use Technological Characteristics Split Predicates Multiple Predicates Examples Reference Device Presentation of Equivalence Data

3. Slide 3 of 19 Rob Packard, President www.MedicalDeviceAcademy.com rob@13485cert.com Most Critical Sections 4 – Indications for Use (1 st ) 5 - 510(k) Summary (4 th ) 10 – Executive Summary (my last) 11 - Device Description (2 nd ) 12 – Substantial Equivalence (3 rd ) RTA Checklist is a great quality 

4. Slide 4 of 19 Rob Packard, President www.MedicalDeviceAcademy.com rob@13485cert.com How FDA Evaluates SE?

5. Slide 5 of 19 Rob Packard, President www.MedicalDeviceAcademy.com rob@13485cert.com 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?

6. Slide 6 of 19 Rob Packard, President www.MedicalDeviceAcademy.com rob@13485cert.com Legally Marketed? Registration and listing database http://bit.ly/CDRH-Registration-Listing-Database A 510(k) is not enough!

7. Slide 7 of 19 Rob Packard, President www.MedicalDeviceAcademy.com rob@13485cert.com Same Intended for Use? Compare with Applicable Regulation Compare with Primary Predicate Carefully Justify Differences with Subject Device – More Narrow Scope – Broader Scope

8. Slide 8 of 19 Rob Packard, President www.MedicalDeviceAcademy.com rob@13485cert.com 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

9. Slide 9 of 19 Rob Packard, President www.MedicalDeviceAcademy.com rob@13485cert.com Split Predicates 1 st Predicate has same intended use 2 nd Predicate has same technological characteristics This is not allowed.

10. Slide 10 of 19 Rob Packard, President www.MedicalDeviceAcademy.com rob@13485cert.com 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

11. Slide 11 of 19 Rob Packard, President www.MedicalDeviceAcademy.com rob@13485cert.com 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

12. Slide 12 of 19 Rob Packard, President www.MedicalDeviceAcademy.com rob@13485cert.com 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.

13. Slide 13 of 19 Rob Packard, President www.MedicalDeviceAcademy.com rob@13485cert.com Examples (continued) 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

14. Slide 14 of 19 Rob Packard, President www.MedicalDeviceAcademy.com rob@13485cert.com Examples (continued) 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

15. Slide 15 of 19 Rob Packard, President www.MedicalDeviceAcademy.com rob@13485cert.com 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)

16. Slide 16 of 19 Rob Packard, President www.MedicalDeviceAcademy.com rob@13485cert.com Why Questions 1-4 first? Predicate = Metal-Ceramic Total ShoulderSubject Device = Metal-Ceramic Total Knee 1. Yes legally marketed deviceN/A 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.

17. Slide 17 of 19 Rob Packard, President www.MedicalDeviceAcademy.com rob@13485cert.com 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

18. Slide 18 of 19 Rob Packard, President www.MedicalDeviceAcademy.com rob@13485cert.com Q & A rob@13485cert.com

19. Slide 19 of 19 Rob Packard, President www.MedicalDeviceAcademy.com rob@13485cert.com Need a quotation for a 510(k) Submission? Rob Packard rob@13485cert.com +1.802.281.4381 rob13485