510(k) Submissions Recent Experience and Perspectives

1. 510(k) SubmissionsRecent Experience and Perspectives Terry Sullivan Vice President, Regulatory Affairs

2. What I will cover today... • Survey of audience • Overview of 510(k) pathways • Traditional • Special • Abbreviated • Perspective on some options available to manufacturers • STED • Third-Party review • Perspective on Gyrus ACMI’s recent experience with submissions to FDA

3. Survey • #’s of participants who are: • New to Regulatory Affairs profession? • Between 1 and 3 years experience? • Between 3 and 5 years experience? • More than 5 years experience?

4. Overview of 510(k) pathways • All 510(k)s introduce new devices that are demonstrated to be substantially equivalent to another legally marketed device • Elements of a substantial equivalence argument often include: • Same intended uses and same technological characteristics • Same intended uses and different technological characteristics but • does not raise new questions of safety, and • demonstrates that device is at least as safe and effective as predicate

5. Overview of 510(k) pathways • Traditional 510(k)s typically introduce: • Significant changes in labeling • Significant performance changes • New clinical data needed for S&E or new S&E issues raised during design validation • Significant material changes • FDA is under a 90-day time frame to review and make a determination

6. Overview of 510(k) pathways • An example of a Traditional 510(k): • Predicate Device: Gyrus ACMI’s DUR-8 Flexible Ureteroscope, originally marketed under K012925

7. Overview of 510(k) pathways • An example of a Traditional 510(k): • Proposed Device: Gyrus ACMI’s DUR-D Digital Flexible Ureteroscope, cleared under K060269

8. Overview of 510(k) pathways • Special 510(k)s introduce changes to an existing device that do not: • Affect the intended uses of the device • Alter the fundamental scientific technology of the device • Some changes that qualify for the Special pathway... • Declaration of Conformity with Design Control requirements • FDA is under a 30-day time frame to make a determination

9. Overview of 510(k) pathways • An example of a Special 510(k): • Predicate Device: Gyrus ACMI’s ICN Digital Flexible CystoNephroscope, originally marketed under K042225

10. Overview of 510(k) pathways • An example of a Special 510(k): • Proposed Device: Gyrus ACMI’s ICN Digital Flexible CystoNephroscope with VGA sensor, cleared under K090814

11. Overview of 510(k) pathways • Abbreviated 510(k)s may be used for the same purposes as a Traditional 510(k), but rely on use of: • FDA Guidance Documents • Applicable Special Controls • FDA Recognized Standards • Summary reports on use of Guidance or Special Controls • Declarations of Conformity to Standards

12. Some manufacturer options • STED format • Developed by GHTF, with intention to provide a harmonized format for use in multiple markets • Some limitations on application • In practice, we have found that STED in general isn’t sufficient for all our needs and have chosen to use a different approach

13. Some manufacturer options • Third Party Review process • In theory, allows for faster reviews for a fee • Has been discussed at some length internally • Some limitations on scope of this program • In practice, we have not chosen to utilize this option • Budgets – greater cost to us • Time savings isn’t significant enough for us

14. Perspectives on our experience • A little background on Gyrus ACMI products... • Urology/Gynecology visualization and minimally invasive surgical devices • RF Energy devices for open and minimally invasive surgical procedures • ENT visualization, minimally invasive surgical procedures, otology implants • In general, 98% of product portfolio falls within Class 1 or Class 2

15. Perspectives on our experience • Gyrus ACMI’s experience with 510(k)s in general since mid-2005 • Most are Traditional • 17 of 22 submitted • Balance are Special • 5 of 22 submitted • By choice we do not use the Abbreviated pathway

16. Perspectives on our experience • Planning for particular pathway • Begins with initial regulatory pathway assessments • US: IDE/510(k)/PMA needed? • Canada: License application needed? • Europe: Tech File review needed? • Latin America: registration dossiers needed? • Pacific Rim: registration dossiers needed?

17. Perspectives on our experience • As previously noted, almost all of our portfolio consists of Class 1 or Class 2 devices • Performance profile is pretty well known for these types of devices • Bench testing or animal testing is usually sufficient for our 510(k) submission • Pre-IDE approach has been used several times as part of our planning for more novel device designs or applications

18. Perspectives on our experience • Since STED doesn’t really work for us, we format our submissions using a series of Sectional Templates built on: • “Guidance for Industry and FDA Staff: Format for Traditional and Abbreviated 510(k)s” • http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm084365.htm • “How To Prepare A Special 510(k)” • http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/ucm134573.htm#content

19. Perspectives on our experience • How much information is too much detail? • Level of detail and description • Inclusion of test data/summaries

20. Perspectives on our experience • Additional Information requests • Nature of requests varies • Often can be addressed through e-mail

21. Conclusion • Lots of useful information about 510(k)s available from FDA on their Device Advice website • http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/default.htm • Thank you for your time and attention!