510(k) Submissions Recent 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” Guidance/GuidanceDocuments/ucm htmhttp:// Guidance/GuidanceDocuments/ucm htm –“How To Prepare A Special 510(k)” Guidance/HowtoMarketYourDevice/PremarketSubmissio ns/PremarketNotification510k/ucm htm#contenthttp:// Guidance/HowtoMarketYourDevice/PremarketSubmissio ns/PremarketNotification510k/ucm 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

21 Conclusion Lots of useful information about 510(k)s available from FDA on their Device Advice website – ionandGuidance/HowtoMarketYourDevice/Premar ketSubmissions/PremarketNotification510k/defaul t.htmhttp:// ionandGuidance/HowtoMarketYourDevice/Premar ketSubmissions/PremarketNotification510k/defaul t.htm Thank you for your time and attention!