510(k) submissions recent experience and perspectives terry sullivan vice president, regulatory...

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!