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510(k) SubmissionsRecent Experience and Perspectives
Terry Sullivan
Vice President, Regulatory Affairs
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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
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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?
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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?
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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
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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
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Perspectives on our experience
• How much information is too much detail?
– Level of detail and description
– Inclusion of test data/summaries
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Perspectives on our experience
• Additional Information requests
– Nature of requests varies
– Often can be addressed through e-mail
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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!