510(k) Submissions
Recent Experience and Perspectives
Terry Sullivan
Vice President, Regulatory Affairs
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/DeviceRegulationand
Guidance/GuidanceDocuments/ucm084365.htm
– “How To Prepare A Special 510(k)”
• http://www.fda.gov/MedicalDevices/DeviceRegulationand
Guidance/HowtoMarketYourDevice/PremarketSubmissio
ns/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/DeviceRegulat
ionandGuidance/HowtoMarketYourDevice/Premar
ketSubmissions/PremarketNotification510k/defaul
t.htm
• Thank you for your time and attention!
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