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Question on testing with predicate device for 510(k)

  • 1.  Question on testing with predicate device for 510(k)

    Posted 21-Jan-2015 14:55

    Dear Regulatory Colleagues,

    In a 510(k) submission, is it necessary to conduct testing that compares the subject and predicate device?  Is it acceptable to have a substantial equivalence discussion on the intended use and technological characteristics but with the V&V conducted with the subject device only?  Your insight is much appreciated.

    -------------------------------------------
    Dawn Chang
    Regulatory Affairs
    Los Altos CA
    United States
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  • 2.  RE: Question on testing with predicate device for 510(k)

    Posted 22-Jan-2015 03:44
    Hi Dawn,

    I have NEVER actually used the predicate device for my V&V.  I have submitted quite a few 510(k)s in the past 15 years and it has never been an issue.  Often, a predicate device is new on the market itself and unobtainable for the purpose of testing.  If you have the technical information from the public resources, and the indications for use statement (from the 510(k) summary), you can make an excellent comparison.

    I hope this is helpful.
    Sharon

    -------------------------------------------
    Sharon Goldfarb-Albak
    Vice President, Regulatory and Clinical Affairs
    Givatayim
    Israel
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    Original Message


  • 3.  RE: Question on testing with predicate device for 510(k)

    Posted 22-Jan-2015 08:25
    We manufacture oral care devices. We do not test against the predicate device either. We do ISO 10993 testing, but do not test specifically against the predicates.

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    Paula Bojsen
    Global Regulatory Compliance Manager
    Holland MI
    United States
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    Original Message


  • 4.  RE: Question on testing with predicate device for 510(k)

    Posted 22-Jan-2015 05:02
    Dear all,

    It is interesting to read Sharon's reply.

    Let me also share with you my ideas. I think the answer is really depending on the type of device and the review branch within CDRH. For IVDs, the area, I work in, I cannot imagine to file a successful 510(k) without testing against a predicate. This is also clear in the available guidance(e.g. http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-gen/documents/document/ucm284443.pdf). As with every guidance you may deviate from the recommendations if you have a good justification. In some cases, like what Sharon explained, if the predicate is unavailable, this may qualify for sufficient justification.In any case I recommend to talk to your review branch upfront in order to avoid surprises post submission.

    Best of luck with your device

    Andreas

    -------------------------------------------
    Andreas Wiegand RAC
    Director US Affairs
    Marburg
    Germany
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    Original Message


  • 5.  RE: Question on testing with predicate device for 510(k)

    Posted 22-Jan-2015 05:54

    Hi Dawn,

    Firtst, it is nice that we connect here...

    I am also surprised about Sharon`s response.

    My experience is with devices, I have no background on IVDs. For the 510(k)s, based on my experience,V&V results for the relevant testing with the predicate devices are provided with the submission.

    Regars,
    Nesli
    -------------------------------------------
    Nesli Karakaya RAC
    Assoc Regulatory Affairs Manager
    Stryker
    Switzerland
    -------------------------------------------


    Original Message


  • 6.  RE: Question on testing with predicate device for 510(k)

    Posted 22-Jan-2015 09:03
    We manufacture IVDs and we have had a successful 510k submission recently where we only compared technological characteristics to the predicate.  In  this case, we had to include clinical comparisons to the gold standard diagnostic method, such as culture or histopathology  (which didn't qualify to be the predicate).

    Hope this helps!

    Joy
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    Joy Pelfrey
    Director of RA/QA
    Norman OK
    United States
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    Original Message


  • 7.  RE: Question on testing with predicate device for 510(k)

    Posted 22-Jan-2015 12:38
    Hi Dawn,

    Nice connecting with you over here. 

    Like any answer in our profession, the answer to your question is also 'it depends'.

    The basis of the 510(k) program is to prove Substantial Equivalence (S.E) to a legally marketed (predicate) device. Sometimes to support your claim of S.E., it might be necessary to do a comparative bench testing. If the predicate device is your own device (same company) then it is easy to get a device and perform the comparison. In certain cases, this might not be a feasible option. If the predicate device (some other company) is not expensive to purchase, one can always get it and do a comparison bench testing.

    I would recommend you review the FDA guidance on SE in pre-market notifications (issued on 28 July, 2014) and see if the comparative testing supports your SE rationale. Identify the key technological characteristics of the subject device and predicate device. If the subject device has a different/new technology, you would have to then evaluate if they raise any new questions of safety and effectiveness. This is where comparative bench testing is helpful. The type and quantity of performance data necessary to support a determination of substantial equivalence depend upon the device and/or device type.

    A link to the guidance is below:
    http://www.fda.gov/downloads/MedicalDevices/.../UCM284443.pdf

    Thanks

    -------------------------------------------
    Shiven Gandhi
    Medtronic
    San Francisco
    Regulatory Affairs Specialist
    United States
    -------------------------------------------


    Original Message


  • 8.  RE: Question on testing with predicate device for 510(k)

    Posted 23-Jan-2015 04:33
    I have the same question for biocompatibility testing. Is it necessary to take the predicate as the control?
    Thank you very much.

    -------------------------------------------
    Rosène Amossé
    Merit Medical
    Roissy En France
    France
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    Original Message


  • 9.  RE: Question on testing with predicate device for 510(k)

    Posted 24-Jan-2015 08:52
    It is not.
    All of the basic 10993 tests have numerical pass/fail criterion. 

    Shayne

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    Shayne Cox Gad ScD PhD
    Principal
    Gad Consulting Services
    Cary NC
    United States
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    Original Message


  • 10.  RE: Question on testing with predicate device for 510(k)

    Posted 24-Jan-2015 11:07
    NO!

    Speaking of "biocompatibility" testing, it is a standalone testing for your device/materials.  Although/when you (may) follow ISO 10993 series, I would recommend your firm ensure to have a comprehensive RM documentation.  

    You may also refer to recent FDA guidance on ISO 10993-1 (Part I) or http://wp.me/P4xpOK-8r

    The guidance also incorporates new hazards/considerations concerning risk assessment. 


    Original Message


  • 11.  RE: Question on testing with predicate device for 510(k)

    Posted 23-Jan-2015 08:39
    Simply put, not required and in 30+ years I have not seem such done other than for marketing )"superiority") reasons.

    Shayne

    -------------------------------------------
    Shayne Cox Gad ScD PhD
    Principal
    Gad Consulting Services
    Cary NC
    United States
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    Original Message


  • 12.  RE:Question on testing with predicate device for 510(k)

    Posted 23-Jan-2015 12:11
    Depends on the device. Substantial equivalence is same intended use and similar technological charecteristics. You can have different technological charecteristics, but testing should demonstrate that they don't raise questions of safety and efficacy. If there are specific standards involved, your SE discussion can focus of the simularities of the devices and testing performed on your device. You will always have a stronger case with side by side testing but that may be impractical with a competitor device, especially if there is no standard to test to.
    Be sure to look at the latest guidance from FDA on the subject of SE. Also look to see if there is a guidance on determining SE for your specific device.
    Hope this helps,
    Jim

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    James Chapman RAC
    Senior Specialist, Regulatory Affairs
    Maplewood MN
    United States
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    Original Message


  • 13.  RE: Question on testing with predicate device for 510(k)

    Posted 23-Jan-2015 13:58
    Dawn,

    I am speaking only for 510(k) submission and clearance purposes. 

    A great majority of devices won't require testing to compare between the subject and the predicate - just no need.  But for R/D purposes, it is a good practice to do some testing with the predicate side by side, IF FEASIBLE.

    However in IVD though, it can require such a testing as shown here at http://wp.me/p4xpOK-GY

    For your device type, your demo of SE and Se discussion can be based on the predicate's 510(k) summary, if available.


    Original Message


  • 14.  RE: Question on testing with predicate device for 510(k)

    Posted 27-Jan-2015 20:11
    Thank you everyone for your valuable input (and Nesli, it was nice to hear from you :))

    The message I got is "it-depends", particularly in situations when the predicate device is not commercially available, there is a gold standard, or there are recognized standards that are acceptable to authorities.  

    If I might, I like to ask the question differently this time, as I still like to understand when testing with predicate device is needed - could you share with me a testing you have encountered which included the predicate device - what was the objective of the testing, why was the predicate device need to be included in the testing, and the impact on the 510(k) if this testing was not conducted.

    Thanks for your time in advance and I look forward to your input.

    -------------------------------------------
    Dawn Chang
    Regulatory Affairs
    Los Altos CA
    United States
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    Original Message


  • 15.  RE: Question on testing with predicate device for 510(k)

    Posted 29-Jan-2015 14:45
    Hello Dawn - you asked "could you share with me a testing you have encountered which included the predicate device - what was the objective of the testing, why was the predicate device need to be included in the testing, and the impact on the 510(k) if this testing was not conducted".

    Example:
    Special 510(k)
    Subject Device - New hydrophilic coated catheter - "slippery when wet, provides for easier insertion"
    Predicate Device - Previously cleared, uncoated catheter - "insert and go"
    Testing - Comparison of Coefficient of Friction between subject device and predicate.

    The answer to the last point about "impact", that would be something I cannot answer - however, you need to be sure that such questions are answered as part of the 510(k) planning process with the development team so that you can anticipate such impact.

    Also, the key issue in all responses really is not "it depends" ... the key issue is "contact the FDA review branch and make sure they are part of the planning process".

    I hope this information is helpful.  Let me know if I can ever do anything for you.

    Best regards,

    -------------------------------------------
    John Beasley RAC (US)
    Founder and Senior Consultant
    Medtech Review, LLC
    Henderson NV
    United States
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    Original Message


  • 16.  RE: Question on testing with predicate device for 510(k)

    Posted 29-Jan-2015 15:18
    There can be many cases in general devices, IVDs, etc.

    For example, 

    If a firm want to expand the indications, the firm can opt to use their own device as a predicate for further testings unless the firm elects to use another device (a legally marketed) as a predicate. 

    Technically speaking, special 510(k)s fall under this category, requiring its own device as a predicate for testing. 

    FYI: I provide 510(k) and PMA drafting seminar series at http://globalcomplianceseminar.com/event/510k-drafting-seminars/



    Original Message