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  • 1.  Predicate device

    This message was posted by a user wishing to remain anonymous
    Posted 04-Dec-2017 09:19
    This message was posted by a user wishing to remain anonymous

    ​​

    Dear RAPS members,

     I am writing my first 510K and need some guidance on how to get detailed information on a predicate device specially when the predicate device is from a competitor? Also, what are the key characteristics that should be listed in the substantial equivalence discussion.

    Thanks



  • 2.  RE: Predicate device

    Posted 04-Dec-2017 12:02
    Hello Anonymous,

    Here are a few links that might be of interest to you:
    How to Find and Effectively Use Predicate Devices
    Content of a 510(k) (see Substantial Equivalence Comparison)
    Testing to Support a 510k

    I would also recommend the CDRH Learn site, which includes FDA presentations on topics such as 510(k)s.  

    Enjoy your first 510(k)!
    Liz


    ------------------------------
    Elizabeth Goldstein RAC
    Regulatory Affairs Project Manager
    United States
    ------------------------------

    Original Message


  • 3.  RE: Predicate device

    This message was posted by a user wishing to remain anonymous
    Posted 05-Dec-2017 09:27
    This message was posted by a user wishing to remain anonymous

    ​Thanks for the links Elizabeth. I have kind of narrowed down the predicate device but there is not much information available in their 510 K summary on FDA.gov. Is there any other way I get more information on the predicate device characteristics?

    Appreciate your help.
    Original Message


  • 4.  RE: Predicate device

    Posted 05-Dec-2017 11:33

    ​Hi Anonymous,

    Michael had some good suggestions - you might want to try an FOIA request, although if no one has requested that particular 510K before, it probably won't be a timely solution for you as the holder will have an opportunity to redact sensitive information.

    It might be a bit obvious, but it might be worth checking the manufacturer's website for spec sheets or other types of labeling material.

    Are you intending to get product samples for comparative testing?

    Hope this helps!

    Liz



    ------------------------------
    Elizabeth Goldstein RAC
    Regulatory Affairs Project Manager
    CA
    United States
    ------------------------------

    Original Message


  • 5.  RE: Predicate device

    Posted 04-Dec-2017 15:53
    Hi Anonymous,

    You could try to find information for your competitors predicate directly on the FDA 510(k) search website:
    510(k) Premarket Notification
    Type in the device name or company name and see what shows up.
    Sometimes the 510(k) summaries already contain quite detailled product specifications.

    On the FDA 510(k) search mainpage there is a small checkbox 'Redacted FOIA 510(k)' -> just tick this box and press search.
    You will now see a list of 510(k)s that are directly accessible (with many blackened pages usually), maybe your are lucky and your predicate is available.
    Since you are working on your first submission it may we worth to check out some of the redacted 510(k)s to see how other companies fill the chapters.
    You could also officially order the 510(k) of your predicate via the FOIA (Freedom Of Information Act):
    How to Make a FOIA Request

    But it may take a while until you receive the documents and most probably you want to submit earlier.
    You could also try to purchase your predicate 510(k) at FOI Services: http://www.foiservices.com/index.cfm

    Good luck with your first submission!

    Best wishes,
    Michael

    ------------------------------
    Michael Hottner
    Straight Forward Medical Device Consulting Gmbh
    Cologne
    Germany
    ------------------------------

    Original Message


  • 6.  RE: Predicate device

    This message was posted by a user wishing to remain anonymous
    Posted 11-Dec-2017 16:19
    This message was posted by a user wishing to remain anonymous

    ​Thanks for the links and suggestions.
    Original Message


  • 7.  RE: Predicate device

    Posted 13-Dec-2017 10:11
    You can do a Freedom of Information Act (FOIA) request to the FDA but that takes a lot of time, and you will be charged for FDA's time.  Additionally, the information will still be redacted.  Along the same lines, consultants sometimes have requested this information in the past and may already have the redacted 510(k), for example for a dilute bleach wound cleanser.

    Since the information is proprietary it is unlikely you would be able to get "detailed" information about a predicate.  If you look at recent 510(k) they give you a good picture of what is required.

    Good luck!

    Will Coulston | M.S., PMP
    Quality and Regulatory Manager
    Project Manager

    Wrk: 210-375-9349
    Cell:  210-870-6534


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    Original Message


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