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  • 1.  is 510k required for positive change in performance

    This message was posted by a user wishing to remain anonymous
    Posted 30-Aug-2021 13:44
    This message was posted by a user wishing to remain anonymous

    If an orthopedic implantable device has a design change that results in significantly improved mechanical performance, is there any reason to submit a new 510k. Looking for factors to consider regarding clinical impact of improved mechanical performance.  
    Thanks in advance for your wisdom.


  • 2.  RE: is 510k required for positive change in performance

    Posted 30-Aug-2021 15:19
    Most likely, assuming you want to document the improved performance as an expanded indication or clinical benefit/claim in the DFU.

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    Vidya
    USA
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    Original Message


  • 3.  RE: is 510k required for positive change in performance

    Posted 30-Aug-2021 17:03
    For a design change resulting in significantly improved performance, some general FDA 510(k) triggers that come to my mind are if the improved performance:

    • is intended to significantly affect safety or effectiveness of a device;
    • results in claims, indications, or use for a new disease, condition, or patient population;
    • deletes a contraindication;
    • alters warnings, precautions, or instructions for use in a way that raises new risks;
    • significantly affects device use;
    • requires clinical data to prove the improved performance or related claims;
    • raises any unexpected verification or validation issues;
    • raises the level of other seemingly unrelated risks, or creates new risks.





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    Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
    Principal Consultant
    Ridgway, CO
    United States
    © Copyright 2021 by ComplianceAcuity, Inc. All rights reserved.
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    Original Message


  • 4.  RE: is 510k required for positive change in performance

    Posted 30-Aug-2021 17:37

    For a device in commercial distribution the regulation, 807.81(a)(3)(i), requires a 510(k) when a "change or modification in the device ... could significantly affect the safety or effectiveness of the device". It sounds like your change meets the effectiveness part. Notice that an improvement is a change.

    Look at the guidance document on when to submit a 510(k). Section IV.1 covers this case. Also, look at Section V.E.3 where the guidance document suggests "the manufacturer should consider the probability and severity (i.e., magnitude) of impacts to device effectiveness".

    As usual, process the change through the flowcharts and record the results of each decision and the reason for making the decision. Put the determination in the DHF.

    Also remember that this change will likely need a new UDI-DI even if you don't submit a new 510(k).



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    Dan O'Leary CQA, CQE
    Swanzey NH
    United States
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    Original Message


  • 5.  RE: is 510k required for positive change in performance

    This message was posted by a user wishing to remain anonymous
    Posted 31-Aug-2021 11:18
    This message was posted by a user wishing to remain anonymous

    Thanks everyone for your feedback!
    Original Message


  • 6.  RE: is 510k required for positive change in performance

    Posted 01-Sep-2021 15:44
    Have you reviewed the guidance document on device modifications (Deciding When to Submit a 510(k) for a Change to an Existing Device )? You will get your answers in that document. The big question to consider is whether the device change could significantly affect Safety and Effectiveness - and with a significant performance improvement - it might. It will depend on what other changes are required - for instance, was there an update to the risk profile of the device (did the change bring in new risks or significantly modify existing risks), were clinical data necessary to validate the change? Answers to these questions and more as detailed in the guidance will help determine if a new 510k is needed. There is no blanket exemption that states that changes in the positive direction do not require a new 510k. Any change that significantly affects device design, whether positive or negative, could significantly affect S&E, and should be considered for impact to a regulatory submission. 

    U.S. Food and Drug Administration remove preview
    Deciding When to Submit a 510(k) for a Change to an Existing Device
    Almost from the enactment of the Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act (the FD&C Act) in 1976, the Food and Drug Administration (FDA or the Agency) has attempted to define with greater clarity when a change in a medical device would trigger the requirement that a manufacturer submit a new premarket notification (510(k)) to the Agency.
    View this on U.S. Food and Drug Administration >



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    Manan Hathi RAC
    Sr. Manager, Regulatory Affairs - Software
    Flower Mound TX
    United States
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    Original Message


  • 7.  RE: is 510k required for positive change in performance

    This message was posted by a user wishing to remain anonymous
    Posted 02-Sep-2021 11:28
    This message was posted by a user wishing to remain anonymous

    I have reviewed the guidance doc. It's just very generic. We're taking the approach in the internal documentation that an improvement that does not introduce any new risks or negatively affect severity or occurrence does not require a 510k.
    Thanks!
    Original Message


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