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  • 1.  Material Change and needs for new 510 K

    This message was posted by a user wishing to remain anonymous
    Posted 02-Jul-2020 09:01
    This message was posted by a user wishing to remain anonymous

    Hello, 
    I wonder how to understand the need for a new 510 K (significant change) in case of a change in material coating for a surgical device. 
    If we would change the coating material of a class II disposable surgical device by an other coating material known to be also biocompatible, medical grade, used in similar type of application and for which we have confirmation by the required ISO 10993 biocompatibility tests that there is no issue. 
    Is this considered as material change with concerns that require a new 510 K (significant change); or can this be considered as non significant change with a letter to file?
    Best regards


  • 2.  RE: Material Change and needs for new 510 K

    Posted 03-Jul-2020 03:40
    Hello there,

    First, if you have not looked at already, go through the FDA guidance document for determining a new 510(k) based on changes: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/deciding-when-submit-510k-change-existing-device.  This provides the flowchart and explanation specifically in part C to walk through.  Just make sure not to just go through the flowchart saying no, yes, no, no: Note to File.  Within each of the decision points generate your justification and rationale.  Without knowing your specific device type and the material before and material after, probably could not help further.  However, the description and information provided in the guidance for part C is quite sufficient to help you determine whether a change is needed or not.  If still unsure, could inquire with an materials expert to determine is the coating materials are equivalent, does not affect the safety, does not raise additional questions of performance, and biocompatibility testing is sufficient.

    ------------------------------
    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 3.  RE: Material Change and needs for new 510 K

    Posted 03-Jul-2020 12:18

     

     

    Good advice, Richard.

     

    I would add that in my experience with FDA biocomp reviewers, it's been very difficult to get agreement materials are equivalent.  Best chance would be if the underlying raw feedstock comes from the same source by way of different suppliers.  Harder would be if they are different sources all the way through the supply chain.  If the change is to an entirely different type of material, I would be very surprised if FDA would agree no submission is needed.

     

    One approach to demonstrating biological equivalence is to follow ISO 10993-18.  If you can document that the compositions are the same (as well as all processing aids and additives), it may be adequate--but this requires a high level of detail from suppliers, and does not often work.  In that case, the general approach would be to carry out instrumental analysis of device extracts, and demonstrate that the profiles of extractables are equivalent.

     

    Hope that is helpful!

     

    Best regards,

     

    Ted

     

    --

    Theodore (Ted) Heise, PHD, RAC

    Vice President Regulatory and Clinical Services

     

    MED Institute Inc.

    1330 Win Hentschel Blvd.

    West Lafayette, IN  47906-4149 USA

    765.463.1633 ext. 4444

    http://medinstitute.com

    theise@medinstitute.com

     

     

     

     




    Original Message


  • 4.  RE: Material Change and needs for new 510 K

    Posted 06-Jul-2020 09:17
      |   view attached
    The FDA GFI: When to submit a new 510(k) for changes to an existing device (attached below) will walk you through the process for making the determinations you refer to in your original question.  Each flowchart has a set of questions that must be answered leading to a determination, either significant or not.  Only the subject matter experts on your coating for the device would be able to analyze and determine the seriousness of the change.  I

    ------------------------------
    William Coulston PMP, MS, RAC
    Quality & Regulatory Manager
    San Antonio TX
    United States
    ------------------------------

    Original Message


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