Regulatory Open Forum

 View Only

  • 1.  510K Substantial Equivalence

    This message was posted by a user wishing to remain anonymous
    Posted 26-Aug-2019 08:05
    This message was posted by a user wishing to remain anonymous

    Can you obtain 510K clearance for a portion of a substantially equivalent device?  For example, making this simple as possible, if a toothbrush was 510K cleared, could I then claim substantial equivalence, if I wanted to introduce a new handle? That would not operate with the toothbrush, but only the handle?


  • 2.  RE: 510K Substantial Equivalence

    Posted 27-Aug-2019 10:43
    Hi,
    I would think it would depend on the indications/intended use of the devices. In some situations, it may be possible but that would be a good presub question. 
    Maddi

    ------------------------------
    Maddi Myers
    Regulatory and Quality Project Manager
    Carver MN
    United States
    ------------------------------

    Original Message


  • 3.  RE: 510K Substantial Equivalence

    Posted 27-Aug-2019 11:14
    Yes, something like this could be done - in your substantial equivalence table you would have to show why the changes would not have a impact on the safety and performance.  Typically you would have a tabular listing of the subject device and predicate device side-by-side with the device safety, performance, functional, and operational characteristics listed.  In your example, the tip and handle could have a few characteristics like softness, material, length, etc. (simplest terms).  For the tip you would show the subject and predicate device are the "Same".  Then for the handle you would go through each characteristic like material or length, describe the differences, and then write the rationale why the change would not raise any additional concerns for safety or efficacy.

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

    Original Message


  • 4.  RE: 510K Substantial Equivalence

    Posted 27-Aug-2019 13:14
    Anon,

    FDA has a guidance for industry: The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]

    I agree with Maddi.  The crux of the comparison is whether you are going to use the toothbrush handle you make for a different intended use, different indications for use, and/or a different use population.  In other words, the toothbrush you are claiming substantial equivalence to, is hypothetically cleared for oral hygiene of the mouth, teeth, gums, etc.  Your handle would also have to be used for oral hygiene of the mouth, teeth, gums, etc. and used in a similar fashion and on the same population of users/patients.

    If this is true you would go about the comparison using Richard's suggestions.

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

    Original Message


Related Content