Regulatory Open Forum

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  • 1.  Reprocessed Catheters

    Posted 17-May-2017 14:21
    Dear RAPS Participants,

    In filing a 510k submission for a reprocessed (SUD) sterile vascular radiofrequency abalation catheter; is it necessary to have the bio-compatibility as described ISO 10993?

    Recently it has been suggested by regulatory professionals that proof of cleaning and removal of the cleaning agents along with sterilization validation should suffice for FDA 510k filing. But there some device predicates in this field that appear to require ISO 10993. Which path is correct?

    Anonymous RAPS Member 

  • 2.  RE: Reprocessed Catheters

    Posted 18-May-2017 08:31
    Edited by John Minier 18-May-2017 08:33
    Hi, Paul,

    The FDA issued a guidance on utilizing ISO 10993-1 for compatibility testing.  They specify other tests to be considered in addition to the original 10993 tests for some devices. 

    Safety of the cleaning materials alone is not enough as the environment where the catheters are processed and how they are packaged and sterilized may effect the biocompatibility of the device.  That is why the testing should ideally be done with the finished devices as they would be processed for production and delivered to the customer.

    The guidance is here:

    John Minier, RAC
    Consultant, Principal
    Minier Medical Device Consulting
    Highland Mills, NY
    United States