Good day anon,
This is one of the main challenges with a predicate device system (or equivalence device system) when maybe the predicate device is a bit older, there is not enough public information, or type of device where there is just not much available information. This is where you get good at doing research, hunting around, and maybe finding some public information from multiple google search terms. In my experience when there is limited information, base the substantial equivalence on your on subject device operational, functional, characteristics, intended use, materials, performance, etc., and fill in what you have available on the other device. In my experience there is some "unknown" or "not available" entries in the comparison table. This then means in the comparison discussion there needs to be rationale, justification why there are no additional questions for safety or efficacy. As an example, maybe your device is made from such-such PVC/ABS and you know the other device is made out of "plastic" but not sure the exact type. The argument or justification can be supported through biocompatibility testing. The challenge will be in the performance characteristics where in my experience we had to conduct side-by-side testing requested by FDA supporting the devices are indeed equivalent. This all depends on the type of device, the technology, how many years on the market, as newer devices this may be more difficult to show substantial equivalence.
Yes, the comparison testing may be supported by testing to standards, such as electrical safety standards, sterilisation standards, biocomp, or even performance standards like some of the 60601-2-xx standards. Again, you have to describe in your justification why your device does not raise any additional concerns of safety or efficacy when your device meets certain safety or performance standards. No, the FDA does not expect a side-by-side comparison in relation to the IFU - but they do expect a side-by-side comparison on characteristics of the device. There are quite a few examples in 510(k) Summary publicly available on the FDA website to give some ideas. This does depend on your device type.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 27-May-2020 10:10
From: Anonymous Member
Subject: substantial equivalence with limited info
This message was posted by a user wishing to remain anonymous
Hello,
how company manage to prove substantial equivalence when the predicate is economically not affordable (so, reverse engineering is not possible, IFU is not available, etc.) and FOIA requests come back completely blank (all redacted)?
Is ok to rely exclusively on the (very concise) information on the 510k summary and very limited info in public brochures?
Also what is expected in term of comparison of testing? Is sufficient to be compliant to the same standards (e.g., 60601-1, 60601-1-2, 10993, etc.) or specific results/levels need to be compared (e.g., levels of emissions, specific performance, etc.). How is it possible to do so, when such info is not known?
Regarding IFU, does the FDA expects a side-by-side comparison?
Thanks!