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Hi all,
we would like to add to our 510k submission an accessory that our predicate does not have.
This accessory is already in the US market as a class I device with a slightly different intended use (i.e., the purpose is the same but the population is slightly different). We also modified its design slightly to make it compatible with our device.
Which level of testing/evidence FDA may request on this accessory in our 510k?
Thanks for any guidance you can provide