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QuidWilson

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QuidWilson

Re: Adrock post# 59052

Tuesday, 09/19/2017 10:05:05 AM

Tuesday, September 19, 2017 10:05:05 AM

Post# of 140471
I agree if you mean "no, animal." But I don't agree if you mean "no animal" or yes human. Since we are filing for 510k on a class II device we are declaring we are substantially equivalent to predicate device (davinci) and from what I can tell that meams preclinical trials on animals are sufficient to establish assumptions. But the degree of differentiation may affect the requisite. Apparently only 10-15% of non PMA/IDE devices filed as class II require preclinical trials.
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