US Listing of Medical Device with Different Models

J

Julie O

#1
A device comes in three different sizes, small, medium, and large, because patients come in different sizes, too.

The device is 510(k) exempt, but if it were the subject of a 510(k), I'd think that all three sizes could be included in the same 510(k). Similarly, I'd think that all three sizes could be covered in a single device listing.

Would I be correct?
 
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paulag

Involved In Discussions
#2
It probably depends... With 510(k)s, it is all about substantial equivalence with the predicate device, so if that was available in different sizes, comparable to the three sizes of your device, that would be correct. Not sure yet how the FDA handles it when your predicate device is only, let's say, XL, and you have an extra-small one for preterm neonates?!
 

QA-Man

Involved In Discussions
#3
A device comes in three different sizes, small, medium, and large, because patients come in different sizes, too.

The device is 510(k) exempt, but if it were the subject of a 510(k), I'd think that all three sizes could be included in the same 510(k). Similarly, I'd think that all three sizes could be covered in a single device listing.

Would I be correct?
You are correct.
 
J

Julie O

#4
These devices are a form of consumer product headgear, so nothing for preterm neonates. The small size would probably be suitable for grade school children; the medium maybe for women, the large maybe for men, but those lines are not that sharply drawn. Customers just have the option of buying a size that fits them well, instead of OSFA.
 
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