Predicate Material 510(k)

[Steve.GP]

Good afternoon members,

I have a doubt if it is acceptable by FDA to select a predicate with material different from our subject device (e.g. the predicate is made from Titanium and our subject device is made from Stainless Steel).
We have all the tests either mechanical and biocompatibility for our device.

Thanks for your attention.

 

[Jen]

Yes. I think you can do that. But you have to prove/justify the difference in material will not increase the risk of the device.

 

[monoj mon]

It will be acceptable if you can prove that the change of material does not affect the 'Safety and Effectiveness' of the device when used as intended. In your substantial equivalence section discuss the difference while making the 'Equivalence/Difference' determination and link to the respective section where you have objective evidence of your device performance.

 

[akp060]

You could look for a reference device