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Some doubts about traditional 510(k) submission

Ashley Fu

Starting to get Involved
#1
we are planning to submit traditional 510(k) of a software. Now we have a difficulty whether a phantom test belongs to bench test since they are all non-clinical performance test. In the phantom test, We use the model to replace the blood vessels and verify the accuracy of measurement analysis our software.
And I'm confused when registered in EU, our clinical data were mainly derived from the literature. I don't know,in 510(k), whether we need to write this relevant scientific literature report into the section of performance testing-clinical of 510(k) submission, because it focus on the determination of the substantive equivalence between proposed device and predicate device.
 
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monoj mon

Quite Involved in Discussions
#2
we are planning to submit traditional 510(k) of a software. Now we have a difficulty whether a phantom test belongs to bench test since they are all non-clinical performance test. In the phantom test, We use the model to replace the blood vessels and verify the accuracy of measurement analysis our software.
And I'm confused when registered in EU, our clinical data were mainly derived from the literature. I don't know,in 510(k), whether we need to write this relevant scientific literature report into the section of performance testing-clinical of 510(k) submission, because it focus on the determination of the substantive equivalence between proposed device and predicate device.
It will go with the "Bench Test Summary", not with the "Clinical Performance Summary" as you have done a bench-top simulation, not an actual test on human being. FDA has some literature for such use of "Modeling or Simulation" of medical device application. For your reference read this.

For the "Clinical Performance Summary" to FDA, you can use the same document what you prepared for the EU, provided your predicate(s) hasn't done any clinical performance testing for their submission.
 
Last edited:

Ashley Fu

Starting to get Involved
#3
The "Clinical Performance Summary" we prepared for the EU, is mainly to prove safety and performance of the device by comparison.
Is it possible not to provide clinical data when my device is substantially equivalent to the predicate device? For most 510 k, clinical tests are not available aren't they?
 

monoj mon

Quite Involved in Discussions
#4
The "Clinical Performance Summary" we prepared for the EU, is mainly to prove safety and performance of the device by comparison.
Is it possible not to provide clinical data when my device is substantially equivalent to the predicate device? For most 510 k, clinical tests are not available aren't they?
Yes, that's what I have said. You can simply provide the same "Clinical Performance Summary" that you submitted for your CE mark. You don't need to provide any actual "Clinical Data" of your device to the FDA, if your predicates haven't provided any "clinical data" in their submission. If your predicates have provided any "Clinical Data" in their submission then FDA might ask you also to provide it. Most of the 510(k)s are without any "Clinical Data", but 510(k) submission with "Clinical Data" also exists. So, you better study the 510(k) summaries of your predicate and find out whether they have provided any "Clinical Data" or not. If they haven't provided any "Clinical Data" then they must have submitted only "Clinical Performance Summary" based on literature. Then you can submit the same document that you prepared for EU.
 
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