How to find required testing for a specific device?

itscloud

Starting to get Involved
#1
Hi,

Just wondering how do you find the performance testing requirements/standards for a specific device for 510k submission?

For surgical masks, there are recognized consensus standards for a device, but for a "Catheter, Thrombus Retriever" product code: NRY, there arent any recognized consensus standard shown.

How do you know what testings are required to be performed?

Thanks a lot in advance
 
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John Predmore

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#2
All recognized consensus standards today started, at one point in the past, with someone saying there is no test for this characteristic, we need a test for this. What would be a good test for this? How might that test be organized and conducted?

You can research industry and academic periodicals and technical publications in your field, for similar work. Contact the authors to see whether they will share any advice on the test methods they used. In the end, your people must document the rationale for the test methods you chose to use, and hope the regulatory authority accepts your justification for the decisions and judgements you made. This is my opinion.
 

mihzago

Trusted Information Resource
#3
you can also look at the description of performance testing performed by the predicate devices. 510(k) summary typically includes that information, though not always in sufficient detail, especially in the older submissions.
 

Watchcat

Trusted Information Resource
#4
510(k) summaries are my favorite source, too. Search FDA's premarket notification database for product code NRY. As mihzago notes, some of them can be pretty skimpy, but you should find a good number of recent summaries available for this product code, as well as the 510(k) summary for your predicate, if it has been posted.
 
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