Where 60601-1 represented in the 510k submission?

[ANicknameToRemember]

Hello folks,
I'm coming up to speed with the requirements of the 510k submission. I've learned a lot about QMS requirements and Risk Management requirements, and I've read a lot of the FDA Guidances associated with the 510k submission.

One thing that I cannot figure out is where in the 510k submission compliance with 60601-1 (Basic Safety and Essential Performance) is represented?

I can see that section 17 (EMC Compatibility) relates to a collateral standard of 60601, particularly 60601-1-2

What am I missing? Do I need to include a test plan, and a summary of results associated with 60601-1? Where does it go? Where can I find more information on this?

 

[Tidge]

Are you planning a 510k submission for a medical electrical device?

 

[ANicknameToRemember]

Are you planning a 510k submission for a medical electrical device?

I'm working with a client who is planning a 510k submission.
I'll be responsible for a small piece of the puzzle.

 

[Tidge]

Does 60601-1 apply to the medical device?

 

[ANicknameToRemember]

It would seem that 60601-1 applies, yes.
This is indeed a ME device, sorry. I missed the "medical electrical device" qualifier.

 

[Tidge]

The submission should absolutely speak to this. Minimally, all the test reports for 60601-1 (and collateral standards, and any appropriate particular standard) should be included... if not, the reviewers will ask where they are. If the test reports come from a NRTL, there is probably no need to include a specific "test plan". If the manufacturer is doing things themselves, or trying to be "cleverer" than a NRTL, the reviewers will have questions... as they say: "mileage varies".

There are many different ways to organize the submission... for example, the 60601-1 family could be called out in (motivated by) the risk management elements of the submission... or the submission's introductory material could bluntly call out the applicable consensus standards and point to NRTL reports as evidence of compliance. The submission should be complete enough that a reviewer on auto-pilot can quickly find all the supporting material.

The 510k packet isn't in the minimum amount of work to be performed during ME device development, it's the expected amount of material that the reviewers need to see (based on the nature of the device) to make a proper assessment. I've worked on submissions that included (some) "planning" documents, but I can't say that those were ever reviewed. From experience: if the agency thinks the submission is missing some testing they won't go reading submitted plans to see how/if a manufacturer rationalized not doing certain testing.

 

[ANicknameToRemember]

Thanks! This response was quite useful to me.