510k Submission - Where to describe firmware and firmware design documentation?

T

tallu

#1
Hello,

We are preparing a 510k submission for class IIa medical device. System contains pc-sw and sensor which is used acquisition of biosignals.System does not provide any automatic analysis or diagnoses.

We have done all the documentation for pc-sw according to FDA guidance. But we are little bit lost with the firmware documentation in submission.

Where we should descripe firmware and firmware design documentation? In section 011 Device Description or in 016 Software Description?

Thanks for all the help.
 
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sagai

Quite Involved in Discussions
#2
Sorry for the dumb question, is ClassIIa for FDA?
I would vote on Software Description in case the device itself includes that firmware.
Cheers!
 
#3
I think it is worth remembering that the different parts of a 510(k) can be reviewed by different people, so it may help if each section has sufficient detail to be reviewed on it's own. Off course, this could mean duplication so don't take it to the extreme.

I would tend to give an outline of the firmware in the device description and then point to Section 16 for the full treatment.

Similarly, in section 16 I would have some hardware description, perhaps something like a block diagram, to help the reviewer understand what they are looking at.
 
T

tallu

#4
Thanks Pads for your post.

Should firmware be separated from sw? Because it feels hard to fit fw and sw in the same document.

Something like:
- 016A Software Description
- 016B Firmware Description


And yes, Device Class is II
 
#5
Should firmware be separated from sw? Because it feels hard to fit fw and sw in the same document.

Something like:
- 016A Software Description
- 016B Firmware Description
That should work.
Include a section contents page at the start to identify all the component parts.
 
T

tallu

#6
That should work.
Include a section contents page at the start to identify all the component parts.
I start wondering on next issue.

If medical device is intended to use only in acquisition of biosignals and it is substantial equivalance with predicate device - How much of firmware documentation is necessary to submit in 510K submission?

Example: Device is used with pc-SW which doesn't provide any automatic diagnoses or analyses or functions.

Is HW documentation more important than firmware documentation?
 
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