No, the "non-significant" changes you've made to the device are not separated out in your SE justification. The SE justification is a comparison of the application device, as you want cleared, against the predicate that was your cleared device.
If the changes you made along the way in the device are pertinent to an SE decision, then you talk about them as if they are new.
I would, however, be very clear in your device description of what changes you've already made so that it's clear that you believe that it was legitimate to include those changes in a device that is currently in commercial distribution.
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Craig Coombs
President, Coombs Medical Device Consulting
Alameda CA
United States
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Original Message:
Sent: 27-Jun-2019 15:03
From: Anonymous Member
Subject: "Clean up 510k"
This message was posted by a user wishing to remain anonymous
Hello,
We are in the process of preparing a 510k that will include a change that we have deemed to require a 510k submission, which has not yet been implemented in the commercial device" as well as a series changes that we deemed to not require a 510k, and which have already been implemented.
We are clear from the guidance that all of these changes should be included and that the full device will be included in the device description. However, in the presentation of the substantial equivalence and performance data, do we separate the two types of changes in some way. For example, do we need to mention the 'non 510k changes' in the SE and do we need to submit performance data?
Any experience you have in doing these effectively is helpful.
Cheers!