510(k) Revision Level History and Submission Requirements

[tebusse]

Greetings,

For the 510(k) submission of medical device software, the guidance documentation states that the revision level history generated during the course of product development should be submitted.

This is simple to understand, however, our device is moving from a Class I to a Class II, so the revision level history will actually have been released product.

Should this be explained in this section of the 510(k) that the revision history, up until the latest version, was for the Class I device?

Or, am I opening up a can of worms for the FDA?

 

[J0anne]

Re: 510(k) Revision Level History

This is not making sense.

I was guessing you hadn't yet submitted this 510 (k).

However, you have released product, so this cannot be so.

How can you just change the classification of a device? The reclassification would mean the SE device and any other SE devices would have to be reclassified as well.

 

[tebusse]

Re: 510(k) Revision Level History

The device is having a feature added to it that will take it from a Class I to a Class II device. Obviously, we have yet to add this particular feature until the 510(k) is submitted and approved.

I'm guessing the revision level history for the Class I device won't apply.

 

[J0anne]

Re: 510(k) Revision Level History

I think I understand.

If this is a new 510 (k) that hasn't been submitted, the design history documentation is sufficient

However, if you are waiting for a 510 (k) approval, you can't reclassify the device, you would need a new 510 (k)

 

[sreenu927]

Hi,
If I understand correctly,
You have a Class I medical device 'A' listed with US FDA.
Now you are adding some features to 'A' to make it as 'B', which is a Class II medical device.

If this is the case, what is the SW version that you are releasing with B?
In your 510(k) submission file, you need to mention, the SW revision history (version with it's release date) and follow the order until the current SW version for B.

Once you obtain the 510(k) clearance, do you intend to do a field upgrade of A to B or sell B as a separate device? If field upgrade, need to work with FDA on seeking acceptance from FDA.

Regards,
Sreenu