Really need some feedback on this one...

My question is in regards to FDA Memorandum #k97-1 "Deciding When to Submit a 510(k) for a Change to an Existing Device". Para. B8.3 of the document (and the attendant flowchart) creates a decision box asking: "Do results of design validation raise new issues of safety and effectiveness?". If the response is "YES", a new 510(k) is required. If "NO", documentation is adequate.

We have a cleared Class II device which we are modifying in a way that creates new risks. These risks are being assessed through our Risk Management process and were determined to be of an acceptable level per our procedure. Nonetheless, they are new risks.

My specific question: Does the creation of a new risk equate to being a "new issue of safety...." as per the memorandum definition? And if so, does that fact that the new risk is acceptably mitigatible "trump" the "YES" path of this particular decision.

As always, I am fully aware that a "guidance" document is just that. Nevertheless, I'd appreciate any feedback from "real" user experience!

Were these new risks identified as a result of your review of design validation or did you identify them earlier?

These are NEW risks identified in the risk evaluation process of the proposed design change. Prior to the new (proposed) change, they did not exist. Again, they are very mitigatible, but nonetheless new.

The key is "Do results of design validation raise new issues of safety and effectiveness?"

We had a 510(k) for a sterile probe that connected to a non-sterile handle and cable. The probe was sterilized via gamma.

We later integrated the cable, handle, and probe into one sterile device. The handle's material changed (but it does not make patient contact). We also changed the sterilization method to ethylene oxide.

As you can imagine, a variety of new risks arose. However, none of the new risks were identified as a result of design validation. The device performed exactly as well and in the same manner as the original and there were no new safety issues. We did not do a new 510(k).

Go back to your design validation documentation.
Is the device less effective than the original? Yes - new 510k. No -documentation.
Is the device more difficult to use? Yes - new 510k. No -documentation.
Are there more ways the user/patient can be harmed? Yes - new 510k. No -documentation.
Are there more things that can go wrong? Yes - new 510k. No -documentation.

As you can imagine, a variety of new risks arose. However, none of the new risks were identified as a result of design validation.

This is the part that is confusing to me. How does a newly identified risk differ from a new risk "identified as a result of design validation"? Understanding this may be the key to my dilemma...!

You should be conducting risk management at each stage of the design & development process (and after product release). When you first think of the device concept, when you create the inpouts, when you manufacture some prototypes, when you do verification, when you do validation, etc.

However, forget about risk management altogether just for a moment. I really don't think the guidance document wasn't created with risk management (ISO 14971) in mind.

Just focus on anwsering the question Have any new issues of safety or effectiveness been uncovered during design validation?" Answer the question in a vacuum, focusing only on what was observed and recorded during simulated use testing / design validation.