I have a question about submitting a new 510(k) for a specific situation. I have a endoscope anti-fog device with a premarket notification clearance from 2000. It was originally submitted and sold as sterile in a bottle with foam pad in a sealed Tyvek pouch. I have over the years added a variant that has the same formulated anti-fog solution with the exact same indications for use, but now offered in a sterile presoaked wipe in a foil pouch. The new variant has a different product number, the name adds "Wipe", other than the name change and instructions, i.e. open pouch, wipe lens instead of open bottle, soak foam pad, wipe lens; did not change. Would these changes necessitate a new 510(k) or can I just document these changes?
Some concerns, obviously process of getting solution onto wipe and in foil pouch differs from bottling process, does this constitute a substantial manufacturing process change?
Material changed from plastic bottle to foil pouch, is this a significant material change?
Label changed with name, product number and instructions for use, while this doesn't change the indications, safety of effectiveness, would it necessitate a new 510(k); the Memo #97-1 flowchart A suggests that if the labeling [is not] being revised for clarity to ensure safer or more effective use then it requires a new 510(k) . . . these seems counter intuitive.
Thanks.