When to submit a 510(k) for a change to an exisiting medical device

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R

ryno fan

#22
Thanks for the information, however, I am still unclear on whether the 1997 guidance on "Deciding when to submit a 510(k)..." is to be used in determining whether a change to a Class I exempt device exceeds limitations of exemptions.

Thanks again.:confused:
 
M

MIREGMGR

#23
The 1997 guidance was vague in a number of areas. Yours is one.

The more recent draft guidance was intended to improve things, but now it's cancelled.

You could call FDA DSMICA and ask to be referred to someone who can provide you with answers. My guess though is they'll tell you you'll have to wait until they've developed the response to Congress that the recent law requires.

If you push, my guess would be that they'll respond that when doubt exists as to whether a new/revised 510(k) is required, the device marketer is obligated to file for that new/revised 510(k).
 
S

stonelinton

#24
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.
 
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M

MIREGMGR

#25
Changes to a sterilization process can require a new 510(k). Your description sounds as if the sterilization process may have changed.

That, it seems to me, is the most significant change. If that one can be justified, I'd think the others could as well.
 
S

stonelinton

#26
We haven't changed the sterilization process, still using gamma, and have confirmed with provider that the dose is sufficient for both plastic bottle and foil pouch, equivalent SAL. Thanks.
 
M

MIREGMGR

#27
And presumably you've shown via at least accelerated aging that the new packaging materials have at least as good sterility stability...?
 
S

stonelinton

#28
We have results from the aging tests performed by a outside testing company on the Tyvek pouch, the sterile barrier which is unchanged in material, process or standards. What has changed is the "container" which we put the product into, from a plastic bottle to a foil pouch, which is then placed in the Tyvek pouch, sealed and sterilized. I'm assuming that the "container" has no effect on the safety and effectiveness or indications for use; and is not considered a significant change. Is this a fair assumption?
 
M

MIREGMGR

#29
What has changed is the "container" which we put the product into, from a plastic bottle to a foil pouch, which is then placed in the Tyvek pouch, sealed and sterilized. I'm assuming that the "container" has no effect on the safety and effectiveness or indications for use; and is not considered a significant change. Is this a fair assumption?
My understanding is no. Sterile barrier packaging system stability is considered an element of the overall sterility issue. You have changed materials/mechanical designs, so at a minimum you have to show that the new design has at least equal sterility stability for the declared product shelf life compared to the prior design.
 

Ronen E

Problem Solver
Staff member
Moderator
#30
We have results from the aging tests performed by a outside testing company on the Tyvek pouch, the sterile barrier which is unchanged in material, process or standards. What has changed is the "container" which we put the product into, from a plastic bottle to a foil pouch, which is then placed in the Tyvek pouch, sealed and sterilized. I'm assuming that the "container" has no effect on the safety and effectiveness or indications for use; and is not considered a significant change. Is this a fair assumption?
Sterility aside, you'd also need to show that the new materials (foil package and wipe) do not significantly affect the solution, for the expected worse-case scenario of storage, shipping and shelf-life.
 
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