Decision to file a new 510(k) - ETO (Ethylene Oxide) Sterilization

N

NathanJR

#1
OK, so this one should be an easy RTFM, but as usual the guidance is a little vague.
Situation: Class II medical device provided sterile by EO, validated and approved to be sterilized by the end user by EO. I would like the end user to be able to use sterrad sterilization also. From K97-1: "Changes which have a lower sterility assurance level (SAL) would routinely need a new 510(k) as would those which ordinarily affect the integrity of the device materials."

OK, so the SAL is 10^-6 on both, so no worries there, but does the FDA consider Sterrad something that would "ordinarily affect the integrity of the device materials?"

In The updated 510K sterility review guidance K90-1, they classify "combined vapor and gas plasma" sterilizers as "non-traditional", however at least for endoscopes it seems to be the gold standard.

I know I will have to get ASP to perform efficacy and functional validations, but I can't discern how much I would be at risk if I didnt file 510K and have them come back later and say it is not substantially equivalent and take my device off the market until a new 510k is approved.

BONUS ADDITIONAL GREY AREA!
I will have to make a design change to my lumen to meet lumen claims of sterrad. (pebax -> PTFE)
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
Hello Nathan and welcome to the Cove :bigwave:

I would guess that if you change a generic polymer (Pebax -> PTFE) of a significant component you'd probably need a new 510k, because it could raise new technological issues regarding safety or effectiveness. Apart from looking at sterilizability and the effects of the sterilization on the device properties, there may be other consequences for changing materials.

Cheers,
Ronen.
 
M

MIREGMGR

#3
The user guide for the Sterrad 200 at https://www.jnjgatewayifu.com/eLabelingContent/Asp/USENG/99712_01_ST200EnglishDom_47968.pdf has a procedure for determining material and lumen-geometry suitability.

The Sterrad 200, for instance, is limited to lumens that are at least 6mm in diameter and no more than 310mm in length. About half the materials in the "acceptable" list are marked with a material-deterioration-over-multiple-cycles qualification, which I think would cause the FDA's "integrity of materials" condition to apply.

I assume you won't be stating qualification to use all Sterrad, but rather either qualifying for one or more specific Sterrad machines or validating for a specific range of Sterrad process parameters that your customers then can match to their Sterrad machine's performance.

Given that, I think your decision process is two step:

1. OK per the appropriate ASP decision tree(s), without a deterioration-of-material issue?

2. Consistent with the other requirements identified in your sterilization validation, i.e. bioburden sensitivity, etc.?
 
Last edited by a moderator:
N

NathanJR

#4
Thanks for the replies!

Ronen, following the chart in K97-1 flowchart C for materials change brings me to C2.2.1 "Consider the requirements of ISO 10993-1, is additional testing required?"
Is this a definitely a yes? -> which would point you to a new 510K, or is using a common and well characterized material like PTFE (which is used for this component in literally all other predicates) acceptable without testing?

MIREGMGR

Yes, we would follow the ASP guide for the NX and 100NX and meet the lumen claims and material claims. I believe validation on the NX is considered worst case for those two.

We want to market for a very limited number of uses, maybe 10- I was going to run the functional validation to maybe 25-50 cycles.

We have a cleaning protocol which is validated for use by the end user, which would probably need to be re-validated with the new lumen design.

Thank you again. I wish I would have found this place a long time ago.
 

Ronen E

Problem Solver
Staff member
Moderator
#5
Ronen, following the chart in K97-1 flowchart C for materials change brings me to C2.2.1 "Consider the requirements of ISO 10993-1, is additional testing required?"
Is this a definitely a yes? -> which would point you to a new 510K, or is using a common and well characterized material like PTFE (which is used for this component in literally all other predicates) acceptable without testing?
Normally, biocompatibility testing is required on the finished device as a whole.

:topic:

I wish I would have found this place a long time ago.
You can thank Google for giving the Elsmar Cove a hard time.

Cheers,
Ronen.
 
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