N
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)
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)