Bioburden sample size and CFU limit

[shimonv]

Hi Felloes,

We have a product (a feeding tube) that goes into the stomach. The device is non-sterilized because the stomach is a contaminated area.

We intend to submit bioburden data to FDA and I'd appreciate your input / thoughts:

1. What should be the sample size for Microbial Limits Test and from how many batches? I realize there are no specific stipulations for non-sterilized medical devices.
2. What should we set as the maximum number of CFUs? I thought of putting an alert at 150 and limit at 200. Here too, there is no official guidance on this matter for non-sterilized medical devices.

Thanks in advance,
Shimon

 

[yodon]

I'll say up front that I don't know! I was thinking, though, that maybe you can glean some information from doing a search on existing 510(k)s. Not sure exactly what the product code, your predicate, etc. would be. I got these results for product code knt (hopefully that link works). At least one I looked at did have sterilization validation in the summary.