510(k) Biocompatibility vs Cleaning Validation

#1
We submitted our 510k for our nasopharyngoscope and our original submission had biocompatibility testing done by our manufacturing partner's testing facility. They performed irritation and cytotoxicity testing. When they performed these tests, they cleaned the device first with a solution of 70% ethanol and then rinsed in PBS with 1% penicillin/ streptomycin solution.

We have submitted two other scopes in the last 5 years and both times we went through and did our own cleaning validation with Cidex OPA and Enzol which are more commonly used solutions in the US. These solutions are both 510(k) approved and sold by J&J.

One of our scopes that we submitted in 2013 for approval was submitted identically to this one. The 2019 scope is a more advanced video scope as opposed to the eye piece one from 2013. There was the same biocomp lab testing using the same cleaning and we also did a separate cleaning validation in the US using the different enzymatic solutions. We also have the exact same FDA auditor. We didn't use the 2013 scope as predicate because it had a different product code and went with two video scopes instead.

Our deficiency question this time is:
In your biocompatibility testing, the non-sterile test article was disinfected with 70% ethanol and then rinsed in PBS with 1% penicillin/streptomycin solution. However, your proposed reprocessing methods for the subject device use an enzymatic detergent, Cidex® OPA and Steris® S40 Sterilant Concentrate. Please explain why your test article was not prepared using the reprocessing methods proposed in your labeling and provide your rationale for considering your adopted approach is appropriate. Similarly, please clarify why your proposed reprocessing methods do not introduce toxic residues into the device. Otherwise, please repeat all biocompatibility tests on the final finished form of the subject device using worst-case cleaning, high-disinfection and sterilization methods.

Any suggestions on how to respond to this? Of course our proposed reprocessing methods does not introduce toxic residues into the device. The solutions used are approved and widely used and our cleaning validation demonstrated that they were efficient in cleaning our scope.
 

Marcelo Antunes

Addicted to standards
Staff member
Admin
#2
You need to do a proper biological evaluation, and any test required to be performed or re-performed would only be the result of your toxicological risk assessment (as per ISO 10993-1 and ISO 14971).
 

yodon

Staff member
Super Moderator
#4
Not surprising they were more critical of the process this time. The whole duodenoscope thing has everyone at heightened awareness of cleaning.

Exposing materials to solutions could have an impact on the biocompatibility assessment so the finding doesn't seem illogical.
 

indubioush

Involved In Discussions
#5
I am confused. Did you clean the device with Cidex OPA and then do a biocompatiblity assessment on that device? Or did you only do biocomp on a device cleaned with isoproanol and the antibiotic mixture? Cidex OPA can cause an allergic reaction in its liquid form. Biocomp should always be done using a device or representative device that has undergone the same processing as the commercialized device.
 

Top Bottom