Three final products in one biocompatibility test?

[Min_t]

We're a young start-up medical device company and our products are bTCP bone graft, bTCP-Hap bone graft and bTCP-calcium sulfate injection type bone graft.
We are now planning the biocompatibility test for 510(k) submission.

According to my regulatory and 10993 knowledge, three final products should conduct their own 10993 test separately.

However, RD department insist that since they can prove these products do not have any interacted effect, so three final products can be extract in one extract solution (used the extraction of bTCP to extract bTCP-Hap and then extract bTCP-calcium sulfate, so it would not have any dilute problem) and conduct one full biocompatibility test. The cost is only 1/3 compare to the three individual product testing.

I am really confusing,
it's sound quite logistic, although i concerned about the thought of one solution extract three sample would be the same situation for single product extraction (based on those solvent/solution chemistry things), and for me, according to the regulatory, it seems not right.

Any experience?or has anyone been facing this problem too?
please help and thousand thanks!

 

[planB]

Re: Help~ three final products in one biocompatibility test?

Min_t,

I would recommend as a first step, you do a thorough material characterization (both literature and your own leachables/extractables studies) and at least a cytotoxicity test on each individual final product before you consider pooling independent product for any further biocompatibility test.

If you can demonstrate that your 3 products have an equivalent leachable/extractable and cytotoxicity profile, whereby equivalency is supported by the material data you unearthed in your literature search, you might be able to present enough objective evidence justifying pooling you three products for any further studies.

But be aware that you might get challenged on your "equivalence" rationale and you would have really convincing data at hand why you would not introduce any masking /suppressing or other artificial effect into your extracts and why you could reliably predict the absence of those effects for any further biocompatibility test you plan to do.

Personally, I would be conservative and not pool the 3 final products, but focus on gathering enough objective data justifying minimizing the (in-vivo) test array for each bone graft, respectively, rather than focusing on pooling extracts and explicitely testing for all biological risks that you have identified for your products, which should be considered according to the "test-to-consider" matrix in ISO 10993-1:2009.

HTH,

Gerhard

 

[Min_t]

Re: Help~ three final products in one biocompatibility test?

Gerhard,
THANKS!!! it's helpful