510(k) 10993 Biocompability Testing

[Mixi_Austria]

Hi!

I'm in the process of preparing a 510(k) for a wound irrigation solution. I've identified predicate devices and read through a lot of FDA guidance documents but there's one thing I currently cannot find an answer for.

Biocompability Testing according to ISO 10993 is required. The question is: Do I have to test my device along with the predicate device to show that they both have the same characteristics?

Take cytotoxicity testing according to 10993-5 for example. I want to test my device according to this standard to show that no cytotoxic effects are to be expected with the intended use. But do I have to also test the predicate device to show that the cytotoxic profiles (of new device and predicate) are similar? Or do I rely on the fact that the predicate obviously proved low / no cytotoxicity or otherwise it would not have passed it's own 510(k) process.

 

[shimonv]

The question is: Do I have to test my device along with the predicate device to show that they both have the same characteristics?

From my experience, you don't need to do a cooperative biocompatibility study. You should subject your device to similar tests as with the predicate, and once you have demonstrated that no cytotoxic or whatever else are to be expected within the intended use - you are good.

 

[Mixi_Austria]

Thanks for your quick reply! That makes sense. But I guess the devil is in the detail. With Cytotoxicity for example you rarely get a yes / no result. Most wound cleaners are cytoxic to some degree after longer time of application. How can I know the "level of cytotoxicity" of my predicate? The 510(k) summary will just say "it has been evaluated for cytotoxicity".

 

[shimonv]

The results of the predicate biocompatibility tests are proprietary. You need to do your own testing first and see if you get conclusive results or not. Your test lab should be able to help you rationalise the results.
If the results are not good you may need to change the raw material, but a comparative biocompatibility study is not a good option.

Shimon

 

[Mixi_Austria]

Thanks! May I ask what your background of experience with 510(K) procedures is?
My test lab can for sure put the results into perspective. Yet they are not very familiar with the 510(k) requirements and they made the suggestion of comperative biocompability

So you're saying first of all my lab should evaluate biocompability according to 10993, then I prepare a 510(k) claiming sustantial equivalence and then (if eveything goes to plan)....i claim that no new questions of safety and effectiveness have been raised.

Right?

 

[shimonv]

So you're saying first of all my lab should evaluate biocompability according to 10993, then I prepare a 510(k) claiming sustantial equivalence and then (if eveything goes to plan)....i claim that no new questions of safety and effectiveness have been raised.

Right?

Right.
To answer your question - I've been involved in few 510(k) submissions.
If someone else in the cove has something to add - please do

 

[Mixi_Austria]

Thanks, really appreciated.
This is the first 510(k) we're working on. We're based in Austria and it's at times difficult to navigate the FDA guidelines when you're based outside the US.

 

[shimonv]

Good luck. First submission to FDA is special

 

[Mixi_Austria]

thanks! lets hope it works ... fingers crossed.

 

[Watchcat]

I don't normally recommend "fingers crossed" as a regulatory strategy.

I just happen to be in the middle of some ongoing conversations with other device RA professionals about FDA and biocompatibility. I will be happy to share what I've learned so far, but it would be very helpful if you could first provide me with some additional info:

How do you know biocompatibility testing is required?

Why are you asking us instead of FDA?