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.
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.