Curious about the advice to do comparative testing in animals, because I was head of RA/QA in a large animal pre-clinical testing facility, and for a time IACUC chair.
I never saw comparative testing to predicate in any of the studies, at best it was sham devices (e.g. Current turned on versus off- neurostim type devices, things with NPWT models), with our lab perhaps being blinded, when practical to the device state.
The impact of a surgical procedure had so much effect, that it was hard to tease out any comparative differences. Much of the early studies to develop the study models were done non-GLP, then a few pivotal GLP studies, which QA audited of course.
Interesting, since most of the devices tested in our lab were those which would have been Class 2 and 3 and the studies were generally safety only and not efficacy.
If you are doing medical device long-term surgical animal studies you are generally going to end up with clinical trials.
------------------------------
Ginger Cantor, MBA, RAC
Founder/Principal Consultant
Centaur Consulting LLC
River Falls, Wisconsin 54022 USA
715-307-1850
centaurconsultingllc@gmail.com------------------------------
Original Message:
Sent: 16-Jan-2020 01:16
From: Richard Vincins
Subject: Comparative testing to currently legally marketed devices in US 510k submission
Wei-Beng,
In most cases when doing a comparative study for a US FDA 510(k) application you would need to acquire the comparative device (assuming predicate device) to complete a side-by-side testing. In your case using an animal model, you would need to perform the same testing with Company A and Company B products in the study. Make sure you clearly identify the performance specifications, use requirements, and acceptance criteria for the study. You are right that access to this type of data for the comparative device is usually not available (unless they have done something and posted in literature or their IFU), so the expectation is would complete this side-by-side study with both devices.
------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs
Original Message:
Sent: 15-Jan-2020 02:39
From: Wei-Beng Ng
Subject: Comparative testing to currently legally marketed devices in US 510k submission
Hi all, I am in the preparation process for a US 510k submission of a balloon catheter. I have a question in relation to animal study in the context of providing comparative testing to a currently legally marketed device in the US. For example, if the identified substantially equivalent device is A and my device is B, for in vivo thromboresistance study in the dog, Jugular vein, do I have to perform two separate animal test, one using device A (substantially equivalent device), the other using device B (own device) in order to fulfill comparative testing requirement? The train of thoughts here is that I would not have access to the similar animal test results of the other company's device A not to mention a comparative assessment unless I were to purchase/acquire the other company's device A and test it together with my own device in my animal study. Would appreciate some pointers on this. Thank you.
------------------------------
Wei-Beng Ng
Singapore
Singapore
------------------------------