Bench Testing as part of 510(k) Submission

Hi Everyone,

I would like to know if we can include in the bench testing data from humans, animals and phantoms? I mean does anyone have experience with FDA auditors in that area? i.e. if I use data from different sources will they challenge that or what are they looking for in a mixed input sources for bench testing.

Thank you.

The recommended format for a 510(k) submission is very general and is meant to cover a wide range of devices.

The purpose of the bench testing section of the 510(k) as I understand it is to gather data on the functionality of the device, measure and quantify relevant parameters, and provide a technical basis for its efficacy. In other words, animal or clinical studies may well prove that it works, but bench testing can demonstrate the principles showing why it works.

Without knowing details about your device it is hard to give a clear cut answer. When you say you have data from humans and animals, does that mean the device was tested on humans and animals? If so then these data should be in the sections on animal testing and clinical testing. If you are saying that the input data were derived from phantoms, animals and humans, but tested literally on a laboratory bench, then it is up to you to structure the section so that you get your point across in a convincing way.

What the reviewers are looking for is evidence that the device does what you say it does in terms of efficacy and safety.

Does that help?