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I have a question about bundling in a 510k submission.
I am working on a 510k submission that includes 4 components packaged in a kit and provided sterile to the user. I have found a suitable predicate. The predicate and subject device kit contains 4 new components that are designed to work together, but one of these 4 components is classified individually as class 2 device, with a different product code, different indications for use. The review panel is the same (general hospital) and the kit and the component are both under regulation 880.5xxx, the testing standards are similar for the two codes.
I read through the bundling 510k guidance and my interpretation is that I can submit one 510k instead of 2 separate 510ks. My strategy is being challenged, because the predicate manufacturer has a 510k for the kit and a different 510k for the individual component.
The engineer designing the device obtained the predicate product for comparative testing and I verified the predicate kit includes the 4 components. My questions:
Have I read the guidance Bundling Multiple Devices or Multiple Indications in a Single Submission correctly?
If yes, would I include both product codes and reference both of the predicate 510ks (I would indicate one as the primary predicate and the other as a reference)?