Is a different 510k is required for each (stand alone) software configurations?

P

Peter So

Registered
Does anyone know if a different 510k is required for each (stand alone)software configurations? For example, let's say this software is called "Anatool" for Windows and the version for MAC OS is called "AnatoolMAC". Both software has same functions and same intended use. Would I need to submit a 510k for "AnatoolMAC"?

What about if I name it completely different name, "Clinictool"? It still has same functions and same intended use but re-branded so that a partner company can include the software in their product package? Would it need a new 510k?:bonk:
 
Y

yodon

Leader
Super Moderator
Shouldn't be separate 510(k)s. You, of course, need to demonstrate that the product meets specification on all platforms. We've had clients offer applications on different platforms and they didn't have to have separate filings.
 
L

locutus

In simplest terms, when you have different software modules or applications then use a Product Family approach. As an example, I have an IVF catheter with 4 versions, but they are all under the Family 'X' designation - thus under 1 510k for Trade Name 'Family X'. The same analogy can be used for software. In your example, you have Product Family Anatool, but then you have one version for Windows, one version for Mac, and one version for mobile platforms. The Trade Name Anatool can be made in 1 510k submission.

As long as the indications for use, basic functionality, operation, etc. (refer to the FDA guidance document on when to submit a change to a 510k) then they could be grouped under the same 510k application. With that said, some may argue that a Windows platform and Mac platform are completely different from a software perspective, thus requiring 2 510k submissions. In my experience with FDA, as long as your Software Architecture Design document is thorough and detailed, i.e. showing that the application is on two platforms, this is most often accepted by FDA.
 
mihzago

mihzago

Trusted Information Resource
You can clear all the versions under a single 510(k); however, when you get clearance for only one, say Windows, and then want to release a new platform, then you'll need a separate 510(k) (probably Special 510(k).
 
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