Should I submit the entire copy of my software in a 510(k) submission??

[Afflin]

Hi, I'm new here . Working on a 510(k) submission involving extensive software with the device. I'm not sure if I need to submit the entire package of the software. Thanks!

[ascherp]

Hello and welcome to Elsmar,

The amount of information you will need to include in your 510(k) depends on the overall Level of Concern, i.e. risk for the patient, of your device.

The Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices located at http://www.fda.gov/MedicalDevices/De.../ucm089543.htm
explains the requirements.

[sagai]

Actually I would like to know what if someone submit the source code and claim ... hey guys, that is the specification, the design, the architecture, everything.
Let us know

[Afflin]

Thank you for reply. Probably because I am not a software guy, I didn't use the correct terminology. I actually meant to ask if I need to submit the source code. I checked the guidance, it looks like I don't need to submit the source code. The level of concern for my device should be minor because it is a non-invasive imaging processing application.

[sagai]

I would suggest to be careful with the determination of the Level of Concern and please read the guidance.
Image processing application easily can be major level of concern by the definition given in the guidance, Cheers

[RussKing3]

No. You will not submit the source code. As others have said, follow the guidance, prepare well all the documentation including the validation package with screen shots (if applicable) and be very thorough in your black box testing. If you like you an give me a call.

[arnaudl]

FDA guidance states that "Software for most medical image management devices is considered to be of minor concern." (including processing, but without "techniques to identify abnormalities in medical images or assist in diagnosis")
From 2008, it seams that most image processing softwares, (with more and more sophisticate functions) are submitted in moderate loc.
Except for treatment planing system (x ray beams calculation), do you know other types of medical software submitted in major level of concern ?

[sagai]

I think I would kindly suggest to read that guidance carefully and instead of set the LoC based on assumption, I would suggest to consider the fact that there is a concise questioner in order to determine the LoC.
Cheers!