Medical Device Software Level of Concern Determination

[Silvertabb]

If you have Device A that has its own software, but you decide to connect it to a standalone software installed on a PC which just extract data/information from Device A and provides reports and other data management related function. When submitting a 510k for the stand alone SW, one is required to indicate the Level of Concern for the SW based on FDA 2005 for Devices containing SW.
Since the Standalone SW is an accessory, one would need to answer the following (Q3). Is the Level of Concern in this case related to the SW(installed on the Device A and not the standalone SW) pre-mitigation hazards- meaning does one have to look up the Hazard Analysis for the Device A and if pre-mitigation hazard Severity is "Potential death or serious injury" then the level of concern for the standalone SW is "Major"? Or other aspect of Device A need to be considered as well.

If the answer to any one question below is Yes, the Level of Concern for the

Software Device is likely to be Major.

3. Is the Software Device an accessory to a medical device that has a Major Level of

Concern?

[yodon]

I think your assertion that the stand-alone software is an accessory is incorrect. The stand-alone software has its 510(k) based on its functions. The software happens to receive data from a device. I would assess the level of concern of the stand-alone software without consideration of the input source (consider it a black box).

Does that help?

[Silvertabb]

yodon,
this standalone SW has a 510k and its own hazard analysis. However, the guidelines as I stated in my first post asks whether or not this standalone device is connected to a device that has a major level of concern. In my case, both class II and Class III can use this SW. So to determine the SW concern level I need to know whether or not I should consider on the pre-mitigation SW hazard of the device to which this standalone SW will be connected to extract data or all hazards associated.

[sagai]

I do not know what is considered as an accessory.
is there any definition for that?

[20110131]

The FDA has 510K database(s) for similar items. A search through these databases might give some common sense guidance. Depending on the application, this software could be the remote output of vital information.
The degree of seriousness or device class would influence the level of software validation. The application could be a few lines of code, (indicating on/off), or a suite of seriously manipulated data graphics.
YEP! in short I would follow the other 510K filers..............

[yodon]

In Reply to Parent Post by Silvertabb

yodon,
this standalone SW has a 510k and its own hazard analysis. However, the guidelines as I stated in my first post asks whether or not this standalone device is connected to a device that has a major level of concern. In my case, both class II and Class III can use this SW. So to determine the SW concern level I need to know whether or not I should consider on the pre-mitigation SW hazard of the device to which this standalone SW will be connected to extract data or all hazards associated.

Maybe I'm not understanding the system. Is the stand-alone software required to use the device? Does the stand-alone software operate while the device is in use? My original thought was that the device does its thing, gathering data. Then you plug it into a PC (or whatever) and pass the data gathered to the stand-alone software. In this case, even though it connects to the device, it can't have an impact on the device use and so I wouldn't consider it in device hazard analysis.

If, however, the device is connected while it's being used or can influence the device then you should consider potential hazards with the device coupled with the software. I think that's what the guidance is driving at (potential influence on the device).

On the stand-alone software side, I still would consider the device as a black box that just provides inputs.

[sagai]

It is only my impression is that the case is that these two devices in the reality is one medical device and the company (there could be several professional or other reasons) decided earlier to clear the monitoring device first, but now, facing with this issue.
br.
Sz.

[sl344]

Hello everyone,

I'm also very confused by the software classification in IEC 62304. here is my situation. We have a product, a class III medical device, that contains a very simple piece of software do control the device to start/stop. Lets say the software can't cause any harm to the patient. Can the software be classified as Class A? Thanks.