Does Windows Service Pack (SP-3) upgrade need supplementary 510(k) submission??

sreenu927

Quite Involved in Discussions
#1
Hi all,

1. For an IVD instrument(has software with it), which has got 510(k) clearance, if the service pack (SP)-2 is changed or upgraded to SP-3 of Microsoft Windows OS, then do we need to submit supplementary 510() for this change?

2. For a 510(k) cleared instrument label, what are the implications for a lable change? The label change includes adding CE symbol, IVD symbol.

Thanks,
Sreenu
 
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M

Martin IT

#2
Hello every one,

I've got the same problem, and more, if I changed the version of our software, I'd have to upgrade the label ( for example if I upgrade my sw version from 1.1.0 to 1.2.0 the label over the MD must be changes? )

many thanks to all
 

Le Chiffre

Quite Involved in Discussions
#4
In my opinion it depends... specifically on your system definition. Does your product description include the host machine and operating system? I've always made sure these were excluded from the device licence or product definition, stopping at the software which requires a minimum version of the O/S and hardware capability. This approach may be acceptable for lower risk classifications and on your product and its dependency on O/S functions, etc. In the end it should be based on the impact this change could have on your product.

In your case Martin, it sounds like you're making a non-trivial change to your software by going from 1.1.0 to 1.2.0 - is this related to the O/S or for other reasons? A common "trick" is for minor revisions to increment the far-right (least-significant) digits in the software version or the build number that aren't specified on the label, e.g. "Ver 1.2".
 

sreenu927

Quite Involved in Discussions
#6
Hi Le Chiffre,

Thanks for the information.
Yeah, we have included the software as part of the instrument system.

The change doesn't effect the performance of the instrument.

Do u think that we do either impact analysis or risk analysis w.r.t. the change of SP-2 to SP-3?

Thanks,
Sreenu
 
J

Juan Dude

#7
Hi Le Chiffre,

Thanks for the information.
Yeah, we have included the software as part of the instrument system.

The change doesn't effect the performance of the instrument.

Do u think that we do either impact analysis or risk analysis w.r.t. the change of SP-2 to SP-3?

Thanks,
Sreenu
Definitively, this will help you determine how to proceed.
 
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