510k Level of Detail Requirements

tebusse

Involved In Discussions
#1
Greetings,

Is anyone able to provide me with some guidance regarding the level of detail for items in the 510k such as providing a summary of configuration management or maintenance activities?

For example, do we have to explain that maintenance activities are requested by internal/external customers, request is documented, goes for quality assessment, etc.

Any advise would be most helpful.

Cheers, Tonia
 
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isoalchemist

#2
At the level I believe you are asking the question the answer is NO. The 510k not to show control of your processes (21CFR820) but to show that the device you are proposing is substantially equivalent to the predicate devices chosen. You must show that it gives the same results and uses similar technology or other technolgy that is proven (usually a second predicate device).

Basically you are proving the device is safe and effective, not telling your processes.

With that said if the User need to perform maintenance, that should be included as part of the Use Manual (i.e. labeling)
 

tebusse

Involved In Discussions
#4
Now I'm a little confused.

The guidance documentation for software states that we have to discuss configuration and change management along with maintenance. How is one to describe this as it relates to the predicate device?

Please note, this information is to be included in the section pertaining to the device's level of concern.

Regards, Tonia
 

tebusse

Involved In Discussions
#6
Thank you. This guidance document is what I've been following and it seems to me that discussing the design process, configuration/change management, maintenance, V&V are all part of demonstrating that the device is safe and effective.

Correct me if I'm wrong, but this section of the 510(k) is not necessarily designed to demonstrate substantial equivalence to the predicate device.

Regards, Tonia
 

Marcelo

Inactive Registered Visitor
#7
This is related to substantial equivalence, but in a weird way. It's more related to safety in general.

The problem is the way safety is ensured for software.

You can assess safety and equivalence in hardware by means of information and testing and related stuff.

For software, you can only assess safety by controlling the development (full) lifecycle. And you really cannot directly compare two different softwares the way you can do to hardware.

So, in a way, the information you have to provide does show that your software is "safe".

Also, you could take a look into IEC 62304 for more help.
 
Last edited:
#8
A Major Level of Concern device requires enough detail to allow for a thorough understanding of the configuration management and maintenance plan.

For a Moderate Level of Concern Device a summary of the configuration management and maintenance plans is sufficient.

Correct me if I'm wrong, but this section of the 510(k) is not necessarily designed to demonstrate substantial equivalence to the predicate device.
You are correct. This section is designed to determine the Level of Concern and to supply the documentation according to that determination of the Level of Concern
 
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