Submit a Special 510(k) or "Documentation by our own"

[bennylee]

Dear All,

For some of products (that we have got 510k),
now, we want to slightly change some specification (device modification without any change in safety & intended for use & contraindication),
I just worry if I need to apply through

• Special 510(k)
• Documentation by our own (such as comparison & related test report )

Based on the following documentation #K97-1
http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm080235.htm
, it seems that Documentation by our own is fine

Based on the following documentation "The New 510(k) Paradigm"
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080187.htm
, it seems that special 510k is required.

Thanks !

 

[J0anne]

If you already have a 510 (k) then the K97-1 is the correct procedure to follow.

 

[bennylee]

Thanks for your reply !

Yes, I have 510(k) for the original version.

For this modification version, it seems that Special 510(k) is also applicable to our situation, so I am still confused.
"The Special 510(k) option will allow the Agency to review modifications that do not affect the device's intended use or alter the device's fundamental scientific technology within this abbreviated time frame.

Can I consider that "Special 510(k) is an optional, not mandatory for device modification ( without any change in safety & intended for use & contraindication) "?

 

[J0anne]

I can't see how you can reach this conclusion from k97-1, when the options are to either submit a new 510 (k) OR documentation.

 

[treesei]

Thanks for your reply !

Yes, I have 510(k) for the original version.

For this modification version, it seems that Special 510(k) is also applicable to our situation, so I am still confused.
"The Special 510(k) option will allow the Agency to review modifications that do not affect the device's intended use or alter the device's fundamental scientific technology within this abbreviated time frame.

Can I consider that "Special 510(k) is an optional, not mandatory for device modification ( without any change in safety & intended for use & contraindication) "?

Here is my understanding:

You first determine if your modification needs a new 510k using K97-1. If the answer is yes, you use the New 510K final guidance to determine which kind of 510k you can use. Under some circumstances, a modification still leads to a 510k (vs documentation) even it does not change the device's intended use, safety, technology, etc.

 

[isoalchemist]

Agree with treesei, first you need to walk down and document your decisions based on the K-97-1.

If documentation is all that's required make sure you have it.

If a 510k is required from the analysis you can then walk down the type of 510k to file. Be critical to make sure you meet the Special 510k criteria, the FDA will. Depending on the specification changes it may or may not be an issue.