Software for a Class II Medical Device - Required Advice for 510(k)

[manju.ado]

Hi,

We are developing software for a class II Medical Device. We are adding a small new functionality to software and this change to software is very minimal. The new functionality is independent of other functionalities software. Addition of this functionality will not affect the existing software in any manner. The old software is being approved by FDA and in the market quite some time.

I have following queries:

1. In this scenario, do we need to go for traditional 510(k) or Special 510(k)?
2. What would DHF contain? Only design history of new functionality and impact analysis document to claim that new functionality will not be affecting old functionalities? Or do we need create all the design history documents for all old functionalities also.

Please advice.

Thank you in advance.

Regards,

Manju
+91-9011081376

[sagai]

Hi,
I am only wondering in case the new functionality is absolutely independent from the old one, than there is a potential, that your original intended use has changed, due to you can not relate the new function to any earlier one.
And if it is the case, you have to have a traditional one.
Special 510k looks tempting, but you shall declare conformance with a couple of standards in that case.
br
Sz.

[manju.ado]

Hi Sagai,

Thank you for your reply. It’s indeed useful.

Actually indented usage won’t change but there could be minor change in indication for use, however it is very negligible.

When I follow the flow-chart B of document “Deciding When to Submit a 510(k) for a Change to an Existing Device” (attached document) through changes to software or firmware (B8 - section), I’ll be reaching to “Documentation”, with certain level of presumptions at this point of time.

1. What exactly documentation meant here? And what all it contains?
2. As 510(k) no ware appearing (new or traditional / abbreviated or special), in this case actually 510(k) itself is required.

Please advice.

Appreciate your help.

Regards,

Manju

[sagai]

Hi,
I'm not sure the change of sw functionality can be categorized among:

"labeling changes, technology or performance specifications changes, and materials changes"

and as such I am not sure this guidance is applicable to your situation.
I feel the traditional 510k is the one required, I would drop special/abbreviated because why would you create more specific requirements to your QMS than already there. The timing of the 510k can be a question.
br
Sz.

[manju.ado]

Thank you Sagai.

Then what should we do if this document as such is not applicable to us, should we contact FDA for more clarification or are there any documents available.

Can I expect some more views on our situation? RA Experts please help

Thanks,
Manju

[sreenu927]

Hi Manju,

When there is a change in the existing software (FDA cleared!!), then you need to consider the following:
1. Has the intended use affected...so it's no in ur case.
2. Follow the FDA Guidance on 510(k) changes..which you already did.
3. re visit the risk assessment and where possible perform risk assessment for the changes affected...evidence in terms of updated of risk management report
4. perform s/w verification and validation withe new changes...evidence in terms of test reports.
5. check for any changes in labeling (indications for use-as u mentioned)?? Update your user documentation.
6. If your decision is just documentation (based on the above investigations, validation, risks), then while releasing your new software, perform a significant changes check (assuming that this is part of your procedures) and justify that there is no need to submit a new 510(k) for this software change and release the software.
7. File a "Letter to File or Memo to File" with the change description, justification into the Design History File or to 510(k) submission file.
8. Once you update the user documentation with the changes in "indications for use", then you must inform the customers through a Customer Advisory Notification or Customer Advisory Letter.

Regarding the types of 510(k), for your information, pls see below:

Traditional 510(k):
--devices or modifications to the existing devices
-- detailed requirements in 21 CFR 807.87
-- a minimum of 90 days for FDA review prior to introducing into commercial distribution
-- review can be longer (3-6 months)

Abbreviated 510(k):
-- device modifications when a guidance doc already exists
-- a special control has already been established
-- FDA has recognized a relevant consensus standard

Special 510(k):
-- for devices modifications that do not:
->affect the device intended use
->alter fundamental scientific technology
--minimum 30 days for FDA review prior to introducing into commercial distribution


I hope this helps.

Regards,
Sreenu

[manju.ado]

Thank you sreenu. This is really helpful.

Regards,

Manju

[manju.ado]

Hi Sreenu,

Could you please further elaborate what route we should take for justifying the new 510(k) is not required?

As you mentioned in description of Special 510(K):

In our case changes to software & firmware will not affect the device indented use. These changes basically help us to improve the performance of the device, I don’t think it affects the intended use or am I interpreting the word indented for use wrongly. If I am interpreting correctly, then can we go for Special 510(k), if yes then what and all documentation we supposed to submit to FDA for approval?

Appreciate your help.

Thank you.

Regards,

Manju