Applying for FDA 510(k) for 21 CFR 892.2050

Hello Everyone,
I'm completely new to the FDA regulations. We are a very small company (2-3 ppl) and wanted to know how we can apply for FDA 510(k) submission for a DEVICE II moderate level 21 CFR PACS device (892.2050) category.

There are part of the software which are off the shelf and open source as well.
What are requirements and steps for me to study, read, consider and to look into for a product developed from OFF THE SHELF software?
What code of FDA regulations do I need to consider?

I would really like your help and guidance. At the moment I would prefer that I learn the process and then perhaps later look into a consultant.

Thanks for listening...
Cheers
Tim

Taimoore said:

Hello Everyone,
I'm completely new to the FDA regulations. We are a very small company (2-3 ppl) and wanted to know how we can apply for FDA 510(k) submission for a DEVICE II moderate level 21 CFR PACS device (892.2050) category.

There are part of the software which are off the shelf and open source as well.
What are requirements and steps for me to study, read, consider and to look into for a product developed from OFF THE SHELF software?
What code of FDA regulations do I need to consider?

I would really like your help and guidance. At the moment I would prefer that I learn the process and then perhaps later look into a consultant.

Thanks for listening...
Cheers
Tim

Click to expand...

Is there someone willing to help Tim?

Thank you very much.

Stijloor.

Hello Tim,

I have submitted a couple of 510ks for class II LLZ moderate level of concern image processing software devices containing both off the shelf and open source components.

You should definitely review the following guidance documents from FDA:
1. Guidance for the Submission of Premarket Notifications for Medical Image Management Devices
2. Determination of Intended Use for 510(k) devices (this is a bit dated but is helpful)
3. Format for Traditional and Abbreviated 510(k)s

Also, the FDA section on Device Advice has some good info walking you through the 510k process.
It is helpful to review the regulations themselves: 21CFR807 Subpart E

Depending on what the device actually does, you should be aware that FDA recently finalized a guidance on contrast related indications (New Contrast Imaging Indication Considerations...) and currently has two draft guidances for computer aided detection devices.

I am on my way out to leave on vacation for a few days but can be reached at qualitybiotech at gmail.com if you have specific questions. I would be happy to try to address them.

A 510k is not rocket science. Anyone can do it. Just make sure you do your homework and put together all the information recommended by the guidances. My last traditional 510k for one of these devices was 2300 pages but I have also submitted them in the 100-200 page range. Just depends on the device.

Taimoore said:

Hello Everyone,
I'm completely new to the FDA regulations. We are a very small company (2-3 ppl) and wanted to know how we can apply for FDA 510(k) submission for a DEVICE II moderate level 21 CFR PACS device (892.2050) category.

There are part of the software which are off the shelf and open source as well.
What are requirements and steps for me to study, read, consider and to look into for a product developed from OFF THE SHELF software?
What code of FDA regulations do I need to consider?

I would really like your help and guidance. At the moment I would prefer that I learn the process and then perhaps later look into a consultant.

Thanks for listening...
Cheers
Tim

Click to expand...

Hi Tim

Check FDA’s guidance database to see if there are guidance documents pertinent to your specific device. The guidance database can be found from here.

Here are some guidance documents that may help you:

Guidance for Industry, FDA Reviewers and Compliance on Off-The-Shelf Software Use in Medical Devices

Guidance for the Submission Of Premarket Notifications for Medical Image Management Devices

21 CFR Part 11 Electronic Records; Electronic Signatures

Regards
S. Subramaniam

Here is a sample 510(k) for you:

Oops error.

Sorry, I am new and am not allowed to post links yet. Got to CDRH site and search for K024149.

Hello
Can yo please send the sample to my e-mail address at taimoore at yahoo dot com please.

Much appreciated.

regards
Tim

dblnkl said:

Here is a sample 510(k) for you:

Oops error.

Sorry, I am new and am not allowed to post links yet. Got to CDRH site and search for K024149.

Click to expand...

Thats fine - I have fixed the weblink