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510(K) File eCopy Submission

Kuldeep Singh

Involved In Discussions
#1
Hi Everyone,

We would like to introduce ourselves as Manufacturer of Medical Diagnostic Equipment's namely X-Ray Machines falls under Class II product of FDA regulation. We prepared a 510(K) file for our High Frequency C-Arm machine. As I read the ecopy FDA guidance document and conclude that we have to submit a pdf equal to or less than 50MB and we arrange the document accordingly. But still i have below questions in my mind

1. For 510(K) file submission , total 4 pdf files were prepared under 50MB . So can we submit all these 4 pdf files in single CD/DVD or multiple CD/DVD have to submit for single pdf in it?
2. As i discussed above total 4 pdf files were prepared , So we have to submit Hard copy accordingly ? that means in File 1 (Hard copy) contains the data according to PDF 1 and so on? if we arrange all the data in hard, it can manage in two files only.
 
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primavesvera

Involved In Discussions
#2
Hi Everyone,

We would like to introduce ourselves as Manufacturer of Medical Diagnostic Equipment's namely X-Ray Machines falls under Class II product of FDA regulation. We prepared a 510(K) file for our High Frequency C-Arm machine. As I read the ecopy FDA guidance document and conclude that we have to submit a pdf equal to or less than 50MB and we arrange the document accordingly. But still i have below questions in my mind

1. For 510(K) file submission , total 4 pdf files were prepared under 50MB . So can we submit all these 4 pdf files in single CD/DVD or multiple CD/DVD have to submit for single pdf in it?
2. As i discussed above total 4 pdf files were prepared , So we have to submit Hard copy accordingly ? that means in File 1 (Hard copy) contains the data according to PDF 1 and so on? if we arrange all the data in hard, it can manage in two files only.
You submit on one CD/DVD. The rule is that an individual pdf file cannot exceed 50MB: https://www.fda.gov/media/83522/download pg. 23
And, as for the hard copy, you don't have to: https://s3.amazonaws.com/public-inspection.federalregister.gov/2019-27047.pdf

I hope this helps.
 

akp060

Involved In Discussions
#3
Yes you can submit them in a single media.

Hard copy- You submit only one file with the print out of all 4pdfs.

Just wondering, Only 4 pdf files for an X-ray machine, you must have done some serious consolidation. Is it a special 510(k), let me know only if you do not have a conflict of Interest with your organization.
 

Ronen E

Problem Solver
Staff member
Moderator
#4
@Kuldeep Singh
Since no hard copy is required anymore (as of Dec 2019), eSubmitter/ESG can do the entire job for you. You can package multiple files in a format that is most convenient for CDRH.

Make sure that you use the latest eCopy and RTA guidances, as they were updated when the hard copy requirement was dropped.

I hope you also observed 21 CFR subchapter J - Radiological Health.
 

Kuldeep Singh

Involved In Discussions
#5

primavesvera

Involved In Discussions
#6
Thanks for your Guidance

Here I read about the signed cover letter requirement along with e-Copy of 510(k) file in Guidance document for e-Copy submission https://www.fda.gov/media/83522/download .

Can anyone guide us, Is it the same cover letter as define in 510(k) Contents : https://www.fda.gov/medical-devices/premarket-notification-510k/content-510k and which we introduce in our 510(k) file.

or it is another requirement. If yes, would anyone help us by sharing the template for same.
You don't need to create another cover letter just because you are sending eCopy. Just do the regular one you already planned for the 510(k).
 

monoj mon

Quite Involved in Discussions
#7
Just wondering, Only 4 pdf files for an X-ray machine, you must have done some serious consolidation. Is it a special 510(k), let me know only if you do not have a conflict of Interest with your organization.
I am also wondering about it. I hope your submission went well. As a general concept for 510(k), FDA wants the submitter to submit all the section as mentioned in their guidance for the content of 510(k). If some sections don't apply to your device, you just simply state a the reason for non-applicability in that section.
 

akp060

Involved In Discussions
#8
I am also wondering about it. I hope your submission went well. As a general concept for 510(k), FDA wants the submitter to submit all the section as mentioned in their guidance for the content of 510(k). If some sections don't apply to your device, you just simply state a the reason for non-applicability in that section.
I am working with an organization that is a consultant for Medical Device submissions. We have made submissions to FDA and for CE marking. So we know the amount of documentation that goes in. Reason why I asked about there being only 4 PDF files. Thanks for the reply though. Wish you good luck.
 

monoj mon

Quite Involved in Discussions
#9
I am working with an organization that is a consultant for Medical Device submissions. We have made submissions to FDA and for CE marking. So we know the amount of documentation that goes in. Reason why I asked about there being only 4 PDF files. Thanks for the reply though. Wish you good luck.
There may be some misunderstanding. :notangel:, I am not the original poster of the question. I just synced my opinion with your.
 

Kuldeep Singh

Involved In Discussions
#10
There may be misunderstanding too related to 4 Pdf files. These files contains near about 1800 pages which covers 23 sections as per 510(k) traditional requirement.

Further administrative review successfully completed that means all the data required in Acceptance checklist is fulfilled. Under technical review they demands for compliance report as per 21 CFR 1020.30 and 21 CFR 1020.32. How can we show the compliance ?

Should we submit the test report as per IEC pattern, as some of the points in 21 CFR 1020.30 and 21 CFR 1020.32 seems that they are quality related requirements .
 
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