510k and DICOM Conformance Statement. - DICOM

This is a discussion on 510k and DICOM Conformance Statement. - DICOM ; Does the FDA Require you to submit a dicom conformance statement when you are applying for 510k approval? (I don't think so.) Others may disagree....

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Thread: 510k and DICOM Conformance Statement.

  1. 510k and DICOM Conformance Statement.

    Does the FDA Require you to submit a dicom conformance statement when
    you are applying for 510k approval? (I don't think so.) Others may
    disagree.


  2. Re: 510k and DICOM Conformance Statement.


    JustSomeGuy wrote:
    > Does the FDA Require you to submit a dicom conformance statement when
    > you are applying for 510k approval? (I don't think so.) Others may
    > disagree.


    No - In 510K filing you're usually doing the opposite of what you try
    to do in your marketing/sales brochure. In the brochure you try to
    claim some unique value for your product that is different from
    anything else in the market (and better). In 510K you claim your
    product is exactly the same as something else the government has
    already given market approval for and so doesnt need further scrutiny.

    However, FDA guidance for class 1 and class 2 device exemptions from
    premarket approval mention the usage of the DICOM standards as evidence
    of interoperability and compliance to industry good practices, etc.
    (i'm paraphrasing here - you should look at the regs yourself). My main
    point is, you don't need a conformance statement, its not the main
    point of the 510K, but it doesn't hurt either, especially if you're
    going for the whole waiver deal.


  3. Re: 510k and DICOM Conformance Statement.


    eric.goodall@gmail.com wrote:
    > JustSomeGuy wrote:
    > > Does the FDA Require you to submit a dicom conformance statement when
    > > you are applying for 510k approval? (I don't think so.) Others may
    > > disagree.

    >
    > No - In 510K filing you're usually doing the opposite of what you try
    > to do in your marketing/sales brochure. In the brochure you try to
    > claim some unique value for your product that is different from
    > anything else in the market (and better). In 510K you claim your
    > product is exactly the same as something else the government has
    > already given market approval for and so doesnt need further scrutiny.
    >
    > However, FDA guidance for class 1 and class 2 device exemptions from
    > premarket approval mention the usage of the DICOM standards as evidence
    > of interoperability and compliance to industry good practices, etc.
    > (i'm paraphrasing here - you should look at the regs yourself). My main
    > point is, you don't need a conformance statement, its not the main
    > point of the 510K, but it doesn't hurt either, especially if you're
    > going for the whole waiver deal.


    You have echoed my sentiments exactly and until this morning I would
    agree
    with you 110%. However because a lawyer said it had to be done, I
    decided
    to do my homework again. What I found was a guidance document that
    stated
    that if you claim dicom conformance, then you 'should' supply a
    conformance
    statement. 1st) 'should' isn't excatly strong wording.. 2nd) By
    supplying do they
    mean supplying to the FDA as part of the submission.

    So till I hear differently from the FDA, who I called today, I guess
    one 'should'
    supply the FDA with a DICOM conformance statement.

    It has allways been my understanding that when it came to 'software'
    and FDA
    approval all you had to do was supply proof that you are following good
    software
    development practices. I understood DICOM to be a good marketing tool
    (not
    to mention a good thing) and the the conformance statement was for the
    client
    to determine interoperability and suitability of your product and their
    needs...

    I'm disappointed to see that the FDA had gotten involved by saying one
    'should'
    supply a conformance statement. That seems redundant since saying you
    are
    DICOM complient implies you have a conformance statement, because if
    you don't
    have a conformance statement your not really DICOM compliant.


  4. Re: 510k and DICOM Conformance Statement.

    Well, the flip side is you can search the FDA website and see the 510K
    submissions that other companies have provided. There is no guarantee
    that what they publish on the website is the complete submission but
    few, (if any) I've looked at have included a DICOM conformance
    statement.


  5. Re: 510k and DICOM Conformance Statement.

    Eric is incorrect:

    If the company is claiming that their PACS product meets DICOM, then a
    DICOM Conformance Statement is required in the 510(k). It is required
    under the CDRH - Recognized Voluntary Standards section of "Guidance
    for the Submission of Premarket Notifications for Medical Image
    Management Devices".

    If PACS device does not conform to the DICOM standard, the manufacturer
    must identify the models of products marketed by other manufacturers
    with compatible image formats.

    We have done quite a few filings (at least 50 or so) for PACS
    systems/software, and all the filings we did for our clients contained
    a confromance statement. So, I don't know what would happen if you file
    w/o the document, but I would assume you get it bounced back.

    Herman O.


    eric.goodall@gmail.com wrote:
    > Well, the flip side is you can search the FDA website and see the 510K
    > submissions that other companies have provided. There is no guarantee
    > that what they publish on the website is the complete submission but
    > few, (if any) I've looked at have included a DICOM conformance
    > statement.



  6. Re: 510k and DICOM Conformance Statement.


    herman o. wrote:
    > Eric is incorrect:
    >
    > If the company is claiming that their PACS product meets DICOM, then a
    > DICOM Conformance Statement is required in the 510(k). It is required
    > under the CDRH - Recognized Voluntary Standards section of "Guidance
    > for the Submission of Premarket Notifications for Medical Image
    > Management Devices".
    >
    > If PACS device does not conform to the DICOM standard, the manufacturer
    > must identify the models of products marketed by other manufacturers
    > with compatible image formats.
    >
    > We have done quite a few filings (at least 50 or so) for PACS
    > systems/software, and all the filings we did for our clients contained
    > a confromance statement. So, I don't know what would happen if you file
    > w/o the document, but I would assume you get it bounced back.
    >
    > Herman O.
    >
    >
    > eric.goodall@gmail.com wrote:
    > > Well, the flip side is you can search the FDA website and see the 510K
    > > submissions that other companies have provided. There is no guarantee
    > > that what they publish on the website is the complete submission but
    > > few, (if any) I've looked at have included a DICOM conformance
    > > statement.


    Its the whole statement about 'should' provide that is concerning me.
    Should doesn't must must.


  7. Re: 510k and DICOM Conformance Statement.

    Hi Herman

    My statements were based on perusal of the documents I'd found on the
    FDA websites granting the 510K requests (examples below).

    http://www.fda.gov/cdrh/pdf4/k042832.pdf
    http://www.fda.gov/cdrh/pdf5/K052618.pdf
    http://www.fda.gov/cdrh/pdf4/K043415.pdf

    I incorrectly identified these as submissions when in fact they are the
    FDA responses to submissions (mea culpa). Also have previously seen the
    guidance and took it at face value: a voluntary standard. Hence the
    advice that it couldn't hurt.

    I acknowledge your superior experience in the area of actual
    submissions. However, I still question whether a conformance statement
    it is actually "required" by the FDA unless you make DICOM conformance
    an element of your claim for market approval in your 510K request.
    Having made that claim, submission of a DICOM conformance statement
    would be one of the faster methods to prove your claim.

    Remember, the question was "does the FDA require you to submit a
    conformance statement when you file your 510K". Maybe a better way of
    stating would be, does the FDA require you to claim DICOM compliance,
    when you file for medical imaging device/system 510K? There are plenty
    of examples of systems which have made it onto the market without DICOM
    only to add it later. It would be interesting to compare the time
    required for FDA to grant (or deny) the request when they do and don't
    include DICOM compliance. I would suggest the set of items you have to
    prove for your system is large when it doesn't include DICOM and the
    methods of proving your claims are likely to be more complex, but it
    doesn't rise to the level of the FDA requiring DICOM conformance


    herman o. wrote:
    > Eric is incorrect:
    >
    > If the company is claiming that their PACS product meets DICOM, then a
    > DICOM Conformance Statement is required in the 510(k). It is required
    > under the CDRH - Recognized Voluntary Standards section of "Guidance
    > for the Submission of Premarket Notifications for Medical Image
    > Management Devices".
    >
    > If PACS device does not conform to the DICOM standard, the manufacturer
    > must identify the models of products marketed by other manufacturers
    > with compatible image formats.
    >
    > We have done quite a few filings (at least 50 or so) for PACS
    > systems/software, and all the filings we did for our clients contained
    > a confromance statement. So, I don't know what would happen if you file
    > w/o the document, but I would assume you get it bounced back.
    >
    > Herman O.
    >
    >
    > eric.goodall@gmail.com wrote:
    > > Well, the flip side is you can search the FDA website and see the 510K
    > > submissions that other companies have provided. There is no guarantee
    > > that what they publish on the website is the complete submission but
    > > few, (if any) I've looked at have included a DICOM conformance
    > > statement.



  8. Re: 510k and DICOM Conformance Statement.

    The document Herman refers to:
    "Guidance for the Submission Of Premarket Notifications for Medical
    Image Management Devices" (Document issued on: July 27, 2000)

    may be found at:
    www.fda.gov/cdrh/ode/guidance/416.pdf
    or
    www.fda.gov/cdrh/ode/guidance/416.html

    This document clarifies classifying your device. Section III
    (Classifications for Medical Image Management Devices) provides
    guidance for classifying your device into one of five categories.
    Sec. 892.2010 Medical image storage device.
    Sec. 892.2020 Medical image communications device.
    Sec. 892.2030 Medical image digitizer.
    Sec. 892.2040 Medical image hardcopy device.
    Sec. 892.2050 Picture archiving and communications system.
    ...product codes and the related classifications are:
    LMA - Image Digitizer (Sec. 892.2030)
    LMB - Digital Image Storage Device (Sec. 892.2010)
    LMC - Multi-format Camera (Sec. 892.2040)
    LMD - Digital Image Communications System (Sec. 892.2020)
    LLZ - Image Processing System (Sec. 892.2050)

    If your device category has a classification of "Class II--special
    controls; voluntary standard...", then it is clear that the FDA expects
    you to submit your DICOM Conformance Statement with your 510K
    application.

    To quote the guidance document:
    "b. CDRH - Recognized Voluntary Standards -
    i. DICOM (Digital Imaging and Communications in Medicine) -
    Developed by the American College of Radiology and
    the National Electrical Manufacturers Association.
    Specifies the format for the communication of digital
    images between individual devices and over networks.
    Note: Sponsors who claim DICOM compliance should provide a
    DICOM Conformance Statement."

    So Eric's re-phrasal of the original question, "...does the FDA require
    you to claim DICOM compliance, when you file for medical imaging
    device/system 510K?", seems like the better question. And the answer
    seems clearly, "Yes".

    Sorry if I restated the obvious; I thought it helpful the have the
    document links available to those interested. The FDA site is
    intimidating, even when you may be familiar with it...

    - Bronson


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