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  • 1.  Dimension Change and Special 510K for medical Device

    This message was posted by a user wishing to remain anonymous
    Posted 07-May-2018 17:51
    This message was posted by a user wishing to remain anonymous

    Hi,
    I have a query regarding dimension change (doubling of tubing length) in a non critical area of my medical device.

    Would a such dimension change need a special  510K or would documentation of the change suffice?

    Thanks in advance for all the help!


  • 2.  RE: Dimension Change and Special 510K for medical Device

    Posted 08-May-2018 03:03

    You need to decide if it changes the labelling, risk assessment, material.  Follow the flow charts that the FDA have provided here:


    https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM514771.pdf
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    View this on Fda >


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    Colleen Powell
    Director of Regulatory Affairs
    Gloucestershire
    United Kingdom
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    Original Message


  • 3.  RE: Dimension Change and Special 510K for medical Device

    Posted 08-May-2018 04:01
    Based on the limited information, this type of change could probably be documented internally with the development documents, change order documents, testing, and rationale for why no 510(k) is done.  As previously noted, as long as the indications for use do not change and the specifications around a critical function or operation, then internal documentation may be acceptable.

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    Richard Vincins RAC
    Vice President Regulatory Affairs
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    Original Message


  • 4.  RE: Dimension Change and Special 510K for medical Device

    Posted 08-May-2018 09:30
    ​Hello,

    Without knowing the reason for the change, it would be hard to determine if a new submission is needed.  Your best bet is to reference the FDA's Guidance Document on When to Submit a 510(k) for a Change to an Existing Device.  https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM514771.pdf

    Some things to think about:
    1. Does the change affect the safety and effectiveness of the device?
    2. Does the change create a new worst case?
    3. Does the change affect the use of the device?
    4. Does the change affect the labeling of the device?

    Overall, if this doubling of the length of the tube does not present a new worst case and does not affect safety and effectiveness of the previously cleared device, and you can justify that through engineering rationale, I would imagine you would be able to document throught a Letter to File to the existing 510(k).  Additionally, if this length falls within the range of lengths of tubes submitting in your 510(k), you would also be able to document internally.

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    Adam Cargill RAC
    Regulatory Affairs Manager
    Warsaw IN
    United States
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    Original Message


  • 5.  RE: Dimension Change and Special 510K for medical Device

    Posted 08-May-2018 11:11
    This is hard to say on limited info. If it is truly a "non-critical" part, as documented by your risk analysis and other documents, it probably can be internally documented. Of course, that assumes that it isn't specifically called out in a range in the original 510(k) [and thus going outside a range] and that the change isn't addressing any type of safety issue and reported complaints. In those cases you'd need to work through the change in more detail to make a decision. I'd encourage, in any case, that you work through the FDA flowcharts in the guidance on when to file a 510(k).

    g-

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    Ginger Glaser RAC
    Chief Technology Officer
    MN
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    Original Message


  • 6.  RE: Dimension Change and Special 510K for medical Device

    Posted 08-May-2018 12:16
    Following the latest FDA guidance (published 2017-10-25):

    First, determine whether or not the modification (to increase tube length) is being made with the specific intent to improve the safety or effectiveness of the medical device.  If yes, then consider filing a Special 510(k).

    Second, conduct a risk-based assessment of the modification (to increase tube length) according to your QMS procedure and determine whether or the modification could significantly change/improve the medical device, even though the modification is being made without the specific intent to do so.  If yes, then consider filing a Special 510(k).

    If both of the above lead to a "no 510(k) required" decision, you are not finished.  The "no 510(k) required" decision now must be confirmed by successful routine design verification and design validation (V&V) activities.  If routine V&V activities produce unexpected results, document what actions are required based on those results, and review the impact of the results and required actions against the risk-based assessment and consider filing a Special 510(k) where there is significant impact to safety or effectiveness.  Consider where increasing the tubing length resulted in packaging failures in the distribution testing, leading to the need to introduce tube coiling. To keep the tube coiled, design engineers introduced a twist tie.  Keeping the tube coiled has never been done, and upon further review of the actions taken, it is determined that tube kinking may occur, which might lead to an adverse event, such as Inappropriate fixation of an endotracheal tube causing cuff malfunction resulting in difficult extubation.  

    Note that if the risk-based assessment resulted in the need to file a Special 510(k), then successful V&V (i.e., not producing unexpected results) does not change the initial decision regarding the need to file a 510(k).

    If I can be of any help, let me know.


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    John Beasley, RAC (US)
    MedTech Review, LLC
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    Original Message


  • 7.  RE: Dimension Change and Special 510K for medical Device

    Posted 09-May-2018 06:18
    I agree with John in part and disagree in part.  Stick to the statute and regulations and consider FDA's new Modifications Guidance, but know it is non-binding guidance and strays from the statute and regulations a bit.  The standard is whether the change a) could significantly affect safety or effectiveness, or b) is a major change to the intended use.  We recently challenged FDA on a case involving a labeling change that we argued was not a major change to the intended use, in fact was not even a change to the intended use, and won with Dr. Maisel and the Office of Chief Counsel.  Please see our Client Alert on this topic at duval@duvalfdalaw.com.  

    Device enhancements or a simple offering of a new length may not require a new 510(k), but it may.  In the case of a biliary stent being lengthened for use in the coronary and peripheral vasculature it required a new 510(k).  

    Mark DuVal

    Sent from my Verizon, Samsung Galaxy smartphone



    Original Message


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