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Software used by surgeon for planning a patient match implant

  • 1.  Software used by surgeon for planning a patient match implant

    Posted 01-Mar-2021 16:09
    Edited by Nadine Adia 01-Mar-2021 20:22
    Dear peers,

    I'm wondering how could I classify a software which is used by a surgeon for planning a design and manufacturing a patient match implant. This software will be use only for planning and based on this information an other software will take the flow for designing en manufacturing.
    Is it  a medical device , how could I proceed for regulatory compliance please?

    Thank you in advance for your advice.

    Rgds,

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    Nadine Adia
    Quebec QC
    Canada
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  • 2.  RE: Software used by surgeon for planning a patient match implant

    Posted 02-Mar-2021 07:55
    Hello Nadine

    This would likely be a Class 2 device under  the "LLZ" ProCode (21 CFR 892.2050).

    There are many planning softwares approved in this classication and for this intended use (became a spinout from radiology software classifications, historically.)

    Feel free to PM if you need outside assistance with this.

    Best regards,


    ------------------------------
    Ginger Cantor, MBA, RAC
    Founder/Principal Consultant
    Centaur Consulting LLC
    River Falls, Wisconsin 54022 USA
    715-307-1850
    centaurconsultingllc@gmail.com
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  • 3.  RE: Software used by surgeon for planning a patient match implant

    Posted 03-Mar-2021 09:06
    Thank you so much Ginger for your reply. Very helpful.
    Rgds,

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    Nadine Adia
    Quebec QC
    Canada
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  • 4.  RE: Software used by surgeon for planning a patient match implant

    Posted 03-Mar-2021 14:35
    You are so welcome.  Let me know if you need anything else.

    Ginger






  • 5.  RE: Software used by surgeon for planning a patient match implant

    This message was posted by a user wishing to remain anonymous
    Posted 04-Mar-2021 16:29
    This message was posted by a user wishing to remain anonymous

    I think it depends on how you're using the software. If you plan to market it to HCPs then it's LLZ. if you plan to use it internally to design your own products then it's part of your device submission. Compare Synthes TruMatch K193540 to Medicare's UNiD K180091


  • 6.  RE: Software used by surgeon for planning a patient match implant

    Posted 08-Mar-2021 10:59
    Thanks Anonymous for your feedback.
    For the time being we do not plan to market the software.
    However if the software in not attached to a device , do I need it separately even if it's not for selling?

    Rgds,

    ------------------------------
    Nadine Adia
    Quebec QC
    Canada
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  • 7.  RE: Software used by surgeon for planning a patient match implant

    This message was posted by a user wishing to remain anonymous
    Posted 09-Mar-2021 13:24
    This message was posted by a user wishing to remain anonymous

    Hi Nadine, I'm in the exact same situation you are and we are going through this decision making process right now. When we first submitted our device 510(k), we were using OTS software to import images, segment anatomy, take measurements, perform corrections then output the files to a CAD program.  Sound familiar? That OTS has its own 510(k). Even thought the software is not embedded in the device (and isn't used outside the company), our reviewer asked for cyber security, risk analysis and OTS software documentation. The concern is that a latent defect in the software can cause a bad design that doesn't match the patients anatomy. Now we are developing our own software that we will use internally only to perform parts of that process. We will be submitting a special 510k when that software is ready. It will be an update to the device submission not a standalone (LLZ) since its part of a design workflow process and not a marketed product. I hope this helps.


  • 8.  RE: Software used by surgeon for planning a patient match implant

    Posted 08-Mar-2021 15:08
    I once worked on class II Medical film printer that printed 48" long films. Surgeons would take an X-Ray of the patient's leg(s) and then print out the film and lay the film (or paper print) next to the patient on the surgery table. They could then anatomically compare the patient's leg and the printout to guide their surgery. 

    Our intended use was not for surgery planning; we just indicated it made diagnostic quality images. A surgeon made the choice to use our product in their planning and surgery steps.

    ------------------------------
    Edward Panek
    VP, QA/RA
    Med Device

    DOD/DARPA/Dept Veterans Affairs Design Controls in Research

    Research into Neural Nets - https://www.twitch.tv/edosani
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  • 9.  RE: Software used by surgeon for planning a patient match implant

    Posted 11-Mar-2021 11:00
    Thank you Ano and Ed for your response. Indeed Ano I'm quite familiar to these words :-)
    by marketed do mean that the client ( surgeon) will be the owner of the software or do you mean that the surgeon should have to pay to get before using the software.
    The second option is our case.
    Thank you.
    Rgds,

    ------------------------------
    Nadine Adia
    Quebec QC
    Canada
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  • 10.  RE: Software used by surgeon for planning a patient match implant

    This message was posted by a user wishing to remain anonymous
    Posted 12-Mar-2021 16:17
    This message was posted by a user wishing to remain anonymous

    Hi Nadine, marketed means made available to a customer (even free) because it's "on the market". I did some digging around the 510(k) database and it looks like older LLZs were submitted to the Office of In Vitro Diagnostics (pre-reorganization), but some newer ones were submitted to the office the product is in (like OHT6 for orthopedics). An example is K193523. Always better to submit to the reviewers who are familiar with your device type (and are hopefully not affected by COVID related product review like they are in diagnostics).


  • 11.  RE: Software used by surgeon for planning a patient match implant

    Posted 11-Mar-2021 12:48
    Edited by Mieke Janssen 11-Mar-2021 12:49
    Dear Nadine,

    In case you are making your software available for use by the surgeon, yes, it should be considered a medical device. It does not matter whether the surgeon pays for its use, or whether he can use the software for free.
    Other than that, I would agree with the response by Anonymous, that it depends on how you use your software. There is a difference between a generic planning software and a software used for planning a specific patient-matched implant.
    Let me know if you need any additional help, we can take this further offline if you wish.

    Good luck!


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    Mieke Janssen
    Sr. Regulatory Expert Medical Devices
    Maaseik
    Belgium
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