Regulatory Open Forum

 View Only

  • 1.  Blue tooth requirement

    Posted 28-Jul-2020 08:11
    Hi everyone, 
    I need to add Bluetooth to our portable oxygen concentrator (Class II) Do I need to submit a special 510K or just update my DHF/DMR 
    Thanks 

    --


    Yasser Estafanous | Director of Regulatory Affairs & Quality Assurance
    203 Avenue A NW, Suite 300 | Winter Haven, FL 33881
    Tel: (863) 226-6285 ext. 131
    Fax: (863) 226-6284

    THIS MESSAGE IS INTENDED ONLY FOR THE USE OF THE PARTY TO WHOM IT IS ADDRESSED AND MAY CONTAIN INFORMATION THAT IS PRIVILEGED, CONFIDENTIAL, AND PROTECTED FROM DISCLOSURE UNDER LAW. If you are not the addressee, or a person authorized to deliver the document to the addressee, you are hereby notified that any review, disclosure, dissemination, copying, or other action based on the content of this communication is not authorized. If you have received this document in error, please notify the sender immediately by e-mail or phone.


  • 2.  RE: Blue tooth requirement

    Posted 29-Jul-2020 07:31
    Hello Yasser 

    This will probably be a significant enough  change from testing perspective that it is a traditional  510k.  You will be looking at wireless coexistence  testing and making  sure your Bluetooth has appropriate  FCC approvals.  Depending on how or if you alter software to accomodate the module, or alter the BT module/antenna design to accommodate this, you may have to repeat testing required  under FCC Part 15.

    Also, if your device has not shown testing previously  to AAMI/IEC60601-1 Ed 3.1 or AAMI/IEC 60601-1-2 (EMC) edition 4, when you  resubmit, FDA will expect  compliance to that. 

    Message me if you want privately. 




    Ginger

    ------------------------------
    Ginger Cantor, MBA, RAC
    Founder/Principal Consultant
    Centaur Consulting LLC
    River Falls, Wisconsin 54022 USA
    715-307-1850
    centaurconsultingllc@gmail.com
    ------------------------------

    Original Message


  • 3.  RE: Blue tooth requirement

    Posted 29-Jul-2020 10:02
    Edited by Colin Morgan 29-Jul-2020 10:03
    Hi Yasser,

    You'll also need to ensure you appropriately address Cybersecurity for the new design, as the attack surface has changed.  This would include creating/updating a threat model, data flow diagrams, cybersecurity requirements (NIST 800-121 is a good starting point), security testing (e.g. penetration testing) and proper labeling (including patch management plans). 

    Let me know if you have any question on this piece!

    Thanks,
    Colin



    ------------------------------
    Colin Morgan
    Managing Director
    Apraciti | Medical Device Cybersecurity 

    colinmorgan@apraciti.com
    United States
    ------------------------------

    Original Message


  • 4.  RE: Blue tooth requirement

    Posted 30-Jul-2020 04:23
    With the wireless coexistence that Ginger mentioned, there are a couple of standards and guidance to be concerned with which includes:

    ANSI C63.27-2017 Standard for Evaluation of Wireless Coexistence – testing standard

    AAMI TIR 69:2017 Risk Management of Radio-frequency Wireless Coexistence for Medical Devices and Systems - addresses how the test results are used in a risk assessment

    ANSI C63.27-2017 and AAMI TIR 69:2017 are meant to work together.




    ------------------------------
    Leonard (Leo) Eisner, P.E.
    The "IEC 60601 Guy"
    Principal Consultant, Eisner Safety Consultants
    Phone: (503) 244-6151
    Mobile: (503) 709-8328
    Email: Leo@EisnerSafety.com
    Website: www.EisnerSafety.com
    ------------------------------

    Original Message


Related Content