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510(k) Data Aggregation

    K Number
    K250078
    Device Name
    Informed Vital Core Application (IVC App) (v2.0.0.2.0.0)
    Manufacturer
    Mindset Medical, Inc.
    Date Cleared
    2025-05-30

    (137 days)

    Product Code
    QME
    Regulation Number
    870.2785
    Why did this record match?
    Applicant Name (Manufacturer) :

    Mindset Medical, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Informed Vital Core Application (IVC App) is intended for non-invasive spot measurement of pulse and respiration rate of adult patients in home use, hospitals, clinics, and long-term care settings. The Informed Vital Core Application is indicated for use on adults 22 years of age or older who do not require critical care or continuous vital signs monitoring. Informed Vital Core is not intended to independently direct therapy.
    Device Description
    The IVC App is a Software as a Medical Device (SaMD) progressive web application that utilizes existing optical camera technology embedded in a smart-phone, tablet, laptop, or desktop computer to estimate an individual's vital signs including pulse rate (PR) and respiration rate (RR) developed by Mindset Medical. The IVC App software algorithms will provide spot checks for PR and RR of the individual. The IVC App software uses proprietary software algorithms to extract a raw video signal through remote plethysmography (rPPG) by detecting subtle color variations in the microvasculature around a patient's face that occur with each cardiac cycle due to changes in blood volume to measure PR. Additionally, this system utilizes software for optical camera-based measurement of respiration rate. The non-contact, periodic, spot measurement of respiration rate is taken when the subject is at rest based on shoulder movement.
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    K Number
    K241633
    Device Name
    Informed Vital Core Application (IVC App)
    Manufacturer
    Mindset Medical, Inc.
    Date Cleared
    2024-11-18

    (165 days)

    Product Code
    QME
    Regulation Number
    870.2785
    Why did this record match?
    Applicant Name (Manufacturer) :

    Mindset Medical, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Informed Vital Core Application (IVC App) is intended for non-invasive spot measurement of pulse rate of adult patients in home use, hospitals, clinics, and long-term care settings. The Informed Vital Core Application is indicated for use on adults 22 years of age or older who do not require critical care or continuous vital signs monitoring. Informed Vital Core is not intended to independently direct therapy.
    Device Description
    The IVC App is a Software as a Medical Device (SaMD) progressive web application that utilizes existing optical camera technology embedded in a smart-phone, tablet, laptop, or desktop computer to estimate an individual's vital signs including pulse rate (PR) developed by Mindset Medical. The IVC App software algorithms will provide spot checks for PR of the individual. The IVC App software uses proprietary software algorithms to extract a raw video signal through remote plethysmography (rPPG) by detecting subtle color variations in the microvasculature around a patient's face that occur with each cardiac cycle due to changes in blood volume to measure PR.
    Ask a Question

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