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510(k) Data Aggregation

    K Number
    K243687
    Device Name
    Vital Signs
    Manufacturer
    Oxehealth Limited
    Date Cleared
    2025-08-27

    (271 days)

    Product Code
    QME
    Regulation Number
    870.2785
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K211906
    Why did this record match?
    Reference Devices :

    K211906

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Vital Signs device is intended for noninvasive spot measurement of pulse rate and breathing rate when the subject is still. It is software assessing video footage from a fixed-installation solution for use within single occupancy rooms within hospitals, general care and secured environments with professional healthcare oversight and where a framework exists which mandates periodic checks by a trained professional to ensure subject safety.

    The system is intended for use by appropriately trained staff and should not be used by untrained users.

    The Vital Signs device is indicated for use on subjects 12 years of age or older who do not require critical care or continuous vital signs monitoring.

    The device is not intended to be the sole method of checking the physical health of a subject.

    Device Description

    The subject device is the next generation device of the predicate (K211906).

    Vital Signs is a software-only medical device (SaMD) that provides retrospective monitoring of non-contact pulse rate and respiratory rate data derived from video, without the need for contact devices to be attached to the patient or bed.

    The device consists of custom-designed software assessing video footage collected using off-the-shelf cameras installed within single occupancy rooms within hospitals, general care and secured environments. Proprietary software-controlled algorithms are used to derive patient spot heart rate and respiratory rate data from the analysis of this video data, once the user has followed a workflow to initiate the system's data analysis.

    Improvements to the device compared to the predicate are as follows:
    • 24 hour trends
    • Expansion of intended population from 18 years and older → 12 years and older
    • Widened respiratory rate range from 8-31 bpm → 8-39 bpm

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided FDA 510(k) Clearance Letter for the Oxehealth Vital Signs Device:

    1. Table of Acceptance Criteria and Reported Device Performance

    ParameterAcceptance Criteria (Target Accuracy)Reported Device Performance (MAE)P-value
    Pulse Rate (HR)± 3 beats per minute (bpm)Significantly
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