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    K Number
    K212385
    Device Name
    YUWELL Finger Pulse Oximeter
    Manufacturer
    Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.
    Date Cleared
    2022-08-16

    (379 days)

    Product Code
    DQA
    Regulation Number
    870.2700
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    K101577
    Why did this record match?
    Device Name :

    YUWELL Finger Pulse Oximeter

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

    The YUWELL® Finger Pulse Oximeter is a non-invasive, non-sterile, spot checking device which can measure and display SpO2 and pulse rate through finger. It is intended for adults and children (weight >30 kg) and is expected for home and hospital inspection. The device is not for continuous monitoring,use during motion or for patients with low perfusion.

    Device Description

    The YUWELL® Finger Pulse Oximeter is a non-invasive, non-sterile, spot checking device which can measure and display SpO2 and pulse rate through finger. It is intended for adults and children (weight >30 kg) and is expected for home and hospital inspection. The device is not for continuous monitoring, use during motion or for patients with low perfusion. The YUWELL® Finger Pulse Oximeter features in small volume, low power consumption, convenient operation and portable. It is only necessary for patient to put one of his fingers into a fingertip photoelectric sensor for measurement, and then the screen will display the measured value of Pulse Oxygen Saturation (SpO2) and pulse rate(PR) . The device consists of electronic circuits, plastic housing. OLED/LED display(differentiated by models) and button (YX301,YX306 equipped, YX102,YX103 not equipped) which powered by two alkaline AAA batteries. The device does not include alarms.

    AI/ML Overview

    The provided text is a 510(k) summary for the YUWELL® Finger Pulse Oximeter. Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided document:

    Acceptance Criteria and Reported Device Performance

    The document primarily focuses on demonstrating substantial equivalence to a predicate device (Beijing Choice Electronic Technology Co., Ltd. Fingertip Pulse Oximeter, K101577). The key performance acceptance criteria can be inferred from the comparison table and the clinical study results.

    Table of Acceptance Criteria and Reported Device Performance (Inferred from comparison and study results):

    Performance CharacteristicAcceptance Criteria (As per Predicate/Standards)Reported Device Performance (YUWELL® Finger Pulse Oximeter)
    SpO2 Accuracy (SpO2 Measurement Range)70%~100%, ± 2% (Predicate)Arms less than 3% during steady states over the range of 70-100% (Clinical Study Result from ISO 80601-2-61)
    SpO2 Accuracy (Specific Ranges)70%100%, ± 2%; 069% no definition (Predicate)70%~80%, 80%~90%, 90%~100%, ± 2% (Subject Device listed values);
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