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510(k) Data Aggregation

    K Number
    K220245
    Device Name
    Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL)
    Manufacturer
    Contec Medical Systems Co., Ltd.
    Date Cleared
    2022-09-28

    (243 days)

    Product Code
    KNG
    Regulation Number
    884.2660
    Type
    Traditional
    Panel
    Obstetrics and Gynecology (OB)
    Reference & Predicate Devices
    K182526
    Why did this record match?
    Device Name :

    Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL)

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

    The Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL) is used to detect the fetal heart rate. The device should be used by health care professionals including nurses, midwives, and specialized technicians in the hospital, clinic, community and home. The device is intended for use at or after 12 weeks gestation.

    Device Description

    The Pocket Fetal Doppler is a hand-held FHR detection device, it is used for non-invasive measurement and display of the fetal heart rate (FHR) utilizing Doppler ultrasound. The Pocket Fetal Doppler consists of two models (CONTEC10C, CONTEC10CL). Both models have two hand-held components, a main unit and a probe. The device contains components of ultrasonic signal transmitter and receiver, analog signals processing unit, FHR calculating unit, and LCD display control unit.

    AI/ML Overview

    The provided text is a 510(k) Premarket Notification for a Pocket Fetal Doppler. It details the device's characteristics, indications for use, comparison to a predicate device, and results of non-clinical testing. However, it does not include information about acceptance criteria for performance metrics (beyond resolution and accuracy values), NOR does it describe a study involving human readers or experts to prove the device meets these criteria.

    Therefore, many of the requested points cannot be extracted from the provided text.

    Based on the information available:

    1. A table of acceptance criteria and the reported device performance

    The document provides performance specifications for the device and a predicate, but doesn't explicitly state "acceptance criteria" in a pass/fail sense in this section. It lists the device's performance characteristics.

    Performance ParameterAcceptance Criteria (Not explicitly stated as such, but implied by device specification)Reported Device Performance (Subject Device)Reported Device Performance (Predicate Device)
    FHR Measuring Range(Not stated as separate criteria, but within acceptable range for fetal heart rate)50 BPM ~ 240 BPM50-210 bpm
    Resolution1 BPM1 BPM1 bpm
    Accuracy±2 BPM±2 BPM±2 bpm
    Acoustic Output (ISATA)
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