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510(k) Data Aggregation

    K Number
    K212084
    Device Name
    Fetal Doppler
    Manufacturer
    Shenzhen Mericonn Technology Co., Ltd.
    Date Cleared
    2021-11-03

    (124 days)

    Product Code
    KNG
    Regulation Number
    884.2660
    Type
    Traditional
    Panel
    Obstetrics and Gynecology (OB)
    Reference & Predicate Devices
    K153475
    Why did this record match?
    Reference Devices :

    K153475

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

    Fetal Doppler is intended to detect fetal heart rate, and play the fetal heart sound. Fetal Doppler is indicated for use by health care professionals in hospital, clinic, community and home for singleton pregnancies after 12 weeks gestation.

    Device Description

    Fetal Doppler is intended to detect fetal heart beats, display fetal heart rate, and play the fetal heart sound. Fetal Doppler is indicated for use by used by health care professionals in hospital, clinic, community and home for singleton pregnancies after 12 weeks gestation. It is comprised of an ultrasonic signal transmitter and receiver, analog signal processing unit, FHR calculating unit, and LCD/TFT display control unit. It has audio output and can be connected with headphones or to a recorder with audio input. The Fetal Doppler is powered by a standard 1.5 V DC alkaline battery.

    AI/ML Overview

    This document seems to be a 510(k) summary for a Fetal Doppler device, not a study evaluating a device's performance against specific acceptance criteria in the way a clinical trial or algorithm validation study would. Therefore, much of the requested information regarding acceptance criteria for an AI/ML algorithm or a comparative effectiveness study is not available in the provided text.

    The document instead focuses on demonstrating substantial equivalence to a predicate device through conformity with standards and basic performance tests.

    Here's a breakdown of what is available and what is not:

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

    The document does not provide a table with "acceptance criteria" and "reported device performance" in the context of an AI/ML algorithm's effectiveness. Instead, it outlines performance data provided to support substantial equivalence, primarily focusing on safety and basic operational characteristics.

    Here's a summary of the performance testing conducted, which might be interpreted as meeting certain "acceptance criteria" for basic functionality:

    Acceptance Criteria CategoryReported Device Performance / Evaluation Method
    BiocompatibilityMet ISO 10993-1, 10993-5, 10993-10 standards. Testing included Cytotoxicity, Skin Sensitization, and Irritation.
    Software Verification & ValidationConducted and completed as per FDA guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (May 11, 2005) for a moderate software level of concern.
    Electromagnetic Compatibility & Electrical SafetyConformed to relevant requirements of ANSI/AAMI ES 60601-1, IEC 60601-1-2:2014, and IEC 60601-1-11 Edition 2.0 2015-01.
    Basic Performance Testing- Use Life Testing
    • Battery Life Testing
    • Battery Indicator Testing
    • Testing per IEC 60601-2-37 Edition 2.1 2015 (ultrasonic medical diagnostic and monitoring)
    • Acoustic output measurement as per FDA guidance "Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" (June 27, 2019) for Track 1 devices. |
      | FHR Measuring Range | 50 – 240 BPM (Matches predicate) |
      | FHR Accuracy | ±2BPM (Matches predicate) |
      | FHR Resolution | 1BPM (Matches predicate) |
      | Iob |
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