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510(k) Data Aggregation

    K Number
    K161902
    Device Name
    Meridian M110 Fetal Monitoring System
    Manufacturer
    MINDCHILD MEDICAL
    Date Cleared
    2017-01-12

    (185 days)

    Product Code
    HGM
    Regulation Number
    884.2740
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    K980484,K001407,K003716,K023616,K033320,K040212,K053306,K060241,K080442,K082697,K083162,K090954,K092019,K100481,K101258,K101416,K111979,K112001,K113063,K113426,K120422,K131362,K140384,K142512,K150616,K152562,K160751,K172314,K180493,K182811,K190691,K191986,K192290
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Meridian M110 Fetal Monitoring System is an intrapartum fetal monitor that externally measures and displays fetal heart rate (FHR), maternal heart rate (MHR), and uterine contractions (UA). The Meridian M110 Fetal Monitoring System acquires and displays the FHR and UA from abdominal surface electrodes that detect the fetal ECG signals, maternal ECG signals, and of uterine muscle contraction signals. Tracings of FHR and UA are displayed onto a primary fetal monitor.

    The Meridian M110 Fetal Monitoring System is indicated for use on women who are at ≥ 37 completed weeks, in labor, with singleton pregnancies using surface electrodes on the maternal abdomen. The Meridian M110 Fetal Monitoring System is intended for use by health care professionals in a clinical setting.

    Device Description

    The Meridian M110 Fetal Monitoring System is an intrapartum fetal monitor that externally measures and displays fetal heart rate (FHR), maternal heart rate (MHR), and uterine contractions (UA). The Meridian M110 Fetal Monitoring System acquires and displays the FHR and UA from abdominal surface electrodes that detect the fetal ECG signals, maternal ECG signals, and of uterine muscle contraction signals. Tracings of FHR and UA are displayed onto a primary fetal monitor.

    AI/ML Overview

    I am sorry, but the provided text does not contain information about the acceptance criteria and study details for the Meridian M110 Fetal Monitoring System. The document is an FDA 510(k) clearance letter confirming that the device is substantially equivalent to legally marketed predicate devices, along with its indications for use. It outlines regulatory requirements but does not include performance acceptance criteria or study results.

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