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510(k) Data Aggregation

    K Number
    K153262
    Device Name
    PUREtrace™
    Manufacturer
    NEMO HEALTHCARE BV
    Date Cleared
    2017-02-07

    (455 days)

    Product Code
    OSP
    Regulation Number
    884.2720
    Why did this record match?
    Applicant Name (Manufacturer) :

    NEMO HEALTHCARE BV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PUREtrace™ is an electromyography (EMG) device that non-invasively measures intrapartum uterine activity. PUREtrace™ is indicated for use on women who are at term (≥37 completed weeks), in labor, with singleton pregnancies. The signal is acquired from surface electrodes that are placed on the maternal abdomen. PUREtrace™ is intended for use by healthcare professionals in a clinical setting.
    Device Description
    PUREtrace is a device for registering the electrical activity of the uterine muscle (myometrium) of laboring patients. PUREtrace consists of a multi surface-electrode patch (Graphium patch) and a hardware module (PUREtrace module). The Graphium patch is applied to the abdomen of the patient and acquires the electromyography (EMG) signal of the uterine muscle (electrohysterography, EHG). During a contraction, a large number of uterine muscle cells contract in a controlled manner and the changes in potential can be measured as changes in electrical on the skin of the pregnant woman's abdomen. This signal is sent to the PUREtrace module, converted into a measure for uterine activity and subsequently sent to a compatible fetal monitor where it is displayed as a tocogram. PUREtrace is available in multiple variants with different output connectors to facilitate interfacing with various fetal monitors.
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