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510(k) Data Aggregation

    K Number
    K190798
    Device Name
    LaborView™ LV1000 Wireless Electrode System
    Manufacturer
    OBMedical Company
    Date Cleared
    2020-09-18

    (540 days)

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

    OBMedical Company

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LaborView ™ LV1000 Wireless Electrode System is a transabdominal electromyography and electrocardiography intrapartum maternal-fetal sensor. It works non-invasively via surface electrodes on the maternal abdomen with appropriate monitors to measure fetal heart rate (FHR), uterine activity (UA), and maternal heart rate (MHR). It is indicated for use on women who are at term (>36 completed weeks), in labor, with singleton pregnancies. It is intended for use by a healthcare professional in a clinical setting.
    Device Description
    The LaborView™ LV1000 Wireless Electrode System is a uterine activity (UA), maternal (MHR) and fetal (FHR) heart rate sensor replacement intended to interface with existing Philips Avalon fetal monitors in hospital delivery environments. Labor View™ LV1000 Wireless Electrode System is comprised of an electrode array, a wireless transmitter ("Transmitter"), computational base station"), a power supply module, and adapters to connect to compatible fetal monitors. The electrode array is sensitive to changes in the electrical activity at the skin surface due to muscle contractions, maternal, and fetal ECG when placed on the expectant mothers abdomen. These signals are passed to the device, converted to a contraction curve, maternal heart rate (MHR), and fetal heart rate (FHR), and subsequently passed to the Philips monitor. All the components of LaborView™ LV1000 Wireless Electrode System work together with the compatible fetal monitors to complete a system that can detect maternal contractions, MHR and FHR during labor. The fetal monitor, in turn, may interface to a central monitoring system in order to conveniently present contraction information to clinicians.
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    K Number
    K142583
    Device Name
    LaborView LV1000
    Manufacturer
    OBMedical Company
    Date Cleared
    2015-01-16

    (123 days)

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

    OBMedical Company

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LaborView LV1000™ Wireless Electrode System is a transabdominal electromyography and electrocardiography intrapartum maternal-fetal sensor. It works non-invasively via surface electrodes on the maternal abdomen with appropriate monitors to measure fetal heart rate (FHR), uterine activity (UA), and maternal heart rate (MHR). It is indicated for use on women who are at >36 completed weeks, in labor, with singleton pregnancies. It is intended for use by a healthcare professional in a clinical setting.
    Device Description
    The LaborView LV1000 is a uterine activity and maternal and fetal heart rate sensor replacement intended to interface to existing perinatal monitors in use in hospital delivery environments. LaborView is comprised of an electrode array, a wireless front-end ("Front-end"), computational back-end ("Back-end"), a power supply module, and optional adapters to connect to various perinatal monitors. The electrode array is sensitive to changes in electrical characteristics of the skin due to muscle contractions, maternal, and fetal ECG when placed on the expectant mother's abdomen. These signals are passed to LaborView, converted to a contraction curve and maternal heart rate (MHR), and fetal heart rate (FHR), and subsequently passed to the perinatal monitor. Note not all perinatal monitors support input of the MHR. Labor View includes the hardware and firmware necessary to convert the electrical signals obtained via the electrode array into contraction, MHR, and FHR curves. Labor View provides analog interfaces to the electrode array and the perinatal monitor but may also interface via USB to a data collection application running on a host PC. The Front-end mates to the electrode array, digitizes the signals and transmits the signals wirelessly to the Back-end component. The Back-end receives the signals from the Front-end. implements the digital signal processing to create the MHR, FHR and contraction curves, then transmits them via the monitor cable/interface to the existing perinatal monitor. A variety of connector adapters may exist between the Back-end and the perinatal monitor such that a single Back-end design can interface to a variety of perinatal monitor manufacturers and models. The LaborView system power is supplied via an isolated power supply or a rechargeable battery pack. All of the components of Labor View work together with the perinatal monitor to complete a system that can detect maternal contractions, MHR and FHR during labor. The perinatal monitor, in turn, may interface to a central monitoring system in order to conveniently present contraction information to clinicians.
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