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510(k) Data Aggregation

    K Number
    K150782
    Device Name
    AbStats Gateway
    Manufacturer
    GI Logic Inc
    Date Cleared
    2015-12-14

    (264 days)

    Product Code
    DQD
    Regulation Number
    870.1875
    Why did this record match?
    Applicant Name (Manufacturer) :

    GI Logic Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AbStats Gateway is a compact device with integrated sensor interfaces and embedded computing system (stethoscope) that in conjunction with external sensors constitutes the AbStats system external sensors are placed on the abdomen and identify the vibratory signals associated with digestive processes. This device should be used under the direction of a licensed healthcare when it is required to determine this patient digestive state. The device has not been tested for and it is not intended for pediatric use.
    Device Description
    The AbStats Gateway is a compact device with integrated sensor interfaces and embedded computing system (stethoscope) that in conjunction with external sensors constitutes the AbStats system. The Ab-Stats system external sensors are placed on the abdomen and identify the vibratory signals associated with digestive processes. The AbStats Gateway system is a compact, rapidly deployable unit that is comfortable for subjects and convenient in application. The AbStats Gateway sensor includes a standard microelectronic microphone for measurement of vibration acoustic signals. The components in patient contact are disposable, avoiding the need for cleaning and disinfection. The only material in direct contact with the subject is standard, FDA-approved 3M Tegaderm wound bandage adhesive material. The AbStats Gateway sensor includes a system that provides usage assurance of proper application to the patient. The AbStats Gateway sensor includes both an electret microphone and a compact vibration source (based on the principle of standard signaling vibration sources in consumer pager and smartphone systems). This small electronic vibration device emits a short duration (50 millisecond length) signal each 2 minutes during usage and alternately from each sensor. This low amplitude and low frequency (less than 1 kHz) vibration signal is not detectable by the subject. lt propagates between the two AbStats sensors where it is detected by the AbStats device and provides direct assurance of proper application of the two sensors. The AbStats Gateway sensor includes fine, flexible cables that connect to the AbStats Gateway. The AbStats Gateway is a low voltage device that is similar in size to a tablet computer. The AbStats Gateway monitors the AbStats sensor signals and provides a measurement of intestinal motility with a Motility Rate. The rate is calculated based on rate of arrival of acoustic events detected by AbStats sensors.
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