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510(k) Data Aggregation

    K Number
    K142327
    Device Name
    smARTrack Feeding Tube System
    Manufacturer
    ART Healthcare Ltd.
    Date Cleared
    2015-06-08

    (292 days)

    Product Code
    KNT
    Regulation Number
    876.5980
    Why did this record match?
    Applicant Name (Manufacturer) :

    ART Healthcare Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    smARTrack™ Feeding Tube System can guide operator to correctly re-position the tube. The smARTrack™ Feeding Tube System is designed to aid qualified operators in the smARTrack Feeding Tube into the stomach of patients requiring enteral feeding. The smARTrack™ tube is equipped with sensors designed to provide information about the location of the tube tip relative to the lower esophageal sphincter (LES) thus assisting in reducing the incidence of misplacement during first positioning. The smARTrack™ tube also monitors the position continuously during the course of the feeding and automatically and in real time alerts of tube migration. The smARTrack equipped with a motorized mechanism which automatically and in real-time stops feeding tube moves out of position during ongoing use. Furthermore, smARTrack™ Feeding Tube System can guide operator to correctly re-position the tube. The smARTrack™ Feeding Tube is intended for gastric decompression, gastric lavage, and the administration of nutrition, fluids and medications by the naso-enteric route for patients who have an intact gastrointestinal tract but are manage nutritional intake through normal mastication and deglutition.
    Device Description
    The smARTrack™ Feeding Tube System is based on sensor-lined tubes that transmit real-time information to an external console. The information relayed to the console is used to transmit information about the location of the tube tip relative to the lower esophageal sphincter (LES). The smARTrack™ System contains the following: a) Feeding tube (multi-lumen, feeding inlet compatible with standard gravity bag unit and impedance sensors) b) Electronic console which: indicate the location of the tube in the body, stops the feeding in case of overfeeding and keep a patient event log.
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