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510(k) Data Aggregation

    K Number
    K071165
    Device Name
    ISCALERT SENSOR SYSTEM
    Manufacturer
    ALERTIS MEDICAL AS
    Date Cleared
    2007-11-07

    (195 days)

    Product Code
    CCC
    Regulation Number
    868.1150
    Why did this record match?
    Applicant Name (Manufacturer) :

    ALERTIS MEDICAL AS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The IscAlert™ sensor system measures the partial pressure of carbon dioxide in peripheral tissue, such as forearm muscle tissue, where the sensor is inserted. The system is intended for monitoring trends in this parameter as an adjunct in the evaluation of the perfusion status of tissue in patients at risk of developing ischemia. IscAlert values are relative within an individual and should not be used as the sole basis for decisions as to diagnosis or therapy. The IscAlert™ sensor system should not be used in peripheral brain tissue, intra cranial tissue, all organ tissues including cardiac and kidney, and other peripheral muscle tissues other than forearm muscle.
    Device Description
    The IscAlert sensor system measures partial pressure of CO2 (pCO2) in peripheral tissue, such as forearm muscle tissue, where the sensor is inserted. The system is intended to monitor pCO2 trends as an adjunct in the evaluation of perfusion status of tissue in patients at risk of developing ischemia. Ischemia is a medical term for a shortage of blood supply to tissue. If severe, it can lead to death of the affected tissue (infarction). The tissue pCO2 increases significantly during the early and reversible stages of ischemia. This methodology provides the ability to identify the onset of ischemia events through real-time data. The IscAlert sensor system consists of three parts: - 1. The sterile disposable Sensors - 2. The Connection Unit (CU) - 3. Software to be installed in an off-the-shelf PC unit The sterile, disposable, catheter tip sensors are placed 2-5 cm into organ tissue with a split-off needle that is removed after insertion. The sensor is connected via a cable to the Connection Unit (CU). The CU processes the signals from the sensor unit. It is connected via a cable to a PC with the IscAlert software application installed. The software enables visualisation of the monitoring results.
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