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510(k) Data Aggregation

    K Number
    DEN170072
    Device Name
    Enlight 1810
    Manufacturer
    Timpel Inc.
    Date Cleared
    2018-12-20

    (447 days)

    Product Code
    QEB
    Regulation Number
    868.1505
    Why did this record match?
    Applicant Name (Manufacturer) :

    Timpel Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ENLIGHT 1810 is a non-invasive, non-radiation medical device that provides information of local impedance variation within a cross-section of a patient's thorax. This information is presented to the clinician user as an adjunctive tool to other clinical information in order to support the user's assessment of variations in regional air content within a cross section of a patient's lungs. It is intended for mechanically ventilated adult patients in a hospital setting, whose thorax perimeter is within the range of 78-122 cm.
    Device Description
    ENLIGHT 1810 is a non-invasive, radiation free medical device intended to provide information on the regional distribution of ventilation in a cross-sectional slice of the thorax. As the total variation in impedance for the thorax corresponds to the total tidal volume, ENLIGHT 1810 can estimate the percentage of tidal volume in regions of interest (ROI) breath by breath, measuring the contribution of the impedance variation of that ROI to the total impedance of the lung. Electrical impedance tomography (EIT) is a technique in which the electrical properties of tissues are estimated from surface electrode voltage measurements and used to provide information on Local Impedance Variation (LIV) within a cross section of a patient's thorax. Considerable electrical impedance variations are imposed on lung tissue by variations in the lung's air content. There is a linear relationship between the variations in air content and the percentage change in lung tissue impedance. This linear relationship is explored in Electrical Impedance Tomography, supporting its use as a tool to support the user's assessment of the variations in regional air content within a cross section of a patient's lungs. The device may be used on adult patients undergoing either fully controlled or assisted mechanical ventilation in the ICU environment.
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