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510(k) Data Aggregation

    K Number
    K161953
    Device Name
    ReDe Mask
    Manufacturer
    TereoPneuma
    Date Cleared
    2017-02-17

    (214 days)

    Product Code
    PRK
    Regulation Number
    868.2375
    Why did this record match?
    Product Code :

    PRK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ReDe Mask is indicated for use by healthcare facility procedural areas and recovery rooms as an adjunct to monitor breathing in adult patients who are sedated for a diagnostic or therapeutic procedure. The ReDe Mask measures the time period between the current and previous exhalation and illuminates a colored light during the exhalation that reflects the interval of time between breaths. If the interval is less than 7.5 seconds, the green light illuminates during exhalation; if the interval is greater than 7.5 seconds, the yellow light illuminates during exhalation; and if the interval between breaths is 20 seconds or longer, the red light flashes continuously. The ReDe Mask is only to be used when supplemental oxygen is provided by the facemask. The ReDe Mask is not a standalone device and is only to be used as an adjunct to pulse oximetry.
    Device Description
    The ReDe Mask is a breathing frequency monitor that provides a visual signal at each breath event (i.e., an inhalation followed by an exhalation). The proposed device consists of a temperature-sensing circuit attached externally to a standard face mask. This circuit continuously analyzes the temperature inside the face mask and determines when a breath event has occurred. The ReDe Mask is designed to detect breathing events (cycles of inhalation followed by exhalation) by measuring temperature changes in the immediate vicinity of a patient's nose and/or mouth. Exhalations produce a temperature warming as expired air exits the mouth and nose, while inhalations result in a temperature cooling as ambient air and supplied oxygen enter the mask. The overall pattern is thus one of repeating periods of a warming and a cooling phase with every breath. The rate of warming and cooling, that is, the slope of the temperature change (degrees C per unit time) depends on the vigor with which the patient is breathing, which can range from very shallow breathing (small slope values) to vigorous breaths (large slope values). The ReDe Mask's breath detection algorithms are based on continuously measuring the warming and cooling slopes coupled with real-time analysis to determine the changeover point from negative slope (inhalation phase) to positive slope (exhalation phase). It is the detection of inflection points in the slope (negative to positive) that yield the elapsed time period between successive breaths. With each new breath the elapsed time between inflection points is used to determine which LED to illuminate.
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