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510(k) Data Aggregation

    K Number
    K022294
    Device Name
    APNEACHECK
    Manufacturer
    Date Cleared
    2003-04-25

    (283 days)

    Product Code
    Regulation Number
    868.2375
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    Applicant Name (Manufacturer) :

    IM SYSTEMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The SleepCheck is intended for use in monitoring nasal and oral airflow. The device is intended for use as a prescreening tool to determine the need for clinical diagnosis and evaluation by polysomnography based on the patient's test score. The SleepCheck is a small monitor designed to assess nasal and oral airflow. Apnea breathing events are counted based on a reduction in airflow. The device is intended for use as a screening device to determine the need for clinical diagnosis and evaluation by polysomnography based on the patient's score.
    Device Description
    The SleepCheck is a pager-sized monitor that clips onto the patient's nightshirt. The monitor utilizes an air cannula sensor to capture the patient's nasal and oral airflow. The sensor cannula, containing 3 airflow ports, is placed under the nostrils, above the lip and held in place around the ears with a lanyard. The unit has an LCD readout that displays the total number of apneas and the apnealhypopnea index (AHI). The LCD also flashes a warning if the sensor is improperly applied or displaced. The LCD also provides a dynamic bar graph that displays the breathing pattern. As the patient inhales and exhales, the bar moves back and forth, verifying proper sensor application and monitor operation. When breathing decreases or is interrupted for 10 seconds or longer, this event is considered an apnea episode and is tallied on the LCD readout. The patient self-applies the unit before going to bed and wears the unit through the night. Upon waking, the patient will take off the unit and return it to the physician. The physician will check the LCD to learn the number of apneas and the rate of apnea events (AHI) that occurred throughout the night. The technical validity of the test is also indicated.
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