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510(k) Data Aggregation

    K Number
    K070855
    Device Name
    SLEEP QUALITY
    Manufacturer
    DYNADX CORPORATION
    Date Cleared
    2008-03-20

    (358 days)

    Product Code
    MNR
    Regulation Number
    868.2375
    Why did this record match?
    Applicant Name (Manufacturer) :

    DYNADX CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    DynaDx Sleep Quality is intended for use on adult patients only as a screening device to determine the need for clinical diagnosis and evaluation by polysomnography based on the patient's score. The ECG recording may be obtained at any location specified by a physician including home, hospital or clinic. Subjects screened for sleep apnea should have periods of sleep of at least 4 hours duration during which the ECG is predominantly sinus rhythm in nature.
    Device Description
    Sleep Quality is a software system, which can probe the dynamical interactions between heart rate and respiratory variability during sleep by using a single lead Electrocardiogram (ECG) recording. It is designed to support FDA approved Holter Monitor devices on the market. Sleep Quality system takes text format ECG recording as input. It requires that supported Holter devices are able to export their recording into ASCII data format. Most of the commencially available Holter Monitors devices have this capability. ECG recording data is first collected by a standard Holter devices na subject's sleep, is converted into ASCII data format, and is then analyzed by the Sleep Quality system. By recognizing episodes of Sleep Disordered Breathing (SDB), the software indicates that apneic events have occurred and estimated the Apnea-Hypopnea Index (AH). To detect SDB, the algorithm derives both RR Interval and ECG-Derived Respiratory (EDR) information from the ECG recording.
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