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510(k) Data Aggregation

    K Number
    K222262
    Device Name
    Sunrise
    Manufacturer
    Date Cleared
    2022-12-22

    (147 days)

    Product Code
    Regulation Number
    868.2376
    Why did this record match?
    Product Code :

    QRS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Sunrise device is a non-invasive home care aid in the evaluation of obstructive sleep apnea (OSA) in patients 18 years and older with suspicions of sleep breathing disorders.
    Device Description
    The Sunrise device is a cloud-based software device that analyzes data from a sensor (Sunrise sensor 1 or Sunrise sensor 2) placed on the patient's chin. The device detects respiratory events, identifies sleep stages and position. The device generates sleep parameters, e.g. apnea hypopnea index "Sunrise AHI", and position discrete states. Data collected by the device is integrated in a report for further interpretation by the healthcare provider.
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    K Number
    DEN210015
    Device Name
    Sunrise Sleep Disorder Diagnostic Aid
    Manufacturer
    Date Cleared
    2022-01-07

    (280 days)

    Product Code
    Regulation Number
    868.2376
    Why did this record match?
    Product Code :

    QRS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Sunrise SDDA device is a non-invasive home care aid in the evaluation of obstructive sleep apnea (OSA) in patients 18 years and older with suspicions of sleep breathing disorders.
    Device Description
    The Sunrise SDDA device consists of a Sunrise sensor and a cloud-based software device that analyzes data from the sensor when placed on the patient's mandible. The device also includes a mobile application to record patient's responses to questions about their sleep quality and transfer sensor data to the cloud. By analyzing patient's mandibular movements, the device also detects obstructive respiratory disturbances, identifies sleep states, notifies about the Obstructive Sleep Apnea (OSA) severity in a categorical format (non-OSA, mild-OSA, moderate-OSA, severe-OSA), generates sleep structure information (namely, total sleep time, sleep onset latency, wake after sleep onset, sleep efficiency, arousal index) and head position discrete states. Data collected by the device is integrated in a report for further interpretation and diagnosis by the healthcare provider.
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