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510(k) Data Aggregation

    K Number
    K182227
    Device Name
    Esprit Nova
    Date Cleared
    2019-01-17

    (154 days)

    Product Code
    Regulation Number
    882.1400
    Why did this record match?
    Applicant Name (Manufacturer) :

    Neurozone MSH Incorporated

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Esprit Nova is a software-only product intended to assist a physician in the diagnostic evaluation of sleep quality and sleep disordered breathing in adults only. Esprit Nova analyzes the physiological signals and automatically scores sleep events; including the stages of sleep, microarousals, snoring, periodic limb movements, desaturations and sleep disordered breathing events apneas, hypopneas, and respiratory event related arousals). This device is to be used under the supervision of a physician. The device does not provide any diagnostic conclusion about the patient's condition.
    Device Description
    Esprit Nova is a software application that analyzes previously recorded physiological signals obtained during sleep. The software can analyze any EDF files acquired with Trackit SleepWalker (K010460) Compumedics Somté PSG System( K072201) and/or Sandman (K040113). Automated algorithms are applied to the raw signals to interpret the raw signal information. The software automates recognition of: - Sleep stages Rapid Eye Movement (REM), nREM (N1, N2, N3) and wake - Heart rate - Snoring - Sleep/wake - Body position - Arousals - EEG, ECG, EOG, EMG waveforms - Sa02 - Airflow - Respiratory Effort - Apneas and Hypopneas - Oxygen desaturations. - Limb movements . The software identifies and rejects periods with poor electroencephalography signal quality. The output of the device is a comprehensive sleep study report. Medical and history information can be entered from a questionnaire. The automated analysis of physiological data is integrated with the questionnaire data, medical and history information and included in the report. The Esprit Nova analysis module is hosted on a central server, while the administrative module is a stand-alone application for use on Microsoft Windows 7 (or higher) operating system platforms. The administrative module works as a local database to keep records of patients' and to transmit data back and forth to the central server.
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