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510(k) Data Aggregation

    K Number
    K020607
    Device Name
    SLEEPFLO, MODEL 101501
    Manufacturer
    BIOMEC, INC.
    Date Cleared
    2002-08-30

    (186 days)

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

    BIOMEC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SleepFLO is intended for use during sleep disorder studies to detect up to five breathing signals: airflow, body position, thoracic effort, abdominal effort and snore.
    Device Description
    The SleepFLO device is a compact breathing sensor used during sleep disorder diagnosis procedures. The device senses airflow, snore (derived from the airflow), body position, thoracic effort, and abdominal effort. The device consists of two enclosures - a sensor unit and a battery unit, and two respiratory effort belts. A 7-foot, eight-conductor cable connects the sensor unit and the battery unit; a 1-foot two-conductor cable connects each of the respiratory sensor belts to the sensor unit. The sensor unit houses the airflow pressure sensor, the body position sensors, and the connectors for both effort belts (abdominal and thoracic). Airflow is measured using a pressure-based technique. Patients wear a nasal cannula that carries breathing air fluctuations to a pressure sensor inside the sensor unit. The cannula attaches to the sensor unit via a luer lock. The pressure measurements are used to indicate airflow and to derive the snore output. The cannula is a one-time use device and contains a 0.2-micron filter. The position sensors utilize miniaturized ball switches that detect five body positions: upright, supine, prone, left, and right. The effort belt connectors (thoracic and abdominal) are used to pass the signal of the effort belts to the polysomnograph system (PSG) device. The two respiratory effort belts use a piezoelectric sensor attached to an elastic belt. The elastic sensor belt is held in place with a Velcro® strap about the thorax and abdomen. The battery unit houses the snore detection circuitry, the connectors to the PSG, and the batteries that power the device (both the sensor unit and the battery unit). The sensor unit signals (airflow, thoracic effort, abdominal effort, and body position) are passed to the battery unit via the interconnecting eight-conductor cable. The battery unit receives these signals and delivers them to the appropriate output cables, which are connected to the PSG. In the case of the snore, the airflow signal is band pass filtered to generate a snore signal, which is then passed to the PSG via the snore output cable. The connections to the PSG junction box are accomplished via five (5) pairs of cables. All five-cable pairs are terminated with standard PSG pluqs (1.5 mm recessed). The battery compartment can be attached to the junction box with Velcro®.
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