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510(k) Data Aggregation

    K Number
    K233001
    Device Name
    Bioscope Neuromonitor Device
    Manufacturer
    Biosys Biyomedikal Muhendislik San. Ve Tic. A.S.
    Date Cleared
    2024-12-13

    (448 days)

    Product Code
    ETN
    Regulation Number
    874.1820
    Why did this record match?
    Applicant Name (Manufacturer) :

    Biosys Biyomedikal Muhendislik San. Ve Tic. A.S.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Bioscope Neuromonitor Device is intended to help surgeons locate, identify, and preserve cranial motor nerves during surgery. Intra-operative monitoring and stimulation of cranial peripheral motor nerves. Indications for Bioscope Neuromonitor Device Procedures include: thyroidectomy and parathyroidectomy, mastoidectomy.
    Device Description
    Bioscope Neuromonitor Device is a nerve locator and monitor. The device has 3 infrastructure; - Electronic - Mechanic - Software These infrastructures are integrated with each other and work with the principle of stimulating current at 0.01-10 mA levels, conceiving EMG signals from related muscles groups. Collected signals are interpreted by the device and auditory and visual notifications will be given. The device basically consists of stimulation and EMG subsystems. Both stimulation and EMG lines can send and collect signals from 2 channels. Depending on the operation, an EMG Endotracheal Tube or needle electrode is inserted into the muscles innervated by the relevant nerves for EMG reading. The electrode parts of the EMG tube are placed in contact with the muscles attached to the vocal cords. Needle electrodes are also inserted into the relevant muscle. Appropriate current is sent with the stimulation probe. The electrical changes in the muscles in the region and are transmitted to the device as a signal. The device gives audible and visual warnings. Channels works on the principle of potentially stimulating the critical region through monopolar or bipolar probe connection and completing the circuit, allowing the device to make a nerve-tissue separation audibly and visually. It allows the detection of nerves such as the recurrent laryngeal nerve, which are connected to the vocal cords. The doctor brings the probe into contact with the area of potential nerve risk. The current sent to the patient through the probe causes a change in the electrical activity of the nerves and the muscles to which the nerves are connected, and this change can be detected by the device. Based on the collected data, the device gives clear audible alerts for nerve-tissue separation. The EMG signal collected from the patient is displayed as a both voltage value and latency times on the output. These values can be recorded and the interface can be used to select specific details, such as the right and left sides of the vagus, and recurrent laryngeal nerves.
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