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510(k) Data Aggregation

    K Number
    K250363

    Validate with FDA (Live)

    Device Name
    Depth Electrode (RSDE-08); Depth Electrode (RSDE-10); Depth Electrode (RSDE-12); Depth Electrode (RSDE-14); Depth Electrode (RSDE-16); Depth Electrode (RSDE-16F); Depth Electrode (RSDE-08S); Depth Electrode (RSDE-10S); Depth Electrode (RSDE-12S); Depth Electrode (RSDE-14S); Depth Electrode (RSDE-16S); Depth Electrode (RSDE-16G); Depth Electrode (RSDE-18); Depth Electrode (RSDE-18F); Depth Electrode (RSDE-18T); Depth Electrode (RSDE-20); Depth Electrode (RSDE-20F); Dept
    Manufacturer
    Beijing Sinovation Medical Technology Co., Ltd.
    Date Cleared
    2025-11-05

    (268 days)

    Product Code
    GZL
    Regulation Number
    882.1330
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    K222404,K170959,K163355
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Depth Electrode is intended for temporary (less than 30 days) use with recording, monitoring, and stimulation equipment for the recording, monitoring, and stimulation of electrical signals at the subsurface level of the brain.

    Device Description

    The Depth Electrode consists of the Depth Electrode (electrode) and accessories. The accessories consists of Connection cable and Guidance screw. The Depth Electrodes are provided sterile after EO sterilization and are single use only. The electrodes are slender, cylindrical tubes inserted into the brain. The electrodes have conductive contacts at the distal end to monitor the brain's electrical signals or deliver electrical stimulation.

    The electrode is a 0.8 mm diameter Polyurethane electrode with platinum-iridium alloy contacts and are available in varying numbers of contacts: 8 to 16 contacts, with an exploration length (recording depth) from 26.5 to 63.0 mm. The longitudinal width of each contact is 2.0 mm, and are spaced 1.5 mm apart (distance between contact groups is 10mm).

    The Guidance screws are secured in the skull to provide an access point while stabilizing the electrode. It consists of a tube through which the electrode can pass. The proximal end is threaded, allowing the surgeon to screw it into the patient's skull via an appropriately sized burr hole. The distal end is threaded to accept the Sealing Cap of electrodes. Guidance screws are available in 20 mm, 25 mm, 30 mm, and 35 mm lengths, and can only be used by inserting through a small 2.1mm burr hole drilled in the skull. Guidance screws should be used only when depth electrodes are warranted.

    The Connection cables are used for the transmission of electrical signals that connects to EEG monitoring equipment. When performing EEG monitoring, the connection cable of each model shall be used in conjunction with the electrode of the corresponding channel.

    The Depth Electrode is temporarily placed (less than 30 days) at the subsurface level of the brain. The system is designed to be used in stereoelectroencephalography (sEEG) procedures.

    AI/ML Overview

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