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510(k) Data Aggregation

    K Number
    K230125
    Device Name
    Neuroblade System
    Manufacturer
    ClearMind Biomedical
    Date Cleared
    2023-10-13

    (269 days)

    Product Code
    GWG, GEI
    Regulation Number
    882.1480
    Why did this record match?
    Applicant Name (Manufacturer) :

    ClearMind Biomedical

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Neuroblade System is a neuroendoscopy system indicated for the illumination and visualization of intracranial tissue and fluids, controlled aspiration of tissue and or fluid, powered cutting of soft tissue, and coagulation of tissue under direct visualization during surgery of the ventricular system or cerebrum.
    Device Description
    The Neuroblade System is comprised of three components: Neuroblade, Neuropad and Cart. The Neuroblade is a hand-held, sterile neuroendoscope with lighting and camera at its distal end. The camera images are displayed on the Neuropad via a connecting cable that extends from the proximal end of the Neuroblade. It has integrated irrigation and aspiration functions. The distal bipolar electrode allows the application of RF energy from a third-party radiofrequency (RF) generator for coagulation of bleeding vessels in the neuro space. A cutting window on the side of distal end is for the removal of blood clots. The Neuroblade System, like other neuroendoscopes, is advanced into the brain through a burr hole created in the patient's skull. The tip of the Neuroblade is advanced under visualization via the illuminated camera image transmitted from the distal tip of the Neuroblade to the Neuropad. The Neuroblade has irrigation and vacuum tubing (2.0 m) that allows for connection to a third party saline infusion bag and a vacuum waste bucket, respectively. The waste bucket is connected to a vacuum regulator which is attached to the hospital's vacuum system. The bipolar electrode is incorporated into the distal tip of the Neuroblade and has a bipolar plug (20 cm) on the proximal end that allows for connection to a third-party bipolar cord. The proximal end of that bipolar cord connects to the RF Generator. An RF Generator and bipolar cord are common accessories in the operating room. The Neuroblade has a working channel that will facilitate the introduction of flexible endoscopic surgical devices (≤1.7 mm outer diameter) into the surgical site. That same working channel will also facilitate irrigation of the target site and is the channel that supports the aspiration of fluid and tissues. The Neuropad can be installed onto the Cart and adjusted by the user for height and tilt. The Neuropad allows the user to input patient data, control some aspects of the image, and record the case.
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    K Number
    K210251
    Device Name
    ClearPath Disposable Introducer
    Manufacturer
    ClearMind Biomedical
    Date Cleared
    2021-04-02

    (63 days)

    Product Code
    GWG
    Regulation Number
    882.1480
    Why did this record match?
    Applicant Name (Manufacturer) :

    ClearMind Biomedical

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ClearPath Disposable Introducer is indicated to obtain and maintain a temporary pathway into the ventricular system and cerebrum of the brain.
    Device Description
    The ClearPath™ Disposable Introducer is a sterile, single-use, neurological endoscope Introducer, consisting of a Sheath and a Dilator. A locking mechanism design allows the Dilator to lock into the Sheath and prevent "push back" during insertion into the brain. The Dilator tip is designed to be atraumatic during insertion. The Sheath is graduated in centimeters to assist the surgeon in determining the Introducer insertion depth. The Sheath's transparency is useful for full endoscopic visualization during insertion. The proximal end of the Sheath is labeled 20F, indicating the inner diameter of the Sheath.
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    K Number
    K201308
    Device Name
    Axonpen, Axonmonitor, Axonbox, Tablet
    Manufacturer
    ClearMind Biomedical
    Date Cleared
    2020-11-27

    (196 days)

    Product Code
    GWG
    Regulation Number
    882.1480
    Why did this record match?
    Applicant Name (Manufacturer) :

    ClearMind Biomedical

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Axonpen System is indicated for the illumination of intracranial tissue and fluids and the controlled aspiration of tissue and/or fluid during surgery of the Ventricular System or Cerebrum.
    Device Description
    The Axonpen System consists of a neuroendoscope (Axonpen) and a monitor (Axonmonitor) to view the image from the distal end of the Axonpen. The Axonpen is a steerable, single-use, neuroendoscope with an integrated camera and LED light source. It has a working channel for third-party tools, irrigation, and aspiration. The distal end is steerable and can be extended. The Axonmonitor is a combination of the Axonbox (firmware) and a third-party tablet for viewing and recording images. It is battery operated.
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