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    K Number
    K241130
    Device Name
    “POINT” Kinguide Agile Hybrid Navigation System (PSHF01-000)
    Date Cleared
    2024-07-24

    (91 days)

    Product Code
    Regulation Number
    882.4560
    Why did this record match?
    Applicant Name (Manufacturer) :

    Point Robotics MedTech Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    "POINT" Kinguide Agile Hybrid Navigation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous neurosurgical and orthopedic procedures. The device is indicated for pedicle screw entry point alignment and angular orientation when using a posterior approach into T12 to S1 vertebrae, and where reference to the rigid anatomical structure can be identified by intraoperative 3D reconstruction images.
    Device Description
    "POINT" Kinguide Agile Hybrid Navigation System (Kinguide Agile) is an imageguided system (IGS) that consists of an infrared navigation camera, a system workstation (computer), navigation software, and surgical instruments. This medical device system can also be referred to as an orthopedic stereotaxic instrument (OLO) according to the U.S. FDA Device Classification. Kinguide Agile uses optical positioning technologies to track the position of surgical instruments in relation to patient anatomy by means of Dynamic Reference Frames (DRFs) and identify the patient anatomical structure on intraoperative images (obtained using the 3D C-arm or CT*). The user loads the software to plan the surgical procedure and then registers the patient anatomy during surgery to allow the software to track the patient's anatomy and the navigable surgical instruments in real-time. The software application primarily provides the stereotactic navigation function to match the coordinates of the patient anatomical structure and establishes a surgical navigation map. The user can perform the operation according to the surgical navigation map through the use of navigable surgical instruments. During surgery, the positions of navigable surgical instruments are continuously updated on the imaging system via optical tracking. *CT image DICOM file reconstructed from the 3D C-arm or the same function equipment.
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    K Number
    K230087
    Device Name
    “POINT” Kinguide Agile Hybrid Navigation System
    Date Cleared
    2023-07-17

    (186 days)

    Product Code
    Regulation Number
    882.4560
    Why did this record match?
    Applicant Name (Manufacturer) :

    Point Robotics Medtech Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    "POINT" Kinguide Agile Hybrid Navigation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous neurosurgical and orthopedic procedures. The device is indicated for pedicle screw entry point alignment and angular orientation when using a posterior approach into T12 and L1 vertebrae, and where reference to the rigid anatomical structure can be identified by intraoperative 3D reconstruction images.
    Device Description
    "POINT" Kinguide Agile Hybrid Navigation System (Kinguide Agile) is an imageguided system (IGS) that consists of an infrared navigation camera, a system workstation (computer), navigation software, and surgical instruments. This medical device system can also be referred to as an orthopedic stereotaxic instrument (OLO) according to the U.S. FDA Device Classification. Kinguide Agile uses optical positioning technologies to track the position of surgical instruments in relation to patient anatomy by means of Dynamic Reference Frames (DRFs) and identify the patient anatomical structure on intraoperative images (obtained using the 3D C-arm or CT*). The user loads the software to plan the surgical procedure and then registers the patient anatomy during surgery to allow the software to track the patient's anatomy and the navigable surgical instruments in real-time. The software application primarily provides the stereotactic navigation function to match the coordinates of the patient anatomical structure and establishes a surgical navigation map. The user can perform the operation according to the surgical navigation map through the use of navigable surgical instruments. During surgery, the positions of navigable surgical instruments are continuously updated on the imaging system via optical tracking. *CT image DICOM file reconstructed from the 3D C-arm or the same function equipment.
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    K Number
    K220241
    Device Name
    “POINT” Kinguide Robotic-Assisted Surgical System
    Date Cleared
    2022-08-09

    (193 days)

    Product Code
    Regulation Number
    882.4560
    Why did this record match?
    Applicant Name (Manufacturer) :

    Point Robotics MedTech Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    "POINT" Kinguide Robotic-Assisted Surgical System is intended as an aid for precisely locating anatomical structures in either open or percutaneous neurosurgical and orthopedic procedures. The device is indicated for medical condition in which the use of stereotactic spinal surgery may be appropriate, and where reference to a rigid anatomical structure can be identified relative to images of the indications include medical procedures in which pedicle screws are implanted posteriorly into lumbar vertebrae (L1-L5) or sacral vertebrae (S1).
    Device Description
    "POINT" Kinguide Robotic-Assisted Surgical System (Kinguide Surgical System) is an orthopedic stereotaxic medical device, which consists of a hand-held robot, a passive arm, a workstation, an infrared navigation camera, navigation software, C-arm ring calibrator and surgical navigation accessories. Among them, the workstation, as the main console for controlling the hand-held robot, is equipped with a computer and control modules, which performs all operations in the surgical procedure through the computer, and transmits its information to the control modules for controlling movements of the hand-held robot. The C-arm ring calibrator and the navigation probe are used to perform registration process. The infrared navigation camera receives the spatial positioning of the patients, the hand-held robot and the surgical accessories through Dynamic Reference Frames (DRFs), and in the meantime the camera sends the data back to the workstation for monitoring stereotactic surgical operation. The Kinguide Surgical System can assist surgeons to find surgical trajectories quickly and precisely during surgical operations. Software application in the system provides the patient's image to match coordinates of the patient's anatomical structure, and establishes a surgical navigation map. The user can perform the operation according to the surgical navigation map with navigable tools.
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