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510(k) Data Aggregation

    K Number
    K231103
    Device Name
    ROSA ONE Brain Application
    Manufacturer
    Medtech S.A.S
    Date Cleared
    2023-07-20

    (92 days)

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

    Medtech S.A.S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended for the spatial positioning and orientation of instruments holders or tool guides to be used by trained neurosurgeons to guide standard neurosurgical instruments (biopsy needle, stimulation or recording electrode, endoscope). The device is indicated for any neurosurgical procedure in which the use of stereotactic neurosurgery may be appropriate.
    Device Description
    The ROSA One Brain application device is a robotized image-guided device that assists the surgeon during brain surgeries. It provides quidance of any surqical instruments compatible with the diameter of the adaptors supplied by Medtech. It allows the user to plan the position of instruments or implants on medical images and provides stable, accurate and reproducible guidance in accordance with the planning. The device is composed of a robot stand with a compact robotic arm and a touchscreen positioned close the operating table. Different types of instruments may be attached to the robot arm and changed according to the intended surgical procedure. For Brain applications, these neurosurgical instruments (e.g. biopsy needle, stimulation or recording electrode, endoscope) remain applicable for a variety of procedures as shown below in Figure 1 for the placement of recording electrodes. The touchscreen ensures the communication between the device and its user by indicating the actions to be performed with respect to the procedure. Adequate quidance of instruments is obtained from three-dimensional calculations performed from desired surgical planning parameters and registration of spatial position of the patient.
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    K Number
    K214065
    Device Name
    ROSA ONE Brain application
    Manufacturer
    Medtech S.A.S
    Date Cleared
    2022-05-04

    (128 days)

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

    Medtech S.A.S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended for the spatial positioning and orientation of instruments holders or tool guides to be used by trained neurosurgeons to guide standard neurosurgical instruments (biopsy needle, stimulation or recording electrode, endoscope). The device is indicated for any neurosurgical procedure in which the use of stereotactic neurosurgery may be appropriate.
    Device Description
    The ROSA One Brain application device is a robotized image-guided device that assists the surgeon during brain surgeries. lt provides guidance of any surgical instruments compatible with the diameter of the adaptors supplied by Medtech. It allows the user to plan the position of instruments or implants on medical images and provides stable, accurate and reproducible guidance in accordance with the planning. The device is composed of a robot stand with a compact robotic arm and a touch screen. Different types of instruments may be attached to the robot arm and changed according to the intended surgical procedure. For Brain applications, these neurosurgical instruments (e.g. biopsy needle, stimulation or recording electrode, endoscope) remain applicable for a variety of procedures as shown below in Figure 1 for the placement of recording electrodes. The touchscreen ensures the communication between the device and its user by indicating the actions to be performed with respect to the procedure. Adequate guidance of instruments is obtained from three-dimensional calculations performed from desired surgical planning parameters and registration of spatial position of the patient.
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