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510(k) Data Aggregation

    K Number
    K230130
    Device Name
    Micromate™ Navi+
    Manufacturer
    ISYS Medizintechnik GMBH
    Date Cleared
    2023-10-10

    (266 days)

    Product Code
    JAK
    Regulation Number
    892.1750
    Why did this record match?
    Applicant Name (Manufacturer) :

    ISYS Medizintechnik GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Micromate™ Navi+ device is a user-controlled electromechanical arm with a needle guide. It is intended to assist the user in the positioning of 8-19 gauge needles in the chest, abdomen and musculoskeletal structures when computed tomography (CT) optical navigation can be used for target trajectory planning and intra-operative tracking. The needle is then manually advanced by the user. Trajectory planning is made with software that is a part of the Micromate™ Navi+ device.
    Device Description
    The Micromate™ Navi+ system allows the percutaneous execution of a surgical intervention by providing instrument guidance according to one or more pre-operative plans defined by an internal planning and navigation software (MicroNav). The alignment to the surgical plan is performed through a manual gross-positioning using a Positioning Arm, followed by automatic or joystick-controlled movement with image guidance, such as optical CT navigation (tracked by camera). After alignment, the advancement of surgical instruments and delivery of therapy is performed manually by the user, while the position is retained by the targeting platform of Micromate™ Navi+, relying on the displayed navigation information or real-time images from third party imaging device. The Micromate Navi+ device is intended for biopsy and percutaneous tumor ablation procedures, in the abdomen, thorax and musculoskeletal tissue. The Micromate™ Navi+ system comprises the following main components: - Targeting Platform, a robotic positioning unit that aligns to the surgical plan and holds the surgical instruments through an end-effector acting as a tool-guide adapter, - Control Unit, device that allows the automatic or manual control of the Targeting Platform movement and can communicate with an internal planning and navigation station, - Positioning Arm, a multi-functional arm that is used to gross-position the Targeting Platform in such a way the traiectory is reachable. - Strain Relief Box, which distributes power and data through the Micromate™ system, - Power and Network Unit, which connects the system to power and allows an optional direct point-to-point connection to an internal planning and navigation station for input of real-time navigation data, - Connecting Cables. and following Accessories: - Sterile Drapes for the Control Unit and Targeting Platform, - Needle guides for instrument guidance, packaged together with a drape for the sterile covering of the Targeting Platform, - Sterile Tracker, to which off-the-shelf mounting spheres can be attached, to enable optical tracking for the localization of the Targeting Platform in space, - A trolley for transport and storage, - Medical grade PC, - Camera tracking system, - Planning and navigation software (MicroNav).
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    K Number
    K203720
    Device Name
    MICROMATE
    Manufacturer
    ISYS Medizintechnik GMBH
    Date Cleared
    2021-06-22

    (183 days)

    Product Code
    JAK
    Regulation Number
    892.1750
    Why did this record match?
    Applicant Name (Manufacturer) :

    ISYS Medizintechnik GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Micromate™ device is a user-controlled electromechanical arm with a needle guide. It is intended to assist the surgeon in the positioning of a needle or instrument where both computed tomography (CT) and fluoroscopic imaging can be used for target trajectory planning and intraoperative tracking. The needle or electrode is then manually advanced by the surgeon. Trajectory planning is made with software that is not part of the Micromate™ device
    Device Description
    The Micromate™ system allows the percutaneous execution of a surgical intervention by providing instrument guidance according to one or more pre-operative plans defined in an external planning or navigation station. The alignment to the surgical plan is performed through a manual gross-positioning using a Positioning Arm, followed by automatic or joystick-controlled movement with image guidance, such as CT and fluoroscopic image. After alignment, the advancement of surgical instruments and delivery of therapy is performed manually by the surgeon, while the position is retained by the system and relying on the displayed navigation information or realtime images. The system comprises the following main components: - Targeting Platform, a robotic positioning unit that aligns to the surgical plan and holds the surgical instruments through an end-effector acting as a tool-guide adapter. - Control Unit, a handheld device that allows the automatic or manual control of the Targeting Platform movement and can communicate with an external planning and navigation station. - Positioning Arm, a multi-functional arm that is used to gross-position the Targeting Platform in such a way the trajectory is reachable. - Strain Relief Box, which distributes power and data through the Micromate™ system. - Power and Network Unit, which connects the system to power and allows an optional direct point-to-point connection to an external planning and navigation station for input of real-time navigation data. - Sterile Drapes for the Control Unit and Targeting Platform (this one containing also needle guides) for instrument guidance. - Connecting Cables - A cart for transport and storage. The system can be mounted to different bed/table through specific adapter accessories and all components are covered with a sterile drape during use. Third-party needle or tool guides are connected to the Targeting Platform end-effector through a customized mechanical interface that preserves the sterile barrier. Micromate™ is not patient contacting.
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    K Number
    K131433
    Device Name
    ISYS 1 (U.S),ACCESSORY, NON-STERILE
    Manufacturer
    ISYS MEDIZINTECHNIK GMBH
    Date Cleared
    2014-03-11

    (298 days)

    Product Code
    JAK
    Regulation Number
    892.1750
    Why did this record match?
    Applicant Name (Manufacturer) :

    ISYS MEDIZINTECHNIK GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The iSYS 1 device is a user-controlled electromechanical arm with a needle guide. It is intended to assist the surgeon in the positioning of a needle or electrode where both computed tomography (CT) and fluoroscopic imaging can be used for target trajectory planning and intraoperative tracking. The needle or electrode is then manually advanced by the surgeon. Trajectory planning is made with software that is not part of the iSYS device.
    Device Description
    The iSYS 1 is a modular needle guidance platform for interventional radiology and related fields. Core components are a 4 DOF micro positioning unit which allows the submillimetric needle positioning from simple needle angulations up to positioning and angulations with adjustable pivot point and a control unit which is directed by a cable connected control panel. The passive macro positioning unit and different table adapters allow different setups of the system around the patient in the region of interest. The needle-guide-kit (manufactured by ECOLAB) provides disposable components that ensure precise and sterile needle guidance. Planning of the tool position/orientation as well as validation of the correctness of the tool position must be performed with an external planning and measurement system which is not part of the iSYS-1 Interventional Platform. The position of iSYS 1 is visible for most imaging systems due to the used markers. During treatment the tool is controlled by the user.
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