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510(k) Data Aggregation

    K Number
    K230185
    Device Name
    ANT-X System
    Date Cleared
    2023-06-01

    (129 days)

    Product Code
    Regulation Number
    892.1650
    Why did this record match?
    Applicant Name (Manufacturer) :

    NDR Medical Technology Pte. Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The ANT-X System is indicated for use in conjunction with fluoroscopy imaging in percutaneous nephrolithotomy (PCNL) procedures to aid in needle positioning and alignment process.
    Device Description
    The ANT-X System is an automated needle positioning medical device that is used in conjunction with fluoroscopy to support percutaneous interventions (PCNL). There are 4 main components to the system - the ANT-X Device. ANT-X Controller Box. ANT- X Needle Holder, and ANT-X Software. It is intended to be used in an operating theatre equipped with standard surgical equipment which are generally found in operating rooms. The ANT-X Device holds a sterile, disposable needle-guide kit, the ANT-X Needle Holder. The main bulk of ANT-X Device is made of biocompatible polyetheretherketone (PEEK) material. PEEK is preferred to build the robot because it is radiolucent and lightweight while being able to provide relatively high material strength. The Device has a fixed base made of three pairs of high stiffness parallel linkages allow millimetric planar needle adjustment. The targeted insertion point will act as a pivot point for the needle. The device will be mounted onto the operating table with a 6-DOF instrument holder (FISSO Articulated arm) such that it can be precisely oriented to the area of interest on the patient. The ANT-X Controller Box powers the ANT-X Device and is the integrating point for the whole ANT-X System. Images from the C-arm fluoroscopy machine will be passed into the ANT-X Controller Box and then to the ANT-X Software, in real-time. The user will then use the ANT-X Software to command the ANT-X Device to commence needle alignment between the chosen insertion point on the skin surface, and the desired target point within the body. Validation of the puncture trajectory and the final needle insertion will be performed by the surgeon.
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