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510(k) Data Aggregation

    K Number
    K251426
    Date Cleared
    2025-10-03

    (148 days)

    Product Code
    Regulation Number
    876.1500
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    da Vinci SP Surgical System, Model SP1098:
    The Intuitive Surgical Endoscopic Instrument Control System (da Vinci SP Surgical System, Model SP1098) is intended to assist in the accurate control of Intuitive Surgical EndoWrist SP Instruments during urologic, colorectal, and general thoracoscopic surgical procedures that are appropriate for a single port approach; and transoral otolaryngology surgical procedures in the oropharynx restricted to benign tumors and malignant tumors classified as T1 and T2. The system is indicated for adult use. It is intended for use by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.

    EndoWrist SP Instruments:
    Intuitive Surgical EndoWrist SP Instruments are controlled by the da Vinci SP Surgical System, Model SP1098, and include flexible endoscopes, blunt and sharp endoscopic dissectors, scissors, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, and suturing through a single port. The system is indicated for urologic, colorectal, and general thoracoscopic surgical procedures that are appropriate for a single port approach; and transoral otolaryngology surgical procedures in the oropharynx restricted to benign tumors and malignant tumors classified as T1 and T2. The system is indicated for adult use. It is intended for use by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.

    Device Description

    The da Vinci SP Surgical System is a robotically-assisted surgical device that is designed to enable complex surgery using a minimally-invasive approach. The system consists of three major subsystems: a Surgeon Console, a Vision Cart, and a Patient Cart.

    At the Surgeon Console, the surgeon controls all movement of the instruments and endoscope by using two hand controls and a set of foot pedals. The surgeon views the live endoscope image on a three-dimensional (3D) viewer, which provides a view of patient anatomy and instrumentation, along with icons and other user interface features.

    The Vision Cart includes supporting electronic equipment, such as the endoscope light source, video and image processing, and the networking hardware. The Vision Cart also has a touchscreen to view the endoscope image and adjust system settings.

    The Patient Cart is the operative component of the da Vinci SP Surgical System. It supports the positioning of the surgical port and manipulation of the surgical instruments and endoscope.

    AI/ML Overview

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