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    K Number
    K253556

    Validate with FDA (Live)

    Device Name
    da Vinci SP Surgical System (SP1098); da Vinci E-200 Generator
    Manufacturer
    Intuitive Surgical, Inc.
    Date Cleared
    2026-01-16

    (63 days)

    Product Code
    NAY
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Age Range
    18 - 999
    Reference & Predicate Devices
    K251817,K241635
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis 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.

    da Vinci SP Instruments
    Intuitive Surgical da Vinci 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.

    da Vinci E-200 Generator
    The da Vinci E-200 Electrosurgical Generator is intended to deliver high-frequency energy for cutting, coagulation and vessel sealing of tissues in da Vinci robotic procedures, and non-robotic open and laparoscopic procedures.

    Device Description

    The subject da Vinci SP Surgical System’s Vision Cart replaces Erbe VIO dV generator and standalone EnergyShield Monitoring (ESM) with the da Vinci E-200 Electrosurgical Generator, which incorporates an integrated ESM.

    da Vinci SP Surgical System:
    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.

    1. 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 endoscope image in a three-dimensional (3D) viewer, which provides a view of patient anatomy and instrumentation, along with icons and other user interface features.

    2. 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.

    3. 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.

    da Vinci E-200 Generator:
    The da Vinci E-200 Generator is an electrosurgical unit (ESU) designed to provide high-frequency (HF) traditional monopolar, bipolar, and advanced bipolar outputs intended for cutting, coagulation and/or vessel sealing of tissues. The da Vinci E-200 Electrosurgical Generator is intended to be used with the da Vinci X, da Vinci Xi, da Vinci 5, and SP Surgical systems, and also operate as a standalone electrosurgical generator. When connected to the da Vinci surgical system, the da Vinci E-200 Generator provides HF output to da Vinci instruments. Control and status messages are passed between the da Vinci E-200 Generator and the da Vinci system through an Ethernet communication cable. The da Vinci E-200 Generator is also compatible with open and laparoscopic third-party handheld monopolar and bipolar instruments, footswitch equipped instruments (where applicable) and Intuitive auxiliary footswitch. The primary function of the da Vinci E-200 Generator is to allow a surgeon to deliver HF output to cut, seal, or coagulate tissue during surgery. The user interface includes audible indicator tones, LED indicators on the front of the generator, and status messages provided on its LCD display.

    AI/ML Overview

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