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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 da Vinci 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 also indicated for use in nipple sparing mastectomy (NSM) procedures. 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.

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 also indicated for use in nipple sparing mastectomy (NSM) procedures. 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.

The da Vinci SP Surgical System is designed to enable complex surgical procedures using a minimally invasive approach. The system consists of a Surgeon Console, a Vision Cart, and a Patient Cart and is used with an endoscope, instruments, and accessories.

The surgeon seated at the Surgeon Console controls all movement of the instruments and endoscope by using two hand controls and a set of foot pedals. The surgeon views the endoscopic 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 light source, video and image processing, and the networking hardware. The Vision Cart also has a touchscreen to view the endoscopic image and adjust system settings.

The Patient Cart is the operative component of the da Vinci SP Surgical System. Its primary function is to support the positioning of the surgical port and to manipulate the surgical instruments and endoscope. The Patient Cart is positioned beside the operating room table and contains an instrument arm that is positioned with respect to the target patient anatomy. The instrument arm contains four instrument drives that hold up to three surgical instruments and the endoscope. The bedside surgical assistant installs and removes the endoscope and instruments intra-operatively as needed.

This 510(k) is for a labeling modification only, to add "nipple sparing mastectomy (NSM) procedures" to the indications, and to add "nipple sparing mastectomy" as new representative, specific procedures in the Professional Instructions for Use. There have been no technical changes to the device.

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