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The Vessel Sealer Curved is a bipolar electrosurgical instrument for use with a compatible da Vinci Surgical System and a compatible electrosurgical generator. It is intended for grasping and blunt dissection of tissue, and for bipolar coagulation and mechanical transection of blood vessels (veins and arteries) up to 7 mm in diameter, lymphatic vessels, and tissue bundles that fit in the jaws of the instrument. The Vessel Sealer Curved has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures, and should not be used for these procedures.

The Vessel Sealer Curved is a sterile, single-use (disposable), 8 mm instrument with an integrated cord that connects to the instrument housing. The Vessel Sealer Curved device consists of a distal wristed end effector and a proximal housing connected by a tubular shaft. The housing contains mechanisms to actuate the end effector when attached to a compatible da Vinci Surgical System. An integrated cord attached to the housing is connected to a receptacle in the Intuitive Electrosurgical generator, E-200. An electrode sealing surface and a cutting blade within the jaws of the instrument enable sealing of vessels and cutting of sealed vessels and other tissues. The sealing and cutting functions are controlled using the compatible da Vinci Surgical System foot pedals.

The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Surgical System, Models: IS4000 and IS4200) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, 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, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, general thoracoscopic surgical procedures and thoracoscopically-assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use. It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.

This 510(k) is for a labeling modification only, to include "tracheobronchoplasty for symptomatic, severe tracheobronchomalacia" as an additional representative, specific procedure under the previously cleared "General Thoracoscopic Surgical Procedures and Thoracoscopically-Assisted Cardiotomy Procedures" Indications for Use for the da Vinci Xi Surgical System, Model IS4000 (K131861) and the da Vinci X Surgical System, Model IS4200 (K171294). There are no changes to the technological characteristics of the cleared da Vinci Xi or X Surgical Systems (Models IS4000 and IS4200) proposed in this submission. The da Vinci Xi and X Surgical Systems, Models IS4000 and IS4200, are software-controlled, electro-mechanical systems designed for surgeons to perform minimally invasive surgery. The Model IS4000 and Model IS4200 Surgical Systems consist of a Surgeon Console, a Patient Side Cart (PSC), and a Vision Side Cart (VSC) and are used with an Endoscope, EndoWrist Instruments, and Accessories.

The da Vinci SP Firefly Imaging System is intended to provide real-time endoscopic visible and near-infrared fluorescence imaging. The da Vinci SP Firefly Imaging System enables surgeons to perform minimally invasive surgery using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion, using near-infrared imaging.

The *da Vinci SP* Firefly Imaging System is a fully integrated, adjunct imaging system for the *da Vinci SP* Surgical System. The *da Vinci SP* Surgical System is a robotic-assisted surgical device (RASD) that is designed to enable complex surgery using a minimally invasive approach. The system consists of three major subsystems: the Surgeon Console, the Vision Cart, and the Patient Cart. The *da Vinci SP* Firefly Imaging System consists of the following components of the *da Vinci SP* Surgical System (refer to *Figure 1*): o the *Endoscope Controller (light source)* on the Vision Cart o the *SP Endoscope, 0° (subject device)*, which is installed on the Patient Cart The *Endoscope Controller* provides a light source, either visible light or a near-infrared (NIR) excitation laser. The *Endoscope* transmits visible light or NIR light from the Endoscope Controller via optical fibers to illuminate the surgical site. The stereoscopic camera at the Endoscope tip images the surgical site in either visible light mode or fluorescence imaging mode.

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 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 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.

The da Vinci SP Surgical System is designed to enable complex surgery using a minimally invasive approach. The system consists of a Surgeon Console, a Vision Cart, and a Patient Cart and is used with a camera, instruments, and accessories. The surgeon seated at the Surgeon Console controls all movement of the instruments and camera by using two hand controls and a set of foot pedals. The surgeon views the camera 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 camera light source, video and image processing, and the networking hardware. The Vision Cart also has a touchscreen to view the camera 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 camera. The Patient Cart is positioned at the operating room 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 camera. The patient-side assistant installs and removes the camera and instruments intra-operatively. This 510(k) is for a labeling modification only, to add "transanal local excision (TALE)" as a new representative, specific procedure in the Professional Instructions for Use.

The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Xi and X Surgical Systems, Models IS4000 and IS4200) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, 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, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, general thoracoscopic surgical procedures and thoracoscopically-assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use. It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use. **Intended Use:** To assist in the accurate control of endoscopic instruments in minimally invasive surgery.

The da Vinci Xi/X Surgical Systems, Models IS4000/IS4200, are software-controlled, electro-mechanical systems designed to enable complex surgery using a minimally invasive approach. The systems consist of a Surgeon Console, a Patient Side Cart (PSC), and a Vision Side Cart (VSC) and are used with an endoscope, instruments, and accessories. The basis for this submission is the modification of the da Vinci Xi/X Surgical Systems, Models IS4000/IS4200, cleared in K240723. The device software is being modified to include a new feature called "Networked Central Configuration Management" which enables Intuitive technical support to remotely push configuration data to a system connected to the network, including customer site preference settings and system feature enabling or disabling. The modification also includes changes to the device labeling.

The Intuitive Surgical da Vinci SP SureForm 45 Stapler, SP SureForm 45 Curved-Tip Stapler, and SureForm 45 Reloads and other accessories are intended to be used with the da Vinci SP Surgical System for resection, transection, and/or creation of anastomoses in Urologic, Thoracic, and Colorectal surgery.

The da Vinci SP SureForm 45 Curved Tip Stapler and da Vinci SP SureForm 45 Stapler, with the existing SureForm 45 Reloads (cleared via K183224 and K190999) are designed for use exclusively with compatible Intuitive da Vinci SP Surgical Systems (Model SP1098). It is intended for resection, transection and/or creation of anastomoses in surgery. The instrument achieves its intended use by placing multiple staggered rows of implantable staples in the target tissues (stapling) followed by cutting of the target tissue along the middle of the staple line (transection). The SP SureForm 45 Curved Tip Stapler and SP SureForm 45 Stapler Instruments are disposable, fully wristed articulating devices and are compatible with the existing, Intuitive manufactured SureForm 45 mm Gray, White, Blue, Green, and Black reloads (hereinafter referred to as SureForm 45 Reloads). The SP SureForm 45 Reloads consist of a single-use cartridge that contains multiple, staggered rows of implantable staples, and a stainless-steel knife.

The SP Advanced Access Port Kit is intended to be used in endoscopic surgery to provide access for da Vinci SP instruments, a da Vinci SP Endoscope, and assist instruments through a single port.

The subject da Vinci SP Advanced Access Port Kit, Large Incision is a sterile, single-use, disposable accessory to the da Vinci SP Surgical System, Model SP1098, the predicate device is the cleared da Vinci SP Access Port Kit 510(k) #K202571). It provides surgical access for the SP1098 system during minimally invasive robotic surgery. The da Vinci SP Advanced Access Port Kit is compatible with the existing EndoWrist SP Instruments, SP Endoscope, and manual laparoscopic instruments (referred to as "assist instruments") and other compatible laparoscopic devices through a single incision while maintaining insufflation, which is identical to the predicate device. It is also compatible with Intuitive da Vinci SP 12mm Instruments, unlike the predicate device. The subject device enables superficial instrument articulation, like the predicate device.