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IRISeg is intended for use as a software application that receives DICOM compliant contrastenhanced CT images, provides manual and machine learning-enabled tools for image analysis and segmentation, and creates an output file that can be used to render a 3D model for preoperative surgical planning and intraoperative display. The use of IRISeq may include the generation of preliminary segmentations using machine learning algorithms. IRISeg is intended for use by qualified professionals. The output file is meant for visual, non-diagnostic use and shall be reviewed by clinicians who are responsible for all final patient management decisions. The machine learning enabled kidney CT auto-seamentation tool is intended for use for adult patients with contrast-enhanced, axial kidney CT images with slice thickness 3mm or less.

IRISeg Version 3.1 ("IRISeg") is a standalone software application created by Intuitive Surgical for segmentation of contrast-enhanced kidney CT images and generation of output files that can be rendered as virtual 3D models of kidney organs. IRISeg is designed to professionals ("users") with manual and machine learning (ML)-based tools for segmentation of kidney anatomy based on CT scans.

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 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. 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 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 "general thoracoscopic surgical procedures" to the indications, and to add "lobectomy, segmentectomy, wedge resection, segmentectomy, lymphadenectomy, thymectomy, and mediastinal mass resection" as new representative, specific procedures in the Professional Instructions for 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 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. Endo Wrist SP Instruments: Intuitive Surgical Endo Wrist SP Instruments are controlled by the da Vinci SP Surgical System, Model SP1098, and include flexible endoscopes, blunt and sharp endoscopic dissectors, 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 surgical procedures that are appropriate for a single port approach and transoral otolaryngology surgical procedures in the oropharynx restricted to benign turnors 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 "simple prostatectomy" as a new representative, specific procedure in the Professional Instructions for Use. Simple prostatectomy is a "covered" procedure under radical prostatectomy as an "umbrella" procedure. This 510(k) also includes the addition of performance data (cadaver) for "transvesical prostatectomy" as validated approach for prostatectomy in the Performance Data section of the User Manual.

The Intuitive Surgical EndoWrist Stapler 45, Stapler 45 Reloads and other Stapler Accessories (including the bladeless obturators) are intended to be used with a compatible da Vinci Surgical System for resection and/or creation of anastomoses in General, Thoracic, Gynecologic and Urologic surgery. The device can be used with staple line or tissue buttressing material (natural or synthetic). The Intuitive Surgical EndoWrist Stapler 30 Instrument and Stapler 30 Reloads are intended to be used with a compatible da Vinci Surgical System for resection and/or creation of anastomoses in General, Thoracic, Gynecologic, and Urologic surgery. The device is indicated for adult and pediativ use. The device can be used with staple line or tissue buttressing material. The Intuitive Surgical SureForm 60 Reloads and accessories are intended to be used with a compatible da Vinci System for resection, transection of anastomoses in General, Thoracic, Gynecologic, Urologic, and Pediatric surgery. The device can be used with staple line or tissue buttressing material (natural or synthetic). The Intuitive Surgical SureForm 45 Stapler, SureForm 45 Reloads and other Stapler accessories are intended to be used with a compatible da Vinci Surgical System for resection, and/or creation of anastomoses in General, Thoracic, Gynecologic, Urologic, and Pediatric surgery. The device can be used with staple line or tissue buttressing material (natural or synthetic). The Intuitive Surgical 8 mm SureForm 30 Curved-Tip and 8 mm SureForm 30 Reloads and accessories are intended to be used with a compatible da Vinci Surgical System for resection of vasculature and tissue, and/or creation of anastomoses in General, Thoracic, Gynecologic, Urologic, and Pediatric Surgery.

The Intuitive Surgical EndoWrist Stapler 30 Staplers, EndoWrist Stapler 45 Staplers, SureForm 45 Staplers, SureForm 60 Stapler, and 8 mm SureForm Staplers are fully wristed, articulating, surgical staplers and are designed for use exclusively with the Intuitive Surgical da Vinci Xi and X Surgical Systems (Models IS4000 and IS4200 Systems). The staplers are controlled by the surgeon using the Surgeon Console of the IS4000/IS4200 Systems. They are intended for resection, transection and/or creation of anastomoses in surgery. The staplers achieve their intended use by placing multiple staggered rows of implantable staples in the target tissue (stapling) followed by cutting of the target tissue along the middle of the staple line (transection). The Reloads consist of a single-use cartridge that contains multiple staggered rows of implantable titanium alloy (Ti3A12.5V) staples. The reloads are sterile, single use devices that are offered in various configurations by product family. Each color represents a different staple leg height and tissue gap for use with various tissue thicknesses.

Upon intravenous administration and use of an ICG drug product consistent with its approved label, the da Vinci Firefly Imaging System is intended to provide real-time endoscopic visible and nearinfrared fluorescence imaging. The da Vinci 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, and at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct or common hepatic duct), using near infrared imaging. Fluorescence imaging of biliary ducts with the da Vinci Firefly Imaging System is intended for use with standard of care white light and, when indicated, intraoperative cholangiography. The device is not intended for standalone use for biliary duct visualization. Upon interstitial administration and use of an ICG drug product consistent with its approved label, the da Vinci Firefly Imaging System is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.

The da Vinci Firefly Imaging System provides visualization in two modes: standard, visible-light imaging mode and a near-infrared fluorescence imaging mode, consisting of either a black-and-white surgical image or completely black background with the nearinfrared fluorescence depicted in a color overlay. For near-infrared fluorescence imaging, indocyanine green (ICG) fluorescence imaging agent is required.

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 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 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 subject da Vinci SP Surgical System, Model SP1098, uses advanced robotic technology to facilitate accurate movement of EndoWrist SP™ Instruments through a single surgical port. The System includes three major subsystems (Surgeon Console, Vision Cart, Patient Cart), which are used with instruments and accessories. The system is software controlled. There are two types of changes that are the focus of this 510(k). The first change is a modification to the Surgeon Console's FootSwitch Panel. The second change is an update to the System Software.

The da Vinci Xi Hasson Cone has applications in laparoscopic surgery to establish a port of entry for Intuitive Surgical da Vinci Xi EndoWrist Instruments, endoscopes, or compatible accessories.

The da Vinci Xi Hasson Cone is a cone-shaped device which is intended to be used in endoscopic surgery to anchor a port of entry (i.e., cannula) to the patient. During Hasson, or open, surgical techniques, the user places a Hasson Cone in the opening of the body wall. The cannula shaft is inserted into the cone, effectively increasing the diameter of the cannula to the contour of the incision made in the body wall. The Hasson Cone will be offered in two sizes; 8 mm and 12 mm & Stapler.