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The Senhance® Surgical System is intended to assist in the accurate control of laparoscopic instruments for visualization and endoscopic manipulation of tissue including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, mobilization, and retraction. The Senhance Surgical System is intended for use in general laparoscopic surgical procedures and laparoscopic gynecological surgery. The system is indicated for adult use. It is intended for use by trained physicians in an operating room environment in accordance with the instructions for use.

The Senhance Surgical System is a multi-arm, console-based robotic system that allows a surgical team to perform laparoscopic surgery in the abdomen and pelvis in a manner similar to a manual laparoscopic approach. Each robotic arm can hold either a laparoscopic surgical instrument or an endoscope to facilitate a surgeon remotely operating the instrument from the cockpit. The purpose of this submission is to seek clearance for modifications to the indications for use to expand the types of surgical procedures for which the Senhance Surgical System may be used. In this submission, the indications for use have been expanded to cover laparoscopic general surgical procedures. The new indications for use statement does not create a new intended use for the system. The Senhance Surgical System consists of: a surgeon console (cockpit), which provides remote manipulators or handles to allow the surgeon to maneuver the surgical instruments and a video monitor to display the endoscopic signal; manipulator arms, which hold and maneuver the instruments and endoscope based on inputs from the surgeon; Intelligent Surgical Unit (ISU), which is the system communication hub, connecting the cockpit and manipulator arms; and instruments, which manipulate the tissue of interest. In addition, force feedback provides an optional tactile sensory input to the surgeon control handles to give a sense of tissue elasticity. An eye tracking feature provides the surgeon an optional method to control the endoscope from the cockpit, rather than using the surgeon control handles. The ISU allows for three additional methods of camera control, in addition to the optional eye tracking method. The Senhance instruments are similar in design and materials to traditional laparoscopic instrumentation.

The Senhance® Surgical System is intended to assist in the accurate control of laparoscopic instruments for visualization and endoscopic manipulation of tissue including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, mobilization. The Senhance Surgical System is intended for use in laparoscopic gynecological surgery, colorectal surgery, cholecystectomy, and inguinal hernia repair. The system is indicated for adult use. It is intended for use by trained physicians in an operating room environment in accordance with the instructions for use.

The purpose of this submission is to seek clearance for an alternate Node component called the Smart Node (to be marketed as the Intelligent Surgical Unit (ISU)), which introduces enhanced image processing features and augments the endoscope movement capabilities of the TransEnterix® Senhance® Surgical System. The Smart Node adds three new methods of camera control for the surgeon operating at the Senhance Cockpit.

The Senhance® Surgical System is intended to assist in the accurate control of laparoscopic instruments for visualization and endoscopic manipulation of tissue including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, mobilization. The Senhance Surgical System is intended for use in laparoscopic gynecological surgery, colorectal surgery, cholecystectomy, and inguinal hernia repair. The system is indicated for adult use. It is intended for use by trained physicians in an operating room environment in accordance with the instructions for use.

The Senhance® 3 mm Monopolar L-Hook Electrode instrument and adapter are intended as additions to the suite of monopolar hook instruments and adapters initially cleared for use with the TransEnterix Senhance Surgical System through K171120 (October 13, 2017) and then expanded through K191482 (July 11, 2019). The subject instrument and adapter are modifications of the predicate TransEnterix Senhance 5 mm Monopolar L-Hook Electrode instrument and adapter FDA cleared through K191482. Like the predicate devices, the subject devices are multi-use surgical devices that are cleaned and steam sterilized by the end user before the first use and after each use. The subject and predicate instruments consist of a polymer coated stainless steel shaft with an electrode at the distal end and a ceramic collar between the two to provide monopolar insulation. In order to be used with the Senhance Surgical System, the typical manual laparoscopic handle at the proximal end of the instrument is removed and replaced by a connector that mates with an adapter. The adapter provides the mechanism which allows the instrument to interface with the robotic manipulator arm of the Senhance Surgical System. Each instrument is laser marked with a unique identification number that matches its corresponding adapter.

The Senhance Ultrasonic System and accessories are indicated for soft tissue surgical incisions when bleeding control and minimal thermal injury are important. The Senhance Ultrasonic Surgical System and accessories are indicated for use with the Senhance Surgical System.

The Senhance Ultrasonic System is an energized instrument system which delivers ultrasonic energy to the tissue of interest for soft tissue incisions. It is designed to be used with the Senhance Surgical System which precisely manipulates laparoscopically based instruments in surgery. The Senhance Ultrasonic System is composed of five components: 1. The Dissector which interfaces with the tissue of interest 2. The Transducer which converts electrical energy into ultrasonic energy 3. The Senhance Adapter which physically attaches the instrument to the Senhance Surgical Robotic System manipulator arm 4. The Ultrasonic Generator which controls the energy settings to be delivered to the tissue 5. The Footswitch

The Senhance Surgical System is intended to assist in the accurate control of laparoscopic instruments for visualization and endoscopic manipulation of tissue including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, mobilization, and retraction. The Senhance Surgical System is intended for use in laparoscopic gynecological surgery, colorectal surgery, cholecystectorny, and inguinal hernia repair. The system is indicated for adult use. It is intended for use by trained physicians in an operating room environment in accordance with the instructions for use.

The Senhance 3 mm bipolar surgical instruments and adapters are additions to the suite of bipolar instruments and adapters previously cleared for use with the Senhance Surgical System (K181517). The instrument designs are adaptations of standard laparoscopic instruments that are commonly used in surgery. Each instrument type has a corresponding system adapter. All instruments and adapters are multi-use devices that are steam sterilized by the end user before the first use and after each use. The Senhance 3 mm bipolar instruments include: - . Bipolar Maryland Dissector – diameter 3 mm / length 280 mm - . Bipolar Grasping Forceps - diameter 3 mm / length 280 mm

The Senhance Surgical System is intended to assist in the accurate control of laparoscopic instruments for visualization and endoscopic manipulation of tissue including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, mobilization and retraction. The Senhance Surgical System is intended for use in laparoscopic gynecological surgery, colorectal surgery, cholecystectomy, and inguinal hernia repair. The system is indicated for adult use. It is intended for use by trained physicians in an operating room environment in accordance with the Instructions for Use.

The Senhance "Additional" surgical instruments and adapters are intended as additions to the predicate suite of instruments and adapters previously cleared for use with the TransEnterix Surgical System (Model Senhance™ - K171120 and K180163). All instruments and adapters are multi-use components that are steam sterilized by the end user before the first use and after each use. The instrument designs are adaptations of standard laparoscopic instruments that are commonly used in surgery. Each instrument type has a corresponding system adapter.

The Senhance Surgical System is intended to assist in the accurate control of laparoscopic instruments for visualization and endoscopic manipulation of tissue including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, mobilization. The Senhance Surgical System is intended for use in laparoscopic gynecological surgery, colorectal surgery, cholecystectomy, and inguinal hernia repair. The system is indicated for adult use. It is intended for use by trained physicians in an operating room environment in accordance with the Instructions for Use.

The Senhance Surgical System is a console-based, multi-arm surgical system, which enables a surgeon to remotely control surgical instrumentation during minimally invasive surgery in the lower abdomen and pelvis. The capital equipment is comprised of three main sub-systems as follows: - . Cockpit - The station where the surgeon inputs information through hand and eye movements to direct the motion of the arms in the surgical field. - . Manipulator Arms - Independent mechanized support arms that interface with the endoscope and surgical instruments. The manipulator arms produce output movements based on the instructions from the surgeon at the cockpit. The system is configurable with up to three arms. - Node A relay unit that connects the cockpit inputs to the manipulator arms in the system as configured, ● and converts and transmits the video signals to the 2D/3D monitor on the cockpit console.

The Senhance Surgical System is intended to assist in the accurate control of laparoscopic instruments for visualization and endoscopic manipulation of tissue including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, mobilization and retraction in laparoscopic colorectal surgery and laparoscopic gynecological surgery. The system is indicated for adult use. It is intended for use by trained physicians in an operating room environment in accordance with the Instructions for Use.

The Senhance Surgical System is a console-based, multi-arm surgical system which enables a surgeon to remotely control surgical instrumentation during minimally invasive surgery in the lower abdomen and pelvis. The capital equipment is comprised of three main sub-systems as follows: - Cockpit The station where the surgeon inputs information through hand and eye movements to direct the motion of the arms in the surgical field. - Manipulator Arms Independent mechanized support arms that interface with the endoscope ● and surgical instruments. The manipulator arms produce output movements based on the instructions from the surgeon at the cockpit. The system is configurable with up to three arms. - Node A relay unit which connects the cockpit inputs to the manipulator arms in the system as configured, and converts and transmits the video signals to the 2D/3D monitor on the cockpit console.

The SPIDER® Surgical Instruments are intended for use in minimally invasive abdominal laparoscopic surgical procedures for grasping, mobilizing, dissecting, cutting, cauterizing, ligating, suction/irrigation and other manipulation of tissues and vessels during laparoscopic procedures.

The SPIDER® Flexible Monopolar Instruments are surgical instruments used to facilitate laparoscopic surgery. The instruments are a part of the SPIDER® Flexible Surgical Instruments family. They are intended for use with the SPIDER® Single Port Device. The instruments may be used with or without electrocautery. The flexible electrocautery instruments are pre-sterilized, single use, disposable devices. The devices have a ring handle with ratchets where applicable, a rotation knob for rotating the shaft and distal tips, an electrocautery post for cable connection to an electrosurgical generator, a flexible shaft, and distal tips to manipulate tissue. The instruments may be used without connecting to a power source. However, when connected by a standard cable to an electrosurgical generator, the instruments may be used for cutting and coagulation of tissue. The instrument set includes: Flexible graspers for grasping tissue, Flexible shears for cutting tissue, Flexible dissectors for dissecting tissue.

The SPIDER® Flexible Blunt Dissector and Band Passer is indicated for use with the SPIDER® single port device (SPIDER® Surgical Platform) during laparoscopic surgery to dissect tissue layers, to pull tubing and to generally assist in the placement of gastric bands.

The SPIDER® Flexible Blunt Dissector and Band Passer device is a surgical instrument used to facilitate laparoscopic surgery. It is intended for use with the SPIDER® Single Port Device or other laparoscopic access device that facilitates the use of rigid and/or flexible instrumentation. The SPIDER® Flexible Blunt Dissector and Band Passer instrument has a flexible shaft with an articulating distal tip is blunt to allow tissue dissection between tissue layers and the articulation is actuated via a proximal ratcheted handle. The blunt tip includes a shallow slot to grab sutures as applicable. It also includes a non-electrical retractable loop (grasping loop) for grasping and pulling tubing, sutures, or tissue. The instrument is provided sterile and is a single use, disposable device.