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The Hugo™ Robotically Assisted Surgery (RAS) System is intended to assist in the accurate control of instruments and accessories including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, forceps/graspers, needle holders, electrosurgical tools and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrosurgery, and suturing during minimally invasive urologic surgical procedures. The system is indicated for adult use. It is intended to be used by trained physicians in an operating room environment in accordance with the representative surgical procedures set forth in the Hugo™ RAS System Indications Document.

The Hugo™ RAS System is a modular assembly of devices intended to assist a surgeon with the accurate control of instruments and accessories for performing tele-operative surgical procedures. It is a system of software-operated, electro-mechanical, cable-connected capital equipment with compatible instruments and accessories.

The major components of the Hugo™ RAS System are capital equipment: (1) System Tower, (2) Surgeon Console, and (3) Arm Cart Assemblies (ACAs). Each Arm Cart Assembly (ACA) consists of a movable cart with casters supporting setup arm connected to a modular and extendable robotic arm containing an instrument drive unit (IDU). Instruments and accessories attach to the IDUs of the robotic arms to perform robotically assisted surgery. The Surgeon Console is the surgeon's interface for controlling the Hugo RAS System. The Surgeon Console is operated by the user to control the robotic arms and attached instruments. The System Tower is a mobile cart that houses system computers, high-definition operating room team interactive (ORTI) display, power-management system and cable hooks for cable storage.

Hugo™ RAS system instruments include wristed instruments enabling surgeons to precisely grab, dissect, manipulate and suture tissue. There are nine different wristed instruments currently part of the Hugo™ RAS System grouped into basic instruments and electrosurgical instruments, including Large Needle Driver, Extra Large Needle Driver, Double Fenestrated Grasper, Toothed Grasper, Cadiere Forceps, Secure Cadiere Forceps, Monopolar Curved Shears, Bipolar Maryland Forceps and Bipolar Fenestrated Grasper. Hugo™ RAS system accessories include 3D glasses, surgical drapes, Endoscope Adapters, Sterile Interface Modules, Instrument Key, and Monopolar Tip Covers. These accessories enable the Hugo™ RAS system and instruments to achieve their intended use.

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