Hugo™ RAS System

The Hugo RAS System is a modular robotic-assisted surgery platform designed to assist surgeons in controlling instruments and accessories for minimally invasive urologic procedures including cystectomy, nephrectomy, and prostatectomy. It consists of a surgeon console, system tower, and up to four interchangeable arm cart assemblies with wristed instruments that enable precise tissue manipulation, grasping, cutting, dissection, ligation, and suturing in an operating room environment.

The Hugo RAS System shares the same modular architecture, 7 degrees of freedom, electromagnetically actuated joints, and open console design as the predicate Versius Surgical System. Key differences include Hugo's fixed mechanical remote center of motion versus Versius's software-based approach, Hugo's pistol-like hand controllers versus Versius's joystick controls, and Hugo's compatible integration with Karl Storz and Rubina endoscopes and Covidien ValleyLab FT10 electrosurgical generator versus Versius's separate system requirements.

ISO 11135 (Ethylene Oxide sterilization), ISO 17665-1 (moist heat sterilization), ISO 11607-1 and -2 (sterile packaging), ISO 11737-1 and -2 (microbial testing), ISO 17664-1 (reprocessing), IEC 60601-2-2 (high-frequency surgical equipment), FDA guidance on device software content and cybersecurity, and PRISMA guidelines for meta-analyses of comparative clinical literature.

The Hugo RAS System is substantially equivalent to the Versius Surgical System predicate device based on identical intended use for urologic minimally invasive procedures, similar technological characteristics and architecture, compliance with Special Controls for product code SCV, and clinical performance data from the Expand URO IDE study demonstrating primary safety and effectiveness endpoints that meet or exceed literature-based comparator performance across cystectomy, nephrectomy, and prostatectomy procedures with no device-related deaths.