High Flow Insufflation Unit (UHI-4)

The UHI-4 is a laparoscopic insufflator that insufflates the abdominal cavity with CO2 gas and provides automatic suction and smoke evacuation to facilitate laparoscopic observation, diagnosis, and treatment. It also performs controlled CO2 insufflation for endoscopic vessel harvesting procedures and colon insufflation for endoscopic procedures.

The subject device has identical technological characteristics and design to the predicate device with no changes to hardware design, performance specifications, materials, sterilization, shelf life, or packaging. The only difference is software modifications to two existing functions: pressure sensor failure detection and alarm delay setting.

Not stated in this summary.

The UHI-4 is substantially equivalent to the predicate device (K122180) because it has identical indications for use, same principle of operation, same design and materials, and leverages non-clinical testing from the predicate in support of equivalence. Software testing and cybersecurity documentation were provided for the two modified software functions. Bench testing validated overpressure protection, tube obstruction detection, CO2 suction control, hardware abnormality response, and failure communication—all demonstrating the device maintains the same safety and effectiveness profile as the predicate.