Flexible Video-Choledochoscope (CHV-110J-U); Flexible Video-Choledochoscope (CHV-US120J-U)

The Flexible Video-Choledochoscope is a medical device with a digital imaging system (CMOS sensor) used to visualize and treat conditions in the biliary and pancreatic ducts, including the hepatic ducts. It consists of a flexible insertion tube with a camera system that transmits images to a processor and monitor for physician observation and diagnosis during endoscopic procedures.

The device uses CMOS chips at the distal end for imaging, LED illumination, a 110° field of view, and comes in variants with outer diameters of 2.6–3.8 mm and working lengths of 2000–2150 mm. It features bending angles up to 120° and uses ethylene oxide sterilization at 10⁻⁶ SAL. Key specifications are substantially similar to the predicate device across all measured parameters.

Not stated in this summary.

The proposed device is substantially equivalent to the predicate (Flexible Video-Choledochoscope System, K222261) because both share identical intended use for diagnostic and therapeutic biliary procedures, use the same CMOS imaging technology with LED illumination, and have nearly identical mechanical specifications (distal diameter, working length, bending angles, sterilization method, and field of view). Non-clinical performance testing including mechanical performance, duodenoscope compatibility, and flexible instrument compatibility demonstrated that the proposed device performs comparably to the predicate, with only minor dimensional differences that do not affect safety or effectiveness.