Biliary Pancreaticobiliary Scope System

The Biliary Pancreaticobiliary Scope System is a flexible endoscope system used for diagnostic and therapeutic procedures in the pancreato-biliary system, including the hepatic ducts. It comprises a single-use Biliary Pancreaticobiliary Scope and an Image Processor that receives, processes, and outputs images from the scope.

The proposed device has the same sterilization method, energy source, principle of operation, and similar design parameters as the predicate (field of view, depth of view, deflection angle, instrument channel width, work length). The primary difference is that the proposed image processor offers more types of signal output than the predicate device.

ISO 10993-1 (biocompatibility), ISO 11135:2014 (sterilization), ISO 10993-7:2008 (residual ethylene oxide/ethylene chlorohydrin), IEC 60601-1 and IEC 60601-2-18 (electrical safety and EMC), ISO 8600 series (optical performance), ASTM F1980-21 and F1886/F1886M-16 (shelf life and accelerated aging), ISO 11607-1:2019 and ISO 11607-2:2019 (package validation).

The devices share identical indications for use, sterilization methods, energy sources, and operating principles with matching design parameters such as field of view, deflection angle, and instrument channel width. Performance testing and compliance with voluntary consensus standards demonstrate functional equivalence. The proposed image processor's additional signal output types do not raise new safety or effectiveness concerns and represent only an enhancement in functionality for clinicians.