Single-use Video Scope; PB Digital Controller

The Pancreaticobiliary Video System consists of a Single-use Video Scope and PB Digital Controller designed for endoscopic imaging and treatment of the pancreatic biliary system. The scope provides visualization and a working channel for diagnostic and therapeutic accessories, while the controller processes and displays images collected by the scope.

The proposed device incorporates the same fundamental illumination source, sterilization packaging, design, energy source, and operational principles as the predicate device (K221784). Both devices have similar operating methods, main structure, main materials, and technological characteristics, though minor differences exist that do not affect substantial equivalence.

ISO 10993-1 (Biological Evaluation of Medical Devices), ISO 10993-5 (Biocompatibility), ISO 11135 (Sterilization by Ethylene Oxide), ASTM F1980 (Accelerated Aging of Sterile Barrier Systems), IEC 60601-1 (Medical electrical equipment general requirements), IEC 60601-2-18 (Endoscopic equipment), and IEC 60601-1-2 (Electromagnetic disturbances).

The proposed device is substantially equivalent because it uses the same fundamental technology, illumination source, and sterilization packaging as the predicate device K221784, with comparable operating methods and materials. Performance testing demonstrated the device works as intended with compatible devices and is as safe and effective as the predicate, despite some minor differences that do not affect safety or effectiveness.