Visualized Access and Delivery Catheter; PB Digital Controller

The Appendiceal Video System consists of a reusable PB Digital Controller and a single-use Visualized Access and Delivery Catheter designed for appendicitis diagnosis and treatment procedures under direct visualization in adults, adolescents, and children. The catheter provides imaging and a working channel for diagnostic and treatment accessories, while the controller processes and displays images from the endoscope.

The proposed device has identical technological characteristics to the predicate device in design, main material, fundamental technology, principle of operation, energy source, sterilization packaging, shelf-life, and manufacturing process. The primary difference is expansion of the PB Digital Controller's compatible scope range to include the new appendiceal catheter in addition to the predicate pancreaticobiliary scope.

ISO 10993-1 (biocompatibility evaluation), ISO 11135 (ethylene oxide sterilization validation), ASTM F1980 (accelerated aging of sterile barriers), IEC 60601-1 (medical electrical equipment safety), IEC 60601-2-18 (endoscopic equipment requirements), and IEC 60601-1-2 (electromagnetic disturbances).