Search Results

The SpyScope Access and Delivery Catheter is intended to guide both optical and accessory devices for diagnostic and therapeutic applications during endoscopic procedures in the pancreatico-biliary system including the hepatic ducts.

The SpyScope Access and Delivery Catheter is a sterile, single-use device comprised of two main components: a flexible delivery catheter and a handle. The device is designed to guide the SpyGlass Direct Visualization Probe or other visualization devices and accessory devices. (such as biopsy forceps, cytology brushes, stone retrieval baskets, etc.) during endoscopic retrograde cholangiopancreatography (ERCP) procedures. The SpyScope Access and Delivery Catheter is introduced to the desired anatomical location through a duodenoscope with a minimum working channel diameter of 4.2mm.

The provided text does not contain information about acceptance criteria, device performance, or a study proving that the device meets acceptance criteria. The relevant sections (6 and 7) state that the proposed device, the SpyScope Access and Delivery Catheter, has identical technological characteristics (materials, construction, and manufacturing processes) to a currently marketed SpyScope Access and Delivery Catheter. Furthermore, it explicitly states, "As this is a request for an expanded indication and introduces no new materials or design changes, performance testing was not repeated to support this submission."

Therefore, I cannot provide the requested information. The submission relies on the substantial equivalence principle and comparison to predicate devices, rather than new performance data or acceptance criteria for this specific submission.

Ask a specific question about this device