Disposable Sphincterotome

The Disposable Sphincterotome is a sterile, single-use endoscopic device designed for transendoscopic sphincterotomy of the Papilla of Vater and/or the Sphincter of Oddi. It can also be used to cannulate and inject contrast medium during pancreaticobiliary procedures. The device consists of a cutting wire, sheath, guide wire connector, injection connector, conductive column, finger ring, handle, and imaging ring, and comes in 72 different specifications varying in cutting length, tip length, working length, and guide wire lumen channel type.

The subject device differs from the predicate (Autotome RX) in cutting wire length (10/20/25/30mm vs. 20/30mm), working length (1800/2000/2300mm vs. 2000mm), tip length (5/10/15mm vs. 5mm), rated high-frequency voltage (1600 Vp vs. 750 Vp), and recommended output power (30–40W vs. 30–70W). Both devices share the same product code (KNS), intended use, sterilization method (ethylene oxide, SAL 10⁻⁶), compatible endoscopy channel (≥2.8mm), and biocompatibility standards (ISO 10993-1).

ISO 10993-1 and ISO 10993-7 (biocompatibility); ISO 11607-1 (sterilization packaging); ISO 11135 and ASTM 1980 (sterilization validation); IEC 60601-1:2020, IEC 60601-1-2:2020, IEC 60601-2-18:2009, and IEC 60601-2-2:2017 (electromagnetic compatibility and electrical safety). Bench testing included appearance, dimensions, operational performance, tensile performance, hydraulic leak resistance, injection connector performance, conduction resistance, contrast agent injection, cutting line function, radiopacity, compatible endoscope tests, and thermal effect tests.

Substantial equivalence is supported by identical intended use, same indications, equivalent material types meeting ISO 10993 biocompatibility, identical sterilization methods, and the same fundamental technology and operating principle. The differences in cutting wire length, working length, tip length, voltage, and power are not safety-or-effectiveness issues because: (1) performance testing on worst-case design specifications showed no clinically significant differences; (2) both devices passed equivalent safety and EMC testing; and (3) performance comparison testing on cutting line function at 30W, 40W, and 70W demonstrated the subject device is as safe and effective as the predicate.