Advanced Tissue Resection Device

The Advanced Tissue Resection Device is a sterile, single-use endoscopic device designed to be used with an endoscope to electrosurgically resect mucosa within the digestive tract. It comes in four specifications that differ primarily in working length and diameter of the distal end attachment.

The proposed device incorporates substantially equivalent intended use, design, operation principles, and sterilization process (EO) to the predicate. Both devices are composed of a loop, outer tube, conductive plug, and handle assembly, with the proposed device adding a distal cap assembly. Both use HF generators as the energy source and conform to the same electrical safety and electromagnetic standards (IEC 60601-1, 60601-1-2, 60601-2-2).

ISO 10993-1:2018 (biocompatibility); ISO 11135:2014+A1:2018 (EO sterilization validation); ASTM F1980-21 (accelerated aging); ISO 11607-1:2019 and ISO 11607-2:2019 (packaging); IEC 60601-1:2005/AMD2:2020, IEC 60601-2-2:2017/AMD1:2023, IEC 60601-2-18:2009, IEC 60601-1-2:2014/AMD1:2020, and IEC 60601-1-6:2010/AMD2:2020 (electrical safety and electromagnetic compatibility).

The device demonstrates substantial equivalence to predicate K955650 through identical indications for use, product code (FDI), regulatory classification (Class II), and sterilization method (EO to SAL 10-6). Although minor design differences exist (distal cap assembly), performance testing confirms these differences do not affect safety or effectiveness, and the device maintains technological parity with the predicate in all material respects.