SB Knife Jr2 (MD-47702 and MD-47702L)

The SB Knife Jr2 is a single-use, sterile electrosurgical knife available in two models (MD-47702 and MD-47702L with working lengths of 1970 mm and 2320 mm respectively). It connects to Olympus and ERBE monopolar high-frequency electrosurgical generators to cut tissue, including Zenker's diverticulum, in the digestive tract during endoscopic submucosal dissection procedures.

Compared to the predicate SB Knife, the subject device features: (1) only Jr and Jr(Long) types versus predicate's Short/Standard variants; (2) a new rotating operation portion for improved handling; (3) polysiloxane coating on forceps/supporting frame versus predicate's polytetrafluoroethylene; and (4) polycarbonate handle/slider materials versus predicate's polyphenylsulfone. Opening width (4.5 mm) and knife length (3.5 mm) are identical to predicate models.

Non-clinical testing included ASTM D4169-22, D4332-14, F1980-21 (transportation/shelf life); ASTM F2096-11, F88/F88M-15 (packaging); ISO 11135 and ISO 10993-7 (sterilization); IEC 60601-1, 60601-2-2, 60601-1-2, 60601-1-6, and 60601-2-18 (electrical safety and EMC); and ISO 10993-1 (biocompatibility).

Substantial equivalence is supported by: identical indications for use and intended patient population; similar overall shape, structure, and key dimensions; performance testing confirming equivalent tissue-cutting and insulation performance despite material changes; clinical literature demonstrating equivalent or superior performance with the new polysiloxane coating and rotating mechanism; biocompatibility testing validating material safety; and comprehensive non-clinical testing demonstrating the device performs as intended with no new safety concerns.