Viction Disposable Irrigation and suction catheter (VC-IRA0532, VC-IRA0523, VC-IRB0532, VC-IRB0523, VC-IRC0532, VC-IRC0523, VC-IRD0532, VC-IRD0532)

The Viction Disposable Irrigation and Suction Catheter is a single-use, sterile medical device designed for laparoscopic surgery. It consists of a battery-powered handpiece with dual tubing (irrigation and suction) that delivers sterile fluids to surgical sites and removes fluid via suction, controlled by an on-off button on the handpiece powered by nine AA alkaline batteries.

The device uses a battery-powered mechanical pumping system with dual tubing and interchangeable probes, constructed from 304 stainless steel, ABS, and PVC. Key differences from the predicate include: uses nine AA batteries instead of six AAA batteries; has four types of non-interchangeable probes versus optional probes on the predicate; and slightly different material composition (omits polycarbonate and 420 stainless steel used in predicate).

IEC 60601-1-2:2014+AMD 1:2020 and IEC 60601-2-18:2009 for electromagnetic compatibility; IEC 60601-1:2005+AMD1:2012+AMD2:2020 for electrical safety; ISO 10993-1:2018 for biocompatibility testing; ethylene oxide sterilization validation per ISO standards.

The device is substantially equivalent because it has the same intended use (controlled powered irrigation during laparoscopic surgery), same regulatory classification (21 CFR 876.1500, Class II, GCJ product code), same operational principle (battery-powered mechanical pump), same sterilization method (ethylene oxide to SAL 10-6), and same single-use disposable design. Design differences (probe shapes, battery count, materials) do not raise new safety or effectiveness issues. All non-clinical testing including biocompatibility, electrical safety, and bench testing met predefined acceptance criteria and demonstrated performance equivalent to the predicate device.