Viction Disposable Irrigation and suction System (VC-FLA0514; VC-FLA0523; VC-FLA0532; VC-FLB0514; VC-FLB0523; VC-FLB0532; VC-FLC0514; VC-FLC0523; VC-FLC0532; VC-FLD0514; VC-FLD0523; VC-FLD0532)

The Viction Disposable Irrigation and Suction System is a single-use, sterile surgical device designed to deliver irrigation fluids to surgical sites and remove fluid waste and tissue debris during general surgery and laparoscopic procedures. It consists of an irrigation and suction device with inner/outer stainless steel tubes, an on-off control button, conical connectors, a hand-piece, and double tubes (irrigation and suction) that connect via Yankee joint, insert needle, and Robert Clip. The device operates passively: irrigation fluid flows by gravity at ≥160 ml/min, and waste is suctioned at ≥600 ml/min via hospital negative pressure (maximum 60 kPa).

Both the proposed device and predicate use identical classification (Class II, GCJ, 21 CFR 876.1500), similar suction-irrigation probe specifications (5mm diameter × 14–32 cm length variants), comparable patient-contacting materials (stainless steel with PTEF coating, ABS, PVC, silicone), equivalent biocompatibility test panels (cytotoxicity, intracutaneous reactivity, acute systemic toxicity, pyrogen), and identical ethylene oxide sterilization per ISO 11135. Both are disposable with optional accessories.

ISO 10993-1 (biocompatibility evaluation and testing); ASTM D3359-23 (coating adhesion per 3B standard); ISO 11135 (ethylene oxide sterilization validation); FDA Blue Book Memorandum #G95-1 (biological evaluation guidance). Bench testing included fluid flow rate, negative pressure resistance, irrigation tube sealing, particulate contamination, and packaging validation.

The proposed device and predicate (K161421) share identical intended use (irrigation and suction in general and laparoscopic surgery), identical regulatory classification and product code, similar device dimensions and specifications (probe diameters and lengths), equivalent materials and biocompatibility profiles, and identical sterilization method. Non-clinical testing demonstrated the proposed device meets all predefined acceptance criteria and design specifications comparable to the predicate. Since the devices have the same intended use, similar design, materials, and performance characteristics with equivalent safety testing, the proposed device is substantially equivalent to the legally marketed predicate.