LAGIS Suction Irrigation System

The LAGIS Suction Irrigation System is a laparoscopic instrument consisting of flexible tubing attached to a plastic handle with a spring-activated valve, a stainless steel probe, and a housing cap. It provides suction and irrigation functions during minimally invasive surgery to flush blood and tissue debris from the operative site and enhance visualization.

The device comes in multiple models with two handle design types (direct and trumpet). It has comparable materials to the predicate device and meets ISO 10993 and 21 CFR Part 58 requirements. Minor differences exist in working length, PVC soft tube length, and button pressure, but these do not affect core functionality. The subject device is indicated specifically for laparoscopic use, whereas the predicate is indicated for both laparoscopic and general surgeries.

ISO 10993-1 (biocompatibility evaluation), ISO 11135 (sterilization validation), and performance testing including airtightness, kinking resistance, flattening resistance, bending resistance, and pressing force assessments.

Both the LAGIS device and predicate (Taiwan Surgical Disposable Suction Irrigation, K150253) share identical intended use, design principles, operational mechanisms, and size ranges. The narrower indication for laparoscopic-only use does not affect safety or effectiveness since the device performs the same suction-irrigation function. All performance tests met predefined criteria and identified no new safety or effectiveness questions, demonstrating functional equivalence despite minor dimensional variations.