Vigeon Laparoscopic Universal Smoke Evacuator (VG003)

The Vigeon Laparoscopic Universal Smoke Evacuator (VG003) is a minimally invasive surgical device consisting of an exhaust tube and control valve that attaches to a 5mm surgical electrode. It uses negative pressure from a vacuum suction system to remove smoke and small amounts of blood and fluid generated during electrocautery procedures, thereby improving surgical visibility and patient safety.

The device differs in design from predicates—it features a control valve and exhaust tube assembly rather than a handle-and-shaft or pencil-body design. Despite this morphological difference, all devices share the same functional compatibility with electrosurgical units, monopolar units, and smoke evacuation systems, and all are single-use, prescription-only instruments sterilized by ethylene oxide or gamma radiation.

ISO 11135:2014 (sterilization validation); in vitro cytotoxicity, skin sensitization, intracutaneous irritation, acute systemic toxicity, pyrogen, and hemolysis testing (biocompatibility); phantom experiments and operational safety testing (performance).

Although the Vigeon device has different physical design, it performs the identical intended function—fluid and smoke evacuation—as both predicates (Endopath Probe Plus II and ShinEvac Pencil). All three devices are compatible with standard electrosurgical systems and smoke evacuation equipment. Performance testing, biocompatibility studies, and sterilization validation confirm the Vigeon device meets the same safety and effectiveness specifications as the predicates, establishing substantial equivalence despite minor technological design differences.