ZZIREN™ Orogastric Tube; ZZIREN™ SGT Orogastric Tube - 32 Fr (ZZ-SGT-32); ZZIREN™ SGT Orogastric Tube - 36 Fr (ZZ-SGT-36); ZZIREN™ SGT Orogastric Tube - 40 Fr (ZZ-SGT-40); ZZIREN™ GBT Orogastric Tube - 32 Fr (ZZ-GBT-32); ZZIREN™ GBT Orogastric Tube - 36 Fr (ZZ-GBT-36); ZZIREN™ GBT Orogastric Tube - 40 Fr (ZZ-GBT-40)

The ZZIREN™ Orogastric Tube is a non-sterile, single-use device consisting of a 37-inch insertion tube with a Y extension containing a suction regulating valve and a pinch clamp. It is indicated for use in gastric and bariatric surgical procedures for gastric aspiration and lavage, to serve as a size guide, and to test for staple line integrity leaks.

The device features a flexible PVC insertion tube available in 32, 36, and 40 Fr diameters with a Y extension (replacing three separate ports on the predicate). Two model families differ in side-hole length: SGT models have side-holes extending 13 cm from the tip, while GBT models have side-holes extending 6 cm. All models incorporate an identical suction regulating valve limiting negative pressure to less than 175 mmHg with an audible alert at approximately 160 mmHg.

Not stated in this summary.

The proposed device is substantially equivalent because it maintains the same functional design and biocompatible materials (PVC) as the predicate SIREN SGT™ tube. Non-clinical testing demonstrated that the insertion tubes have equivalent stiffness, compressibility, and kink propensity to the predicate; the pinch clamp performs identically; and the accessory connectors function reliably with the same suction tubing. The addition of side-hole length variation (6 cm vs. 13 cm) and the Y extension design represent minor structural modifications that do not alter the fundamental intended use or safety profile for gastric aspiration, lavage, and leak testing.