XNY Disposable Gastric Calibration Tube

The XNY Disposable Gastric Calibration Tube is a single-use medical device designed for gastric and bariatric surgical procedures to decompress the stomach, drain and remove gastric fluid, and size the gastric pouch. The tube can be connected to a suction device to extract gas or liquid from the patient's stomach and is available in multiple sizes with dual-lumen or single-lumen configurations.

The device features outer diameters ranging from 10.5mm to 14.5mm (±0.5mm tolerance), working lengths of 700mm or 900mm (dual-lumen JZGA or single-lumen JZGB models), medical-grade silicone tubing, a balloon with ≥100cc inflation capacity, 3 aspiration holes distal to the balloon, and various centimeter markings along the tube length. The device is sterile, single-use, and includes adapters for connection to suction equipment, distinguishing it from the non-sterile predicate device.

The device was evaluated against ISO 10993 for biocompatibility testing, which assessed cytotoxicity, sensitization, and irritation. This is the only consensus standard explicitly cited in the submission.

Substantial equivalence is established because both devices share identical indications for use (gastric and bariatric decompression and sizing), employ the same operational principle (tube-based aspiration and drainage), incorporate the same basic design (calibration tube with balloon and suction ports), and use similar materials (medical-grade silicone). Differences such as the number of aspiration holes (3 vs. 12), sterility status, and specific marking patterns are deemed non-material because they do not affect the fundamental safety and effectiveness of the device's intended function. All performance testing (balloon firmness, aspiration capability, biocompatibility, dimensional specifications) demonstrated compliance with acceptance criteria.