Enteral Drainage System, Enteral Medicine straw

The Enteral Drainage System is a vented bag with tubing and connectors designed to evacuate excess gas and drain gastrointestinal fluids from patients using enteral feeding tubes. The Enteral Medicine Straw is a simple tube with a male enteral connector for drawing and delivering medicine to patients through an ENFit syringe. Both devices are single-patient use items sterilized with ethylene oxide, available in multiple sizes, and intended for neonatal, pediatric, and adult patients with compromised gastric motility.

Both devices use PVC and ABS materials with enteral connectors compliant with ISO 80369-3 (ENFit standard). The Enteral Drainage System includes a hydrophobic 3μm filter, male/female enteral connectors, and tubing with clamps; it is available in five bag sizes (50–1000 mL) versus the predicate's single 500 mL size. The Enteral Medicine Straw has a simpler design with only a male connector and thermoplastic polyurethane tubing, eliminating the cross-spike connector and clamp found in the predicate device.

ISO 10993 series (biocompatibility), ISO 80369-3:2016 and ISO 80369-20:2015 (connector testing and dimensional requirements), ISO 20695:2020 (enteral nutrition), ISO 11607-1:2019 and ASTM standards (F1980-16, D4332-14, D4169-16, F1929-15) for packaging integrity and accelerated aging.

The devices are substantially equivalent because they share the same fundamental technological design and materials as the predicate (PVC, ABS, similar connectors and operation principles). Performance testing confirmed that differences in tube dimensions and the Enteral Medicine Straw's simpler design do not affect safety or effectiveness. Both connect to ISO 80369-3 compliant enteral fittings, use well-established materials already cleared under the same product code, and nonclinical testing demonstrated biocompatibility and mechanical performance equivalent to the predicate. The intended uses are narrower or substantially within the predicate's scope (drainage and medicine delivery via enteral access), and no new safety concerns were identified.