RELiZORB (100300/ 100301)

RELiZORB is a point-of-care enzyme cartridge that breaks down fats in enteral (tube feeding) formulas into absorbable fatty acids and monoglycerides, mimicking the action of pancreatic lipase. It is indicated for pediatric patients ages 1 year and above and adults receiving enteral nutrition support.

RELiZORB is a cylindrical hollow cartridge containing small acrylic beads coated with immobilized lipase enzyme (iLipase). It connects inline to standard enteral feeding circuits in single or tandem configuration, is ENFit compatible, rated for up to 6 cartridges per day as single-use devices, and is stable for 24 months when stored at 2–27°C. The device design, materials, principle of operation, and usage conditions are identical to the predicate.

Not stated in this summary.

The subject device is substantially equivalent to predicate K232784 because it has identical design, materials, principle of operation, and usage specifications. The only change is expanding the indication from ages 2 years and above to 1 year and above, supported by real-world evidence from a retrospective observational study of 1–2 year old patients demonstrating safety and effectiveness, plus postmarket surveillance data confirming no new safety signals in this age group. Two minor labeling updates (extended shelf-life to 24 months and added syringe gravity feeding instructions) do not alter the special controls or performance standards previously established.