RELiZORB (100300/100301)

RELiZORB is a point-of-care enzyme cartridge device that fits inline with enteral feeding circuits to break down (hydrolyze) fats in formulas from triglycerides into fatty acids and monoglycerides for patient absorption. It mimics the function of pancreatic lipase using immobilized lipase enzyme bound to small beads retained within a cartridge. The device is indicated for use in pediatric patients (including neonates and infants ≤6 months and infants/children >6 months) and adult patients during enteral feeding.

The subject device is identical to the predicate in all technological characteristics: both feature a cylindrical cartridge housing filled with immobilized lipase, single-use non-sterile design, ENFit compatibility, and identical storage conditions (2–27°C, 24-month shelf life). The only differences are in indications for use (subject now includes neonates/infants <1 year) and conditions of use (subject allows up to 2 cartridges/day for neonates ≤6 months versus up to 6 cartridges/day for older patients, versus predicate allowing up to 6 cartridges/day for all patients).

Not stated in this summary.

Substantial equivalence is based on the fact that the subject device has undergone no changes in technological characteristics, design, material composition, or principle of operation since the predicate's clearance in January 2025. The company submitted real-world evidence (RWD) from medical records of patients <1 year old using RELiZORB between January 2020 and October 2024 across 60+ US centers, demonstrating safety and effectiveness in the neonatal/infant population, plus post-market surveillance showing no newly identified complaints in <1 year versus >1 year users. Since the device itself is unchanged and RWE supports safe use in the expanded age group, the expansion of indications to include neonates and infants raises no new safety or effectiveness questions.