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RELIZORB™ is indicated for use in adults to hydrolyze fats in enteral formula.

The RELIZORB™ device is a point-of-care accessory designed to fit in series with currently used enteral feeding circuits. During the submission process, the device was also known as the Enteral Feeding In-Line Cartridge (EFIC). Therefore, the subject device may be referred to as EFIC in some figures within this document. RELIZORB™ is designed to hydrolyze (break down) fats present in enteral formulas from triglycerides into fatty acids and monoglycerides to allow for their absorption and utilization by the body. This breakdown of fats by the RELIZORB™ is intended to mimic the function of the enzyme lipase in patients who do not excrete sufficient levels of pancreatic lipase. The subject device is shown below in Figure 1. The RELIZORB™ is comprised of a cylindrical, hollow port and a single outlet port connection. RELIZORB™ is packed with polymeric beads that have lipase enzyme immobilized on the surface. This lipase enzyme is Generally Regarded as Safe (GRAS). The chemical action of the lipase enzyme is shown in Figure 2, where triglyceride molecules are broken into constituent monoglycerides and fatty acids. The food contacting substance (FCS) of (b) (4) beads manufactured using the RELIZORBTM are (b) (4). The lipase enzyme is chemically bound to the FCS and is intended to remain within the cartridge. RELIZORB™ is an intermediary between an enteral feeding source (infusion pump) and an implanted feeding tube, as shown in Figure 3. The distal end of compatible infusion pump administration sets (Figure 3A) should have a stepped connector (Christmas tree). This connector plugs into the proximal end of the RELIZORB™ device (Figure 3B). The distal end of the RELIZORB™ (Figure 3C) connects to the enteral funnel of an extension set (Figure 3D). This extension set connects to an enteral feeding tube on the patient, such as a nasogastric or gastrostomy tube.