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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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the studies performed for the RELIZORB™ device:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document primarily focuses on non-clinical and animal studies. There is no information provided about human-in-the-loop performance, multi-reader multi-case studies, or traditional algorithm-only performance metrics like sensitivity, specificity, etc., as this is a medical device (enzyme-packed cartridge) performing a chemical function, not an AI/imaging device.

Biocompatibility Testing

Test	Purpose	Acceptance Criteria	Reported Device Performance
Cytotoxicity – MEM Elution Test	Assess biological activity of mouse fibroblast cells after exposure to extracts.	Non-cytotoxic	Non-cytotoxic
Irritation – Intracutaneous reactivity	Determine if extracts produce an irritation reaction when injected intracutaneously.	Non-irritating	Non-irritating
Sensitization – Guinea Pig Maximization	Determine potential for sensitization of extracts.	Non-sensitizing	Non-sensitizing
Acute systemic toxicity	Determine potential for acute systemic toxicity of extracts by injection into mice.	Not systemically toxic	Not systemically toxic
Genotoxicity – In Vitro Gene Mutations	Determine potential mutagenic activity of extracts by measuring reversion rates in bacteria.	Non-mutagenic	Non-mutagenic
Genotoxicity – In Vitro Mouse Lymphoma	Determine if extracts induce forward mutations at the thymidine kinase locus.	Non-mutagenic	Non-mutagenic
Genotoxicity – In Vivo Mouse Micronucleus	Determine potential for extracts to induce micronuclei formation in immature polychromatic erythrocytes in the bone marrow of mice.	Non-mutagenic	Non-mutagenic

Performance Testing - Bench

Test	Purpose	Acceptance Criteria	Reported Device Performance
Torque strength	Determine torque necessary to separate small bore connectors from the cartridge body.	Torque at separation higher than 3 times the estimated clinical force.	RELIZORB™ met the acceptance criteria.
Tensile strength	Determine force required to separate small bore connectors from the cartridge using a linear tensile force.	Linear tensile strength shall be greater than [b)(4) psi] (value obscured in document).	RELIZORB™ met the established acceptance criteria.
Air leakage test	Establish that material bonds would not fail or leak when challenged with pressurized air.	Material bonds shall not leak when challenged with [b)(4) psi] compressed air.	RELIZORB™ did not leak and met the acceptance criteria.
Filter integrity	Ensure FCS/enzyme beads are retained within the cartridge, by subjecting device to maximum pump flow rate in forward and reverse flow.	Should not allow for beads to pass the filter and leave the cartridge.	Allowed 5 particles in 3 forward flow repetitions and 1 particle in reverse flow. Only 1 particle had a diameter of [b)(4) - size obscured]. Justified as contamination and clinically acceptable due to small number and biocompatibility.
Fat hydrolysis	Determine amount of free fatty acids (FFA) produced by enzymatic hydrolysis using a simulated enteral circuit.	Produce [b)(4) FFA] per serving.	Breaks down ≈90% of fats in most enteral formulas. (Detailed results added to labeling).
Unconjugated lipase analysis	Evaluate potential leaching of lipase enzyme from beads.	No formal acceptance criteria. Measured lipase concentration using a [b)(4) assay].	Observed [b)(4) %] leaching by BCA assay and [b)(4) %] by absorbance. Deemed safe due to biocompatibility and GRAS status of lipase.
Assessment of impact to other nutrients	Ensure device does not adversely affect other nutrients (vitamins, minerals) in enteral formula under simulated use.	No formal acceptance criteria. Conducted nutritional analysis of vitamins and minerals.	No meaningful difference for any vitamins or minerals after exposure to RELIZORB™.
Flow rate	Ensure device does not restrict the flow of formula using an enteral feeding pump.	Presence of RELIZORB™ should not affect the flow rate of formula.	No statistical differences between flow rate with or without RELIZORB™.
Liquid leakage test	Inspect material joints for leaks during priming or flow rate testing after simulated feeding.	Should not leak under normal and worst-case conditions.	No leaking observed using two formulas and two different enteral feeding pumps.
Pump alarm verification	Verify that the flow error alarm works both before and after RELIZORB™ by kinking the tubing during flow rate testing.	Shall not cause pump alarm failure.	Verified that the flow alarm sounds if tubing becomes occluded before or after RELIZORB™.

Shelf Life Testing (6 months)

Test	Purpose/Acceptance Criteria (identical to bench tests)	Reported Device Performance
Fat hydrolysis	Demonstrate equivalent fat hydrolysis after aging.	No meaningful difference between baseline and aged product
Tensile strength	Not compromised after aging.	Not compromised
Filter integrity	Not compromised after aging.	Not compromised
Flow rate	Not compromised after aging.	Not compromised
Package integrity	Demonstrate package integrity (visual inspection, peel strength, bubble leak test).	Clean barrier not compromised after simulated shipping.

Animal Studies (Effectiveness - primarily based on increased fat absorption)

Study	Acceptance Criteria	Reported Device Performance
Chronic Porcine Study 1	Enhanced absorption of LCPUFAs, reflected by reduced total and PUFA fecal fats, and increase in %CFA (Coefficient of Fat Absorption), and increased AA and DHA in plasma/tissues. No adverse clinical effects.	Increased LCPUFA absorption, reduced total stool fat, fecal AA, and DHA. 20-30% improvement in %CFA (e.g., CV lipase 86.6±4.3% vs. control 67±5.8%, p=0.002; RO lipase 87.1±3.5% vs. control 67±5.8%, p=0.003). No adverse clinical effects or pathologic macroscopic findings.
Chronic Porcine Study 2	Safety and effectiveness of continuous feeding (RO lipase enzyme in beads) over 6 weeks. Reduced fecal fats, improved AA/DHA levels, normalized blood lipid profile, improved consumption of LCPUFA, and improved Vitamins A and E absorption. No safety signals on histopathology.	38% and 53% reduction in omega-3 and omega-6 fecal LCPUFA. 66% and 50% respective reduction in fecal AA and DHA. Normalized blood lipid profile, improved LCPUFA consumption, and improved Vitamins A and E absorption. No safety signals related to treatment in blinded GLP histopathology (observed issues related to EPI status, not treatment).
12 Day Efficacy Study	Increased fat absorption, measured as %CFA, and reduced stool weight. No adverse events. Validation of simulated use of RELIZORB™.	Statistically significant decrease in stool weight (p=0.014). Statistically significant increase in %CFA (approx. 60% for PepAF+EFIC vs. 42% for PepAF, p=0.036). No adverse events.
24 Hour Pharmacodynamics	Statistically significant improvement in fat absorption in the treatment arm (prototype device) as evidenced by increased plasma omega-3 fat (DHA and EPA) concentrations.	Statistically significant (p

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