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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.

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

Performance Testing - Bench

Shelf Life Testing (6 months)

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

2. Sample Size Used for the Test Set and Data Provenance

• Biocompatibility, Mechanical, Filter Integrity, Leakage, Flow Rate, Pump Alarm, Unconjugated Lipase, Nutrient Impact Bench Tests: Sample sizes are not explicitly stated for individual bench tests, but the results indicate testing was performed (e.g., "several lots" for lipase analysis, repetitions for filter integrity).
• Fat Hydrolysis Bench Test: Sample size not explicitly stated for the benchmark, but shelf-life fat hydrolysis included 4 time points.
• Shelf Life Testing: Includes testing at t=0, 1 month, 3 months, and 6 months.
• Animal Studies:
  • Chronic Porcine Study 1: n=3 pigs per arm (Control, CV Lipase, RO Lipase).
  • Chronic Porcine Study 2: Number of pigs not explicitly stated, but refers to "(b)(4) control pigs" and "O (b)(4) pigs treated with the RO enzyme."
  • 12 Day Efficacy study (Study 3): Comparing "(8) (4) control" and "(8) treatment pigs" (number obscured).
  • 24 Hour Pharmacodynamics Study (Study 4): n=11 pigs.
• Data Provenance: All non-clinical/bench tests and animal studies were conducted by the sponsor. The animal studies used porcine (pig) models. There is no information regarding the country of origin of the data provided explicitly, but it's presented in an FDA submission, implying it meets U.S. regulatory standards. All studies are prospective as they were conducted by the sponsor for the submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This section is not applicable in the traditional sense for this device. The "ground truth" for the device's performance, such as fat hydrolysis, mechanical strength, or biocompatibility, is established through direct measurements, chemical assays, and observation against defined physical and chemical criteria, not human expert consensus.

For the animal studies:

• Chronic Porcine Study 2: A blinded GLP histopathology examination was conducted, and the pathologist's findings were peer-reviewed. Specific qualifications (e.g., years of experience) for the pathologist and peer-reviewers are not provided.

4. Adjudication Method for the Test Set

Adjudication methods (like 2+1, 3+1) are typically used in clinical trials involving human observation or interpretation (e.g., radiology reads). This is not relevant for the bench tests or the animal studies described, which involve objective measurements or histological evaluations. The histopathology was "blinded" to treatment group.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No. MRMC studies are primarily for evaluating diagnostic imaging devices or other tools where human readers interpret results. This is an enzyme-packed cartridge, so such a study is not applicable.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the vast majority of the studies presented in the document are "standalone" performance evaluations of the device itself (the enzyme-packed cartridge) without human interpretation as part of its primary function. The device's "performance" is its ability to hydrolyze fat or maintain mechanical integrity, which is measured directly.

7. The Type of Ground Truth Used

• Bench and Shelf-Life Tests: Objective, quantitative measurements from chemical assays (e.g., FFA production, lipase concentration), physical tests (e.g., torque, tensile strength, flow rate), and direct observation against defined criteria (e.g., leakage, particle escape).
• Animal Studies (Effectiveness):
  • Physiological measurements: Fecal fat analysis (total, PUFA, AA, DHA), Coefficient of Fat Absorption (%CFA), plasma AA/DHA levels, blood lipid profiles, Vitamin A/E absorption, stool weight. These act as objective indicators of fat digestion and absorption.
  • Histopathology: Microscopic examination of tissues.
• Animal Studies (Safety): Observation for adverse clinical effects, macroscopic pathological findings, blinded GLP histopathology.

8. The Sample Size for the Training Set

The concept of a "training set" is relevant for machine learning algorithms. This document describes a physical medical device. Therefore, there is no "training set" in the context of an AI algorithm. The development and optimization of the RELIZORB™ device itself would have involved iterative design and testing, but not in the format of a machine learning training set.

9. How the Ground Truth for the Training Set Was Established

As noted above, there is no training set for this type of device. The specifications and performance targets for the device were established through scientific understanding of fat hydrolysis, engineering principles, and regulatory requirements.

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