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510(k) Data Aggregation
(253 days)
RELiZORB™ is indicated for use in pediatric patients (ages 5 years and above) and adult patients to hydrolyze fats in enteral formula.
RELiZORB is a single-use, point-of-care digestive enzyme cartridge that connects in-line with existing enteral feeding circuits. RELiZORB is designed to hydrolyze (digest) fats contained in enteral formulas from triglycerides into fatty acids and monoglycerides to allow for their absorption and utilization by the body. This hydrolysis of fats by RELiZORB is intended to mimic the function of the digestive enzyme lipase in patients who do not excr ete sufficient levels of the lipase enzyme. RELiZORB is comprised of a clear cylindrical, plastic cartridge with a single inlet connection port and a single outlet connection port. Inside the cartridge, there are small white beads. The digestive enzyme, lipase, is covalently bound to the small white beads. The lipase-bead complex, iLipaseTM (immobilized lipase), is retained within the cartridge during use by filters on both ends of the cartridge. The fat in enteral formulas is hydrolyzed as it comes in contact with iLipase as the formula passes through the cartridge.
This document is a 510(k) summary for the RELiZORB™ device, submitted by Alcresta Therapeutics, Inc. The purpose of the submission is to expand the indications for use to include pediatric patients (ages 5 years and above) and to update the shelf life. The device, an enzyme-packed cartridge, is designed to hydrolyze fats in enteral formulas.
Here's an analysis of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a quantitative format for the clinical study. However, it describes the outcomes and findings from the clinical study that supported the expanded indication. For shelf life, it generally states "Shelf life test results support labeled shelf life of RELiZORB," implying that the performance met internal criteria.
| Acceptance Criteria (Inferred from study outcomes) | Reported Device Performance |
|---|---|
| Safety and Tolerability (evaluated through GI symptoms and adverse events) in pediatric and adult patients with CF | The most commonly reported GI events were abdominal pain, gas and bloating, while the most common non-gastrointestinal adverse event reported was headache. The implication is that these were acceptable given the patient population and the overall context of the study. |
| Efficacy in fat absorption (measured by plasma concentrations of LCPUFAs like DHA and EPA) in pediatric and adult patients with CF | RELiZORB use resulted in a 2.8-fold change in plasma concentrations of physiologically relevant long-chain polyunsaturated fatty acids (LCPUFAs) such as DHA and EPA, as measured by plasma absorption kinetics and bioavailability profile (Area Under the Curve - AUC). |
| Additionally, there was a 2.1-fold change in peak plasma concentrations (Cmax) of DHA and EPA. These results confirmed previous findings in a porcine model. | |
| Shelf Life (tensile, mechanical strength, flow rate, hydrolysis, microbiological testing) | "Shelf life test results support labeled shelf life of RELiZORB." (Specific numerical acceptance criteria and performance values are not provided in this summary). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set (Clinical Study): 33 evaluable patients completed the study (from an initial enrollment of 35 patients; 2 withdrew before exposure).
- Data Provenance: The study was a "multicenter, randomized, double-blind, placebo-controlled crossover clinical study in adult and pediatric patients with cystic fibrosis (CF)." While the specific country of origin is not explicitly stated, "multicenter" implies multiple sites, likely within the United States given the FDA submission. The study design is prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to this device and study. The RELiZORB device is an enzyme-packed cartridge; its "ground truth" for performance is based on biochemical hydrolysis of fats and physiological absorption, not subjective expert interpretation of images or other data that require inter-rater agreement. The "ground truth" for efficacy was established through objective biochemical markers (LCPUFAs in plasma).
4. Adjudication Method for the Test Set
This is not applicable as the outcome measures (LCPUFA concentrations, adverse events) are objective and do not require adjudication by experts in the way clinical images or diagnoses might.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
This is not applicable. The RELiZORB is a medical device (enzyme-packed cartridge), not an AI-powered diagnostic or assistive technology for human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable. The RELiZORB is a physical device, not an algorithm. Its performance is inherent to its enzymatic activity.
7. The Type of Ground Truth Used
For the clinical study, the ground truth for device efficacy was established using outcome data:
- Plasma absorption kinetics and bioavailability profile (Area Under the Concentration Time Curve - AUC) of physiologically relevant long-chain polyunsaturated fatty acids (LCPUFAs) like DHA and EPA.
- Peak plasma concentrations (Cmax) of DHA and EPA.
- Gastrointestinal (GI) symptoms and non-GI adverse events for safety and tolerability.
8. The Sample Size for the Training Set
This is not applicable to the RELiZORB device. The device is not learning or being trained in a computational sense. Its design and enzymatic function are pre-defined.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the same reasons as #8.
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(58 days)
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 line with currently used enteral feeding circuits. 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 excr ete sufficient levels of pancreatic lipase. RELiZORB is comprised of a cylindrical, hollow cartridge with a single inlet port and a single outlet port connection. Inside the cartridge, there are small white beads. The digestive enzyme, lipase, is covalently bound to the small white beads. The lipase-bead complex, iLipaseTM (immobilized lipase), is retained within the cartridge during use by filters on both ends of the cartridge. The fat in enteral formulas is hydrolyzed as it comes in contact with iLipase as the formula passes through the cartridge.
This document describes a 510(k) premarket notification for the RELiZORB™ device, an enzyme-packed cartridge designed to hydrolyze fats in enteral formula. The submission aims to demonstrate substantial equivalence to a previously cleared RELiZORB™ device (DEN150001).
Since this is a submission for an enzyme-packed cartridge and not a diagnostic AI/ML device, the detailed questions about acceptance criteria, test sets, ground truth establishment, expert adjudication, and comparative effectiveness studies as typically applied to AI/ML software are not directly applicable in the same manner. This submission focuses on the chemical and mechanical performance of the device rather than the diagnostic accuracy of an algorithm.
However, I can extract the relevant performance data and criteria mentioned in the document in the spirit of your request:
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria Category | Specific Criteria (Implicitly Met) | Reported Device Performance |
|---|---|---|
| Shelf Life | Product stability over time, retaining intended function. | "Shelf life testing of RELIZORB was completed and met the acceptance criteria in the protocol. The shelf life test results support the proposed edit to the labeling with respect to product stability." |
| Device Performance | Device performs as intended under anticipated conditions of use. | "The RELIZORB device was previously tested to demonstrate that the device performs as intended under anticipated conditions of use, and safety, including: Tensile and mechanical strength, Flow rate, Demonstration of enzymatic effect on macronutrients, Impurities/degradants characterization, Animal testing to demonstrate hydrolysis effect, Human factors testing." (These tests were deemed sufficient for the predicate device and are implicitly accepted for the current device due to no changes in design, technology, or functionality). |
| Safety | No significant changes to risk assessment due to proposed minor labeling change. | "The Risk management file was reviewed and there was no significant change to the risk assessment as a result of the proposed minor change to the labeling." |
| Quality System Compliance | Compliance with medical device quality system regulations. | "Alcresta develops and manufactures RELIZORB in compliance with the Quality System regulations (21 CFR 820)." |
| Biocompatibility | Biological safety of materials in contact with the body/formula. | Referenced standard: ISO 10993-1:2009/Cor 1:2010 Biological evaluation of medical devices. (Implicitly met through prior testing of predicate). |
| Usability/Human Factors | Device is safe and effective for users. | Referenced standard: EN 62366:2008 Medical devices - Application of usability engineering. (Implicitly met through prior testing of predicate). |
| Risk Management | Application of risk management processes. | Referenced standard: EN ISO 14971:2012 Medical devices. Application of risk management. (Implicitly met through prior testing of predicate and current review). |
| Packaging/Shipping | Device integrity maintained during transport. | Referenced standard: ISTA 2A: Packaged-Products weighing 150 lb (68 kg) or Less. Basic Requirements: atmospheric conditioning, compression, fixed displacement or random vibration and shock testing. (Implicitly met through prior testing of predicate). |
| Connectors/Adapters | Compatibility and safety of enteral feeding set adapters and connectors. | Referenced standard: AAMI/ANSI ID54: 1996/(R)2012: Enteral feeding set adapters and connectors. (Implicitly met through prior testing of predicate). |
| Controlled Environments | Manufacturing in appropriate environments. | Referenced standard: ISO-14644: Cleanrooms and associated controlled environments. (Implicitly met through prior manufacturing of predicate). |
2. Sample size used for the test set and the data provenance:
- Test set sample size: Not explicitly stated for each specific performance test (tensile, flow rate, enzymatic effect, etc.). The document mentions "shelf life testing" was completed, but not the number of units or replicates. For prior testing of the predicate device, it indicates a range of tests were performed, but no numbers of devices tested are provided.
- Data provenance: Not explicitly stated (e.g., country of origin). The testing seems to have been conducted by or for Alcresta Therapeutics, Inc. (Newton, MA, USA). The studies appear to be prospective as they involve testing the device under various conditions.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in the typical sense for this device. This device is not a diagnostic tool requiring expert interpretation of results for ground truth. The "ground truth" for this device would be established by objective measurements of its physical properties (tensile strength, flow rate) and chemical activity (enzymatic effect on macronutrients), likely performed by laboratory technicians or engineers following validated protocols, rather than expert interpretation of a diagnostic outcome.
4. Adjudication method for the test set:
- Not applicable. Adjudication methods like 2+1 or 3+1 are used to reconcile disagreements among human readers in diagnostic studies. For this device, performance is evaluated against objective, measurable criteria and laboratory standards.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is not an AI/ML diagnostic device and does not involve human readers interpreting cases with or without AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used:
- For the enzymatic effect: Objective chemical measurements (e.g., measuring the breakdown of triglycerides into fatty acids and monoglycerides).
- For mechanical/physical properties: Engineering measurements against established standards (e.g., tensile strength, flow rate).
- For biocompatibility: Laboratory testing results compared to biological safety standards.
8. The sample size for the training set:
- Not applicable. This device does not use an algorithm that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. As there is no training set for an algorithm, there is no ground truth to be established for it.
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