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RELiZORB is indicated for use in pediatric (including neonates and infants) and adult patients to hydrolyze fats during enteral feeding.

RELiZORB® is a point-of-care device designed to fit in-line with currently used enteral feeding circuits. RELiZORB functions to hydrolyze (break down) fats present in formulas from triglycerides into fatty acids and monoglycerides to allow for their absorption and utilization by the body. Formulas are liquid food products that are specially formulated and designed to increase the amount of various food elements and nutrients that will maintain proper physiological function of the body. The breakdown of fats by RELiZORB is intended to mimic the function of the enzyme 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, iLipase® (immobilized lipase), is retained within the cartridge during use by filters on both ends of the cartridge. The fat in formulas is hydrolyzed when it encounters iLipase as the formula passes through the cartridge.

The provided FDA 510(k) clearance letter describes a device called RELiZORB, an enzyme packed cartridge designed to hydrolyze fats in enteral feeding formulas. The clearance is for an updated indication for use to include neonates and infants.

The document does not contain acceptance criteria in the traditional sense of specific performance metrics (e.g., accuracy, sensitivity, specificity, or fat hydrolysis rate thresholds) that the device must meet, nor does it provide a study that explicitly demonstrates the device's performance against such criteria.

Instead, the submission focuses on demonstrating substantial equivalence to a previously cleared predicate device (K243284) and expanding the indications for use based on Real-World Evidence (RWE) and functional performance testing with infant formulas.

Here's an breakdown of the information provided, categorized according to your request, with a clear statement where information is not present in the document.

Analysis of Acceptance Criteria and Device Performance Study for RELiZORB (K250499)

The 510(k) clearance for RELiZORB (K250499) primarily addresses an expansion of its Indications for Use to include neonates and infants, building upon its previous clearance (K243284). The submission aims to demonstrate that this expanded use introduces no new questions of safety or effectiveness and maintains substantial equivalence to the predicate device.

Crucially, the provided document does not detail specific quantitative acceptance criteria (e.g., specific thresholds for fat hydrolysis rates) that RELiZORB had to meet for this clearance, nor does it present a formal clinical study with performance outcomes against such criteria. The evidence presented is largely qualitative and focused on the safety and functional compatibility of the device with infant formulas and its historical safety profile in a real-world setting.

1. Table of Acceptance Criteria and Reported Device Performance

As stated above, the document does not provide a table of acceptance criteria with corresponding device performance metrics in the manner of a typical analytical or clinical performance study for a diagnostic or AI device. The "performance" discussed is related to "functional performance... compatible with commercially available infant formulas" and a review of post-market surveillance data for safety. No quantitative outcomes (e.g., specific fat hydrolysis percentages) are reported as acceptance criteria or performance metrics in this document.

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

• Test Set (Real-World Data):
  • Sample Size: "multiple data outputs in Medical Records for patients initiating RELiZORB use between ages

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RELiZORB is indicated for use in pediatric (ages 1 year and above) and adults patients to hydrolyze fats in enteral formula.

RELiZORB® is a point-of-care device designed to fit in-line with currently used enteral feeding circuits. RELiZORB functions 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 RELiZORB is intended to mimic the function of the enzyme 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 acrylic beads. The digestive enzyme, lipase, is covalently bound to the small white beads. The lipase-bead complex, iLipase® (immobilized lipase), is retained within the cartridge during use by filters on both ends of the cartridge. The fat in enteral formulas is hydrolyzed when it comes in contact with iLipase as the formula passes through the cartridge.

The provided text is a 510(k) summary for the RELiZORB device. It details various aspects of the device, its intended use, and substantial equivalence to a predicate device. However, it does not contain a typical acceptance criteria table with reported device performance metrics in the format usually associated with diagnostic device evaluation (e.g., sensitivity, specificity, accuracy).

Instead, the submission focuses on extending the Indications for Use for the RELiZORB device to include pediatric patients aged 1 year and above, compared to the previous indication of 2 years and above. The "acceptance criteria" in this context are primarily related to demonstrating that this change in indication does not introduce new safety or effectiveness concerns, and that the device remains substantially equivalent to the predicate.

Here's an analysis of the "acceptance criteria" and the study that supports the change, based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not present a formal table of acceptance criteria with specific performance metrics (like sensitivity, specificity, or AUC) as one might expect for a diagnostic AI/ML device. Instead, the acceptance criteria for extending the age indication are implicitly:

• Safety: The device is safe for use in pediatric patients aged 1 to

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RELiZORB® is indicated for use with pediatric (ages 2 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. 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 covalently bonded to the digestive enzyme, lipase. This lipase-bead complex, iLipase™ (immobilized lipase) is retained within the cartridge during use by filters on both ends of the cartridge. The fat in enteral formulas is hydrolyzed upon contact with iLipase as the formula passes through the cartridge.

This document is a 510(k) summary for the RELiZORB® device, which is an enzyme-packed cartridge used to hydrolyze fats in enteral formula. It is a submission to the FDA seeking clearance for a modified version of an already cleared device.

The provided text focuses on demonstrating the substantial equivalence of the subject device (RELiZORB® K232784) to its predicate device (RELiZORB® K231156). It does not contain information about the acceptance criteria and study proving performance for an AI/Software as a Medical Device (SaMD).

Specifically, the document does not contain the following information typically found in acceptance criteria and study designs for AI/SaMD devices:

• A table of acceptance criteria and reported device performance (for an AI/SaMD)
• Sample sizes used for a test set (as would be used for an AI/SaMD model's performance evaluation)
• Data provenance for a test set
• Number of experts and qualifications for ground truth establishment
• Adjudication method for a test set
• MRMC comparative effectiveness study details
• Standalone (algorithm-only) performance results
• Type of ground truth used (e.g., pathology, outcomes data)
• Sample size for the training set (for an AI/ML model)
• How ground truth for the training set was established

Instead, the document details performance testing related to the physical and chemical characteristics of the RELiZORB® cartridge, which is a hardware medical device with an enzymatic function.

Here's a breakdown of the performance testing cited for this hardware device, which is different from "acceptance criteria" for an AI/SaMD:

Overview of Performance Testing for RELiZORB® (Hardware Device):

The performance testing listed is geared towards a physical device with a biological function (enzyme action). The "acceptance criteria" for this device would therefore relate to its physical integrity, chemical activity, and biocompatibility, rather than diagnostic accuracy or algorithmic performance.

1. Table of "Acceptance Criteria" (Inferred from Performance Testing) and Reported Device Performance:

The document lists categories of testing rather than specific numerical acceptance criteria or detailed results. However, we can infer some "acceptance criteria" that would be met by these tests:

2. Sample size used for the test set and the data provenance:

• Test Set Sample Size: Not applicable in the context of an AI/ML test set. For physical and chemical tests, typically specific numbers of units are tested according to standard protocols (e.g., n=3, n=5, n=10 per batch), but these specific numbers are not provided in the summary.
• Data Provenance: The preclinical studies were conducted in a porcine model. The document does not specify the country of origin for the studies, nor whether they were retrospective or prospective, though preclinical animal studies are typically prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable as this is not an AI/ML diagnostic device requiring human expert ground truth for interpretation of imaging or other complex data. The "ground truth" for this device's performance would be the scientific measurement of its physical properties and chemical activity (e.g., fat hydrolysis percentage).

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Not applicable. Adjudication methods are relevant for human interpretation or consensus in diagnostic studies, not for the performance testing of a physical medical device.

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:

• No. This is not an AI-assisted diagnostic device, so an MRMC study is not relevant or performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• No. This is a physical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• For this device, the "ground truth" for its performance is established through standard laboratory testing for:
  • Chemical Analysis: Measuring the hydrolysis of fats (e.g., quantifying fatty acids and monoglycerides produced).
  • Physical Measurements: Tensile strength, flow rates, bead retention, appearance.
  • Biological Testing: Biocompatibility tests (e.g., cytotoxicity, sensitization), and in vivo animal studies (porcine model) to assess safety and efficacy (fat absorption, impact on parenteral nutrition weaning).

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device that requires a "training set."

9. How the ground truth for the training set was established:

• Not applicable.

In summary: The provided text details the regulatory clearance process for a physical medical device (enzyme-packed cartridge), not an AI/Software as a Medical Device (SaMD). Therefore, the criteria and study types described in the prompt (which are typical for AI/SaMD) are not present in this document. The "performance data" here refers to standard engineering, chemical, and biological testing of a hardware product.

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RELiZORB™ is indicated for use with pediatric (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 lipasebead complex, iLipase™ (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.

Here's a breakdown of the acceptance criteria and study information for the RELiZORB device, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" with numerical targets for each performance metric for the subject device (K191379), but rather implies equivalence to a predicate device. The performance data listed are the types of tests conducted to demonstrate this equivalence. The "Reported Device Performance" for the subject device is simply that it met the equivalence requirements for these tests. The predicate device's performance would have established the original acceptance criteria.

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

The document does not specify a distinct "test set" sample size or data provenance (e.g., country of origin, retrospective/prospective) for a clinical study. The performance data focuses on non-clinical testing of the device itself (e.g., integrity, flow, hydrolysis), rather than clinical outcomes with human subjects.

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

Not applicable. This device is an enzyme-packed cartridge for hydrolyzing fats in enteral formula. The "ground truth" would be objective measurements of its physical and chemical properties and its ability to break down fats, not a diagnostic interpretation by human experts.

4. Adjudication Method for the Test Set

Not applicable, as no human expert adjudication is involved in the technical performance testing described.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document describes non-clinical performance testing for a device that acts on enteral formula. It focuses on the device's functional equivalence to a predicate, not on human reader performance with or without AI assistance.

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

Yes, in a way. The testing described is "standalone" in the sense that it evaluates the device's performance (hydrolysis, flow rate, integrity) directly, without human interaction during the measurement process. However, this is not an "algorithm-only" performance as the device is a physical product, not a software algorithm.

7. The Type of Ground Truth Used

The ground truth used is primarily based on objective physical and chemical measurements of the device's performance, such as:

• Measurement of seal strength, tensile strength, visual inspection results for pouch testing.
• Results from standardized shipping tests (ISTA 2A).
• Quantitative measurements of filter integrity.
• Biochemical assays to measure the extent of fat hydrolysis.
• Measurements of fluid flow rate through the cartridge.
• Leak detection methods.

These measurements are compared against established specifications for the predicate device to demonstrate equivalence.

8. The Sample Size for the Training Set

Not applicable. This device is a physical product, not an AI/ML algorithm that requires a "training set." The development would involve engineering and materials science, not machine learning training.

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

Not applicable, as there is no "training set" for this type of device.

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