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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 <1 year". The exact number of patients is not specified beyond "patients, <1 year, received formula... at more than 60 centers across the US."
  • Data Provenance:
    • Country of Origin: United States ("60 centers across the US").
    • Retrospective or Prospective: Retrospective observational study.
    • Time Period: January 16, 2020 to October 31, 2024.

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

• The document does not describe the use of experts to establish a "ground truth" for the retrospective observational study.
• The data analyzed were "Medical Records" and "Post Market Surveillance data," which likely reflect standard clinical practice and reported adverse events rather than expert-adjudicated ground truth for a specific diagnostic outcome.

4. Adjudication Method for the Test Set

• Not Applicable: Given that the study was a retrospective observational review of medical records and post-market surveillance data, there is no mention of an adjudication method (e.g., 2+1, 3+1 consensus) for establishing ground truth or evaluating device performance. The focus was on safety and compatibility over a defined performance metric.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, an MRMC comparative effectiveness study was not done. This type of study is typically relevant for diagnostic imaging AI devices where human reader performance is being evaluated with or without AI assistance. RELiZORB is an enzyme-packed cartridge for fat hydrolysis, not a diagnostic imaging AI.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Not Applicable in the AI/Software context: RELiZORB is a physical medical device (enzyme-packed cartridge), not a software algorithm or AI. Therefore, a "standalone algorithm performance" study as typically understood for AI/software devices is not relevant.
• However, the document does mention "RELiZORB functional performance was evaluated and found to be compatible with commercially available infant formulas." This can be considered a "standalone" evaluation of the device's functional capability, but specific methodology and quantitative results are not provided in this document.

7. Type of Ground Truth Used

• Implicit "Ground Truth": The "ground truth" for the retrospective observational study was based on real-world patient outcomes reported in medical records and post-market surveillance data (complaints) for safety and "effectiveness" (implied functional compatibility and lack of adverse events). It was not based on expert consensus, pathology, or specific outcomes data regarding fat absorption, but rather on the overall clinical experience and safety profile in the real world.
• For the "functional performance" evaluation, the ground truth would be the actual fat hydrolysis achieved by the device when tested with infant formulas in a lab setting, but these specific results are not detailed.

8. Sample Size for the Training Set

• Not Applicable: As this is a physical device and not an AI/Machine Learning model, there is no concept of a "training set" in the conventional sense for this submission.

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

• Not Applicable: Since there is no training set for an AI model, this information is not relevant.

Summary of Study and Evidence Presented:

The submission for K250499 does not present a typical performance study with pre-defined acceptance criteria (e.g., accuracy, sensitivity, or specific hydrolysis rates). Instead, it makes a case for substantial equivalence and expanded indication based on:

1. Identity with Predicate Device: The subject device is identical in design, materials, and principle of operation to the cleared predicate device.
2. Real-World Evidence (RWE): A retrospective observational study of RELiZORB use in patients <1 year old (neonates and infants) in real-world clinical settings, analyzing medical records. The key outcome from this RWE was that RELiZORB use in this population was deemed "safe and effective," seemingly based on the absence of new or significant safety concerns.
3. Post-Market Surveillance Data Review: A review of complaint data from the existing marketed device (predicate) when used in the <1-year-old population showed "no newly identified complaints."
4. Functional Performance Evaluation: The device's functional performance was evaluated for compatibility with commercially available infant formulas. The results are reported qualitatively as "found to be compatible."

The "acceptance criteria" appear to be implicit: that the device's use in neonates and infants (with the specific cartridge limits specified) would not introduce new safety or effectiveness concerns, and that its functional compatibility with infant formulas was confirmed. This approach aligns with the FDA's guidance on using Real-World Evidence to support regulatory decision-making for medical devices, particularly when expanding indications for a device that already has a established safety and performance profile.

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