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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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