(56 days)
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
§ 876.5985 Enzyme packed cartridge.
(a)
Identification. An enzyme packed cartridge is anex vivo prescription device that is used in enzymatic hydrolysis of macronutrients into their essential nutrient forms at the time of delivery. The device consists of an outer casing containing an inert polymer with a covalently bound enzyme through which nutritional formula is directed. The device fits in line with enteral feeding systems.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The patient contacting components of the device must be demonstrated to be biocompatible.
(2)
In vivo testing must be performed and must demonstrate that the device causes neither an adverse tissue response nor adverse performance.(3) Non-clinical testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be demonstrated:
(i) Mechanical testing to demonstrate that the device can withstand clinical forces;
(ii) Flow rate and leakage testing to demonstrate that the device does not impede the flow of enteral formula;
(iii) Demonstration of enzymatic effect on intended macronutrient;
(iv) The amount of enzyme that exits the cartridge must be characterized;
(v) Validation that the device does not adversely impact the nutritional composition of enteral formula; and
(vi) Validation that the device does not impede flow alarms on enteral feeding pumps.
(4) Human factors testing must be performed to characterize use error risks.
(5) Performance data must support shelf life by demonstrating package integrity and device functionality over the identified shelf life.
(6) Labeling must include the following:
(i) A detailed summary of
in vivo testing pertinent to use of the device, including device-related adverse events;(ii) A detailed summary of compatible formulas that is supported by non-clinical testing, including the expected enzymatic conversion as a percentage;
(iii) Detailed instructions on how to place the device into an enteral feeding circuit;
(iv) A warning regarding the possibility for misconnections; and
(v) Expiration date or shelf life.
(7) Patient labeling must be provided and must include:
(i) Relevant warnings, precautions, adverse effects, and complications;
(ii) A description of the device and how it operates;
(iii) Instructions on how to correctly use the device; and
(iv) The benefits and risks associated with the use of the device.