K Number
K243284
Date Cleared
2025-01-15

(90 days)

Product Code
Regulation Number
876.5985
Panel
GU
Reference & Predicate Devices
Predicate For
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

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

Device Description

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.

AI/ML Overview

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

§ 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.