(128 days)
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 who do not excretesufficient 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 that the digestive enzyme, lipase, is covalently bound to. 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 as it comes in contact with iLipase as the formula passes through the cartridge.
The provided text describes a 510(k) premarket notification for the RELiZORB® enzyme packed cartridge. This submission is primarily focused on updating the indications for use to include pediatric patients aged 2 years and above, extending from the previous clearance for 5 years and above. The core device (RELiZORB®) itself has not changed technologically since its previous clearance (K191379).
Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of quantitative acceptance criteria for device performance. Instead, it states that the technological characteristics, design, materials composition, principal of operation, and all other features of RELiZORB® have not changed since the clearance of K191379. Therefore, the device performance is assumed to be consistent with the performance demonstrated for the predicate device.
The primary "acceptance criterion" addressed in this specific submission is the safety and effectiveness of the device for a younger pediatric population (2-5 years old). The device's performance in terms of fat hydrolysis would be the same as previously established.
Regarding the expanded indication for use:
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Safety and effectiveness for pediatric patients aged 2-5 years | "This Real World Data supports the Real World Evidence that use in this use population is both safe and effective." (Based on a retrospective registry study evaluating multiple data outputs in Electronic Medical Records (EMRs) for patients in this age group who had been prescribed RELiZORB®). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document states that the retrospective registry study "evaluated multiple data outputs in Electronic Medical Records (EMRs) for patients between ages 2 year and 5 years to whom RELiZORB® had been prescribed to them." However, the exact sample size (number of patients) used in this retrospective study is not specified.
- Data Provenance: The data is described as "Real World Data" from "Electronic Medical Records (EMRs)". The specific country of origin is not mentioned, but given the FDA submission, it's highly likely to be U.S. data. The study is explicitly described as retrospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not describe the use of experts to establish ground truth for this particular retrospective registry study. The study appears to rely on clinical outcomes and data from Electronic Medical Records, implying that the "ground truth" concerning safety and effectiveness in the 2-5 year old population was derived from the real-world clinical experience and documentation within those EMRs.
4. Adjudication Method for the Test Set
No adjudication method is described. The retrospective EMR data analysis would likely involve data extraction and analysis by the submitting company, Alcresta Therapeutics, Inc.
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
This section is not applicable as the device is an enzyme packed cartridge, not an AI or imaging diagnostic device that involves human readers or an AI assistance component.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This section is not applicable. The RELiZORB® is a physical device that performs a chemical function (fat hydrolysis), not an algorithm.
7. The Type of Ground Truth Used
The ground truth for the expanded indication of use (safety and effectiveness in 2-5 year olds) was established through Real World Evidence (RWE) derived from Real World Data (RWD), specifically "multiple data outputs in Electronic Medical Records (EMRs)" reflecting actual clinical outcomes and experiences of patients who had already used the device.
8. The Sample Size for the Training Set
There is no mention of a "training set" in the context of this submission. The device itself (enzyme cartridge) is not a machine learning model that requires a training set. The retrospective registry study is analyzing existing real-world data to support an expanded indication for use, not to train a device or algorithm.
9. How the Ground Truth for the Training Set Was Established
This section is not applicable as there is no training set for the device itself or a machine learning component.
§ 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.