(195 days)
RELiZORB™ is indicated for use with pediatric (ages 5 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 excr ete sufficient 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. The digestive enzyme, lipase, is covalently bound to the small white beads. The lipasebead 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.
Here's a breakdown of the acceptance criteria and study information for the RELiZORB device, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" with numerical targets for each performance metric for the subject device (K191379), but rather implies equivalence to a predicate device. The performance data listed are the types of tests conducted to demonstrate this equivalence. The "Reported Device Performance" for the subject device is simply that it met the equivalence requirements for these tests. The predicate device's performance would have established the original acceptance criteria.
| Performance Metric | Implied Acceptance Criteria (via Predicate Equivalence) | Reported Device Performance (Subject Device) |
|---|---|---|
| Pouch seal/tensile/visual testing | Met predicate specifications | Demonstrated equivalence |
| Primary pouch ship testing (ISTA 2A) | Met predicate specifications | Demonstrated equivalence |
| Filter integrity performance | Met predicate specifications | Demonstrated equivalence |
| Hydrolysis | Functionally equivalent to predicate | Demonstrated equivalence |
| Flow rate | Functionally equivalent to predicate | Demonstrated equivalence |
| Leak testing | Met predicate specifications | Demonstrated equivalence |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a distinct "test set" sample size or data provenance (e.g., country of origin, retrospective/prospective) for a clinical study. The performance data focuses on non-clinical testing of the device itself (e.g., integrity, flow, hydrolysis), rather than clinical outcomes with human subjects.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. This device is an enzyme-packed cartridge for hydrolyzing fats in enteral formula. The "ground truth" would be objective measurements of its physical and chemical properties and its ability to break down fats, not a diagnostic interpretation by human experts.
4. Adjudication Method for the Test Set
Not applicable, as no human expert adjudication is involved in the technical performance testing described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document describes non-clinical performance testing for a device that acts on enteral formula. It focuses on the device's functional equivalence to a predicate, not on human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in a way. The testing described is "standalone" in the sense that it evaluates the device's performance (hydrolysis, flow rate, integrity) directly, without human interaction during the measurement process. However, this is not an "algorithm-only" performance as the device is a physical product, not a software algorithm.
7. The Type of Ground Truth Used
The ground truth used is primarily based on objective physical and chemical measurements of the device's performance, such as:
- Measurement of seal strength, tensile strength, visual inspection results for pouch testing.
- Results from standardized shipping tests (ISTA 2A).
- Quantitative measurements of filter integrity.
- Biochemical assays to measure the extent of fat hydrolysis.
- Measurements of fluid flow rate through the cartridge.
- Leak detection methods.
These measurements are compared against established specifications for the predicate device to demonstrate equivalence.
8. The Sample Size for the Training Set
Not applicable. This device is a physical product, not an AI/ML algorithm that requires a "training set." The development would involve engineering and materials science, not machine learning training.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for this type of device.
§ 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.