(121 days)
The devices in this product family are used to dispense liquid nutrients (feeding solution) at a preprogrammed pump or user controlled rate. These enteral feeding sets interface with the patient's feeding tube and may use gravity or an enteral feeding pump to dispense feeding solution. The devices may include a bag to contain the feeding solution and/or a spike to connect to a prefilled container.
These enteral feeding sets are designed to be used with or without an enteral feeding pump, (pump is not in scope for this 510k) model specific. Refer to diagrams below for explanation of components. The enteral sets terminate in a bonded conical connector, the ENFit connector; that is designed to be incompatible with ISO 594-1/2 and other non-enteral feeding connections. The ENFit connector is a new connector and it is anticipated that not all patient feeding tubes will be compatible with it, so the administration sets include an adapter that connects to the ENFit connector on one end while providing the traditional "Christmas Tree" shaped transitional stepped connector on the other.
This document appears to be a 510(k) summary for an enteral feeding set, which is a medical device. Based on the provided text, the device is not an AI/ML device. Therefore, the specific criteria for AI/ML device studies (such as sample sizes for test/training sets, number of experts for ground truth, adjudication methods, MRMC studies, or standalone performance) are not applicable or detailed in this document.
The document primarily focuses on demonstrating substantial equivalence to a predicate device, as required for 510(k) submissions. This is achieved through non-clinical performance data.
Here's an analysis of the acceptance criteria and supporting study information, focusing on the available details from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document lists various non-clinical tests performed to support substantial equivalence. While specific quantitative acceptance criteria are not explicitly stated in a table format in the provided text, the performance is reported as "Passed" or "Acceptable" for each test.
| Test Category | Reported Device Performance |
|---|---|
| Mechanical/Physical Integrity | |
| Bond Strength | Passed |
| Leak Testing | Passed |
| Volumetric accuracy testing | Passed |
| Dimensional analysis | Passed |
| Accelerated Aging | Passed |
| Biocompatibility | |
| Biocompatibility | Passed |
| Connection Safety | |
| Misconnection assessment | Passed |
| Enteral Connector Risk Management Report | Acceptable |
| Human Factors | |
| Human Factors Testing | Acceptable |
| Failure Modes and Effects Analysis (FMEA) | Acceptable |
| ISO 80369-3 Compliant Testing | |
| Falling drop positive pressure liquid leakage | Passed |
| Stress cracking | Passed |
| Resistance to separation from axial load | Passed |
| Resistance to unscrewing | Passed |
| Resistance to overriding | Passed |
| Disconnection by unscrewing | Passed |
| Falling drop positive pressure liquid leakage after 20 cycles of connection and separation | Passed |
2. Sample size used for the test set and the data provenance
Not applicable for an AI/ML device. For this physical medical device, specific sample sizes for tests like bond strength or leak testing are not provided in the summary. The provenance would be the manufacturing facility where the tests were performed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a physical device, and its performance is evaluated against engineering specifications and industry standards, not through expert-labeled ground truth in the context of an AI/ML model.
4. Adjudication method for the test set
Not applicable. This is a physical device.
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
No. This is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This is not an AI/ML device.
7. The type of ground truth used
The "ground truth" for this device is defined by:
- Engineering specifications: The device's design inputs and required performance characteristics.
- Industry standards: Notably ISO 80369-3 for small-bore connectors.
- Predicate device performance: The new device is compared to a legally marketed predicate device (K012147) to demonstrate similar safety and effectiveness.
8. The sample size for the training set
Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.
Summary for the provided document:
The document describes an enteral feeding set, which is a physical medical device, not an AI/ML device. Therefore, most of the requested information pertaining to AI/ML device studies (such as test/training set sample sizes, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance) is not relevant or available in this submission.
The device's conformity is established through non-clinical performance data, showing that it "Passed" or was "Acceptable" for a series of tests related to its physical integrity, biocompatibility, connection safety (especially ISO 80369-3 compliance), human factors, and risk management. The "ground truth" here refers to the device meeting its design specifications and applicable industry standards. The submission asserts substantial equivalence to a predicate device based on these non-clinical tests, without requiring clinical testing.
§ 876.5980 Gastrointestinal tube and accessories.
(a)
Identification. A gastrointestinal tube and accessories is a device that consists of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract. This device may incorporate an integral inflatable balloon for retention or hemostasis. This generic type of device includes the hemostatic bag, irrigation and aspiration catheter (gastric, colonic, etc.), rectal catheter, sterile infant gavage set, gastrointestinal string and tubes to locate internal bleeding, double lumen tube for intestinal decompression or intubation, feeding tube, gastroenterostomy tube, Levine tube, nasogastric tube, single lumen tube with mercury weight balloon for intestinal intubation or decompression, and gastro-urological irrigation tray (for gastrological use).(b)
Classification. (1) Class II (special controls). The barium enema retention catheter and tip with or without a bag that is a gastrointestinal tube and accessory or a gastronomy tube holder accessory is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I (general controls) for the dissolvable nasogastric feed tube guide for the nasogastric tube. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.