(133 days)
The Gabriel 3-way EnFit valve is a three-way closed system valve with three ports for control of fluid flow (nutrition, medication and water) between devices with EnFit connectors and catheter tip syringe. It can be used in pediatric, adult and elderly patients, for up to 7 days.
The Gabriel 3-way EnFit Valve is a three-way stopcock valve that is intended to control fluid flow between enteral devices (feeding tubes and feeding lines) with EnFit compatible connectors in a closed system fashion that reduces the need for frequent connection of the EnFit ports. It has one male EnFit port, one female EnFit port and one catheter tip port. The catheter tip port can be used for flushing and administration of medication using a catheter tip syringe. The male EnFit port is provided with a tethered cap and the catheter tip port is provided with a tethered cap. The ability to use a catheter tip syringe for flushing and administration of medicine in health care facilities that do not carry EnFit syringes, may facilitate adoption of feeding tubes and feeding lines with EnFit connectors.
The provided text describes a medical device, the "Gabriel 3-Way EnFit Valve," and its 510(k) submission to the FDA. However, this document does not contain information about an AI/ML-enabled device or its acceptance criteria and study results for such a device.
The document primarily focuses on demonstrating substantial equivalence of a physical medical device (a 3-way valve) to a predicate device based on design, materials, intended use, and bench testing for mechanical performance and biocompatibility.
Therefore, I cannot answer the questions related to AI/ML acceptance criteria, performance studies (like MRMC or standalone performance), ground truth establishment, sample sizes for training/test sets, or expert qualifications/adjudication. These concepts are not discussed in the provided text.
The closest information provided is the summary of bench testing for the physical valve. Below is a table of the acceptance criteria (stated as "PASS" for each test) and the reported device performance from the document.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (Implied by "PASS") | Reported Device Performance |
|---|---|---|
| Male EnFit Measurement Verification Test | Meets specified measurements for male EnFit connectors | PASS |
| Female EnFit Measurements Verification Test | Meets specified measurements for female EnFit connectors | PASS |
| Catheter Tip Port Measurement Verification Test | Meets specified measurements for catheter tip ports | PASS |
| Tensile Test | Withstands specified tensile forces | PASS |
| Cytotoxicity test | Non-cytotoxic | PASS |
| Sensitization Test | Non-sensitizing | PASS |
| Irritation Test | Non-irritant | PASS |
| Leakage by Pressure Decay Test | No leakage under pressure decay conditions | PASS |
| Positive Pressure Liquid Leakage Test | No leakage under positive pressure liquid conditions | PASS |
| Stress Cracking Test | Resistant to stress cracking | PASS |
| Resistance to Separation from Axial Load Test | Resists separation from axial load | PASS |
| Resistance to Separation from Unscrewing Test | Resists separation from unscrewing | PASS |
| Thread Overriding Resistance Test | Resistant to thread overriding | PASS |
| Disconnection by Unscrewing Test | Resists disconnection by unscrewing | PASS |
| Flexure modulus | Above 700 Mpa | PASS |
| Feeding Formula Flow Rate Test | Achieves specified feeding formula flow rate | PASS |
The following information is NOT available in the provided text, as it pertains to AI/ML device studies, which this document does not describe:
- Sample sizes used for the test set and the data provenance: Not applicable, no AI/ML test set described.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, no ground truth for image/data interpretation described.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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 versus without AI assistance: Not applicable.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
§ 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.