(135 days)
The Gabriel® Feeding Tube with Balloon functions as a conduit to facilitate enteral feeding, and may be used in adult or elderly patients who cannot consume an adequate diet orally. Small bowel feeding may be indicated for patients with functioning gut who require short to moderate term feeding support, such as post-trauma patients, burn patients, general trauma patients, high-risk patients prone to tube misplacement complications, and patients in whom malnutrition exist, or may result, secondary to an underlying disease or condition.
The Gabriel Feeding Tube with Balloon serves as conduit through which enteral feeding solutions are directly infused into patients small bowel. The tube has two distal end openings, one distal end balloon, one proximal end pilot balloon that indicates the status of the inflation of the distal end balloon and a proximal end EnFit connector that replaced our Y shaped catheter tip connector of the predicate device. The tube shaft is lined by a monofilament spiral wire to prevent occlusion from kinking. A braided 7 strands stainless steel stiffening central stylet prevents coiling in the mouth during insertion and provides column strength to facilitate placement into the stomach.The tube patient contacting material is made from DEHP-free PVC. Size 12 Fr tube is 130 cm long.
The provided text is a 510(k) Premarket Notification from the FDA for a medical device called the "Gabriel® Feeding Tube with Balloon, and EnFit Connector." This document focuses on demonstrating substantial equivalence to a predicate device (K160787) rather than providing detailed acceptance criteria and study results for a novel AI/software-as-a-medical-device (SaMD) product.
Therefore, the information required to answer the specific questions about acceptance criteria, study design, sample sizes, expert involvement, and ground truth for an AI device is not present in the provided text. The document describes a traditional medical device (a feeding tube) and its physical and functional characteristics, along with non-clinical tests for its performance and safety compared to its predicate.
Here's what can be extracted from the document regarding the device and its testing, but it does not fulfill the prompt's request for AI device study details:
Device Description and Purpose:
The Gabriel® Feeding Tube with Balloon, and EnFit Connector is a nasoenteral feeding tube designed to facilitate enteral feeding in adult or elderly patients who cannot orally consume an adequate diet. It's intended for bedside insertion and use in patients requiring short to moderate-term feeding support. Key features include a distal end balloon for peristaltic advancement and airway misplacement detection, a flexible shaft with a spiral wire to prevent kinking, and a central stainless steel stylet for insertion. The primary changes from the predicate device are the replacement of a Y-shaped catheter tip connector with a rigid male EnFit connector to mitigate misconnection risk, a change from MR unsafe to MR conditional, and the addition of certain items to a convenience kit.
Acceptance Criteria and Reported Device Performance (Based on Non-Clinical Testing for Substantial Equivalence):
As this is a physical medical device and not an AI/SaMD, the "acceptance criteria" are implied by successful completion of mechanical, functional, and safety tests to demonstrate equivalence to a predicate device. The reported performance is that the device "passed" these tests.
| Acceptance Criteria Category/Test | Reported Device Performance |
|---|---|
| Functional Equivalence | |
| Feeding formula flow rate test (model with EnFit connector vs. predicate with catheter tip connector) | Pass |
| Mechanical Integrity/Safety | |
| Tube shaft to male EnFit connector tensile test | Pass |
| Stylet to stylet hub tensile test | Pass |
| Leakage by pressure decay test (EnFit connector) | Pass |
| Positive pressure liquid leakage test (EnFit connector) | Pass |
| Stress cracking test (EnFit connector) | Pass |
| Resistance to separation from Axial load test (EnFit connector) | Pass |
| Resistance to separation from unscrewing test (EnFit connector) | Pass |
| Thread overriding resistance test (EnFit connector) | Pass |
| Dimensional Conformance | |
| Dimensional verification of EnFit connector | Pass |
| Material Properties | |
| EnFit connector material elasticity modulus above 700 MPa | Pass |
| Shelf Life | |
| 48 Months shelf life test (on device with catheter tip connector, applied to new device) | Pass (shelf life increased to 48 months) |
| Biocompatibility | |
| Cytotoxicity, sensitization, acute and sub-acute toxicity tests of materials | Confirmed biocompatible |
| MR Safety | |
| MR safety test | MR Conditional |
Information NOT available in the provided text (as it pertains to AI/SaMD studies):
The prompt specifically asks for details related to AI/SaMD acceptance criteria and studies which are not relevant to this 510(k) submission for a non-AI medical device. Therefore, the following points cannot be addressed from the given document:
- Sample size used for the test set and the data provenance: Not applicable to this type of device submission.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method 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 vs without AI assistance: Not applicable, as this is not an AI-assisted device.
- 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, as this is not an AI device relying on interpreted data.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
Clinical Testing:
The document explicitly states: "No clinical testing was performed in association with this submission." This is common for 510(k) submissions where substantial equivalence can be demonstrated through non-clinical testing and comparison to an existing predicate device.
§ 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.