(306 days)
The Entuit The Thrive Balloon Retention Gastrostomy Feeding Tube is indicated in adult and pediations for use in percutaneous placement of an Enteral feeding tube for feeding tube feeding and/or administration of medication in conjunction with an established GI stoma to act The replacement tube may also be used for gastric decompression.
The Entuit™ Thrive I.P Balloon Retention Gastrostomy Feeding Tube is constructed primarily of silicone. The low profile device consists of a hub which is overmolded onto a previously extruded bilumen shaft. At the proximal end, a silicone balloon is bonded to the shaft using a silicone RTV. The tip of the shaft is filled with radiopaque barium RTV. In use, the balloon end of the catheter is inserted through a gastrointestinal stoma tract and into the stomach lumen. The balloon is then inflated with 5mL sterile or distilled water to secure the device in place. Accessories for the Low Profile device include two extension set configurations, an inflation syringe, a catheter tip syringe, gauzes and a stoma measuring device to facilitate device placement and use.
This document describes the 510(k) submission for the Entuit™ Thrive LP Balloon Retention Gastrostomy Feeding Tube, comparing it to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance:
The document refers to a single performance test with multiple sub-components. The acceptance criteria were primarily based on a standard, and where not explicitly defined, the device's performance was compared to the predicate device.
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Flow rate | In accordance to ASTM F2528-06 (Procedure A) | Met all performance requirements or performed equivalent to/better than the predicate device. |
| Balloon Burst Volume | In accordance to ASTM F2528-06 (Procedure B) | Met all performance requirements or performed equivalent to/better than the predicate device. |
| Balloon Volume Maintenance | In accordance to ASTM F2528-06 (Procedure C) | Met all performance requirements or performed equivalent to/better than the predicate device. |
| Balloon Concentricity | In accordance to ASTM F2528-06 (Procedure D) | Met all performance requirements or performed equivalent to/better than the predicate device. |
| Balloon Over Shaft Size | In accordance to ASTM F2528-06 (Procedure E) | Met all performance requirements or performed equivalent to/better than the predicate device. |
| Balloon Integrity | In accordance to ASTM F2528-06 (Procedure F) | Met all performance requirements or performed equivalent to/better than the predicate device. |
| Balloon Integrity in simulated gastric fluid | In accordance to ASTM F2528-06 (Procedure G) | Met all performance requirements or performed equivalent to/better than the predicate device. |
| Overall Conclusion | Device performs as intended. | Candidate device met all performance requirements. Where acceptance criteria were not defined in the standard, the candidate device performed equivalent to or better than the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the exact sample size for the test set used for performance testing (e.g., number of devices tested for each parameter). The data provenance is not explicitly mentioned in terms of country of origin or retrospective/prospective, but it is clear that these were bench tests conducted in a laboratory setting as part of the 510(k) submission, not clinical studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
Not applicable. The performance testing described is bench testing against an ASTM standard and comparison to a predicate device, not clinical evaluation requiring expert ground truth for interpretation.
4. Adjudication Method for the Test Set:
Not applicable. This was bench testing, not a clinical study requiring adjudication of expert interpretations.
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:
Not applicable. This is a medical device (gastrostomy feeding tube), not an AI-powered diagnostic or interpretive tool. Therefore, an MRMC study related to human reader improvement with AI assistance is irrelevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. As noted above, this is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.):
The "ground truth" for the performance testing was adherence to the specified ASTM F2528-06 standard and comparative performance against a legally marketed predicate device.
8. The Sample Size for the Training Set:
Not applicable. This is a physical medical device. The concept of a "training set" is relevant for machine learning algorithms, not for the engineering and design of a gastrostomy tube.
9. How the Ground Truth for the Training Set Was Established:
Not applicable (as above).
§ 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.