(195 days)
The EndoVive™ Low Profile Replacement Gastrostomy Tube is indicated in adult and pediatric populations for use in percutaneous placement of an Enteral feeding tube for feeding and/or administration of medication in conjunction with an established GI stoma tract. The replacement tube may also be used for decompression.
The EndoVive™ Low Profile Replacement GastrostomyTube is constructed primarily of silicone. The device consists of a tri-port funnel which is overmolded onto a previously extruded bi-lumen shaft. A retention bolster is molded separately and placed over the shaft. At the proximal end, a silicone balloon is bonded to the shaft using a silicone RTV. The shaft is filled with a radiopague barium RTV. In use, the balloon end of the catheter is inserted into an established stoma, the balloon inflated with 3 mL saline, and the bolster slide down to the skin to secure the device in place. There are two versions of the bolster, a straight version and a right angle
This document describes a 510(k) submission for the EndoVive™ Low Profile Replacement Gastrostomy Tube.
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document does not list explicit numerical acceptance criteria for performance metrics (e.g., tensile strength, leak rate, burst pressure) or report specific quantitative device performance values against such criteria. Instead, the study's primary objective was to demonstrate substantial equivalence to predicate devices.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Performance, safety, and effectiveness equivalent to predicate devices (K962375 and K014297). | Bench testing demonstrated no difference in performance, safety, or effectiveness between the EndoVive™ Low Profile Replacement Gastrostomy Tube and the specified predicate devices. |
| Materials equivalent to predicate devices. | Materials (primarily silicone) are described and compared to predicates. |
| Indications for Use equivalent to predicate devices. | Indications for Use are stated and shown to align with predicate devices. |
| Device description aligns with good manufacturing practices. | Device description is provided. |
| Labeling aligns with good manufacturing practices. | Labeling is mentioned as part of the submission package. |
2. Sample Size and Data Provenance:
The document refers to "bench test results" but does not specify any sample sizes for these tests. There is no information about the country of origin of the data, and the nature of "bench testing" inherently implies a prospective collection of data under controlled laboratory conditions, rather than retrospective data from patients.
3. Number of Experts and Qualifications for Ground Truth:
This submission does not involve human clinical data or expert-established ground truth in the way typically seen for diagnostic AI/ML devices. The "ground truth" here is established through engineering and material science principles, comparing the new device against existing, legally marketed predicate devices through bench testing. Therefore, there are no "experts" in the context of clinical evaluation of patient data, nor their qualifications, mentioned.
4. Adjudication Method for the Test Set:
Not applicable. As described above, there is no test set involving human interpretation or clinical outcomes that would require an adjudication method. Bench testing results are typically evaluated against engineering specifications.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This type of study is specifically designed for evaluating the impact of AI on human reader performance in diagnostic tasks, which is not relevant to this medical device (a gastrostomy tube).
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study:
Not applicable. This device is a physical medical device (gastrostomy tube), not an algorithm or software. Therefore, the concept of a "standalone algorithm performance" study is not relevant. The "standalone" performance could be interpreted as the device's intrinsic mechanical and material performance, which was assessed via bench testing.
7. Type of Ground Truth Used:
The "ground truth" for this device's performance, in the context of demonstrating substantial equivalence, is based on:
- Engineering specifications and measurements: For properties like material composition, dimensions, and functional performance (e.g., balloon inflation, fluid flow through the tube, mechanical integrity).
- Comparison to predicate device performance: The critical "ground truth" is that the new device performs identically or acceptably similarly to the legally marketed predicate devices, as demonstrated through bench testing.
8. Sample Size for the Training Set:
Not applicable. This device is a physical medical device and does not involve an algorithm that requires a "training set" in the context of machine learning.
9. How Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for an algorithm.
§ 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.