(55 days)
The EndoVive™ Standard 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. Typical uses include the replacement of existing gastrostomy feeding tubes. In addition, the 20F tube is also used for the replacement of initial placement jejunostromy feeding tubes. The replacement tube may also be used for decompression. Note: Only the 20F tube is indicated for jejunal replacement.
The EndoVive™ Standard Replacement GastrostomyTube is constructed primarily of silcone. 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 banum 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
The provided text describes a 510(k) summary for the "EndoVive™ Standard Replacement Gastrostomy Tube." This document primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study with performance metrics.
The submission relies on bench test results to demonstrate that "there was no difference in the performance, safety, or effectiveness between the EndoVive™ Standard Replacement Gastrostomy Tube and the specified predicate devices." This is a common approach for devices seeking 510(k) clearance where the new device is technologically similar to previously cleared devices.
Therefore, many of the requested details about acceptance criteria, clinical study specifics, and expert involvement are not explicitly stated or applicable in the context of this 510(k) submission as it's presented.
Here's a breakdown based on the provided information, noting where details are not available:
1. Table of Acceptance Criteria and Reported Device Performance
As the submission relies on bench testing for substantial equivalence, specific numerical "acceptance criteria" and "reported device performance" in terms of clinical outcomes or diagnostic accuracy are not provided. The acceptance criterion is implied as "no difference in performance, safety, or effectiveness" compared to predicate devices based on bench testing.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| No difference in performance compared to predicate devices | Bench tests demonstrated no difference in performance. |
| No difference in safety compared to predicate devices | Bench tests demonstrated no difference in safety. |
| No difference in effectiveness compared to predicate devices | Bench tests demonstrated no difference in effectiveness. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified. The submission refers to "bench test results," which typically involve a limited number of device samples rather than human subjects.
- Data Provenance (e.g., country of origin, retrospective/prospective): Not specified. Bench testing is conducted in a laboratory setting, not typically patient-based.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. For bench testing comparing physical device characteristics and performance, "ground truth" as established by medical experts for diagnostic accuracy is not relevant. The "ground truth" would be engineering specifications and predicate device performance.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods like 2+1 or 3+1 are used for evaluating human expert disagreements in image interpretation or clinical diagnosis. This submission describes bench testing of a physical medical device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Reader Improvement with AI vs. Without AI Assistance
- MRMC Study: No, an MRMC study was not done.
- Effect Size of AI Assistance: Not applicable. This device is a gastrostomy tube, not an AI-powered diagnostic or assistive technology.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
- Type of Ground Truth: For the "bench test results," the ground truth would be established engineering specifications, material properties, and the known performance characteristics of the legally marketed predicate devices (Microvasive Balloon Gastrostomy Tube Kit, K962375, and EndoVive™ Low Profile Button Replacement Gastrostomy Tube, K014297).
8. The Sample Size for the Training Set
Not applicable. The concept of a "training set" is relevant for machine learning algorithms. This submission describes a physical medical device.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As described above, the concept of a training set and its ground truth is not relevant to this device's premarket submission.
§ 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.