(354 days)
The VR Medical Feeding Tube is intended for nasogastric delivery of various types of liquid nutritional media through the gastro intestinal tract of neonatal and small pediatric patients, and is not intended for use beyond 30 days.
The Enteral Feeding Extension Set (EFES) is intended for use as an extension set for nasogastric / oralgastric or gastric tube enteral feeding tubes, incorporating safety connectors/small bore connectors which are intended to reduce the misconnection between the following applications: I.V. system and Enteral Feeding System.
The EFES is indicated for use in neonatal and pediatric patients in connection with an enteral feeding tube to provide nutrition via nasal or oral gastric placements.
The VR Medical Feeding Tube is intended for nasogastric delivery of various types of liquid nutritional media through the qastro intestinal tract of neonatal, pediatric and is not intended for use beyond 30 days. They are sterile, individually packaged. The orange color coding provides easy visual recognition of the enteral connection. They are designed with a radiopague stripe for X-ray visualization to confirm proper feeding tube placement. They are marked with French size and markings to assist tube placement or check for migration. A tethered plug for connector closure is incorporated when not in use.
The Enteral Feeding Extension Sets ("EFES") are intended to provide access from the feeding tube to a syringe or nutritional source accepting a connector for enteral applications. They are available in multiple configurations: with and without an in-line Y port and lengths. The EFES are sterile disposable device for single patient use only. The EFES is designed to connect existing feeding tubes (nasogastric, gastric, etc.) to various delivery enteral syringes as well as to help minimize the potential for inadvertent delivery of enteral feedings through the intravenous route. i.e., the device cannot be connected to a luer connector. The EFES consists of flexible tubing with an orange strip for easy quick identification of enteral feeding lines as well as a "For Enteral Feeding Only" tag and a slide clamp to provide the additional safety assurance for connection errors.
This document describes the premarket notification for the VR Medical Feeding Tube and Enteral Feeding Extension Set (EFES). The submission aims to demonstrate substantial equivalence to legally marketed predicate devices.
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria are derived from various international and national standards relevant to enteral feeding devices and their connectors. The reported device performance is indicated by its successful completion of these tests, demonstrating compliance with the standards.
Table 1: Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (Standard Reference) | Reported Device Performance |
|---|---|---|
| Connector Compatibility | EN1615: 2000 Section 4.2.1; ANSI/AAMI ID54: 1996/(R) 2012 | Complies with standard |
| Tensile Property Test of tubing (EFT) | EN1615: 2000 Section 4.2.2.1 | Complies with standard |
| Tensile Property Test of bonding (EFT) | EN1615: 2000 Section 4.2.2.1 | Complies with standard |
| Liquid Leakage Test (EFT) | EN1615: 2000 Section 4.3.2 | Complies with standard |
| Tensile Property test of Assembled connection of connectors (EFT) | EN1615: 2000 Section 4.3.1 | Complies with standard |
| Connector Performance (EFT) | ISO 80369-3: 2016 | Complies with standard |
| Printing Firmness Test (EFT) | ASTM D3359-09 | Complies with standard |
| Priming Volume Test (EFT/EFES) | (Standard not explicitly listed, but performed) | Complies (implied by acceptance) |
| Flow Rate Test (EFT/EFES) | (Standard not explicitly listed, but performed) | Complies (implied by acceptance) |
| Radiopaque Capacity Test (EFT) | (Standard not explicitly listed, but performed) | Complies (implied by acceptance) |
| Connector Incapability test (EFT/EFES) | ISO 80369-1: 2010 Section 5.1 & Annex B | Complies with standard |
| Connector Compatibility Test (EFES) | EN1615: 2000 Section 4.1.2; ANSI/AAMI ID54: 1996/(R) 2012 | Complies with standard |
| Connector Performance (EFES) | ISO 80369-3: 2016 | Complies with standard |
| Tensile Property Test of tubing (EFES) | EN1615: 2000 Section 4.1.1 | Complies with standard |
| Tensile Property Test of bonding (EFES) | EN1615: 2000 Section 4.1.1 | Complies with standard |
| Liquid Leakage Test (EFES) | EN1615: 2000 Section 4.1.3 & 4.3.2 | Complies with standard |
| Tensile Property test of Assembled connection of connectors (EFES) | EN1615: 2000 Section 4.3.1 | Complies with standard |
| Biocompatibility (EFT) | ISO 10993-1 (Cytotoxicity, Sensitization, Irritation, Acute systemic and Sub-acute toxicity, Implantation (14 day), Pyrogenicity) | Complies with standard |
| Biocompatibility (EFES) | ISO 10993-1 (Cytotoxicity, Sensitization, Irritation) | Complies with standard |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for each specific test in the "test set" (bench testing). However, it refers to performance testing conducted in accordance with established international and national standards (e.g., ISO, EN, ASTM, ANSI/AAMI). These standards typically specify minimum sample sizes for different types of tests to ensure statistically significant results. The data provenance is from bench testing, which is a form of prospective data collection under controlled laboratory conditions, not from human subjects or retrospective clinical data. The country of origin of the data is not specified beyond the submitter being in China, implying the testing was performed there or by a contracted lab.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This document describes technical performance and biocompatibility testing, not studies requiring expert interpretation of clinical data to establish ground truth. Therefore, there were no experts used to establish ground truth in the context of clinical interpretation, as the tests are against objective engineering and biological standards.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where multiple human readers interpret data, and a consensus or tie-breaker mechanism is needed. The described testing involves objective measurements against predefined standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission focuses on demonstrating substantial equivalence through technical and biocompatibility testing of the device itself, not on evaluating the effectiveness of human readers using the device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the performance evaluation in this document is a standalone assessment of the device's physical and biological characteristics against engineering and safety standards. There is no algorithm or human-in-the-loop component being evaluated.
7. The Type of Ground Truth Used
The ground truth used for these tests are the established performance criteria and pass/fail thresholds defined within the referenced international and national consensus standards (e.g., ISO 80369-3, EN1615, ISO 10993-1, ASTM D3359-09, ANSI/AAMI ID54). These standards represent industry-accepted benchmarks for device safety and performance.
8. The Sample Size for the Training Set
Not applicable. This is a premarket notification for a physical medical device (feeding tube and extension set), not an artificial intelligence/machine learning algorithm. Therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device 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.