(90 days)
This product is intended for short-term use
The NeoMed Gastrointestinal Tube and Accessories is a PVC single lumen catheter that is used to deliver liquid nutritional media. This NeoMed PVC feeding tube is designed to connect with other NeoMed accessories such as the NeoMed Extension tubing under FDA clearance K100288 and NeoMed oral syringe under FDA clearance K092908.
The device consists of the following main components: a feeding tube single lumen catheter and a one-piece molded enteral only connector hub with integral tethered connection closure plug. The catheter tubing has an orange radiopaque stripe of barium sulfate embedded in the tubing wall which can be visualized on x-ray, for exact placement of the tip. The tip is closed. The single lumen catheter tubing has side holes for better flow and to provide multiple openings for aspiration.
The provided text describes a 510(k) submission for the NeoMed Gastrointestinal Tube and Accessories, which seeks substantial equivalence to existing predicate devices. The study conducted to demonstrate this equivalence is primarily an engineering bench test study rather than a clinical study involving human patients or complex AI algorithms.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (General Purpose of Test) | Reported Device Performance |
|---|---|
| Biocompatibility | Materials have a long history of use in feeding tube manufacturing, are biocompatible, and testing in accordance with ISO 10993-1: Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing passed. |
| Tensile Strength | Design verification functional test results, including tensile strength, demonstrate that the NeoMed Gastrointestinal Tube and Accessories performs its intended use. |
| Dimensions | Design verification functional test results, including dimensions, demonstrate that the NeoMed Gastrointestinal Tube and Accessories performs its intended use. |
| Non-Interconnectability | Design verification functional test results, including non-interconnectability, demonstrate that the NeoMed Gastrointestinal Tube and Accessories performs its intended use. |
| Priming Volume | Design verification functional test results, including priming volume, demonstrate that the NeoMed Gastrointestinal Tube and Accessories performs its intended use. |
| Substantial Equivalence (Overall) | Bench testing has demonstrated that the NeoMed Gastrointestinal Tube and Accessories is functionally equivalent to the proposed predicate feeding tubes. The device is concluded to be equivalent to the Vygon Nutrisafe 2 (KQ60944) and Kendall Argyle PVC Feeding Tube (K820441) with respect to intended use, materials, design, and technological characteristics. |
2. Sample Size Used for the Test Set and Data Provenance
The document describes "bench testing" and "design verification functional test results." It does not specify a "test set" in the context of patient data or algorithm performance. The testing involved physical tubes and components. No information is provided regarding the specific number of units tested for each functional test (tensile strength, dimensions, etc.), nor is there any mention of data provenance (e.g., country of origin) as the tests are laboratory-based engineering evaluations.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. The study is a bench test, and there is no mention of experts establishing a "ground truth" for a test set in the context of clinical or image-based evaluations. The "ground truth" for these engineering tests would be the established engineering specifications and performance standards.
4. Adjudication Method for the Test Set
Not applicable. There is no mention of adjudication, as this study does not involve human interpretation or subjective assessments that would require adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This study is an engineering bench test for physical device characteristics and does not involve human readers, AI assistance, or comparative effectiveness in a clinical setting.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
No. This device is a physical medical tube, not an AI algorithm. Therefore, no standalone algorithm performance study was conducted.
7. Type of Ground Truth Used
The ground truth used for this study is based on engineering specifications, material properties, and functional performance standards derived from the intended use and comparison with predicate devices. For example, for dimensions, the ground truth would be the specified dimensions in the design; for tensile strength, it would be the minimum required strength; for biocompatibility, it would be successful compliance with ISO 10993-1.
8. Sample Size for the Training Set
Not applicable. This study does not involve a "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This study does not involve a "training set" for which ground truth would need to be established.
§ 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.