(51 days)
For nasogastric oralgastric enteral feeding, incorporating safety connectors which eliminates the risk of IV administration through the feeding tube.
Nutrifit is a combined system of feeding tubes and extension sets. The feeding tubes are available in several configurations: Not made with DEHP PVC and Polyurethane (PUR). The PUR versions are available without stylet. All tubes include centimeter numerical markings from 5 to 35 cm for the 40, 50 and 75 cm feeding tubes and markings from 5 to 70 cm for the 90, 125 and 160 cm feeding tubes.
The Nutrifit devices are single-use, disposable devices intention in adults and children. Nutrifit PVC feeding tubes are intended for enteral nutrition and for a short-term use, not longer than 5 days. Nutrifit PUR feeding tubes are intended for enteral nutrition and for a short-term use, not longer than 29 days.
The Nutrifit accessories for this submission sets, which enable longer connections for the feeding tubes. They allow greater freedom of movement and greater flexibility and are available with or without a pinch clamp.
Nutrift is ENFit compliant, meeting requirements for design and functional performance of small-bore connectors intended to be used for connections on enteral medical devices and accessories as detailed in ISO 80369-3.
The provided text is a 510(k) summary for the Vygon USA Nutrifit device, a gastrointestinal tube and accessories. It asserts the device's substantial equivalence to a predicate device (Nutrisafe 2) based on non-clinical performance bench testing.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Resistance to separation from unscrewing | Conformance to ISO 80369-3 specifications | Met predetermined acceptance criteria |
| Resistance to overriding | Conformance to ISO 80369-3 specifications | Met predetermined acceptance criteria |
| Disconnection by unscrewing | Conformance to ISO 80369-3 specifications | Met predetermined acceptance criteria |
| Fluid leakage at 3.2 bar for 30 seconds | Conformance to ISO 80369-3 specifications | Met predetermined acceptance criteria |
| Stress cracking | Conformance to ISO 80369-3 specifications | Met predetermined acceptance criteria |
| Resistance to separation from axial load | Conformance to ISO 80369-3 specifications | Met predetermined acceptance criteria |
| Flow rate testing (comparison to Nutrisafe 2) | Demonstrated similar flow rate performance to the predicate device per FDA cited protocol | Met predetermined acceptance criteria (implies similar flow) |
| Packaging Validation | Sterile barrier system maintains strength, integrity, and microbial barrier until end of shelf life | Test results demonstrate compliance |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the test set for any of the bench tests mentioned. It states "Adequate non-clinical performance bench testing was conducted" and "The VYGON's Nutrifit device met all predetermined acceptance criteria."
The data provenance is from non-clinical performance bench testing conducted by Vygon; the country of origin is not explicitly stated but implied to be internal testing by the manufacturer. The data is prospective for this device's evaluation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. The tests performed are engineering/performance-based bench tests, not clinical evaluations requiring expert interpretation of ground truth in the traditional sense (e.g., medical image interpretation). The "ground truth" for these tests would be the established specifications and standards (e.g., ISO 80369-3).
4. Adjudication Method for the Test Set
This is not applicable as the tests are objective, performance-based bench tests against defined specifications, not subjective assessments requiring adjudication by multiple experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The document explicitly states "Bench Testing was conducted in order to support this submission." There is no mention of human readers or AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
No, a standalone (algorithm only) performance study was not done. The Nutrifit is a medical device (tubing and accessories), not an AI algorithm or software. The testing focuses on its physical performance and safety characteristics.
7. The Type of Ground Truth Used
The ground truth used for the performance testing cited is based on established engineering specifications, international standards (ISO 80369-3), and FDA guidance protocols (e.g., "Gravity Flow Rate Testing in Enteral Tube"). This falls under objective technical standards rather than expert consensus, pathology, or outcomes data.
8. The Sample Size for the Training Set
This information is not applicable as the Nutrifit device is a physical medical device, not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as point 8.
§ 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.