(273 days)
For nasogastric/oralgastric enteral feeding, incorporating safety connectors which eliminate the risk of accidental connection of an I.V. system to the enteral system, or the enteral system to an I.V. system.
Nutrisafe® Enteral Feeding Tube
The provided text is a 510(k) clearance letter from the FDA for a medical device: "Vygon Nutrisafe Enteral Feeding Tube". This type of document primarily confirms that a device is substantially equivalent to a predicate device already on the market and can be legally marketed. It does not typically contain detailed information about the acceptance criteria or a specific study proving the device meets those criteria in the way described in your request (e.g., performance metrics like sensitivity, specificity, or AUC, and details about study design).
Therefore, I cannot extract the requested information from the provided text because it is not present. The letter focuses on regulatory clearance, not a performance study report.
To answer your questions, I would need a document that presents the results of a performance study for the device, including:
- A table of acceptance criteria and the reported device performance: This would typically list metrics like tensile strength, flow rate, biocompatibility testing results, etc. against predefined acceptance limits.
- Sample size used for the test set and the data provenance: Details on how many tubes were tested, where the materials came from, and if the testing was prospective (designed for the device) or retrospective (using existing data).
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience): This is highly relevant for AI/imaging devices but unlikely for a physical medical device like an enteral feeding tube. For physical devices, ground truth is usually established through validated measurement methods or established standards.
- Adjudication method: Again, more relevant to diagnostic interpretations than physical device performance.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable for a physical feeding tube. This is for AI-powered diagnostic tools comparing human performance with and without AI assistance.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable for a physical feeding tube.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For a feeding tube, this would likely be physical measurements, chemical analyses, or biocompatibility tests.
- The sample size for the training set: Not applicable for a non-AI physical device.
- How the ground truth for the training set was established: Not applicable for a non-AI physical device.
In summary, the provided document is a regulatory clearance letter and does not contain the detailed performance study information you are asking for.
§ 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.