(183 days)
The Anti-I.V. Enteral Feeding System is intended for use in those patients who require intermittent or continuous tube feedings via the nasogastric or nasoentric route. The Anti-I.V. Enteral Feeding Tube is intended for use in those patients who require intermittent or continuous tube feedings via the nasogastric or nasoentic route. The Anti-I.V. Enteral Feeding Extension Set is intended to be connected to the nutritional source to the Anti-I.V. Enteral Feeding Tube. The Anti-I.V. Enteral Feeding System is for pediatric and neonatal use only.
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The provided text is a 510(k) clearance letter from the FDA for the "Anti-I.V. Enteral Feeding System". This document establishes that the device is substantially equivalent to a predicate device already on the market. It is not a study report and does not contain the detailed information necessary to describe acceptance criteria, device performance, or the methodologies of a study as requested in your prompt.
Specifically, the document does not include:
- A table of acceptance criteria and reported device performance: This letter is a notification of clearance, not a performance report.
- Sample size used for the test set and data provenance: No study details are provided.
- Number of experts and their qualifications for ground truth: No study details are provided.
- Adjudication method for the test set: No study details are provided.
- Multi-reader multi-case (MRMC) comparative effectiveness study information: This type of study is not mentioned.
- Standalone (algorithm only) performance: This device is a physical medical device, not an algorithm.
- Type of ground truth used: No study details are provided.
- Sample size for the training set: Not applicable for this type of device and document.
- How ground truth for the training set was established: Not applicable for this type of device and document.
In summary, the provided FDA 510(k) clearance letter confirms that the "Anti-I.V. Enteral Feeding System" is cleared for marketing based on substantial equivalence to predicate devices, but it does not describe the specific studies, acceptance criteria, or performance metrics in the way you've outlined for AI/algorithm-based devices.
To obtain the information you requested, you would typically need to refer to the original 510(k) submission document or any referenced clinical study reports, which are not included in this FDA clearance letter.
§ 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.