(131 days)
Indications for use would be when the patient cannot feed him/herself and cannot be fed by another person. This catheter would be placed Nasogastrically and nutrients supplied through catheter to the patient.
Nasogastric Feeding Tube (4Fr, 6Fr, 10Fr and 12Fr; sterile and non-sterile)
The provided document is a 510(k) premarket notification approval letter for a Nasogastric Feeding Tube. It does not contain any information about acceptance criteria, device performance studies, or AI/software validation.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance
- Sample sizes or data provenance for a test set
- Number and qualifications of experts for ground truth
- Adjudication method
- MRMC comparative effectiveness study or effect size
- Standalone performance study
- Type of ground truth used
- Sample size for the training set
- How ground truth for the training set was established
The document is a regulatory approval notice, confirming that the FDA found the device (a physical medical device, not a software or AI product) substantially equivalent to a predicate device. It focuses on regulatory compliance rather than detailed performance study results.
§ 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.