(120 days)
For use in dispensing liquid nutrients (feeding solutions) by connecting an enteral feeding container to a patient's feeding tube.
For connecting a universal enteral spike set to a feeding container having a SpikeRight™ connection port.
Enteral Feeding Spike Adapter to be used for enteral administration. This device serves as a connection between the feeding container and the enteral set (gravity or pump fed).
The provided text is a 510(k) summary for the Cedic Enteral Feeding Spike Adapter. It describes the device, its intended use, and compares it to a predicate device to establish substantial equivalence. However, it does not contain information about acceptance criteria or specific study results proving the device meets acceptance criteria.
The document is a submission to the FDA for market clearance, where the primary goal is to demonstrate "substantial equivalence" to a legally marketed predicate device, rather than to present detailed performance studies against specific acceptance criteria.
Therefore, I cannot provide the requested information from the given input. The document focuses on regulatory comparison, not performance testing against defined criteria.
§ 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.