(452 days)
The devices in the iMed Technology Enteral Feeding Set family are used to dispense liquid nutrients (feeding solutions) at a user controlled rate. These enteral feeding sets interface with the patient's feeding tube and may use gravity or an enteral feeding pump to dispense the feeding solution. The devices may include a bag to contain the feeding solution and/or a spike to connect to a pre-filled container. These devices are food containing. These devices are to be issued by prescription only.
iMed Gravity Set, iMed Pump Set
The provided text describes a 510(k) premarket notification for "iMed Gravity Set, iMed Pump Set," which are enteral feeding sets. The FDA letter confirms substantial equivalence to legally marketed predicate devices, but it does not contain information about acceptance criteria, device performance testing, sample sizes, expert involvement, or any of the detailed study parameters requested in the prompt.
Therefore, it's impossible to answer your request with the provided input. This document is a regulatory communication, not a study report.
§ 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.