(26 days)
The COMPAT® Enteral Delivery Pump Sets are intended to deliver liquid nutrition formulas or hydration to an enteral access device (a feeding tube).
The COMPAT Pump administration sets are designed specifically for use with the COMPAT® Enteral Pumps. The SpikeRight piercing spike with 1000 mL water bag is compatible with all SpikeRight compatible enteral feeding systems. The twist and lock feature ensures safe and effective connection and prevents inadvertent connections to IV sets. The 1000 mL formula vinyl bag with 1000 mL water bag has 50 mL graduations to make it easier for reading and better accuracy when filling. The different-colored print on the bags make it easy to identify water and formula and the nutrition orders can be written directly on the formula bag for convenience. Single Use Only.
The COMPAT Pump administration sets are designed specifically for use with the COMPAT® Enteral Pumps. The SpikeRight piercing spike is compatible with all SpikeRight compatible enteral feeding systems. The COMPAT pump set with the in-line "Y" adapter is DEHP and latex free. Easy to use "Y" adapter - simply disconnect "Y" adapter cap and insert syringe for flushing. The in-line "Y" saves time - no need to disconnect set from the feeding tube when flushing medications, water or bolus feeding. Ready to use. Single use only.
The provided text is for a 510(k) premarket notification for a modified medical device. This type of document is about regulatory clearance for a device based on its substantial equivalence to a predicate device, not about a study proving the device meets clinical acceptance criteria in terms of diagnostic performance or efficacy for AI/imaging devices.
Therefore, the information requested (acceptance criteria table, sample sizes, expert qualifications, adjudication, MRMC studies, standalone performance, ground truth types, training set size and ground truth establishment) is not applicable to this document.
Manufacturers use bench testing and engineering verification to demonstrate that a modified device functions as intended and meets its design specifications, and that these specifications are equivalent to the predicate device. The statement "All test results verify that the device meets or exceeds all predetermined specifications" confirms this. However, the specific details of these technical specifications and their corresponding test results are generally proprietary and not included in the public 510(k) summary.
§ 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.