(444 days)
The Barone Jejunostomy Catheter Set is intended for patients older than 12 years old requiring jejunal feeding and delivery of medication. The device can be placed via a surgically open or laparoscopic technique.
The Barone Jejunostomy Catheter Set is comprised of a jejunostomy catheter with a pre-loaded stiffening cannula, a Coons wire guide, a dilator, an enteral feeding adapter (funnel), two entry access needles, and a enteral transition connector. The Barone Jejunostomy Catheter is manufactured from polyether-urethane tubing. This catheter is a 10.2 Fr device with a proximal connector cap and a luer lock adapter, 6 distal sideports, a silicone suture wing, and a tapered distal tip; it has a length of 52 cm. The luer lock adapter is glued to the enteral feeding adapter (funnel) and thus is not functional for connecting to other devices. A 5.5 Fr polyethylene stiffener is also provided with the catheter and is matched for a transitional fit. The stiffener is designed with a pre-molded locking hub and a 0.035 inch diameter endhole.
The provided document is a 510(k) summary for a medical device, the Barone Jejunostomy Catheter Set. It outlines the device's intended use, comparison to predicate devices, and performance data from various tests. However, the document does NOT contain information about a study proving the device meets acceptance criteria related to AI/algorithm performance on a test set, nor does it involve human readers, expert consensus for ground truth in the context of an algorithm, or training sets.
The information provided describes physical and material performance tests (e.g., tensile testing, fracture testing, corrosion resistance, liquid leakage, biocompatibility, MRI compatibility) to demonstrate substantial equivalence to predicate devices, as required for a 510(k) submission to the FDA. It does not mention any AI or machine learning components or studies involving image analysis or diagnostic performance.
Therefore, I cannot fulfill the request to describe the acceptance criteria and a study proving the device meets AI-related acceptance criteria, as the provided text pertains to a traditional medical device (catheter set) without any AI or algorithmic component described.
If the request was intended for a different type of medical device (e.g., an AI-powered diagnostic tool), the provided text is not suitable.
§ 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.