(125 days)
For initial percutaneous placement of a gastrostomy feeding and/or decompression device into a stoma created by tissue dilation.
Also for percutaneous replacement of a gastrostomy feeding and/or decompression device into an established stoma site.
Bard® Balloon Dilation Kit with Tri-Funnel Gastrostomy Tube
I am sorry, but the provided document does not contain information on acceptance criteria, device performance, a study, or any of the specific details you requested regarding sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.
The document is a 510(k) summary and FDA clearance letter for a medical device (Bard® Balloon Dilation Kit with Tri-Funnel Gastrostomy Tube). It outlines general information about the device, its intended use, and its substantial equivalence to a predicate device, but it does not include the type of detailed performance study results you are looking for.
§ 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.