(73 days)
Percutaneous endoscopic gastrostomy (PEG) has become the method of choice for patients, both adults and children, unable to take nutrition through normal means, yet, have a functional gastrointestinal tract. Percutaneous endoscopic gastrostomy is a less invasive and less traumatic method of placement than a surgical procedure.
A U.S.E. PATIENT CARE KIT includes all necessary products for maintenance of the Pull or Guidewire P.E.G. (eg. feeding adapter, and accessory products - manual, cleaning brush, antibiotic ointment, etc...)
A U.S.E. PATIENT CARE KIT includes all necessary products for maintenance of the Pull or Guidewire P.E.G. (eg. feeding adapter, and accessory products - manual, cleaning brush, antibiotic ointment, etc...)
The provided text describes a "P.E.G. Patient Care Kit" and its intended use, but it does not contain information about acceptance criteria or a study proving the device meets specific performance criteria.
The document is a "Summary of Safety and Effectiveness" which briefly outlines the product, its overview, contraindications, and manufacturing processes based on existing standards and predicate devices. It lists bibliographic references for the medical procedure itself, not for a specific study validating the performance of this particular kit against defined acceptance criteria.
Therefore, I cannot populate the requested information because the input text does not contain it.
§ 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.