(494 days)
The Flexiflo Low-Profile Balloon Gastrostomy tube is indicated for use as a replacement tube in an established stoma tract for pediatric, adult and elderly patients who cannot consume an adequate diet orally. Gastrostomy feeding may be indicated for patients with a functioning gut who require long-term feeding support. This includes patients in whom malnutrition already exists, or may result, secondary to neurologic diseases resulting in an abnormality in swallowing; tumors of the head, neck or esophagus; or upper airway diseases or oropharyngeal trauma resulting in an abnormality in swallowing. Some patients requiring chronic use of supplemental fluids are candidates for gastrostomy.
Flexiflo® Low-Profile Balloon Gastrostomy Tube Kit and Accessories
I am sorry, but based on the provided text, I cannot describe the acceptance criteria and the study that proves the device meets them. The document is an FDA 510(k) clearance letter for the Flexiflo® Low-Profile Balloon Gastrostomy Tube Kit and Accessories. It states that the device is "substantially equivalent" to previously marketed devices and outlines regulatory responsibilities.
However, the document does not contain any information about acceptance criteria, device performance metrics, study designs, sample sizes, expert qualifications, ground truth establishment, or comparative effectiveness studies (MRMC or standalone). It is a regulatory approval letter, not a scientific 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.