(162 days)
The Domed Percutaneous Endoscopic Gastrostomy (P.E.G.) Feeding Tube is a percutaneously placed gastrostomy feeding device used to administer nutrition directly into the stomach.
The device is available in either the guidewire or pullwire method. The domed shaped internal bolster is injection molded onto clear medical grade silicone tubing. The tubing has graduated markings which allows for verification of tube positioning. The internal bolster is also composed of medical grade silicone but which has been pigmented with barium sulfate which provides radiopacity. The internal bolsters' shape allows for ease of passage during placement and is advantages because it permits passage of a jeujenostomy tube if jeujenal feeding is required.
The provided 510(k) summary for the Domed Percutaneous Endoscopic Gastrostomy (P.E.G.) Feeding Tube does not contain any information related to acceptance criteria or a study proving the device meets said criteria in the context of an AI/ML-based device.
The summary describes a traditional medical device (a PEG feeding tube) and focuses on its substantial equivalence to existing devices based on its design, materials, and intended use.
Therefore, I cannot provide the requested information. The document does not discuss:
- Acceptance criteria for performance metrics (e.g., sensitivity, specificity, accuracy).
- Any study involving a test set, ground truth, or expert evaluation.
- Multi-reader multi-case studies or standalone algorithm performance.
- Training sets for an AI/ML model.
This is a traditional medical device submission, not an AI/ML device submission.
§ 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.