(177 days)
The Entuit PEG is intended for percutaneous endoscopic gastrostomy placement to provide enteral nutrition and/or medication to patients requiring nutritional support, and gastric decompression. This device is indicated for adult use only.
The Entuit PEGJ is intended for percutaneous endoscopic placement to provide enteral nutrition and/or medication to patients requiring nutritional support, and gastric decompression. This device is indicated for adult use only.
The Entuit PEG includes a silicone enteral feeding tube (PEG tube) available in 24 Fr or 20 Fr, with site preparation components, introduction components, adapters. The PEG tube is supplied sterile and is intended for single use in adults. Entuit PEGJ includes a polyurethane enteral feeding tube (PEGJ tube) that is available in 12 Fr or 9 Fr. The Entuit PEGJ tube is available for direct access to the jejunum. The 12 Fr PEGJ tube is designed to be inserted through the 24 Fr PEG tube and the 9 Fr tube is designed to be inserted through the 20 Fr PEG tube such that the distal end extends into the jejunum and the proximal end extends out of the existing PEG tube.
There are several feeding adapters for use with the PEG and PEGJ tubes. The PEG kit has two feeding adapters that are ENF it compatible and two feeding adapters that are compatible with Christmas tree or slip tip giving sets and syringes (Non-ENFit). The PEGJ tubes are available with either ENFit compatible or Christmas tree compatible feeding adapters (Non-ENFit). The Entuit PEG is provided as a kit to facilitate either push or pull techniques of placement. In addition, the Entuit PEG are available in standard, safety, and international versions. The PEGJ tubes are sold as a separate kit.
This document is an FDA 510(k) clearance letter for the Entuit PEG and Entuit PEGJ devices. It is a review of the substantial equivalence of these devices to a previously marketed predicate device. This document describes the device itself and its intended use, along with non-clinical testing conducted to demonstrate performance.
However, this document does NOT contain information about an AI/ML-driven medical device, nor does it detail a study involving human readers or the establishment of ground truth for AI model training or testing.
Therefore, I cannot provide the requested information, which pertains to the acceptance criteria and study proving an AI/ML device meets those criteria. The provided text does not describe an AI medical device or its validation.
§ 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.