(188 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.
A U.S.E. PULL PEG Tray includes all necessary products (eg. silicone feeding tube, bolster, feeding adapter, etc.) and accessory products (eg. lubricating jelly, disposable hemostat, grasping snare) to complete the endoscopic gastrostomy.
A U.S.E. GUIDEWIRE PEG Tray includes all necessary products (eg. silicone feeding tube, bolster, feeding adapter, etc.) and accessory products (eg. lubricating jelly, disposable hemostat, grasping snare) to complete the endoscopic gastrostomy.
This document does not contain information about acceptance criteria or a study proving the device meets those criteria. The provided text is a "Summary and Certification" for two different Percutaneous Endoscopic Gastrostomy (PEG) trays (PULL PEG Tray and Guidewire PEG Tray).
Here's a breakdown of what the document does include:
- Device Overview: Describes the purpose and components of the PULL PEG Tray and Guidewire PEG Tray, stating they are used for percutaneous endoscopic gastrostomies.
- Contraindications: Lists conditions for which PEG procedures are not suitable (e.g., massive ascites, sepsis, inability to transluminate the stomach).
- Manufacturing Overview: Briefly outlines U.S.E.'s manufacturing processes and quality assurance based on good manufacturing practices and MIL-STD-9858.
- Bibliography: Provides a list of scientific articles related to Percutaneous Endoscopic Gastrostomy.
The document does not include:
- Acceptance Criteria: There are no specific performance metrics or thresholds defined for the device's acceptable performance.
- Device Performance: No data or results from any study demonstrating how the device performs against any criteria are reported.
- Study Design Details: Information typically found in a study (like sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance) is entirely absent.
Therefore, I cannot provide the requested table or study details based on the input. The text focuses on describing the device and its general context within medical procedures, not on proving its effectiveness through defined performance measures and studies.
§ 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.