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...)

Device Description

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...)

AI/ML Overview

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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.

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Summary

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MAR 2 9 1996 - 1

SECTION II SUMMARY AND CERTIFICATION

SAFETY AND EFFECTIVENESS P.E.G. PATIENT CARE KIT

The Summary of Safety and Effectiveness on percutaneous endoscopic gastrostomy patient care kit used reflects data available and presented at the time the submission was prepared, but, caution should be exercised in interpreting the data. The results of future studies may require alterations of the conclusions or recommendations set forth.

Procedure/Product Overview

The placement of PEGs, via endoscopy, has been clinical acceptable for more than 10 years. Several manufacturers provide PEG units to the market.

Contraindications For Utilizing a PEG

The following are contraindications for percutaneous endoscopic gastrostomy.

Patients with massive ascites, sepsis, esophageal or (1) gastric obstructions, esophageal or gastric varices and morbid obesity.
(2) If the patient's stomach can not be transluminated.
If the patient is combative and can not be sedated. (3)

Manufacturing Overview

U.S.E. manufactures and tests the product to performance specifications based on predicate and/or substantially equivalent devices.

U.S.E. manufacturing processes and procedures are based on good manufacturing practices. Quality assurance methods and procedures based on MIL-STD-9858 are utilized to assure conformance to design specifications.

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Materials used in the manufacturing process are certified to standards appropriate for their use.

Bibliography

Percutaneous Endoscopic Gastrostomy: A Review. Mamel, J.J .: American Society of Parenteral & Enteral Nutrition 87: 65, 1987.
Endoscopic Mellinger, J.D. and Ponsky, J.L.: Percutaneous Gastrostomy. Endoscopy 24: 64-67, Jan-Feb 1992.

Ponsky, J.L. and Gauderer,M.: Percutaneous Endoscopic Gastrostomy: Feeding Gastrostomy. Nonoperative A Technique for Gastrointestinal Endoscopy 27: 9-11, 1981.

Ponsky , J.L., Gauderer, M. and Stellato, T.A.: Percutaneous Endoscopic Gastrostomy in Children. Gastrointestinal Endoscopy 27: 128, May 1981.
Ponsky , J.L., Gauderer, M. and Stellato, T.A.: Percutaneous Endoscopic Gastrostomy: Review of 150 Cases. Archives of Surgery 118: 913-914, August 1983.
Ponsky, J.L. . . Gauderer,M., Stellato, T.A. and Aszodi, A.: Percutaneous Approaches to Enteral Alimentation. The American Journal of Surgery 149: 102-105, January 1985.

Ponsky, J.L.: Percutaneous Endoscopic Gastrostomy - A Closer Look. Endoscopy Review 1: 24-29, December 1984.

Starkey J.F., Jefferson P.A., Kirby, D.F.: Taking Care of Percutaneous Endoscopic Gastrostomy. American Journal of Nursing 88: 42, 1988.

Regulation Number and Section

§ 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.