K960177 · United States Endoscopy Group, Inc. · KNT · Mar 29, 1996 · Gastroenterology, Urology
Device Facts
Record ID
K960177
Device Name
P.E.G. PATIENT CARE KIT
Applicant
United States Endoscopy Group, Inc.
Product Code
KNT · Gastroenterology, Urology
Decision Date
Mar 29, 1996
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 876.5980
Device Class
Class 2
Attributes
Therapeutic, Pediatric
Device Story
P.E.G. Patient Care Kit provides maintenance accessories for Pull or Guidewire Percutaneous Endoscopic Gastrostomy (PEG) tubes. Kit includes feeding adapter, cleaning brush, manual, and antibiotic ointment. Used in clinical settings for patients requiring enteral nutrition. Facilitates post-placement care and maintenance of PEG tubes. Benefits include support for non-surgical, less invasive nutritional access.
Clinical Evidence
No clinical data provided; bibliography cites literature regarding PEG technique and care.
Technological Characteristics
Kit contains manual, feeding adapter, cleaning brush, and antibiotic ointment. Manufacturing utilizes quality assurance methods based on MIL-STD-9858. Materials certified to standards appropriate for use.
Indications for Use
Indicated for adults and children unable to take nutrition through normal means with a functional gastrointestinal tract. Contraindicated in patients with massive ascites, sepsis, esophageal or gastric obstructions, esophageal or gastric varices, morbid obesity, inability to transluminate the stomach, or combative patients who cannot be sedated.
Regulatory Classification
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).
Special Controls
*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.
Submission Summary (Full Text)
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MAR 29 1996
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
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.
The placement of PEGs, via endoscopy, has been clinical acceptable for more than 10 years. Several manufacturers provide PEG units to the market.
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...)
## Contraindications For Utilizing a PEG
The following are contraindications for percutaneous endoscopic gastrostomy.
1. Patients with massive ascites, sepsis, esophageal or gastric obstructions, esophageal or gastric varices and morbid obesity.
2. If the patient’s stomach can not be transluminated.
3. If the patient is combative and can not be sedated.
## 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
Mamel, J.J.: *Percutaneous Endoscopic Gastrostomy: A Review*. *American Society of Parenteral & Enteral Nutrition* 87: 65, 1987.
Mellinger, J.D. and Ponsky, J.L.: *Percutaneous Endoscopic Gastrostomy*. *Endoscopy* 24: 64-67, Jan-Feb 1992.
Ponsky, J.L. and Gauderer, M.: *Percutaneous Endoscopic Gastrostomy: A Nonoperative Technique for Feeding Gastrostomy*. *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.
