U.S. ENDOSCOPY PULL PEG KIT & U.S. ENDOSCOPY GUIDEWIRE PEG KIT
K955248 · United States Endoscopy Group, Inc. · KNT · May 21, 1996 · Gastroenterology, Urology
Device Facts
Record ID
K955248
Device Name
U.S. ENDOSCOPY PULL PEG KIT & U.S. ENDOSCOPY GUIDEWIRE PEG KIT
Applicant
United States Endoscopy Group, Inc.
Product Code
KNT · Gastroenterology, Urology
Decision Date
May 21, 1996
Decision
SESK
Submission Type
Traditional
Regulation
21 CFR 876.5980
Device Class
Class 2
Attributes
Therapeutic, Pediatric
Indications for Use
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 traumatic method of placement than a surgical procedure.
Device Story
U.S.E. PULL PEG and GUIDEWIRE PEG Trays provide necessary components for percutaneous endoscopic gastrostomy. Trays include silicone feeding tubes, bolsters, feeding adapters, and accessories (lubricating jelly, disposable hemostat, grasping snare). Used by clinicians to establish enteral access in patients with functional GI tracts but impaired oral intake. Procedure involves endoscopic placement of feeding tube through abdominal wall into stomach. Benefits include less invasive/traumatic alternative to surgical gastrostomy. Device performance verified against predicate specifications.
Clinical Evidence
No clinical data provided. Safety and effectiveness supported by literature review of established percutaneous endoscopic gastrostomy procedures and adherence to performance specifications.
Technological Characteristics
Components include silicone feeding tubes, bolsters, and adapters. Manufacturing utilizes quality assurance procedures based on MIL-STD-9858. Materials are certified to standards appropriate for medical use.
Indications for Use
Indicated for adults and children unable to take nutrition orally but possessing a functional gastrointestinal tract. Contraindications: massive ascites, sepsis, esophageal/gastric obstructions, esophageal/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)
{0}
K955248
MAY 21 1996
# SECTION II
## SUMMARY AND CERTIFICATION
### SAFETY AND EFFECTIVENESS
#### PULL PEG TRAY SUMMARY
The Summary of Safety and Effectiveness on percutaneous endoscopic gastrostomy and the Pull PEG tray 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 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. 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.
## 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
{1}
specifications.
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.
{2}
# SAFETY AND EFFECTIVENESS
## GUIDEWIRE PEG TRAY SUMMARY
The Summary of Safety and Effectiveness on percutaneous endoscopic gastrostomy and the Guidewire PEG tray 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 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. 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.
## 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.
Materials used in the manufacturing process are certified to
{3}
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.
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