U.S. ENDOSCOPY GROUP, INC. BALLOON REPLACEMENT GASTROSTOMY TUBE

K955181 · United States Endoscopy Group, Inc. · KNT · Jun 5, 1996 · Gastroenterology, Urology

Device Facts

• Record ID: K955181
• Device Name: U.S. ENDOSCOPY GROUP, INC. BALLOON REPLACEMENT GASTROSTOMY TUBE
• Applicant: United States Endoscopy Group, Inc.
• Product Code: KNT · Gastroenterology, Urology
• Decision Date: Jun 5, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5980
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Replacement Gastrostomy Tube is intended for use in patients, both adults and children, unable to take nutrition through normal means, yet, have a functional gastrointestinal tract, specifically for the replacement of a percutaneous endoscopic gastrostomy (PEG) tube due to indications such as a blocked feeding tube, patient comfort and esthetics, and the need for long-term nutritional support.

Device Story

Replacement Gastrostomy Tube serves as a substitute for existing percutaneous endoscopic gastrostomy (PEG) tubes. Used in clinical settings for patients requiring long-term nutritional support via a functional gastrointestinal tract. Device replaces blocked or uncomfortable tubes to maintain enteral access. Operated by physicians or trained clinical staff. Benefits include continued nutritional delivery for patients unable to ingest food normally, providing a less invasive alternative to surgical gastrostomy.

Clinical Evidence

No clinical data provided. Device safety and effectiveness are supported by established clinical acceptance of PEG procedures and literature review.

Technological Characteristics

Replacement Gastrostomy Tube; materials certified to appropriate standards; manufactured using quality assurance methods based on MIL-STD-9858; sterilized via Ethylene Oxide (ETO).

Indications for Use

Indicated for adults and children requiring long-term enteral nutrition via a well-established gastrostomy tract. Contraindicated in patients with massive ascites, sepsis, esophageal/gastric obstructions, esophageal/gastric varices, morbid obesity, lack of established tract, combative state, active bleeding, or stoma site infection/irritation/granulation tissue.

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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K955181

JUN - 5 1996

## SECTION II

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

## REPLACEMENT GASTROSTOMY TUBE

The Summary of Safety and Effectiveness on percutaneous endoscopic gastrostomy and the Replacement Gastrostomy Tube 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 clinically acceptable for more than 10 years. Several manufacturers provide PEG units to the market. The Gastrostomy tube is replaced with a Replacement Gastrostomy Tube for such things as indications of a blocked feeding tube, patient comfort and esthetics, and the need for long-term nutritional support.

## Contraindications For Utilizing a Replacement Gastrostomy Tube and Percutaneous Endoscopic Gastrostomy

1. Patients with massive ascites, sepsis, esophageal or gastric obstructions, esophageal or gastric varices and morbid obesity.
2. Individuals who do not have a well established gastrostomy tract.
3. If the patient is combative and can not be sedated.
4. If the patient is bleeding.
5. If the patient has signs of infection or irritation of stoma tissue.
6. If the patient has evidence of granulation tissue at stoma site.
7. A patient who does not have a well established gastrostomy tract.
8. Evidence of granulation tissue, infection or irritation should be addressed medically prior to insertion of this device.
9. Other contraindications as determined by physician.

## Manufacturing Overview

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

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K455181

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 standards appropriate for their use.

## Sterility

The Replacement Gastrostomy Tube will be sterilized using ETO. Sterilization parameters are on file with U.S. Endoscopy Group, Inc.

## Bibliography

Hardick, Marcia and Beck, Marjorie (Editors), *Manual of Gastrointestinal Procedures*, (2nd Edition). New York: Society of Gastroenterology Nurses and Associates, Inc., 1989.

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.