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.

AI/ML Overview

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.

Summary

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K 955248

MAY 2 1 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.

Contraindications For Utilizing a FEG

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.
If the patient's stomach can not be transluminated. (2)
(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

Image /page/0/Picture/17 description: The image shows a black circle with a jagged white line running vertically through the center. The circle is solid black, except for the white line, which appears to be a crack or a streak. The white line is not perfectly straight, and it has some small branches or offshoots along its length. The overall impression is of a damaged or imperfect object.

Image /page/0/Picture/19 description: The image contains a black circle. The circle is solid black and is positioned in the upper portion of the image. The background is white, providing a stark contrast to the black circle. The circle appears to be a simple, isolated graphic element.

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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
Stellato, Ponsky, J.L., Gauderer,M., 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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SAFETY AND EFFECTIVENESS GUIDEWIRE PEG TRAY SUMMARY

The Summary of Safety and Effectiveness on percutaneous endoscopic qastrostomy and the Guidewire PEG tray ised 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.

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 :or 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.
If the patient is combative and can not be sedated. ( 3 )

Manufacturing Overview

manufactures and tests the product to performance U.S.E. 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

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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: Nonoperative Technique for Feeding A 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.
y, J.L., Gauderer, M. and Stellato, T.A.: Percutaneous
Endoscopic Gastrostomy: Review of 150 Cases. Archives of Ponsky , 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.