U.S. ENDOSCOPY PULL PEG KIT & U.S. ENDOSCOPY GUIDEWIRE PEG KIT

• K Number: K955248
• Device Name: U.S. ENDOSCOPY PULL PEG KIT & U.S. ENDOSCOPY GUIDEWIRE PEG KIT
• Manufacturer: UNITED STATES ENDOSCOPY GROUP, INC.
• Date Cleared: 1996-05-21 ( 188 days)
• Product Code: KNT
• Regulation Number: 876.5980

Intended 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.

Device Description

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.

Predicate Devices

Not Found

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a kit of standard medical devices used for PEG procedures and does not mention any AI or ML components or functionalities.

Therapeutic

No
The device facilitates the placement of a feeding tube for nutritional support, but it does not directly treat a disease or medical condition. It's a tool for a procedure that enables a therapeutic outcome (nutrition delivery), but it's not a therapeutic device itself.

Diagnostic

No
The device is a PEG tray, which provides the necessary components for a percutaneous endoscopic gastrostomy procedure, a method for providing nutrition. It facilitates a medical intervention rather than diagnosing a condition.

SaMD (Software as a Medical Device)

No

The device description explicitly lists physical components like feeding tubes, bolsters, adapters, lubricating jelly, hemostats, and grasping snares, indicating it is a kit containing hardware, not a software-only device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use is for percutaneous endoscopic gastrostomy (PEG), which is a surgical procedure to provide nutrition directly to the stomach. This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
• Device Description: The device description lists components used in the surgical procedure itself (feeding tube, bolster, adapters, etc.) and accessories for the procedure (lubricating jelly, hemostat, snare). These are tools for a medical procedure, not reagents or instruments for analyzing biological samples.
• No mention of in vitro testing: There is no mention of analyzing blood, urine, tissue, or any other biological sample outside of the body.

IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device is used directly on the patient during a medical procedure.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes

Not Found

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

gastrointestinal tract, stomach

Indicated Patient Age Range

both adults and children

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

Not Found

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

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.

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 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

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 :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.