IRRIGATION/ASPIRATION POLYPECTOMY

K970356 · United States Endoscopy Group, Inc. · FDI · Mar 25, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K970356
• Device Name: IRRIGATION/ASPIRATION POLYPECTOMY
• Applicant: United States Endoscopy Group, Inc.
• Product Code: FDI · Gastroenterology, Urology
• Decision Date: Mar 25, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.4300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Polypectomy is a procedure whereby a polyp is removed from the gastrointestinal tract. A polypectomy snare is an instrument which enables the physician to grasp the polyp, transmit electrical current and transect the polyp. The polypectomy snare is introduced through an endoscope and the snare wire is place around the polyp. The snare wire is closed while simultaneously transmitting electrocautery to excise the polyp. The irrigation/aspiration polypectomy snare incorporates these capabilities into one device.

Device Story

Irrigation/aspiration polypectomy snare; used during flexible endoscopy for polyp removal. Device introduced through endoscope; snare wire placed around polyp; wire closed while transmitting electrocautery to excise tissue. Integrated irrigation and suction capabilities allow for simultaneous cleaning and removal of debris during procedure. Operated by physician; used in clinical settings. Benefits include combined functionality for efficient polyp excision and site management.

Clinical Evidence

No clinical data provided. Device relies on established clinical history of polypectomy procedures and predicate/substantially equivalent device performance specifications.

Technological Characteristics

Irrigation/aspiration polypectomy snare; ETO sterilization; quality assurance per MIL-STD-9858; materials certified for medical use. Mechanical snare mechanism with integrated irrigation and suction channels.

Indications for Use

Indicated for removal of polyps from the gastrointestinal tract via flexible endoscopy. Contraindicated in cases of: polyps too large for safe removal; indeterminate polyp depth/wall thickness/thermal penetration; coagulopathy; poor bowel preparation; uncooperative patient; or any contraindication to colonoscopy.

Regulatory Classification

Identification

An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.

Submission Summary (Full Text)

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K970356
MAR 25 1997
P192

# SECTION II
## 510k Summary of Safety and Effectiveness

### SAFETY AND EFFECTIVENESS
#### U.S.E. IRRIGATION/ASPIRATION POLYPECTOMY SNARES

The Summary of Safety and Effectiveness on the endoscopic procedure for removal of polyps and the polypectomy snare used reflects data available and present at the time the summary was prepared, but, caution should be exercised in interpreting the data. The results of future studies may require alteration for the conclusions or recommendations set forth.

### Procedure/Product Overview

Polypectomy is a procedure whereby a polyp is removed from the gastrointestinal tract. A polypectomy snare is an instrument which enables the physician to grasp the polyp, transmit electrical current and transect the polyp.

The polypectomy snare is introduced through an endoscope and the snare wire is place around the polyp. The snare wire is closed while simultaneously transmitting electrocautery to excise the polyp. Polypectomy snares have been clinically used for more than 20 years. Some Endoscope models have irrigation and suction capabilities that are commonly used during polypectomy procedures. The irrigation/aspiration polypectomy snare incorporates these capabilities into one device.

### Contraindications for Polypectomy

Polypectomy via flexible endoscopy is contraindicated in the following cases:

1. If the polyp is too large to safely remove via flexible endoscopy.
2. If the depth of the polyp and the thickness of the wall and the level of penetration of thermal energy can not be determined.
3. Coagulopathy.
4. Poor bowel preparation.
5. Uncooperative patient.
6. Any contraindication to performing a colonoscopy.

The physician will determine patient’s appropriateness for the procedure.

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K970356
P292

## Manufacturing Overview

U.S.E. designs, 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 standards appropriate for their use.

## Sterility Testing

This product is sterilized using ETO sterilization method.

## Bibliography

Drossman, D.A. (Editor). *Manual of Gastroenterologic Procedures* (2nd Edition), New York: Raven Press, 1987.

Society of Gastroenterology Nurses & Associates, Inc. *Manual of Gastrointestinal Procedures*. (2nd Edition). Rochester: SGNA, 1989.

Waye, Jerome D. "The Management of Colonoscopy Complications." *Gastroenterology & Endoscopy*, May 1993, pp 23.

Waye, J., Geenan, J., Fleischer, D. and Venue, R. *Techniques in Therapeutic Endoscopy*, New York: Gowen Medical Publishing, Ltd., 1987.

Zuro, Lynne M., McCulloch, Catherine S., Saclarides, Theodore J. "Laparoscopic Colotomy, Polypectomy." *AORN Journal*, December 1992, pp. 1068-1073.