ANGLED TIP POLYPECTOMY SNARE

K970945 · United States Endoscopy Group, Inc. · KNS · May 7, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K970945
• Device Name: ANGLED TIP POLYPECTOMY SNARE
• Applicant: United States Endoscopy Group, Inc.
• Product Code: KNS · Gastroenterology, Urology
• Decision Date: May 7, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.4300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Angled Tip Polypectomy Snare will be used in Flexible Endoscopy in order to grasp and electrosurgically dissect and transect flat (sessile) or stalked polyps during endoscopic procedures.

Device Story

Angled Tip Polypectomy Snare; endoscopic instrument for polyp removal. Physician operates device during flexible endoscopy; grasps polyp; transmits electrical current to electrosurgically dissect and transect sessile or stalked polyps. Benefits patient by enabling minimally invasive removal of gastrointestinal polyps.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Angled tip snare for electrosurgical dissection. Materials certified to standards appropriate for use. Sterilization via ETO. Quality assurance based on MIL-STD-9858.

Indications for Use

Indicated for patients undergoing flexible endoscopy requiring removal of flat (sessile) or stalked polyps. Contraindicated in cases of large polyps unsafe for endoscopic removal, indeterminate polyp depth/wall thickness/thermal penetration, coagulopathy, poor bowel preparation, uncooperative patients, or general contraindications 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.

Reference Devices

• Manual of Gastroenterologic Procedures (2nd Edition)
• Manual of Gastrointestinal Procedures (2nd Edition)
• The Management of Colonoscopy Complications (Waye, 1993)
• Techniques in Therapeutic Endoscopy (Waye et al., 1987)
• Laparoscopic Colotomy, Polypectomy (Zuro et al., 1992)

Submission Summary (Full Text)

{0}

05/07/97 13:59
USE. Inc.
002
MAY - 7 1997
K970945
P192

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

## SAFETY AND EFFECTIVENESS
### U.S.E. ANGLED TIP SNARE SUMMARY

The Summary of Safety and Effectiveness on the endoscopic procedure for removal of polyps and the Angled Tip 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 Angled Tip Polypectomy Snare will be used in Flexible Endoscopy in order to grasp and electrosurgically dissect and transect flat (sessile) or stalked polyps during endoscopic procedures.

## 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.

## Manufacturing Overview

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

{1}

05/07/97 14:00
USE, Inc.
003
K970945
p2 02

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.