LogoFDA 510(k) Search
K Number
K970356
Device Name
IRRIGATION/ASPIRATION POLYPECTOMY
Manufacturer
UNITED STATES ENDOSCOPY GROUP, INC.
Date Cleared
1997-03-25

(54 days)

Product Code
FDI
Regulation Number
876.4300
Type
Traditional
Panel
Gastroenterology/Urology
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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.

Device Description

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 years. Some Endoscope models have irrigation and suction 20 capabilities that are commonly used during polypectomy procedures. irrigation/aspiration polypectomy snare incorporates these The capabilities into one device.

AI/ML Overview

This document does not contain the specific information requested regarding acceptance criteria and a study proving device performance in the format of a clinical trial or performance study. The provided text is a 510(k) summary for a polypectomy snare, focusing on its intended use, contraindications, and manufacturing overview. It references general clinical use of polypectomy snares and manufacturing standards but does not detail a study with specific acceptance criteria, sample sizes, ground truth establishment, or expert involvement for assessing the performance of this particular device.

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K970356

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P102

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 years. Some Endoscope models have irrigation and suction 20 capabilities that are commonly used during polypectomy procedures. irrigation/aspiration polypectomy snare incorporates these The 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 .
    1. If the depth of the polyp and the thickness of the wall and the level of penetration of thermal energy can not be determined.
    1. Coagulopathy. ·
    1. Poor bowel preparation.
    1. Uncooperative patient.
    1. Any contraindication to performing a colonoscopy.

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

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K9703J6

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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.

are certified to Materials used in the manufacturing process 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.
  • "The Management of Colonoscopy Complications." Jerome D. Waye, 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.

4

§ 876.4300 Endoscopic electrosurgical unit and accessories.

(a)
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.(b)
Classification. Class II (performance standards).