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K Number
K970945

Validate with FDA (Live)

Device Name
ANGLED TIP POLYPECTOMY SNARE
Manufacturer
UNITED STATES ENDOSCOPY GROUP, INC.
Date Cleared
1997-05-07

(54 days)

Product Code
KNS
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

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 Description

A polypectory 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.

AI/ML Overview

This 510(k) summary (K970945) describes a polypectomy snare, which is a medical device, not an AI/ML algorithm. Therefore, the requested information regarding acceptance criteria and studies proving device performance, especially those related to AI/ML specific aspects, are not applicable in this context.

The document discusses the product's intended use, contraindications for the procedure, manufacturing processes, quality assurance, and sterility testing for this physical medical device. It does not mention any software, algorithms, AI, or machine learning components.

Therefore, I cannot provide the requested information in the format specified, as the input document does not contain data relevant to AI/ML device performance studies.

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K970945

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SECTION TO 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 polypectory 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 .
    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.

Manufacturing Overview

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

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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

Manual of Gastroenterologic Procedures Drossman, D.A. (Editor). (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." Waye, Jerome D. Gastroenterology & Endoscopy, May 1993, pp 23.
  • J., Geenan, J., Fleischer, D. and Venue, R. Techniques in Waye, Therapeutic Endoscopy, New York: Gowen Medical Publishing, Ltd., 1987.
  • Lynne M., McCulloch, Catherine S., Saclarides, Theodore J.
    "Laparoscopic Colotomy, Polypectomy." AQRN Journal, December Zuro, 1992, pp. 1068-1073.

§ 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).