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K Number
K961762
Device Name
REUSABLE ENDOSCOPIC ACCESSORY HANDLE
Manufacturer
UNITED STATES ENDOSCOPY GROUP, INC.
Date Cleared
1996-07-22

(76 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 Reusable Endoscopic Accessory Handle can be used with various types of endoscopic accessories including biopsy forceps and polypectomy snares.

Device Description

The Reusable Endoscopic Accessory Handle can be used with various types of endoscopic accessories including biopsy forceps and polypectomy snares.

AI/ML Overview

This document describes a reusable endoscopic accessory handle, not an AI/ML powered medical device. Therefore, a table of acceptance criteria and device performance based on AI/ML metrics, as well as details regarding training and test sets, expert ground truth, and comparative effectiveness studies, cannot be extracted or inferred from the provided text.

The document focuses on the safety and effectiveness of a reusable handle for endoscopic accessories. It mentions:

  • Product Overview: Its use with various endoscopic accessories (biopsy forceps, polypectomy snares).
  • Contraindications: Only general contraindications related to endoscopic procedures themselves.
  • Manufacturing Overview: Design, manufacturing, and testing to performance specifications based on predicate devices, good manufacturing practices, and quality assurance methods (MIL-STD-9858).
  • Bibliography: References related to gastroenterologic procedures and endoscopy.

There is no mention of an algorithm, AI, machine learning, or any form of automated analysis or interpretation. The performance of this device would be assessed through mechanical, biocompatibility, and sterilization validation testing, not through AI/ML specific metrics.

§ 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).