(76 days)
The Reusable Endoscopic Accessory Handle can be used with various types of endoscopic accessories including biopsy forceps and polypectomy snares.
The Reusable Endoscopic Accessory Handle can be used with various types of endoscopic accessories including biopsy forceps and polypectomy snares.
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.
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JUL 222 1996
SECTION II SAFETY AND EFFECTIVENESS U.S.E. REUSABLE HANDLE SUMMARY
The Summary of Safety and Effectiveness on the Reusable Endoscopic Accessory Handle 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
The Reusable Endoscopic Accessory Handle can be used with various types of endoscopic accessories including biopsy forceps and polypectomy snares.
Contraindications
Reusable handle is contraindicated for use in The any contraindication to performing any type of endoscopic procedure.
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.
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.
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.
- J., Geenan, J., Fleischer, D. and Venue, R. Techniques in Waye, Therapeutic Endoscopy, New York: Gowen Medical Publishing, Ltd., 1987.
§ 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).