(87 days)
Endoscopic Retrieval is a procedure whereby a foreign body, polyp or tissue, stone or calculi is removed from the gastrointestinal tract or biliary tract. A retrieval device is an instrument which enables the physician to grasp and retrieve the object via endoscopic methods.
The retrieval basket is introduced through an endoscope and the basket is placed around the object. Retrieval baskets have been clinically used for more than 20 years.
This document is a 510(k) summary for an endoscopic retrieval device from 1996. It does not contain the detailed information requested regarding acceptance criteria, device performance metrics, study design, expert qualifications, or ground truth establishment for a modern AI/ML-based medical device.
The document describes a traditional medical device (retrieval basket) and its intended use, contraindications, manufacturing overview, and sterilization methods. It references clinical use of retrieval baskets for over 20 years, implying established safety and effectiveness. However, it does not present any specific study data or acceptance criteria in the format requested for AI/ML performance evaluation.
Therefore, I cannot provide the requested table and study details based on the provided text. The information is not present in this 510(k) summary.
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OCT = 4 1996
K962676
SECTION II 510(k) Summary of SAFETY AND BFFECTIVENESS U.S.E. BNDOSCOPIC RETRIEVAL DEVICES (all versions) SUMMARY
The Summary of Safety and Effectiveness on the endoscopic procedure for retrieval of foreign bodies, tissue or polyps, stones or calculi used but, caution should be exercised in interpreting the data. The results of future studies may require alterations of the conclusions or recommendations set forth.
Procedure/Product Overview
Endoscopic Retrieval is a procedure whereby a foreign body, polyp or tissue, stone or calculi is removed from the gastrointestinal tract or biliary tract. A retrieval device is an instrument which enables the physician to grasp and retrieve the object via endoscopic methods.
The retrieval basket is introduced through an endoscope and the basket is placed around the object. Retrieval baskets have been clinically used for more than 20 years.
Contraindications for retrieval of foreign body, tissue or polyp, stones or calculi
Retrieval via flexible endoscopy is contraindicated in the following cases:
- If the risk or removal of the object is greater than the endoscopic 1) procedure.
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- Uncooperative patient
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- Any contraindication to performing endoscopy
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- Known or suspected perforated viscus
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- Presence of large stones in biliary tract and other associated contraindications for therapeutic biliary procedures.
The physician will determine patient's appropriateness for procedure.
Manufacturing Overview
U.S.E. manufactures and tests the product to performance designs, 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.
Sterility Testing
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The Endoscopic Retrieval Devices will be sterilized using ETO gas and the methods will conform to AMI standards for sterilization of medical devices.
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Bibliography
Hardick, Marcia and Beck, Marjorie (Editors), Manual of Gastrointestinal Procedures, (2nd Edition). New York: Society of Gastroenterology Nurses and Associates, Inc., 1989.
Ravenscroft, M.M. and Swan, C.H.J. Gastrointestinal Endoscopy and Related Procedures. Baltimore: Williams & Wilkins, 1984.
Berci, George Endoscopy. New York: Appleton-Century-Crofts, 1976.
§ 876.4680 Ureteral stone dislodger.
(a)
Identification. A ureteral stone dislodger is a device that consists of a bougie or a catheter with an expandable wire basket near the tip, a special flexible tip, or other special construction. It is inserted through a cystoscope and used to entrap and remove stones from the ureter. This generic type of device includes the metal basket and the flexible ureteral stone dislodger.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.