(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.
§ 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.