(38 days)
This device is used for the endoscopic removal of stones in the biliary system and foreign bodies.
The proposed device is a sterile, single-use accessory to be used with endoscopic, intended to be used for the removal of stones in the biliary system and foreign bodies. The proposed device includes two types, one type (Hereinafter referred to Type 1) is working through the channel provided by duodenoscopy, cross the duodenal papilla and insert into the bile duct, with the assistance of Imaging field of view formed by X-ray, capture and remove stones out of bile duct. Another one (Hereinafter referred to Type 2) is working through the channel provided by choledochoscope, after the choledochoscope was inserted into the bile duct successfully, inserted the extraction basket into the bile duct by the channel of choledochoscope, capture and remove stones out of bile duct by the direct field view of choledochoscope.
The proposed device is EO sterilized to achieve the Sterility Assurance Level (SAL) of 106 and placed in a sterility maintenance package to ensure a shelf life of 1 year for Type 1 and 3 years for Type 2.
The provided text is a 510(k) summary for a medical device called "Extraction Basket". It describes the device, its intended use, and comparison to a predicate device, along with performance data. However, this document does not describe acceptance criteria and a study that proves the device meets those criteria in the context of diagnostic or AI-driven performance.
The document primarily focuses on demonstrating substantial equivalence to a predicate device for regulatory clearance, which involves:
- Biocompatibility testing: To ensure the materials are safe for use in the human body.
- Performance testing: To confirm the mechanical functionality and intended operation of the physical device.
- Shelf-life and packaging integrity testing: To ensure the device remains sterile and functional over time.
- Sterilization validation: To confirm the sterilization process is effective.
Therefore, the information required to answer your request (acceptance criteria, device performance, sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance) is not present in this document.
The "Performance Data" section lists various types of tests conducted, such as "Dimension Testing," "Connection Force Testing," "Simulated-Use Testing," and "Stone Capture and Durability Testing," but it does not provide specific acceptance criteria or quantitative results of these tests.
The document explicitly states:
- No animal study is included in this submission.
- No clinical study is included in this submission.
The question you've posed is typically relevant for AI/ML-driven diagnostic devices or devices where performance is measured against a clinical outcome or diagnostic accuracy. This document describes a physical medical tool (an extraction basket) for removing stones/foreign bodies, and its clearance is based on demonstrating mechanical and material safety and effectiveness, not diagnostic performance.
§ 876.5010 Biliary catheter and accessories.
(a)
Identification. A biliary catheter and accessories is a tubular flexible device used for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. This generic type of device may include a bile collecting bag that is attached to the biliary catheter by a connector and fastened to the patient with a strap.(b)
Classification. Class II (special controls). The device, when it is a bile collecting bag or a surgical biliary catheter that does not include a balloon component, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.