(10 days)
This device is used for endoscopic removal of biliary stones and for contrast injection.
The subject extraction balloon is comprised of a latex balloon mounted at the distal end of a nylon catheter with three internal lumens. The balloon can be inflated to three diameter sizes, 8.5 mm, 12 mm and 15 mm. Radiopaque bands placed at the distal and proximal ends of the balloon provide fluoroscopic visualization of the balloon location. The catheter length is 275 cm with a diameter of 6.6 Fr. The three lumens correspond to a balloon inflation port, a wire guide port and an injection port. The hubs on the respective lumens are color-coded white, purple, and gray. A stopcock is included at the proximal end of the balloon inflation port to control air movement into or out of the balloon.
The provided text describes a 510(k) premarket notification for a medical device called the "Tri-Ex Extraction Balloon with Multiple Sizing." This device is used for endoscopic removal of biliary stones and for contrast injection. The submission seeks to demonstrate substantial equivalence to a predicate device (Tri-Ex Extraction Balloon K170292).
However, the document does NOT contain information about acceptance criteria, a study proving the device meets those criteria, or details regarding AI device performance. It is a regulatory submission for a physical medical device, not an AI-powered one. Therefore, I cannotExtract the requested information about AI device acceptance criteria and study details from this document.
The document only states the following regarding performance:
- Performance Data: "Performance testing consisting of non-clinical bench testing demonstrates the subject device met the performance requirements to fulfill the intended use. This testing provides reasonable assurance that the subject device will function as intended."
- Summary of non-clinical testing:
- Functional Testing/ Design Verification Testing
- Biocompatibility Assessment
- Fluoroscopic Visibility
This information indicates that bench testing was performed to demonstrate that the device meets its intended performance, but no specifics on "acceptance criteria" or detailed study results are provided, nor is there any mention of AI elements.
§ 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.