(30 days)
The AngioDynamics® Balloon Expandable Biliary Stent System is indicated for palliative treatment of malignant strictures in the biliary tree.
AngioDynamics® Balloon Expandable Biliary Stent System
This document is a 510(k) clearance letter from the FDA for a medical device: the AngioDynamics® Balloon Expandable Biliary Stent System. It approves the device for marketing based on "substantial equivalence" to legally marketed predicate devices.
Crucially, this document does not contain the acceptance criteria of a study or a study that proves the device meets acceptance criteria.
Instead, it indicates:
- Marketing Clearance: The device received FDA clearance (K991793) for marketing.
- Intended Use: The device is "indicated for palliative treatment of malignant strictures in the biliary tree."
- Regulatory Class: Class II (Product Code: 78 FGE).
- Limitations/Warnings: The FDA explicitly states, "The safety and effectiveness of this device for use in the vascular system have not been established," and requires this warning to be prominently displayed.
The 510(k) process for this type of device typically relies on demonstrating substantial equivalence to a predicate device already on the market, rather than requiring new, full-scale clinical trials proving safety and effectiveness from scratch against predefined acceptance criteria. The document mentions "review of your Section 510(k) notification of intent to market the device," which would have included a comparison to predicate devices and potentially performance data, but that specific data and the associated acceptance criteria are not in these provided pages.
Therefore, I cannot provide the requested information as it is not present in the given text. The document is a regulatory approval, not a scientific study report.
§ 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.