(84 days)
The FlexStent® Biliary Self Expanding Stent System is indicated for use in the palliation of malignant strictures in the biliary tree.
Not Found
I am sorry, but based on the provided text, there is no information about the acceptance criteria or a study that proves a device meets such criteria. The document is a 510(k) clearance letter from the FDA for a device called "FlexStent® Biliary Self Expanding Stent System".
The letter primarily:
- Confirms the device's substantial equivalence to a legally marketed predicate device.
- Specifies limitations on its labeling, particularly regarding its use in the vascular system and the prominent display of its biliary indication.
- Outlines general regulatory requirements for the manufacturer.
- Provides contact information for further regulatory guidance.
The "Indications for Use" section (page 2) simply states the intended use of the device ("palliation of malignant strictures in the biliary tree") but does not include any performance metrics, study details, or acceptance criteria.
Therefore, I cannot provide the requested table or details about a study from this document.
§ 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.