(352 days)
The X-Suit NIR® Biliary Metallic Stent is indicated for palliation of malignant strictures in the biliary tre.
Not Found
This document is a 510(k) premarket notification letter from the FDA for a medical device called the X-Suit NIR® Biliary Metallic Stent. It does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment. This type of FDA letter is an approval for market, not a study report.
Therefore, I cannot provide the requested information from the given text. The document states "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent...". This means the device was found to be substantially equivalent to a legally marketed predicate device, rather than having specific performance criteria and studies detailed in this letter.
§ 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.