(134 days)
The LeMaitre Biliary Catheter is indicated for the removal of stones and ductal debris.
Not Found
This document is correspondence from the FDA regarding a 510(k) premarket notification for the "LeMaitre Biliary Catheter." It is NOT a study report or a document describing acceptance criteria and device performance.
Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, or MRMC studies for this device based on the provided text. The document only states that the device is deemed "substantially equivalent" to legally marketed predicate devices for its stated indications for use (removal of stones and ductal debris).
§ 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.