(17 days)
The Manan™ Introducer Sheath/Needle is for the introduction of a .038 in. guidewire used in abscess, biliary, nephrostomy, and other fluid collection drainage procedures.
The Manan Introducer Sheath/Needle is a 18 or 19 gauge trocar needle(Surgical grade 304 Stainless Steel) inside a 5 French radiopaque Teflon sheath. The sheath is tapered down to the trocar needle. The sheath accepts up to and including a .038 in. diameter guidewire. The usable length of this assembly is up to 20 cm.
This document is about a 510(k) submission for a medical device called the "Manan™ Introducer Sheath/Needle" and does not contain information about acceptance criteria, device performance from a study, or any details related to AI or algorithm performance.
The document is a notification of intent to market the device, a description of the device, and the FDA's letter of substantial equivalence. It compares the device to a predicate device based on its intended use and characteristics, not on a detailed performance study with acceptance criteria.
Therefore, I cannot provide the requested information, as it is not present in the provided text.
§ 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.