(30 days)
The Protégé™ Self-expanding Nitinol Stent with StarPort™ Delivery Technology is intended as a palliative treatment of malignant neoplasms in the biliary tree.
The Protégé™ stent is a self-expanding nitinol (nickel-titanium alloy) stent provided in multiple lengths, (20, 30, 40, 50, 60, 70 and 80 mm) and diameters (6, 7, 8 and 9 mm). The stent is electropolished. The stent is premounted on an 80 or 120 cm working length, 0.035" over-thewire delivery catheter designed for transhepatic access. Upon deployment, the stent achieves its predetermined diameter and exerts a constant, gentle outward force to establish patency in the biliary ducts. The disposable StarPort Delivery Technology system is comprised of an inner and outer sheath, which are locked together with a safety lock.
The modified Protégé™ Self-expanding Nitinol Stent with StarPort™ Delivery Technology, is substantially equivalent to the currently marketed Protége™ Self-expanding Nitinol Stent with StarPort™ Delivery Technology (K003040) in intended use, materials, technological characteristics and performance. A stent retainer feature has been added to enhance the smoothness of deployment and additional ports for enhanced contrast injection.
The provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) summary and an FDA letter confirming substantial equivalence for a medical device (Protégé™ Self-expanding Nitinol Stent with StarPort™ Delivery Technology for biliary indications).
The 510(k) summary states that the modified device "is substantially equivalent to the currently marketed Protége™ Self-expanding Nitinol Stent with StarPort™ Delivery Technology (K003040) in intended use, materials, technological characteristics and performance." It does not present specific performance criteria or a study that evaluates them for the modified device. The FDA letter confirms this substantial equivalence based on the provided information, but it also doesn't detail performance studies or criteria.
Therefore, I cannot provide the requested information in the table or the subsequent numbered points based on the input 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.