(74 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 Protége™ stent is a self-expanding nitinol (nickel-titanium alloy) stent provided in multiple lengths, (20 - 150 mm) and diameters (6 - 12 mm). The stent is electropolished. The stent is premounted on a 6 or 7 Fr delivery catheter over-the-wire 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 provided text is a 510(k) summary and FDA clearance letter for a medical device (Protégé™ Self-expanding Nitinol Stent with StarPort™ Delivery Technology). This document does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria.
The FDA clearance is based on the device being substantially equivalent to a predicate device already on the market, not on new clinical trial data demonstrating performance against specific acceptance criteria.
Therefore, I cannot fulfill your request for the detailed information about acceptance criteria and a study from the provided text. The document primarily focuses on:
- Device Identification: Product name, common name, class, submitter information.
- Intended Use: Palliative treatment of malignant neoplasms in the biliary tree.
- Device Description: Self-expanding nitinol stent, delivery catheter, "StarPort Delivery Technology" system.
- Modification: Increased radiopacity compared to a previously marketed version of the same device.
- Substantial Equivalence: The primary basis for clearance, stating it is substantially equivalent to the currently marketed Protégé™ stent in intended use, materials, technological characteristics, and performance.
- FDA Conditions: Specific labeling requirements regarding the limitation of use to the biliary system and the unestablished safety/effectiveness in the vascular system.
There is no mention of a study with specific performance metrics, sample sizes, expert ground truth establishment, or comparative effectiveness studies with human readers.
§ 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.