(31 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 - 80 mm) and diameters (6 - 10 mm). The stent is electropolished. The stent is premounted on an 80 or 120 cm working length, 0.035" over-the-wire delivery catheter designed promountou on an over of Ipon 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 for a medical device (Protégé™ Self-expanding Nitinol Stent with StarPort™ Delivery Technology for Biliary Indication) and does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in the way typically found for an AI or diagnostic device.
This document describes a stent, which is a physical implant used for palliative treatment of malignant neoplasms in the biliary tree. The 510(k) process for such a device focuses on demonstrating substantial equivalence to a previously marketed device, rather than proving performance against specific acceptance criteria for an AI algorithm.
Therefore, I cannot extract the requested information as it is not present in the provided text. The document primarily discusses:
- Device Description: What the stent is, its materials, sizes, and delivery system.
- Intended Use: Palliative treatment of malignant neoplasms in the biliary tree.
- Substantial Equivalence: Claims that the modified device is substantially equivalent to previously marketed versions with the addition of a 12mm stent diameter.
- Regulatory Information: Classification, regulation number, product code, and specific labeling limitations imposed by the FDA (e.g., limitation on vascular use and prominent display of biliary indication).
There is no mention of an AI algorithm, diagnostic performance metrics (like sensitivity, specificity, AUC), sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone algorithm performance, or training set details.
§ 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.