(61 days)
The SMART™ Control™ Nitinol Stent Transhepatic Biliary System is intended for use in the palliation of malignant neoplasms in the biliary tree.
The device description of the proposed SMART™ Control™ Nitinol Stent Transhepatic Biliary System is as follows:
6 French stent delivery system profile;
Stent material - Nickel Titanium alloy and tantalum micromarkers;
Expanded stent diameters 9, and 10 mm
Stent lengths: 100 mm;
Stent delivery system usable length 80 and 120 cm; and
Guidewire lumen 0.035".
Proximal Deployment handle
I am sorry, but the provided text describes a medical device (a biliary stent) and its regulatory clearance (510(k) submission). It does not contain information about studies or acceptance criteria that would allow me to populate the requested table and answer the questions about device performance against acceptance criteria, sample sizes, ground truth establishment, or human reader performance with AI assistance. The document is primarily a regulatory summary stating substantial equivalence to predicate devices based on pre-clinical testing, rather than a clinical study report.
§ 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.