(370 days)
BullsEye Biliary Stent System is indicated for use in the palliation of malignant neoplasms in the biliary tree.
The BullsEye Biliary Stent System is a 316L stainless steel, balloon-expandable stent design with a 6.2mm diameter and 15mm length (unexpanded). The stent is comprised of a distal cylindrical segment, which provides permanent structural support and subsequently restores and maintains bile flow by scaffolding the duct wall, and a 3.7mm proximal conformable flare segment, which helps to prevent post deployment stent migration and dislocation. The stent is pre-mounted on a dual-balloon, monorail, delivery device with 80cm working length and a crossing profile compatible with guide catheters/introducer sheaths with a minimum inner diameter of 0.081". The system is also compatible with standard 0.014″ guidewires. Two radiopaque marker bands aid in positioning of the stent during the delivery procedure.
The provided text is for the BullsEye Biliary Stent System, which is a medical device, not an AI/ML algorithm. Therefore, none of the requested information regarding acceptance criteria, study details proving device performance based on AI/ML metrics (like accuracy, precision, recall, sample sizes for training/test sets, expert adjudication, MRMC studies, or standalone performance), ground truth establishment, or data provenance from an AI/ML perspective is present.
The document discusses the regulatory approval (510(k)) of a medical device and its substantial equivalence to other legally marketed predicate devices, focusing on:
- Device Description: 316L stainless steel, balloon-expandable stent for biliary use.
- Intended Use: Palliation of malignant neoplasms in the biliary tree.
- Regulatory Classification: Class II, per 21 CFR 876.5010.
- Substantial Equivalence: Demonstrated through "a variety of tests, assessments, and comparisons" to predicate devices (Cordis PALMAZ GENESIS Transhepatic Billiary Stent and Delivery System (K010411) and Bard LUMINEXX 3 Biliary Stent and Delivery System (K033497)) in terms of composition, design, intended use, and performance attributes.
- Labeling Limitations: Specific warnings regarding established safety and effectiveness only for biliary use, not vascular, to be prominently displayed.
The approval is based on demonstrating substantial equivalence to existing devices through traditional device performance testing (mechanical, biocompatibility, etc.), not through clinical performance metrics related to diagnostic accuracy or AI/ML algorithm evaluation.
§ 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.