Search Results

The OMNILINK® .018 Biliary Stent System is indicated for palliation of malignant strictures in the biliary tree.
The OMNILINKR® .018 Biliary Stent System is intended for palliation of malignant strictures in the biliary tree.

The OMNILINK® .018 Biliary Stent System is comprised of a stainless steel, balloonexpandable stent pre-mounted onto an over-the-wire (OTW) delivery catheter. This system is designed for percutaneous placement in the common bile duct and intended to treat malignant strictures in the biliary tree.
The OMNILINK® Biliary Stent consists of a dual stent design, fabricated from a single piece of 316L medical grade stainless steel tubing. The delivery catheter's central lumen is designed to permit the use of a 0.018" guide wire to facilitate advancement of the catheter to and through the stricture to be dilated. Once the delivery system is placed in the desired location, the stent expands upon inflating the balloon with contrast medium. The balloon provides an expandable segment of known diameter and length at specific pressures. In addition, the balloon has two radiopaque markers to aid in stent prositioning. The stent is designed to remain in the biliary duct as a permanent implant.
The subject OMNILINK® .018 Biliary Stent System consists of additional stent sizes of 110 5.0, 6.0, 7.0mm stent diameter, 12 and 16mm stent lengths, and 4.0mm stent diameter x 18mm stent length. The stent and delivery system are supplied sterile and intended for single use only.

The provided text describes a 510(k) submission for a medical device, the OMNILINK® .018 Biliary Stent System. While it details the device, its intended use, and substantial equivalence to predicate devices, it does not contain information about acceptance criteria or a study proving that the device meets such criteria.

The document states: "The safety and effectiveness of the subject OMNILINK® .018 Biliary Stent System has been demonstrated through data collected from in vitro bench tests and analyses." This indicates that performance data was collected, but the specifics requested in your prompt (like acceptance criteria, sample sizes, ground truth, expert involvement, or comparative effectiveness studies) are not present in this document.

Therefore, I cannot populate the table or answer the specific questions based on the provided text. The document is primarily a regulatory submission summarizing the device and its equivalence, rather than a detailed report of clinical or performance studies.

Ask a specific question about this device