(125 days)
The Ultraflex™ Tracheobronchial Stent System is intended for use in the treatment of tracheobronchial strictures produced by malignant neoplasms.
The Ultraflex Tracheobronchial Stent Systems are permanently implanted expandable metal stents designed to serve as an intralumenal support to keep open the inner of the tracheobronchial tree. They consist of a flexible delivery catheter preloaded with an expandable metallic stent.
The stent is an open-ended cylindrical mesh constructed from a single strand of nitinol wire. The wire is configured into a series of circumferential interwoven loops, with the number of loops being dependent on the diameter of the stent. The stent is elongated and compressed onto a plastic delivery catheter. The stent is held onto the delivery catheter by nylon suture wrapped around the stent. The delivery catheter has a flush taper tip at the distal end, and a round hub handle at the proximal end.
The covered stent has a single layer of translucent polyurethane that covers the midsection of the stent.
Covered stents are available with a distal release system only. The distal release system begins stent deployment from the lower (distal) end of the delivery catheter.
The radiopaque (RO) markers on the delivery system and stent facilitate fluoroscopic placement.
The covered stent has four RO markers. The outer two (2) RO markers indicate the estimated final position of the ends of the deployed stent. The inner two (2) RO markers indicate the estimated final position of the margins of the deployed stent cover (Figure 1B).
The delivery system accepts a 0.035 in (0.89 mm) or 0.038 in (0.97 mm) guidewire. The delivery system is passed over the guidewire into the tracheobronchial lumen. The stent is positioned appropriately using the RO markers for guidance under fluoroscopy and by bronchoscopic visualization of the stent.
The stent is deployed by holding the handle hub in the palm of one hand, and grasping the finger ring with the other hand. By retracting the finger ring the suture crochet knots are unraveled in a circular manner along the length of the stent, gradually deploying the stent. When using the proximal release system, stent deployment begins from the upper (proximal) end of the delivery system, and continues to release toward the tip of the delivery system (distally) as the entire suture unravels. When using the distal release system, stent deployment begins from the lower (distal) end of delivery system, and continues to release towards the operator (proximally) as the entire suture unravels.
After the stent is completely released, and the nylon suture has been completely removed, the delivery system catheter can be removed.
The provided document is a 510(k) premarket notification for a medical device (Ultraflex™ Tracheobronchial Partially Covered Stent System). It describes the device, its intended use, and its substantial equivalence to previously cleared predicate devices.
However, this document does not contain information about a study based on statistical performance metrics (like accuracy, sensitivity, specificity, or AUC) or human reader performance. The "Performance Data" section (Section 7) on page 5 details in-vitro testing and compliance with various standards for aspects like dimensions, fatigue, compression, deployment accuracy, magnetic resonance, corrosion, sterility, pyrogenicity, and biocompatibility.
Therefore, I cannot provide a table of acceptance criteria and reported device performance related to a statistical study, nor can I answer questions 2 through 9, as these pertain to information that is not present in the provided text.
The information provided only demonstrates that the device ("Ultraflex™ Tracheobronchial Partially Covered Stent System") met required specifications for a series of in-vitro tests and complies with various safety and material standards. This is the basis for its substantial equivalence determination by the FDA for market clearance.
§ 878.3720 Tracheal prosthesis.
(a)
Identification. The tracheal prosthesis is a rigid, flexible, or expandable tubular device made of a silicone, metal, or polymeric material that is intended to be implanted to restore the structure and/or function of the trachea or trachealbronchial tree. It may be unbranched or contain one or two branches. The metal tracheal prosthesis may be uncovered or covered with a polymeric material. This device may also include a device delivery system.(b)
Classification. Class II. The special control for this device is FDA's “Guidance for the Content of Premarket Notification Submissions for Esophageal and Tracheal Prostheses.”