(64 days)
The GORE VIABAHN® Endoprosthesis is indicated for the treatment of tracheobronchial strictures produced by malignant neoplasms.
The VIABAHN™ Endoprosthesis is a self-expanding implantable endoprosthesis that is compressed and secured on the distal end of a catheter delivery system. The catheter delivery system provides a means for implanting the endoprosthesis at a target location within the tracheobronchial tract. The endoprosthesis consists of a fluoropolymeric tube with a nitinol structure located over its external surface. The catheter delivery system is configured with radiopaque markers and is designed for use with guidewires.
This is a premarket notification (510(k)) for the GORE VIABAHN® Endoprosthesis. This submission is for substantial equivalence to legally marketed predicate devices, not for a new device requiring a clinical study with acceptance criteria.
Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are not applicable in this context.
The document states:
- "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..."
- "A variety of tests, assessments, and comparisons demonstrate that the VIABAHN™ Endoprosthesis is substantially equivalent to the cited predicates in terms of composition, design, intended use, and performance attributes."
The study undertaken here is a demonstration of substantial equivalence to predicate devices, not a study setting acceptance criteria for a novel device.
§ 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.”