(131 days)
The IntraCoil® Peripheral Stent is indicated for use in the treatment of bronchial strictures produced by malignant neoplasms.
The IntraCoil® Stent is a self-expanding nickel-titanium (Nitinol) coil premounted on a delivery catheter. Upon deployment the stent expands to conform to the bronchial lumen surface. The stent's purpose is to increase or maintain the inner lumenal diameter of the bronchial passage.
I am sorry, but there is no information about acceptance criteria or a study proving the device meets acceptance criteria in the provided text. The document is a 510(k) premarket notification summary for a medical device (IntraCoil® Peripheral Stent), which focuses on establishing substantial equivalence to previously cleared devices rather than presenting the results of a primary clinical study with acceptance criteria.
§ 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.”