(93 days)
The AERO DV™ Tracheobronchial Stent System is indicated for use in the treatment of tracheobronchial strictures produced by malignant neoplasms.
The Alveolus AERO DV™ Tracheobronchial Stent System described in this Notice consists of the exact same stent as the AERO™ predicate stent (K082284) but with an alternate delivery system. The Direct Visualization (DV) delivery system of AERO DV™ allows the physician to use a bronchoscope to directly view the stent as it is being positioned and deployed at the tarqet implant site. This direct visualization is made possible with a slightly larger delivery catheter lumen that allows passage of a flexible bronchoscope through the delivery catheter.
The provided text describes a medical device called the Alveolus AERO DV™ Tracheobronchial Stent System, which is a stent used to treat tracheobronchial strictures. This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive details about acceptance criteria and a dedicated study to prove that the device meets those criteria.
Therefore, the requested information regarding acceptance criteria, device performance, study details, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, or standalone performance studies, and training set information is not available in the provided document.
The document primarily states:
- The AERO DV™ Tracheobronchial Stent System uses the exact same stent as a predicate device (AERO™ K082284) but with an alternate delivery system (Direct Visualization (DV) delivery system).
- The delivery system allows direct visualization using a bronchoscope.
- Substantial equivalence is claimed based on:
- Using the same stent as K082284.
- Materials meeting biocompatibility requirements of the FDA "Guidance for the Content of Premarket Notifications for Esophageal and Tracheal Prostheses" document.
- Same indications for use.
- Same principle of operation as the AERO DV™ Tracheobronchial Stent System predicate device (K071604).
- Physical test results for the delivery system were performed as specified in the FDA "Guidance for the Content of Premarket Notifications for Esophageal and Tracheal Prostheses" document (April 28, 1998). These tests "demonstrate that the device is suitable for its indicated use." Specific acceptance criteria or reported performance from these tests are not detailed.
In summary, the document asserts that the device meets regulatory requirements through substantial equivalence, supported by physical testing of the delivery system and biocompatibility data. However, the specific, quantitative acceptance criteria and detailed results of performance studies are not provided.
§ 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.”