Search Results

The Aegis Transit System is intended to aid the surgeon in direct visualization of the mediastinum and facilitate the introduction and removal of surgical instruments during surgical procedures (e.g., lung, tracheal and esophageal procedures, access to aorta for transcatheter valve procedures and/or thoracic endovascular aortic repair). The Aegis Transit System is specifically indicated for use in the anterior, superior and middle mediastinum.

The proposed Aegis Transit System introduces modifications to the Instructions for Use to propose the use of the two previously cleared Aegis Illuminated Mediastinal Access Ports as a two-step system to improve access and visualization during surgical procedures. The predicate Illuminated Mediastinal Access Ports were cleared under K141622 and K160171. The modifications discussed in this 510(k) submission are listed below: - . The Directions for Use in the IFU have been clarified to address the use of the two previously cleared Illuminated Mediastinal Access Ports as a two-step system within a single procedure. Please note, the procedural steps that are included in the revised IFU are consistent with the procedural steps that were submitted in K141622 and K160171; - The indications for use statement has been enhanced to provide examples of the types of procedures in which the transit system may be used; - . The small (dissecting) trocar handle has been revised to incorporate the ergonomic handle cleared with the large (delivery) trocar under K160171; - . The polycarbonate material used in the trocar and cannula of both devices has been changed from industrial grade polycarbonate to medical grade polycarbonate; and - . The packaging has been changed from a nylon/Tyvek heat sealed pouch to a PETG tray with a Tyvek lid. Both devices are being used in accordance with their cleared indications for use.