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The HD Mediastinoscope is intended to aid the surgeon in viewing the mediastinum and facilitate the introduction and removal of surgical instruments during ENT endoscopic surgical procedures.

The HD Mediastinoscope is a reusable videoendoscope intended to be used in conjunction with the X-link module of the Image1 S Camera Control Unit. The HD Mediastinoscope is comprised of four main components: CMOS sensor at the distal end of the endoscope, an oval insertion portion (spatula), handle, and internal LED light source. The spatula can accommodate up to 2 x 5 mm instruments.

The HD Mediastinoscope is intended to aid the surgeon in viewing the mediastinum and facilitate the introduction and removal of surgical instruments during ENT endoscopic surgical procedures.

The components subject of this submission are: HD Mediastinoscope (Part Number: 10973HD), and the IMAGE1 S CCU. The CCU consists of the IMAGE1 S Connect Module (Model Number: TC200US) and IMAGE1 S X-Link (Model Number: TC301US).

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.

The Illuminated Mediastinal Access Port is intended to aid the surgeon in direct visualization of the mediastinum and facilitate the introduction and removal of surgical instruments during surgical procedures. The Illuminated Mediastinal Access Port is specifically indicated for use in the anterior, superior and middle mediastinum.

Illuminated Mediastinal Access Port is a trocar/cannula system used to provide mediastinal surgical access. The device provides open, illuminated surgical access to the mediastinum. The device consists of the following components: Cannula with a working channel, fiber optic bundles, ergonomic handle and blunt tip trocar. The base of the cannula has fiber optic bundles incorporated that may be connected to a standard endoscopic light source. This enhances lighting and visualization within the access device. The device does not include a light source. The ergonomic handle provides a secure grip and ease of maneuverability to the user. The device includes a blunt trocar for dissecting tissue planes. The trocar/cannula access device also includes a handle for connection to a support arm. The handle allows the Mediastinoscope to be held in position so that the surgeon can operate using both hands, without holding or re-positioning the Mediastinoscope and to provide stability for the Mediastinoscope during operation. The entire device is disposable, single use and provided pre-sterilized.

The Illuminated Mediastinal Access Port is intended to aid the surgeon in direct visualization of the mediastinum and facilitate the introduction and removal of surgical instruments during surgical procedures. The Illuminated Mediastinal Access Port is specifically indicated for use in the anterior, superior and middle mediastinum.

The Illuminated Mediastinal Access Port is a trocar/cannula system used to provide mediastinal surgical access. The device includes a blunt trocar for dissecting tissue planes. The open cannula provides for direct visualization of the surgical space and includes small notches at the rim to anchor sutures. The base of the cannula has fiber optic bundles incorporated that may be connected to a fiber optic light cable and an endoscopic light source. This enhances lighting and visualization within the access device. The device does not include a light source. The trocar/cannula access device also includes a handle for connection to a support arm. This allows the mediastinoscope to be held in position so that the surgeon can operate using both hands, without holding or re-positioning the mediastinoscope, and to provide stability for the mediastinoscope during operation. The entire device is disposable, single use and is provided pre-sterilized.

The Mediastinoscope, in connection with various auxiliary instruments, is used for diagnostic and/or surgical interventions in the upper area of the mediastinum. Mediastinoscopy is carried out - In order to evaluate the operability of patients suffering from bronchial carcinoma which have . already been verified, for treatment planning of other carcinomas in the mediastinal area and for biopsies. - For diagnostic clarification of primary and secondary diseases of the mediastinum, when other . examination methods have been unable to provide the nature, and in particular the histological character of the disturbance. - For the removal of nodes and tumors. . - For the diagnosis and removal of lymphatic nodes. Various auxiliary instruments are used in mediastinoscopy: - The smoke evacuation tube is used to evacuate smoke during HF or laser applications. - The telescope rinsing tube (optic irriyation tube) is used to keep the distal area of the telescope clear by rinsing with irrigation fluid. - The mediastinal puncture tube is used to puncture lymph nodules and aspirate the content for . cyto/histological purposes. - The tumor grasping forceps are used for grasping and manipulating tissue. . - The micro grasping forceps with HF are used for coagulating small vessels and grasping. . - The HF coagulation suction devices are used for suction and for coagulation while holding tissue 'out of the way' during endoscopic operations of the larynx in connection with CO, lasers or in mediastinoscopy. - The bipolar aspiration tube (bipolar coagulation suction tube) is used for aspiration and for . coagulation of small lesions.

The Optical Mediastinoscope is a tubular, conical shaped endoscope with a handle and a build-in telescope with fiber illumination which is bent at a 90° angle. The endoscope tube consists of two spreadable spatulas which allow distention of the operative field, and therefore, optimizes vision. The spatulas may be dismounted for easier cleaning. For efficiency during diagnostic and therapeutic procedures, a variety of accessory instruments are needed, e.g. biopsy and grasping forceps, puncture, suction and coagulation tubes or telescope rinsing tubes