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The LIA-1 Catheter is intended for use through a compatible bronchoscope in the tracheobronchial tree for Optical Coherence Tomography (OCT) guided Fine Needle Aspiration (FNA) and Fine Needle Biopsy (FNB) of endobronchial lesions, peripheral lung nodules, and lung masses. The device collects real-time two-dimensional, cross-sectional depth images which are visualized for evaluation of human tissue microstructure on the LIA Console.

Do not use this device for any purpose other than its intended use. This device is intended to provide an image of tissue microstructure in the tracheobronchial tree and parenchyma. The safety and effectiveness of this device for diagnostic analysis (i.e., differentiating normal versus specific abnormalities) in any tissue microstructure or specific disease has not been evaluated.

LIA-1 Catheter is a sterile, single-use, Optical Coherence Tomography (OCT) image-guided biopsy needle which is an assembly consisting of a Handle, Outer Sheath, Needle, and Imaging Stylet (iStylet). The Outer Sheath and Needle are attached to Actuation Handle and the iStylet is located within the Needle.

Outer Sheath: The LIA-1 Catheter Outer Sheath consists of a clear tube attached to the Handle.

Handle: The LIA-1 Catheter Handle allows the user to actuate the needle from the distal tip of the Outer Sheath, and to actuate the iStylet into or out of the Needle tip, or to be retracted for biopsy collection, as necessary.

Needle: The 21G stainless-steel Needle has a beveled, sharpened tip for puncture and tissue collection.

Imaging Stylet: The iStylet consists of a shaft and imaging core serving as an optical imaging probe. It provides real-time imaging for its intended use.

The LIA-1 Catheter is intended to be used only in conjunction with the LIA Console in order to function as intended.

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The LIA Console is indicated for use as an imaging tool in the evaluation of human tissue microstructure in the tracheobronchial tree by providing two-dimensional, cross-sectional, real-time depth visualization using Optical Coherence Tomography (OCT).

The safety and effectiveness of this device for diagnostic analysis (i.e., differentiating normal versus specific abnormalities) in any tissue microstructure or specific disease has not been evaluated.

The LIA Console is indicated for use as an imaging tool in the evaluation of human tissue microstructure in the tracheobronchial tree by providing two-dimensional, cross-sectional, real-time depth visualization using Optical Coherence Tomography (OCT).

The LIA Console is intended to be used only in conjunction with the LIA-1 Catheter in order to function as intended.

LIA Console consists of the following main parts:

1. Monitor: 24-inch multi-touch display monitor allowing software user interface.

2. Catheter Driving Unit (CDU): Electromechanical and optical interface between the LIA Console and the LIA-1 Catheter. A rotary motor inside drives the LIA-1 Catheter to form 360-degree side view real-time imaging.

3. Catheter Driving Arm (CDA): A supporting arm allowing CDU positioning, mobility and flexibility during the procedure.

4. Image Engine: The main body of the LIA Console contains laser source, computing unit, data acquisition and power distribution module and other components.

5. Caster: Four caster wheels installed at the base provide mobility for the LIA Console. Each caster is equipped with a brake that can lock the LIA Console in place as needed.

6. OCTICA Software: A proprietary GUI-based software that controls data acquisition, rotary motor and other hardware components to enable real-time OCT imaging of tissue microstructure.

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