LIA Console (542-7)

The LIA Console is an Optical Coherence Tomography (OCT) imaging system designed to evaluate tissue microstructure in the tracheobronchial tree (airways). It provides real-time, cross-sectional, two-dimensional images using near-infrared light. The device is intended solely as an imaging tool for visualization and does not diagnose or differentiate disease.

The LIA Console uses Swept-Source OCT (SS-OCT) at 1300 nm wavelength with a 100 kHz A-line rate, compared to the predicate's 1305 nm and 20 kHz. Both are mobile consoles with reusable imaging systems and single-use disposable catheters. The LIA Console employs proprietary OCTICA software (IEC 62304 compliant) and is classified as a Class 1M laser product per IEC 60825-1:2014.

Electrical safety: ANSI/AAMI ES 60601-1:2005 and IEC 60601-1-2:2014. Laser safety: IEC 60825-1:2014. Packaging: ASTM D4169. Fluid ingress: IEC 60529. Software: IEC 62304. The device also underwent bench testing for OCT sensitivity, resolution, service life, and optical efficiency.

Both the LIA Console and predicate (NvisionVLE Imaging System K182616) are swept-source OCT systems classified under 21 CFR 892.1560, product code NQQ. They share the same intended use (tissue microstructure imaging without diagnostic claims), comparable technological characteristics, and identical primary functions using infrared light to create real-time cross-sectional images. Differences in A-line rate and wavelength do not raise new safety or effectiveness concerns; pre-clinical porcine testing demonstrated 100% biopsy success with no complications.