Pentacam® Cornea OCT

The Pentacam® Cornea OCT is a multifunction ophthalmic imaging device that combines Scheimpflug imaging with optical coherence tomography (OCT) to acquire anterior segment images of the eye. It uses spectral-domain OCT with broadband Multi-SLD light sources (780-1000 nm) to perform in vivo imaging, cross-sectional, and three-dimensional imaging and measurement of corneal epithelium. The device is indicated as a diagnostic tool to aid in the detection and management of ocular diseases affecting the anterior segment of the eye.

The Pentacam® Cornea OCT uses spectral-domain OCT (same as predicate Optovue Solix) with an OCT light source at 780-1000 nm and maximum optical power of 1.2 mW. It features a 50,000 A-scan/second scan rate, axial resolution ≤2 µm (higher than Solix's 5 µm), and 3.6 mm scan depth. The device incorporates a digital CMOS Scheimpflug camera with 1360×1024 pixel resolution, 28 mm slit length, and 45 mm working distance. Minor differences include a red LED fixation light (versus blue in Solix) and slightly different IR eye illumination wavelengths (840 nm versus 810 nm).

EMC and electrical safety testing performed in accordance with IEC 60601-1 and IEC 60601-1-2. Additional testing per ISO 15004-1, ISO 15004-2, ANSI Z80.36-2016, and IEC 60825-1 (laser safety). Clinical studies validated agreement and precision of epithelial thickness measurements using repeatability and reproducibility analysis via random-effects ANOVA models and Bland-Altman analysis.

The Pentacam® Cornea OCT is substantially equivalent to the Optovue Solix (K222166) because both devices use spectral-domain OCT technology with the same intended use for in vivo corneal epithelium imaging and measurement. Minor technological differences (scan rate, axial resolution, light source wavelengths, working distance) do not raise new safety or effectiveness questions and are supported by compliance with existing standards. The device also incorporates Scheimpflug functionality consistent with the cleared Pentacam® AXL Wave (K201724). Clinical studies demonstrate high repeatability, reproducibility, and agreement in epithelial thickness measurements between the two devices across normal and pathologic corneas.