CLARUS (700)

The CLARUS 700 v 1.2 is an ophthalmic imaging device that captures, displays, and stores images of the retina, ocular surface, and visible adnexa to aid in diagnosis and monitoring of eye diseases. It provides true color, autofluorescence, and angiography imaging modes in stereo, widefield, ultra-widefield, and montage fields of view, and uses a slit-scanning methodology with LEDs and laser illumination.

The device is based on identical hardware to the predicate v1.1, but adds new capability for simultaneous Fluorescein Angiography (FA) and Indocyanine Green Angiography (ICGA) imaging. Hardware additions include an IR laser lightbox, modified excitation and barrier filters, a second turret filter, and alignment tools. Software v1.2 adds angiography movie capture, ETDRS grid overlays, ICGA boost mode, and 8-up image view. Illumination wavelengths were expanded to support ICGA while maintaining existing modalities.

ISO 10993-1 (biocompatibility), ISO 10940:2009, ANSI/AAMI ES60601-1:2005/(R)2012, ANSI Z80.36-2021, IEC 60601-1-2:2014, IEC 60825-1:2007, IEC 60601-2-22:2012, and IEC 62133:2012. Software verification and validation followed FDA guidance for medical device software.

The indications for use, principle of operation (slit-scanning), methodology, anatomical site, target population, and basic device configuration are identical to the predicate device. The new ICGA functionality is integrated solely through targeted hardware and software enhancements that do not alter the fundamental imaging principle or intended use. Clinical testing demonstrated that the new simultaneous FA+ICGA and standalone ICGA modes produce high-quality angiography images clinically acceptable by independent graders, and non-clinical testing confirmed the system meets all specifications. Since differences are limited to new imaging modalities that pose no new safety or effectiveness concerns, substantial equivalence is established.