CLARUS
Carl Zeiss Meditec, IncThe CLARUS 700 by Carl Zeiss Meditec, Inc. is a high-resolution ophthalmic imaging device used for capturing and analyzing images of the retina and ocular structures. It supports multiple imaging modes including true color, autofluorescence, and fluorescein angiography, aiding clinicians in diagnosing and monitoring retinal diseases by providing widefield and ultra-widefield views with AI assistance for optic nerve detection and montage creation. The device improves patient comfort and provides advanced tools for image annotation and review.
Intended Use
The CLARUS 700 ophthalmic camera is indicated to capture, display, annotate and store images to aid in the diagnosis and monitoring of diseases and disorders occurring in the retina, ocular surface and visible adnexa. It provides true color and autofluorescence imaging modes for stereo, widefield, ultra-widefield, and montage fields of view. The CLARUS 700 angiography is indicated as an aid in the visualization of vascular structures of the retina and the choroid.
Technology
The CLARUS 700 device employs slit scanning ophthalmoscope (Broad Line Fundus Imaging) technology combining LED and laser illumination across multiple wavelengths to capture high-resolution color, autofluorescence, and fluorescein angiography images. It features an active, software-controlled system with AI-enabled optic nerve head detection to automate montage image stitching and enhanced patient comfort features such as a stable head and chin rest and swiveling optics.
Performance
The device was validated through design verification and validation testing to meet system requirements and user acceptance. A clinical study with 20 eyes from 13 subjects demonstrated effective capture of clinically useful fluorescein angiography images with high passing rates in lesion visibility (85%), clinical usefulness (95%), and artifact interference (95%). Bench testing confirmed electrical safety, EMC compliance, optical safety, and biocompatibility.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
5/3/2019
1 month - 2
FDA Approval
6/25/2019
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