ICS Dizcovery (1091)
Natus Medical Denmark ApsICS Dizcovery (1091) is a portable video-oculography system designed as goggles with built-in cameras and motion sensors to track eye and head movements simultaneously. It is used to assess vestibular-ocular reflex and nystagmus in patients experiencing dizziness, vertigo, or balance disorders. The system connects to software that analyzes the collected eye movement data to aid clinicians in diagnosing vestibular conditions.
Intended Use
Used in the assessment of the vestibular-ocular reflex (VOR) and nystagmus by measuring, recording, displaying, and analyzing eye and head movements in patients with vestibular complaints such as dizziness, disequilibrium, and vertigo.
Technology
ICS Dizcovery is a portable video-oculography device in the form of goggles with two cameras recording binocular eye movements and a motion sensor tracking head movement. Data are processed by accompanying Otosuite Vestibular PC software through a USB connection to analyze responses to stimuli presented visually. Features include Shadeshift Vision Denied panels and LCD panels to aid specific tests.
Performance
The device underwent performance testing including biocompatibility, electrical safety, EMC, usability, software lifecycle, and mechanical testing. Verification and validation showed the device meets acceptance criteria and is as safe and effective as the predicate device ICS Impulse. Standards such as IEC 60601 series, ISO 10993-1, and ANSI S3.45 were applied.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
7/26/2024
6 months - 2
FDA Approval
2/14/2025
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