ICS Dizcovery (1091)

The ICS Dizcovery is a wearable video-oculography (VOG) device consisting of binocular goggles with built-in cameras and motion sensors connected to a PC running Otosuite Vestibular software. It measures, records, displays, and analyzes eye and head movements to assess the vestibular-ocular reflex (VOR) and nystagmus in patients with dizziness, disequilibrium, and vertigo. The device does not diagnose; diagnosis is determined by a credentialed physician.

Compared to the predicate ICS Impulse, the ICS Dizcovery uses two binocular cameras (1280×1024 resolution) instead of one monocular camera (320×240), records both eyes simultaneously rather than right eye only, incorporates a movable laser (freedom laser®) instead of a static laser, replaces Vision Denied cups with Shadeshift® panels, adds LCD panels for Skew Deviation testing, and includes onsite-serviceable components (USB cable, head strap, hot mirror). Power consumption increases from 500 mA to 900 mA.

IEC 60601-1:2005+AMD1:2012+AMD2:2020, IEC 60601-1-2:2014+AMD1:2020, IEC 60601-4-2 Ed. 1.0 (2016), IEC 60601-1-6:2010+A1:2013+A2:2020, IEC 62366-1:2015+AMD1:2020, IEC 62304:2006+A1:2015, IEC 60825-1:2014+ISH1:2017+ISH2:2017, IEC 62471:2006, ANSI S3.45-2009 (R2019), ISO 10993-1:2018 (biocompatibility).

Both devices share identical intended use, indications for use, clinical users, anatomical site, operating principle, and software. The design improvements (binocular imaging, higher resolution cameras, movable laser, and improved accessories) enhance usability and capability without changing the fundamental clinical function or raising new safety concerns. Nonclinical testing including biocompatibility, electrical safety, EMC, mechanical durability, software verification/validation, and compliance with vestibular testing standards (ANSI S3.45) demonstrates the subject device performs as safely and effectively as the predicate device.