Sentinel Camera

The Sentinel Camera is a non-mydriatic medical digital camera designed to capture digital images of the human eye without requiring pupil dilation. It features a 5 MP color CMOS sensor, internal image storage, rechargeable Li-ion battery, Wi-Fi connectivity, and three internal fixation targets to enable macula-centered and disc-centered imaging.

Both the Sentinel Camera and predicate Optomed Aurora use similar high-resolution color CMOS imaging (5 MP maximum), comparable field of view (50 x 40 degrees), and white and infrared light sources for non-mydriatic imaging. Key differences include Sentinel's internal PNG storage versus Aurora's microSDHC card with JPEG/MPEG-4 formats, Sentinel's Wi-Fi data transfer versus Aurora's USB 1.1, and diopter compensation ranges (-20 to +15 D versus -20 to +20 D), but these variations do not raise new safety or effectiveness questions.

IEC 60601-1:2005+A2:2020 (medical device safety), IEC 60601-1-2:2014+A1:2020 (electromagnetic compatibility), ISO 15004-1:2020 (ophthalmic instruments), ANSI Z80.36:2016 (ophthalmic devices), ISO 10940:2009 (safety of laser products), IEC 62304:2015 (medical device software lifecycle), and ISO 10993-1:2018 (biocompatibility).

Both devices are AC-powered Class II ophthalmic cameras with identical regulatory classifications (HKI product code, 21 CFR 886.1120), intended for prescription use in non-mydriatic retinal imaging without patient-population restrictions. The Sentinel Camera underwent similar testing to external standards and meets necessary safety and performance criteria. Minor specification variations in storage media, data transfer method, and diopter range do not introduce new safety or effectiveness concerns because both devices employ fundamentally the same imaging technology and clinical application approach.