Verily Numetric Retinal Camera

The Verily Numetric Retinal Camera is a non-contact, tabletop fundus camera that captures high-resolution color images of the retina under non-mydriatic (undilated pupil) conditions. It is intended as a diagnostic aid for clinicians to evaluate, diagnose, and document ocular health by photographing and storing posterior segment images of the eye.

Key differences from the predicate NFC-700 include: interactive (rather than automatic) alignment performed by the patient viewing a microdisplay collocated with the image sensor; patient-controlled manual focusing via a peripheral knob; lower image resolution (2.1 MP vs. 12 MP); ability to image smaller pupils (3.0 mm vs. 4.0 mm); wider focus adjustment range without compensation lens (-20 to +20D vs. -15 to +10D); and different data interfaces (USB2.0/Wi-Fi vs. USB2.0/Ethernet/HDMI). The subject device acquires only posterior segment images, whereas the predicate also captures external eye images.

The device was tested against ANSI Z80.36-2021 (Group 1 Instrument), ISO 10940 (Second edition 2009), IEEE ANSI C63.27-2017, AAMI TIR69:2017/(R2020), IEC 60601-1 (electrical safety), and IEC 60601-1-2 (EMC). Software was validated per IEC-62304:2015 and classified as Class A per IEC 62340:2015.

Both devices are non-contact, high-resolution digital cameras designed to photograph and store retinal images under non-mydriatic conditions as aids in ocular diagnosis. The technological differences in alignment methodology (interactive vs. automatic) and focusing approach (patient-controlled vs. automatic) do not raise new safety or effectiveness questions because both methods achieve comparable image quality and gradability. The subject device's superior minimum pupil size capability and wider focus range without compensation lenses represent improvements, not new risks. All safety parameters (light hazard, biocompatibility, IEC-60601 compliance) meet or exceed the predicate's standards, and bench testing confirms image quality equivalent to the predicate on the same patient population.