QQU · Digital Therapy Device For Amblyopia

Ophthalmic · 21 CFR 886.5500 · Class 2

Overview

Identification

A digital therapy device for amblyopia is a device that incorporates dichoptic presentations on visual displays through therapeutic algorithms to treat amblyopia or to improve visual acuity of patients with amblyopia. Luminopia One is a software-only digital therapeutic designed to be used with commercially available Head-Mounted Displays (HMDs) which are compatible with the software application. It is indicated for improvement in visual acuity in amblyopia patients, aged 4-7, associated with anisometropia and/or with mild strabismus, as an adjunct to full-time refractive correction.

Classification Rationale

Class II (special controls). The device is granted under the De Novo process, and the probable benefits of visual acuity improvement in the amblyopic eye outweigh the probable risks of non-serious adverse events, which can be mitigated by the use of general controls and the identified special controls.

Special Controls

In combination with the general controls of the FD&C Act, the digital therapy device for amblyopia is subject to the following special controls: - Clinical performance testing must demonstrate that the device performs as intended (1) under anticipated conditions of use with labeled compatible visual display devices, including evaluation of all adverse events and device performance to improve measures of visual function. - (2) Software verification, validation, and hazard analysis must be performed. Documentation must include characterizations of the technical specifications of the software. - (3) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. All visual displays intended for use must undergo compatibility testing to ensure adequate display resolution, luminance, contrast, field of view, image quality, appropriate optical image distance, and verify their compatibility with the software and intended user (such as appropriate interpupillary distance). - (4) Labeling must include the following: - (i) The minimum hardware and operating system requirements that support the software of the device: - (ii) The models of the visual displays validated to be compatible with this device; - The length of treatment and/or retreatment supported by clinical performance (iii) testing; and - A summary of the clinical performance testing conducted with the device. (iv) - Labeling comprehension testing with intended users must be performed. (૨)

Recent Cleared Devices (5 of 5)

Top Applicants

• Luminopia, Inc. — 4 clearances
• Novasight , Ltd. — 1 clearance