MAIA (AHMACME001)
CENTERVUE SPAMAIA is a medical imaging device used to take detailed digital images of the human retina without the need for pharmacological dilation. It uses confocal imaging and white light illumination to capture sharp, naturally colored retinal images, aiding clinicians in retina examination. The device also features pupil tracking and automatic perimetry for measuring retinal sensitivity and fixation analysis, improving accuracy in eye diagnostics.
Intended Use
MAIA is intended for taking digital images of a human retina without the use of a mydriatic agent.
Technology
MAIA operates as a standalone unit with multi-touch display and embedded software. It captures confocal retinal images using visible white light and infrared light for tracking, including pupil tracking via two cameras for automatic alignment. The imaging is confocal, with illumination focused on the same plane as acquisition optics, capturing sharp, detailed, naturally colored retinal images. Additional functions include automated perimetry for retinal threshold sensitivity and fixation analysis, supported by retinal tracking correcting stimuli projection for eye movement.
Performance
Bench tests confirm safety and performance equivalence to the predicate device COMPASS (K150320). Tests included electromagnetic compatibility, basic safety, functional safety, usability, biocompatibility, packaging and environmental validation, software validation per IEC 62304, security penetration, and labeling validation. No clinical tests were needed. Device meets ophthalmic standards ISO 15004-1, ANSI Z80.36, ISO 12866.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/12/2024
4 months - 2
FDA Approval
3/17/2025
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