Ophthalmic · 510(k) · 2022
AEYE-DS
AEYE Health, Inc.. Cleared by FDA on 10 November 2022 under submission K221183, product code PIB (diabetic retinopathy detection device). What FDA's record says, in FDA's words.
Device record · K221183
- Device. AEYE-DSDEVICE
- Company. AEYE Health, Inc.COMPANY
- Decision. 10 November 2022, 510(k), substantially equivalent (traditional review); received 25 April 2022DECISION
- Panel. OphthalmicPANEL
- Product code. PIB, Diabetic Retinopathy Detection DeviceCODE
- Regulation. 21 CFR 886.1100, Class IIREG
- Source. FDA database entry · decision document (15 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
The AEYE-DS is indicated for use by health care providers to automatically detect more than mild diabetic retinopathy (mtmDR) in adults diagnosed with diabetes who have not been previously diagnosed with diabetic retinopathy. The AEYE -DS is indicated for use with the Topcon NW400. IDx-DR is indicated for use by health care providers to automatically detect more than mild diabetic retinopathy (mtmDR) in adults diagnosed with diabetes who have not been previously diagnosed with diabetic retinopathy. IDx-DR is indicated for use with the Topcon NW400. Target Population Adult subjects diagnosed with Diabetes Adult subjects diagnosed with Diabetes Anatomical Sites Eye examination Eye examination Environment Used Hospitals, Clinics Hospitals, Clinics Energy Used / Delivered Not Applicable Not Applicable Design: A fundus camera is attached to a computer, where the AEYE -DS Client module is installed. The Client module allows the user to interact with the server-based analysis software over a secure internet connection. Using the Client module, users identify one (macular) or two (macular and disc) fundus images per eye to be dispatched to the Service module. The Service is installed on a server hosted at a secure datacenter. The Analytics modu le, which runs alongside the Service module, processes the fundus images and returns information on the image quality and the presence or absence of mtmDR to the Service module. The Service then returns the results to the Client module. A […]
The product code's definition, from FDA's classification record. A retinal diagnostic software device is a prescription software device that incorporates an adaptive algorithm to evaluate ophthalmic images for diagnostic screening to identify retinal diseases or conditions.
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Mentionsdetection or identification of findings
- Mentionsadult patients
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 1 report filed against devices carrying product code PIB. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification. The latest reports, in the reporter’s words:
22 January 2025 · Injury · AEYE-DS RETINA SCREENING · AEYE HEALTH INC. · report MW5165159
I WITNESSED THE AEYE-DS SAMD SOFTWARE DIAGNOSE A PATIENTS RETINA IMAGE LEVERING IT'S AI(ARTIFICIAL INTELLIGENCE) TECHNOLOGY AND FAIL TO PROVIDE A COMPLETE DIAGNOSIS OF ISSUES PERTAINING TO THE PATIENT'S EYES. THE PATIENT HAD RETINA CONDITIONS THAT WOULD REQUIRE MEDICAL EVALUATIONS BASED ON RETINA CUPPING AND GLAUCOMA WITHOUT HAVING DIABETIC RETINOPATHY AND THE AEYE-DS SYSTEM DID NOT INFORM THE PATIENT OF THIS CONDITION OR REFER THE PATIENT TO ANOTHER SPECIALIST. IT ONLY STATED, "NEGATIVE FOR […]
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code PIB, in Ophthalmic, from AEYE Health, Inc., or cleared in 2022. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.