Cleared Traditional

K221183 - AEYE-DS (FDA 510(k) Clearance)

Class II Ophthalmic device cleared through predicate-based substantial equivalence.

K221183 · Aeye Health, Inc. · Ophthalmic device
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Nov 2022
Decision
199d
Days
Class 2
Risk

K221183 is an FDA 510(k) clearance for the AEYE-DS. Classified as Diabetic Retinopathy Detection Device (product code PIB), Class II - Special Controls.

Submitted by Aeye Health, Inc. (New York, US). The FDA issued a Cleared decision on November 10, 2022 after a review of 199 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1100 - the FDA ophthalmic device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Aeye Health, Inc. devices

Submission Details

510(k) Number K221183 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 2022
Decision Date November 10, 2022
Days to Decision 199 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
89d slower than avg
Panel avg: 110d · This submission: 199d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code PIB Diabetic Retinopathy Detection Device
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.1100
Definition 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 this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Ophthalmic devices follow this clearance model.

Regulatory Consultant

Hogan Lovells US LLP
John Smith

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Clinical Evidence

ClinicalTrials.gov
NCT04612868 Completed Interventional Industry-sponsored

Efficacy and Safety of AEYE-DS Software Device for Automated Detection of Diabetic Retinopathy From Digital Fundus Images

Pivotal Prospective Clinical Trial to Demonstrate the Efficacy and Safety of AEYE-DS Software Device for Automated Diabetic Retinopathy Detection From Digital Fundoscopic Images

531
Patients (actual)
1
Site
Diagnostic
Purpose
Open label
Masking
Condition studied Diabetes Mellitus; Diabetic Retinopathy
Study design Single group
Eligibility All sexes · 22 Years+
Sponsor AEYE Health Inc (industry)
Started 2020-10-16 → Primary completion 2021-11-28 → Completed 2021-12-26
Primary outcome
Sensitivity and Specificity, Based on Two Macula-centered Images (One Image From Each Eye of the Patient)
Secondary outcome
Sensitivity and Specificity, Based on Four Images (One Macula Centered Image and One Optic Disc Centered Image Per Eye)
View full study on ClinicalTrials.gov