Not Cleared Direct

DEN200055 - GI Genius (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN200055 · Cosmo Artificial Intelligence - Ai, Ltd. · Gastroenterology & Urology device
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Apr 2021
Decision
213d
Days
Class 2
Risk

DEN200055 is an FDA 510(k) submission (not cleared) for the GI Genius. Classified as Gastrointesinal Lesion Software Detection System (product code QNP), Class II - Special Controls.

Submitted by Cosmo Artificial Intelligence - Ai, Ltd. (Dublin, IE). The FDA issued a Not Cleared (DENG) decision on April 9, 2021 after a review of 213 days.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1520 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. This submission did not achieve clearance, indicating the FDA determined the device lacked sufficient predicate equivalence under the Gastroenterology & Urology review framework.

View all Cosmo Artificial Intelligence - Ai, Ltd. devices

Submission Details

510(k) Number DEN200055 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received September 08, 2020
Decision Date April 09, 2021
Days to Decision 213 days
Submission Type Direct
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
83d slower than avg
Panel avg: 130d · This submission: 213d
Pathway characteristics

Device Classification

Product Code QNP Gastrointesinal Lesion Software Detection System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1520
Definition A Gastrointestinal Lesion Software Detection System Is A Computer-assisted Detection Device Used In Conjunction With Endoscopy For The Detection Of Abnormal Lesions In The Gastrointestinal Tract. This Device With Advanced Software Algorithms Brings Attention To Images To Aid In The Detection Of Lesions. The Device May Contain Hardware To Support Interfacing With An Endoscope.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - QNP Gastrointesinal Lesion Software Detection System

All 18
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