Not Cleared Post-NSE

DEN120015 - EEVA 2.0 (FDA 510(k) Clearance)

Class II Obstetrics & Gynecology device cleared through the Post-NSE 510(k) pathway - typically does not require clinical trials.

DEN120015 · Auxogyn, Inc. · Obstetrics & Gynecology device
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Jun 2014
Decision
651d
Days
Class 2
Risk

DEN120015 is an FDA 510(k) submission (not cleared) for the EEVA 2.0. Classified as Embryo Image Assessment System, Assisted Reproduction (product code PBH), Class II - Special Controls.

Submitted by Auxogyn, Inc. (Hillsborough, US). The FDA issued a Not Cleared (DENG) decision on June 6, 2014 after a review of 651 days.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.6195 - the FDA obstetrics and gynecology 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: Regulatory edge-case submission. High predicate equivalence gap. With 651 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

View all Auxogyn, Inc. devices

Submission Details

510(k) Number DEN120015 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received August 24, 2012
Decision Date June 06, 2014
Days to Decision 651 days
Submission Type Post-NSE
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
491d slower than avg
Panel avg: 160d · This submission: 651d
Pathway characteristics

Device Classification

Product Code PBH Embryo Image Assessment System, Assisted Reproduction
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.6195
Definition The Device Will Obtain And Analyze Light Microscopy Images Of Developing Embryos. This Device Provides Information To Aid In The Selection Of Embryo(s) For Transfer When There Are Multiple Embryos Deemed Suitable For Transfer Or Freezing .
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 Obstetrics & Gynecology devices follow this clearance model.