Cleared Traditional

K142147 - EEVA SYSTEM

K142147 is an FDA 510(k) clearance for EEVA SYSTEM, manufactured by Auxogyn, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code PBH cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K142147 · Auxogyn, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2014
Decision
111d
Days
Class 2
Risk

K142147 is an FDA 510(k) clearance for the EEVA SYSTEM. Classified as Embryo Image Assessment System, Assisted Reproduction (product code PBH), Class II - Special Controls.

Submitted by Auxogyn, Inc. (Menlo Park, US). The FDA issued a Cleared decision on November 24, 2014 after a review of 111 days - within the typical 510(k) review window.

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 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 Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Auxogyn, Inc. devices

FDA 510(k) Submission Details - K142147

510(k) Number K142147 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 2014
Decision Date November 24, 2014
Days to Decision 111 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 160d · This submission: 111d
Pathway characteristics
Predicate-based equivalence.

PBH Device Classification - Class 2, Special Controls

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Obstetrics & Gynecology devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT01369446 Completed Observational Industry-sponsored

Eeva™ System Study: Noninvasive Recording and Visualization of Individual Embryos Cultured to Blastocyst Stage

160
Patients (actual)
5
Sites
Condition studied Infertility
Eligibility Female only · 18 Years+
Principal investigator Sheua Shen, MD, ELD
Sponsor Progyny, Inc. (industry)
Started 2011-06-01 → Primary completion 2012-04-01
Primary outcome
Eeva System correctly predicts on day 2 those embryos that will reach blastocyst stage at day 5.
Secondary outcome
Pregnancy Outcome
Study completed - no results published. This trial concluded in 2012 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov