The Eeva™ System’s De Novo FDA Clearance

The Eeva System is the first device cleared by the FDA to aid in embryo selection and enables IVF clinics to offer the breakthrough Eeva™ Test for early, prognostic assessment of embryo developmental potential.

Combining state-of-the art time-lapse imaging with proprietary software, the Eeva System automatically analyzes key early embryo development markers to objectively predict which embryos are most likely to reach the critical blastocyst stage.

The Eeva System’s FDA clearance sets it apart from traditional time-lapse systems and marks an important first for the field of IVF. As the first device of its kind with a prognostic assessment capability (the Eeva Test), the Eeva System’s regulatory clearance resulted in creation of a new device category with an intended use to aid in the critically important process of embryo selection.

• Establishes a new category of embryo image assessment capabilities
• Defines rigorous benchmarks for safety and effectiveness for the new device category
• Demonstrates consistency and generalizability of results between labs and operators
• Provides the highest level of regulatory assurance for clinicians and patients

The De Novo Pathway

The majority of FDA-regulated equipment in the IVF laboratory comes to market through the 510(k) pathway. FDA 510(k) clearance requires that a new device demonstrate that it is at least as safe and effective as an existing, legally marketed device with the same intended use and the same technical characteristics as the predicate device.

Derived from a Latin expression meaning “anew”, the FDA’s De Novo regulatory pathway was designed for novel, low-to-moderate risk devices for which there exists no predicate device to serve as a benchmark for demonstrating equivalent safety and efficacy.

The Rigor of Creating a New Standard

The De Novo application requirements are more rigorous than the 510(k) submission as it creates a benchmark standard for a new device classification:

The Eeva System’s New Intended Use Drives a Novel Path to Market

As the first device of its kind, the Eeva Test was cleared through the De Novo pathway, which resulted in the creation of a new device classification: Assisted Reproduction Embryo Image Assessment System.

Leadership Has Its Advantages

As the first to market in a new device category, Auxogyn created a new technology standard for improving the process of embryo selection. Having worked closely with the FDA to define this category and establish the special regulatory controls that will apply to any new device that applies for clearance in this category through the 510(k) pathway, Auxogyn benefits from an in-depth understanding of the FDA’s expectations and the ability to leverage existing test data in hopes of reducing time required to bring new product features and assessment capabilities to market.

June 2014: De Novo Decision Summary for the Eeva System:
http://www.accessdata.fda.gov/cdrh_docs/reviews/K120427.pdf

Auxogyn has since enhanced the Eeva System and received a second FDA clearance.

November 2014: 510(k) Summary for the Eeva System:
http://www.accessdata.fda.gov/cdrh_docs/pdf14/K142147.pdf