Marie Thibault

In a final order to be published Thursday, FDA is confirming that the Assisted Reproduction Embryo Image Assessment System is now classified as a Class II medical device with special controls. This includes devices used to analyze images to determine the development potential of embryos. The data helps clinicians select the embryos best suited for IVF procedures.

The Eeva System, made by Auxogyn, was the original impetus for the reclassification process. According to the final order, FDA originally assigned the Eeva System into Class III on August 3, 2012. Later that month, Auxogyn requested classification as a Class II device, a necessary step under the de novo classification process.

FDA reviewed the request and decided that Class II classification with special controls was suitable, issuing the classification on June 6, 2014. Auxogyn’s Eeva System received FDA clearance at the same time.

In a statement announcing FDA approval last June, Lissa Goldenstein, president and chief executive officer of Auxogyn, said, “We have followed a rigorous, years-long clinical validation process and regulatory pathway to bring the Eeva Test to market. Our clearance provides a new level of confidence to IVF clinicians who, for the first time, have quantitative information that can be used in addition to traditional morphology to aid in deciding which embryo or embryos to transfer.”

After the final order becomes effective, any company filing a 510(k) for an Assisted Reproduction Embryo Image Assessment System must meet the special controls required by the order. These special controls include various testing, cleaning, and validation processes to ensure that the system does not result in possible harm, such as damage to the embryo, infection, inaccuracy, or user error.

Marie Thibault is the associate editor at MD+DI. Reach her at [email protected] and on Twitter @medtechmarie.

[Image courtesy of DREAM DESIGNS/FREEDIGITALPHOTOS.NET]