CHLOE BLAST

CHLOE BLAST is a cloud-based software tool that automatically analyzes time-lapse videos of embryo development from insemination to Day 3 using a convolutional neural network. It generates a predictive score (CHLOE Score) indicating the likelihood an embryo will reach blastocyst stage by Day 5, providing adjunctive information to embryologists for embryo selection during assisted reproduction procedures when multiple suitable embryos exist for transfer or freezing.

CHLOE BLAST is standalone software accessory designed for EmbryoScope version D incubator videos, employing cell tracking and event inference algorithms to identify morphokinetic developmental events automatically. The predicate EEVA 2.0 is an integrated time-lapse imaging system used in conventional incubators with similar automated image analysis and event detection. While the subject device uses different predictive algorithms and has different software architecture, both employ software-based automated morphokinetic analysis to predict blastocyst development.

Not stated in this summary. The document references FDA 2023 guidance on device software functions and mentions compliance with special controls for Embryo Image Assessment Systems, but does not cite specific consensus standards (ISO, IEC, ASTM, etc.).

The intended use is identical—both provide adjunctive Day 3 decision support for embryo selection during IVF. Although technological characteristics differ (software accessory versus integrated system), the FDA determined these differences do not raise different questions of safety and effectiveness. Non-clinical testing demonstrated algorithm accuracy and reproducibility meeting acceptance criteria across subgroups. Clinical data showed the device achieved superior predictive performance compared to morphology alone (OR 5.67 vs 3.77 for Good/Fair embryos), with consistent performance across age, BMI, and site subgroups, demonstrating substantial equivalence in both safety and effectiveness profiles.