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The KIDScore D3 tool provides decision support for prediction of embryos developing to the blastocyst stage by scoring them according to their statistical viability. Adjunctive information provided by KIDScore D3 aids in the selection of embryo(s) for either transfer on Day 3, freezing or continued embryo development when, following morphological assessment on Day 3, there are multiple embryos deemed suitable for transfer or freezing. The KIDScore D3 tool is only to be used with the EmbryoScope timelapse incubator systems.

The KIDScore D3 decision support tool is an adjunctive algorithm that is designed to support embryologists in their decision about which embryos are suitable for transfer. The tool is an optional accessory to the EmbryoViewer software. It is used in the "Compare & Select" function. The "D3" in the name refers to the use of the algorithm on Day 3 for aiding the embryologist in preparing for transfer of the embryo to the female patient. KIDScore D3 utilizes the following manually annotated parameters to aid in identifying embryos that are suitable for transfer: - Pronuclei (number of pronuclei): ● - tPNf (time from insemination until pronuclei is fading) ● - t2 (time from insemination to complete division to two cells) ● - t3 (time from insemination to complete division to three cells) ● - t4 (time for insemination to complete division to four cells) . - t5 (time from insemination to complete division to five cells) ● - t8 (time from insemination to complete division to eight cells) ● The KIDScore D3 assigns scores by comparing the parameters above in embryos to the model criteria, one criterion at a time until the process stops either because the embryo did not pass one of the criteria in the sequence or because the last criterion in the model was reached. From the information available at day three of incubation, the KIDScore D3 divides embryos into five score groups (1-5, as described below): - 0 = The embryo is not 2PN - 1 = Initial development was too fast or the embryo displayed a direct cleavage from one to three cells - 2 = The embryo was slow to develop - 3 = Embryo development was irregular and the development pace increased from day two to day three - 4 = Embryo development was irregular and the development pace slowed from day two to day three and/or The number of cells annotated at 66 hours was not as expected 5 = The embryo passed all of the avoidance criteria included in the model. One or more computers running the EmbryoViewer software may be connected to the ES Server. KIDScore D3 is stored on the computer running the ES Server software. Calculations related to the model in KIDScore D3 are performed on the computer running the ES Server software.

The Eeva System is indicated to provide adjunctive information on events occurring during the first two days of development that may predict further development to the blastocyst stage on Day 5 of development. This adjunctive information aids in the selection of embryo(s) for transfer on Day 3 when, following morphological assessment on Day 3, there are multiple embryos deemed suitable for transfer or freezing. The device may also be used to collect additional time-lapse images until Day 5 of development for embryos not selected for transfer, to allow monitoring of continued embryo development.

The Eeva™ System is an Assisted Reproduction Embryo Image Assessment System (21 CFR 884.6195), installed in an IVF lab and used by embryologists and other IVF professionals. None of the System components have an individual, prior 510(k) clearance. Eeva System, Model EVS210 requires the use of the 12-microwell configuration of the Eeva™ Dish (K141663, also referred to as the "dish"), which is placed on the Eeva Scope (an assisted reproductive microscope). The Eeva Scopes are placed in commercially-available standard-sized incubators. The microscope employs high resolution time-lapse imaging to record an embryo's development during its first two days of incubation. Automated measurements of cell division timing parameters and the Eeva Test results are provided to the user after approximately 42 hours predicting the likelihood of whether an embryo will develop to the blastocyst stage. In Eeva System, Model EVS2210, image recording may continue through Day 5 of embryo development.

The Eeva System is indicated to provide adjunctive information on events occurring during the first two days of development that may predict further development to the blastocyst stage on Day 5 of development. This adjunctive information aids in the selection of embryo(s) for transfer on Day 3 when, following morphological assessment on Day 3, there are multiple embryos deemed suitable for transfer or freezing.

The Eeva System provides image recording and automated analysis of cell division from high resolution time-lapse images collected until day 3 (72 hours) of development. Results of cell division timing parameters (time from first to second mitosis: and time from second to third mitosis) are provided to the user in addition to a prediction of the likelihood that an embryo will develop to the blastocyst stage. These timing parameters are based on those published in a study by Wong, et. al. (2010). The Eeva System incorporates: (1) a set of up to four time-lapse image microscopes that automatically take darkfield microscopy images of embryos at regular intervals (every 5 minutes) while the embryos remain in the incubator environment, (2) Eeva Computer and other components (Control Box, Station, Scope Screen and Printer), (3) system software for image capture and recording, user interface, and patient database and (4) image analysis software that automatically identifies embryo development events, compares their times to specified timing parameters and makes a prediction of embryo development to the blastocyst stage. The system is installed in an In Vitro Fertilization (IVF) laboratory, and is to be used as an adjunct to the traditional morphological method to identify the embryos that are more likely to develop into blastocysts.