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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™ Dish is intended to be used to hold human oocytes and embryos during handling and culture.

The Eeva Dish is a round dish with an outer diameter of 38 mm; the inner diameter of the dish is 35mm. The dish is provided with a lid. The interior of the dish contains a large central ring approximately 10mm in diameter, which contains 12 smaller, round microwells, each intended to hold a single human oocyte or embryo. The device allows for the segregation of embryos while they are immersed in the same drop of culture media The microwells are 350 microns in diameter and 134 microns deep, which creates sufficient room for handling of human oocytes and embryos with a pipette. The center ring has a tapered wall to stabilize and minimize embryo movement in the microwells. The dish also contains three smaller outer rings, approximately 8mm in diameter each, that are intended to hold media drops for rinsing oocytes or embryos. The center and three outer rings can each hold 100ul of media. The dish is constructed of virgin polystyrene and is non-pyrogenic and non-embryotoxic. The dish is single use only and is packaged with 3 units per sterile pouch, 12 pouches per corrugated cardboard shipping carton.

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.

The Eeva™ Petri Dish is intended to be used to hold human oocytes and embryos during handling and culture.

The Eeva™ Petri Dish is 39mm in diameter with a lid and consists of a large center well containing 16 or 25 micro-wells. The Eeva Petri dish also contains three smaller outer rings, approximately 7mm in diameter each, which are intended to hold media drops for rinsing the oocytes or embryos. The Eeva™ Petri Dish is constructed of polystyrene and is non-pyrogenic and non-embryotoxic.