Risks and Benefits

INDICATIONS AND IMPORTANT SAFETY INFORMATION

1.0 INDICATION FOR USE (U.S.)

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.

INDICATION FOR USE (non U.S.)

The Eeva System is an imaging system combined with software providing embryologists the capability for automated evaluation of early embryo development to improve embryo selection.

2.0 CONTRAINDICATIONS

There are no contraindications for the Eeva System.

3.0 WARNINGS

WARNING: The Eeva System is not to be used as a substitute for traditional morphology evaluation. When using the Eeva System, always conduct traditional morphology evaluation first to identify the embryos that are suitable for transfer or freezing. The Eeva System evaluation begins only after embryos that are morphologically good/fair have been identified. The Eeva System is then used to assist in predicting which of the good/fair embryos will develop to the blastocyst stage.

  • Use of the equipment other than as directed in the Instructions for Use may impair proper protection of the user and operation of the equipment, and may impair the embryo prediction capability of the system.
  • Only an authorized Auxogyn, Inc. service representative can install, repair, remove, or service the equipment. Failure to properly install and service the Eeva System according to the instructions and specifications provided may result in harm to the embryo and/or the operator, and may also result in the Eeva System not being able to capture images and/or not being able to provide prediction results.
  • To avoid risk of electrical shock, the equipment must only be connected to supply mains with protective earth (ground).

4.0 PRECAUTIONS

  • The adjunctive value of the Eeva Test to predict which embryo is likely to achieve implantation and live birth has not been evaluated.
  • Determination of good/fair embryo retention (cryopreservation) should be made according to traditional morphology only (not based on the Eeva Test Result).
  • The safety and effectiveness of the Eeva System as an aid in selecting blastocyst stage embryos for transfer of cryopreservation have not been evaluated.
  • Users of the system should be trained in, and familiar with, standard in vitro fertilization (IVF) and incubator operating procedures. Only users trained on the use of the Eeva System should use the Eeva System. Eeva System training is provided by an authorized Auxogyn Trainer during the installation process or may be given by a trained member of the site personnel.
  • The Eeva Test result does not provide any information on embryo genetic quality beyond providing information about the embryo’s likelihood to progress to the blastocyst stage.
  • Only Eeva Dishes may be used with the Eeva System. The system will not permit the initiation of imaging with other types of dishes.
  • The Eeva Dish containing embryos should be loaded onto the scope stage and the patient session initiated ≤ 20 hours from time of insemination. Delays may prevent proper imaging and/or prevent the analysis of all embryo development events, which may result in a “No Result” (NR).
  • Laboratory Standard Operating Procedures should be followed to verify and ensure embryo identification. Do not rely exclusively on the patient information displayed on the scope screen or the scope.
  • If any of the Eeva System’s internal diagnostic tests fail, the Eeva System will display an error message and halt. In the event of an error, discontinue use and contact an Auxogyn, Inc. service representative immediately.
  • An Eeva Dish may only contain embryos from a single patient. Each dish is associated with a patient session. Do not mix embryos from different patients into a single dish. Depending on the number of embryos that a patient has, it may be required to use multiple dishes and run multiple patient sessions in order to analyze all embryos.
  • Any obstruction of the scope’s view of the embryo or interruption of the recording of the images prior to the completion of the analysis for all embryos in the Dish may prevent the generation of a blastocyst prediction for that patient.
  • When cleaning and disinfecting the Eeva System always refer to the Instructions for Use for effective cleaning and disinfection procedures to avoid damage to the system or residual contamination.
  • Portable and mobile radio frequency communications equipment can affect the Eeva System. Special Electromechanical Compatibility (EMC) precautions should be observed when installing and using the Eeva System. Do not attempt to modify the Eeva System installation or any of the components.

5.0 POTENTIAL ADVERSE EVENTS

Based on clinical and commercial experience with the Eeva System, the following adverse events may be associated with use of the Eeva System or IVF treatment: Embryo damage during pipetting, incubation, embryo manipulation, or embryo transfer into / out of the Eeva Dish • Embryo loss • Hyperemesis • Ovarian hyperstimulation • Ovarian enlargement • Pain • Ruptured corpus luteal cyst • Vaginal bleeding in early pregnancy.

Prior to use of the Eeva System, please reference the Instructions for Use for more information on indications, contraindications, warnings, precautions, and adverse events.