Search Results

The Geri Embryo Incubator is intended to provide an environment with controlled temperature and mixed gas (CO2 and other gases) for the development of embryos. The Geri Embryo Incubator has an integrated camera and optics for imaging and viewing embryos during incubation, for a maximum time of 120 hours.

The Geri Dish is intended to be used for preparation, storage and imaging of human embryos. The Geri Dish is intended to be used only with the Geri Embryo Incubator.

The Geri Embryo Incubator is a benchtop incubator with six modular incubation chambers each with its own temperature control capability and separate gas inlet feed. Each chamber contains heating elements in its lid and base, together with an orange light source (591 nm) and camera with integrated optics that take time-lapse images of embryos and allows operators to view embryos without removing them from the incubation chamber. Inside each chamber is a filter the gas mixture entering the incubation chamber from the gas supply. The gas is supplied from standard premixed medical gas cylinders. Each chamber can also contain an optional water bottle (Geri Water Bottle) to generate humidity. The Geri Water Bottle is supplied sterile with a sterility assurance level (SAL) of 10°, and has a shelf-life of three years. The Geri Water Bottle is designed to be used with the Geri Embryo Incubator only.

The embryos are maintained in Geri Dishes that are supplied separately. The Geri Dish is an optically-clear polystyrene dish designed to be compatible with the Geri Embryo Incubator. Up to 16 embryos can be stored in one Geri Dish. Geri Dishes are supplied sterile with a sterility assurance level (SAL) of 10°, and have a shelflife of 12 months.

The Geri Embryo Incubator and Geri Dish are intended to be used together for embryo imaging purposes. The Geri Dish is not compatible with other embryo time-lapse incubators. However, other assisted reproduction culture dishes may be used in the Geri Embryo Incubator in separate non-time-lapse positions located within each chamber.

The Geri Embryo Incubator includes firmware to control the incubator settings, and software to control patient information and settings.

This document, a 510(k) Summary for the Geri Embryo Incubator and Geri Dish, outlines the characteristics and testing for a medical device. It is not a document about an AI/ML-based medical device. Therefore, none of the specific questions regarding AI/ML device acceptance criteria, study design for AI/ML, sample sizes for AI/ML test and training sets, expert adjudication methods for AI/ML ground truth, or MRMC studies for AI assistance, can be answered from the provided text.

The document focuses on the substantial equivalence of the Geri Embryo Incubator and Geri Dish to a predicate device, with the main change being the addition of a humidity control system. The studies described are traditional non-clinical performance tests for an incubator and culture dish, such as electrical safety, EMC, cleaning validation, gas maintenance, temperature control, time-lapse imaging function, embryo development testing (mouse embryo assay), and sterilization validation.

Therefore, I cannot provide the requested information as the provided text relates to a medical device that does not appear to be an AI/ML device.

Ask a specific question about this device