(373 days)
Gems Fertilisation Medium is used to provide a suitable environment for both oocytes and sperm and support in vitro fertilisation. This medium can be used for transfer of zygotes into the uterus.
Gems Cleavage Medium is for in vitro culture of embryos following fertilization to the 4-8 cell stage. This medium can be used for transfer of cleavage stage embryos into the uterus.
Gems Blastocyst Medium is for in vitro culture of embryos from the cleavage stage to the blastocyst stage of development. This medium can be used for transfer of blastocyst stage embryos into the uterus.
Gems Geri Medium is for in vitro culture of embryos from fertilization to the blastocyst stage of development. This medium can be used for transfer of embryos into the uterus.
Gems VitBase is used to maintain embryos for a short period of time in a non-gassed environment during embryo vitrification and warming procedures. The embryos can be placed in this medium for a maximum of 10 minutes.
The subject devices are culture media consisting of salts, energy substrates, amino acids, buffering agents, nutrients supplements and antibiotics, with or without L-Carnitine and/or human serum albumin. These devices have different applications in Assisted Reproduction Technology (ART) procedures in a hospital environment. These media are single-use devices that are aseptically filled into the sterilized bottles and have a sterility assurance level (SAL) of 10-3. The products are tested for pH, osmolality, embryotoxicity, endotoxin, and sterility before lot release.
This document describes the Genea Biomedx Genea Embryo Culture Media and its associated performance testing for substantial equivalence to predicate devices, as reviewed by the FDA.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for several key parameters are presented, primarily for shelf-life studies and comparison to predicate devices/literature.
| Parameter | Acceptance Criteria (Internal/Comparative) | Reported Device Performance |
|---|---|---|
| pH | Varies by medium (e.g., Gems Fertilisation: 7.5-7.7, Gems Cleavage: 7.4-7.6, Gems Blastocyst: 7.6-7.80, Gems Geri: 7.4-7.6, Gems VitBase: 7.3-7.5) | Similar to predicate devices, met internal specifications. Included in shelf-life studies. |
| Osmolality | Varies by medium (e.g., Gems Fertilisation: 295-305 mOsm/kg, Gems Cleavage: 285-295 mOsm/kg, Gems Blastocyst: 285-295 mOsm/kg, Gems Geri: 285-295 mOsm/kg, Gems VitBase: 295-305 mOsm/kg) | Similar to predicate devices, met internal specifications. Included in shelf-life studies. |
| 1-cell MEA (Mouse Embryo Assay) | ≥80% developed to the blastocyst stage at 96 hours | Met acceptance criteria (implied by "performance data demonstrate that the subject devices are substantially equivalent"). Included in shelf-life studies. |
| Endotoxin |
§ 884.6180 Reproductive media and supplements.
(a)
Identification. Reproductive media and supplement are products that are used for assisted reproduction procedures. Media include liquid and powder versions of various substances that come in direct physical contact with human gametes or embryos (including water, acid solutions used to treat gametes or embryos, rinsing solutions, sperm separation media, supplements, or oil used to cover the media) for the purposes of preparation, maintenance, transfer or storage. Supplements are specific reagents added to media to enhance specific properties of the media (e.g., proteins, sera, antibiotics, etc.).(b)
Classification. Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, biocompatibility testing, and clinical testing). The device, when it is phosphate-buffered saline used for washing, and short-term handling and manipulation of gametes and embryos; culture oil used as an overlay for culture media containing gametes and embryos; and water for assisted reproduction applications, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.