(132 days)
The G-Vitri™ Vitrification Freeze Media is indicated for use in the vitrification of occytes (MI), pronuclear (PN) zygotes through day 3 cleavage stage embryos, and blastocyst stage embryos.
The G-Vitri™ Vitrification Thawing Media is indicated for use in the thawing of vitrified oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos, and blastocyst stage embryos.
Not Found
This is a 510(k) clearance letter for G-Vitri™ Vitrification Freeze Media and G-Vitri™ Vitrification Thawing Media. The document focuses on regulatory approval and does not contain information about the device's technical acceptance criteria or a study proving those criteria.
Therefore, I cannot provide the requested information, which typically pertains to performance studies for medical devices with algorithmic components or diagnostic functions. The G-Vitri™ products are reproductive media and supplements, and their clearance is based on substantial equivalence to predicate devices, rather than a quantifiable performance study against specific acceptance criteria as detailed in your request.
§ 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.