(298 days)
Intended Use: Medium for In Vitro Fertilization Procedures
Indications for Use: Media for thawing of blastocyst stage embryos
MOPS buffered media. For use in sequence after the addition of G-MM™ or HSA-solution™ and pre-equilibration at +20 ± 5°C and ambient atmosphere.
This document is a 510(k) premarket notification for the G-ThawKit Blast™ Assisted Reproductive Media. It does not contain detailed information about acceptance criteria or a specific study proving the device meets those criteria. The document primarily establishes substantial equivalence to a predicate device.
Therefore, I cannot extract the requested information from the provided text. To answer your query, a document containing the detailed results of performance studies and acceptance criteria for the G-ThawKit Blast™ would be needed.
§ 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.