(235 days)
For the support of the oocyte during intracytoplasmic sperm injection.
Medium for In Vitro Fertilization Procedures
MOPS buffered medium. For use after the addition of G-MM™ or HSA-solution™ and temperature equilibration at +37°C and ambient atmosphere.
The provided document is a 510(k) premarket notification summary for G-OOCYTE™, an Assisted Reproduction Media. It includes information about the device's intended use and technological characteristics, as well as the FDA's substantial equivalence determination. However, it does not contain any information regarding specific acceptance criteria, study methodologies, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, or ground truth establishment for a device performance study.
The document states that the "Technological characteristics of G-OOCYTE are essentially similar to those of the predicate device. Formulation changes were made with the needs of the denuded unfertilized oocyte in mind. None of these changes raise new questions of safety or effectiveness." This suggests that the substantial equivalence was primarily based on the similarity to the predicate device (G-MOPS™ K021893) and the assessment that the formulation changes did not introduce new safety or effectiveness concerns, rather than a new performance study demonstrating specific acceptance criteria.
Therefore, I cannot provide the requested information as it is not present in the provided text.
§ 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.