(58 days)
Solution for use during In Vitro fertilization procedures
Solution for rinsing of contact materials and for washing of the cervix. Not for culture.
Bicarbonate buffered salt solution. For use after pre-equilibration at +37℃ and 6% CO2.
The provided text is a 510(k) Premarket Notification Summary for the G-RINSE™ Assisted Reproduction Media. It does not contain a study that establishes acceptance criteria or reports device performance through experimental data or clinical trials.
The document primarily focuses on establishing substantial equivalence to a predicate device (ASPTM) based on similar technological characteristics and formulation changes to improve performance without raising new safety or effectiveness concerns.
Therefore, I cannot provide the requested information regarding acceptance criteria, reported device performance, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth details. These types of studies are not described 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.