(41 days)
Culture of human embryos from zygote to blastocyst, embryo transfer.
Not Found
The provided text from the FDA 510(k) clearance letter for the LifeGlobal Global HP does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.
The document is a clearance letter stating that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed. It outlines regulatory requirements, but it does not include details of a performance study or acceptance criteria.
Therefore, I cannot provide the requested information based on the given text.
To provide this information, I would need access to the full 510(k) submission document, specifically the sections detailing performance data, clinical studies, or non-clinical testing.
§ 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.