(287 days)
LifeGlobal Global Total: Culture of human embryos from zygote to blastocyst, and embryo transfer
LifeGlobal Global Total for Fertilization: Human oocyte culture and fertilization
LifeGlobal Global Total w/HEPES: Human oocyte and embryo washing and manipulation, fertilization by intracytoplasmic sperm injection (ICSI), and embryo transfer
Not Found
I am sorry, but based on the provided document, I cannot extract the information required to describe the acceptance criteria and the study that proves the device meets them. The document is a 510(k) clearance letter from the FDA for a reproductive media device, not an AI/ML device.
The letter confirms substantial equivalence but does not describe the specific performance studies, acceptance criteria, or ground truth methodologies that would be relevant for an AI/ML product. The document focuses on regulatory compliance and classification of a medical device (reproductive media), not on the evaluation of an AI algorithm's performance.
§ 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.