(336 days)
ARTSMedia In Vitro Culture Medium (AM-IVC Medium) is a culture medium intended for in vitro fertilization and in vitro culture of human gametes and embryos from fertilization until the blastocyst stage of development (day 5). The medium can also be used for embryo transfer.
ARTSMedia In Vitro Culture Medium (AM-IVC Medium) is a medium for in vitro fertilization and culture of human gametes and embryos from fertilization until the blastocyst stage of development (day 5). The medium can also be used for embryo transfer procedures. The medium is aseptically filtered and provided in in a volume of 10 mL in pre-sterilized 10 mL glass bottles closed with Fluorotec-coated stoppers and aluminum caps. The medium has a shelflife of 10 months when stored at 2-8℃ and is for single-use only.
This document is a 510(k) Summary for a medical device called ARTSMedia In Vitro Culture Medium (AM-IVC Medium). It seeks to demonstrate substantial equivalence to a predicate device. The document is not a study proving an AI device meets acceptance criteria. Therefore, I cannot extract the requested information like expert consensus, MRMC study results, or AI algorithm performance details.
The document discusses non-clinical performance testing for a culture medium, which is a laboratory product used for in vitro fertilization, not an AI device. The tests performed are standard for biological media to ensure aspects like biocompatibility, sterility, pH, osmolality, endotoxin levels, and shelf-life, and include a Mouse Embryo Assay (MEA) to demonstrate functionality.
Therefore, the requested information elements related to AI device performance, such as human reader improvement with AI assistance, standalone algorithm performance, number of experts for ground truth, sample sizes for test and training sets for an AI model, and adjudication methods, are not present in this document.
§ 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.