(196 days)
System for maturing immature oocytes of infertile women undergoing in vitro fertilization who for medical reasons cannot or choose not to undergo conventional ovarian stimulation using drugs.
Oocyte Washing Medium: This medium is used for washing immature oocytes contained within cumulus-oocyte complexes (COCs), collected from the follicles before maturation in culture.
Oocyte Maturation Medium: This medium is used for maturation in culture of immature oocytes in an incubator.
Embryo Maintenance: This medium is used for embryonic culture following insemination by intracytoplasmic sperm injection (ICSI).
Oocyte Washing Medium is a balanced salt solution containing nutrients, amino acids and vitamins to maintain immature oocytes during their collection and washing.
Oocyte Maturation Medium is a balanced salt solution containing nutrients, amino acids and vitamins for the in vitro culture of immature oocytes.
Embryo Maintenance Medium is a balanced salt solution containing nutrients and amino acids for maintaining embryos in culture.
This document is a 510(k) summary for reproductive media (Oocyte Washing Medium, Oocyte Maturation Medium, and Embryo Maintenance Medium) and does not describe an AI medical device. Therefore, it does not contain the information required to answer your questions regarding acceptance criteria and studies proving a device meets those criteria for an AI device.
Specifically, the document focuses on demonstrating substantial equivalence to legally marketed predicate devices based on:
- Formula
- Indications for Use
- Performance Testing (though the details of this testing are not provided in the excerpt, it's mentioned as an area of comparison).
The submission is for an "IVM System" (In-Vitro Maturation System) consisting of chemical media, not a software algorithm or AI. As such, concepts like "test set," "ground truth," "experts," "adjudication method," "MRMC study," "standalone performance," or "training set" for an AI device are not applicable to the information provided 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.