(36 days)
Lite oil is used as an in vitro oil overlay for gametes and zygotes during storage or manipulation.
Not Found
The provided document, K022332 for Lite™ Mineral Oil, is a Premarket Notification (510(k)) from the FDA. This type of document primarily focuses on demonstrating substantial equivalence to a predicate device, rather than detailed performance studies and acceptance criteria as would be found in a De Novo or PMA submission.
Therefore, this document does not contain the specific information required to answer your request about acceptance criteria and a study proving device adherence to those criteria.
The 510(k) essentially confirms that the device, Lite™ Mineral Oil, is "substantially equivalent" to a previously legally marketed device (a predicate device) for its stated indications for use: "as an in vitro oil overlay for gametes and zygotes during storage or manipulation."
To provide the information you requested, a different type of regulatory submission or scientific publication would be needed.
§ 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.