(42 days)
Hyaluronidase in HTF Medium is used prior to intracytoplasmic sperm injections (ICSI) procedures to digest the hyaluronic acid holding the cumulus cells together to permit easy handling of the oocytes.
Hyaluronidase in HTF Medium; Hyaluronidase in EBSS Medium
This document is a 510(k) premarket notification from the FDA, specifically approving a device called "Hyaluronidase in HTF Medium" for use in intracytoplasmic sperm injection (ICSI) procedures. It does not contain information about acceptance criteria, study details, or device performance metrics like accuracy, sensitivity, or specificity.
The document is primarily an approval letter and a statement of the device's intended use. It confirms that the device is "substantially equivalent" to legally marketed predicate devices.
Therefore, I cannot provide the requested information from this document. To fulfill your request, I would need a different type of document, such as a clinical study report, a scientific paper, or a detailed device performance specification sheet.
§ 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.