(30 days)
Cell isolation media used for separation and purification of human sperm for assisted reproduction procedures.
Not Found
I am sorry, but the provided text does not contain information about acceptance criteria, device performance, or any studies conducted on the "Enhance-S Plus" device.
The document is a 510(k) premarket notification letter from the FDA, indicating that the device "Enhance-S Plus" has been determined to be substantially equivalent to legally marketed predicate devices. It discusses regulatory classifications, general controls, and responsibilities of the manufacturer. The "Indications for Use Statement" on the last page merely specifies the intended use of the device: "Cell isolation media used for separation and purification of human sperm for assisted reproduction procedures."
Therefore, I cannot provide the requested information.
§ 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.