(22 days)
HSA is intended as a protein supplement for in-vitro mammalian-cell culture media. These procedures include in vitro fertilization, gamete washing, embryo culture, micromanipulation and embryo cryopreservation.
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I am sorry, but based on the provided text, there is no information about acceptance criteria, a study proving device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details.
The document is a 510(k) premarket notification letter from the FDA regarding a device named "Enhance-HSA." It states that the device is substantially equivalent to legally marketed predicate devices and outlines the regulatory requirements the manufacturer must comply with. The "Indications for Use Statement" indicates that "HSA is intended as a protein supplement for in-vitro mammalian-cell culture media," listing procedures like in vitro fertilization, gamete washing, embryo culture, micromanipulation, and embryo cryopreservation.
This type of document confirms regulatory clearance but does not typically include detailed performance study results or acceptance criteria.
§ 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.