(88 days)
HSA-solution contains Human Serum Albumin solution (100 mg/mL) and is intended for use in assisted reproductive procedures which include gamete and embryo manipulation. These procedures include the use of HSA-solution as a supplement for culture medium. Not for use as an injectable product.
Human Serum Albumin solution. For supplementation of gamete and embryo media.
The provided text is a 510(k) premarket notification summary for a medical device called HSA-solution™. It primarily discusses the regulatory aspects of the device, its intended use, and its substantial equivalence to a predicate device.
It does not contain information about acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone algorithm performance, or training set details.
Therefore, I cannot provide the requested information based on the input text. The document is a regulatory approval notice, not a performance study report.
§ 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.