(40 days)
HTF Plus with HEPES (HTF with non-essential amino acids) is used as a holding media for human gametes and embryos for assisted reproduction.
Not Found
The provided text is a 510(k) clearance letter from the FDA for a medical device called "HTF Plus with HEPES" (also referred to as "HTF with non-essential amino acids"). This letter does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.
The letter only states that the FDA has determined the device is substantially equivalent to legally marketed predicate devices. This means that for this particular device (a reproductive media and supplement), the FDA's decision is based on its similarity to existing products, rather than a new study demonstrating its efficacy against specific pre-defined acceptance criteria.
Therefore, I cannot fulfill your request with the provided input. The information you are asking for typically comes from a detailed clinical study report or a different section of a 510(k) submission that outlines performance testing.
§ 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.