(27 days)
To be used for the softening of the embryo zona during assisted reproductive procedures
Not Found
I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance described by a study, sample sizes, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone algorithm performance, or training set details.
The document is a 510(k) clearance letter from the FDA for a device called "Acidified Tyrodes Solution." It primarily confirms that the device is substantially equivalent to a legally marketed predicate device and outlines regulatory compliance requirements.
The "Indications for Use" section states: "To be used for the softening of the embryo zona during assisted reproductive procedures." This indicates the intended purpose of the product but does not provide any performance metrics or study details.
§ 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.