(75 days)
AllGrad Wash is used for sperm washing procedures such as in vitro washing and incubation of sperm in Assisted Reproduction techniques
Not Found
The provided document is a 510(k) premarket notification letter from the FDA for a device called "AllGrad Wash (Hepes Buffered Wash Medium)." This document does not describe acceptance criteria, a study that proves the device meets those criteria, or any details about AI/ML algorithms, sample sizes, ground truth, or expert adjudications.
It is a regulatory clearance document for a reproductive media product, not an AI/ML-driven medical device. Therefore, I cannot extract the requested information from this document.
§ 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.