(300 days)
Water for Tissue Culture is to be used for tissue culture in assisted reproduction procedures.
Water for Tissue Culture 500mL
This document is a letter from the FDA regarding a 510(k) premarket notification for "Water for Tissue Culture" by Advanced Reproductive Technologies, Inc. It details the FDA's determination of substantial equivalence to a legally marketed predicate device.
There is no information in the provided text that describes acceptance criteria, device performance, sampling methods, expert qualifications, ground truth establishment, or any study details as requested in your prompt.
The document primarily focuses on regulatory approval, classification, and general controls applicable to the device. It states the intended "Indications For Use" for the device: "Water for Tissue Culture is to be used for tissue culture in assisted reproduction procedures." However, it does not include any performance metrics or study results.
§ 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.