(38 days)
Sperm Wash Medium is used for in vitro washing for IUI procedures, incubation and manipulation.
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This document is a 510(k) premarket notification decision letter from the FDA for "Sperm Wash Medium & Sperm Wash Medium with Gentamicin". It does not contain information about acceptance criteria or a study proving device performance in the way requested for AI/medical device performance.
Therefore, I cannot provide the details about acceptance criteria or a study from the provided text. The letter primarily states the device's substantial equivalence to a predicate device and outlines regulatory requirements.
§ 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.