(264 days)
PVP is used for the intracytoplasmic sperm injection (ICSI) procedure to decrease the motility of spermatozoa, prevent their sticking to the injection pipette during the procedure and to give more control over the flow of fluid in the ICSI needle.
PVP, 10%, (W/V) in Hepes-HTF (Tissue Culture Media)
This document is a 510(k) clearance letter for "PVP, 10%, (W/V) in Hepes-HTF (Tissue Culture Media)" for use in ICSI procedures. It's a regulatory approval document and does not contain information about acceptance criteria or specific study details often found in scientific publications or clinical trial reports.
Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details from the provided text.
The closest information available is the "Indications For Use," which describes what the device is intended for: to decrease sperm motility, prevent sticking to the injection pipette, and provide more control over fluid flow during ICSI. This is a functional description, not a set of performance metrics or acceptance criteria as you've defined them.
§ 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.