(25 days)
Used to slow the motility of spermatozoa for the use in ICSI procedure.
Not Found
The provided text is a 510(k) clearance letter for a medical device called PVP (Polyvinylpyrrolidone), used to slow the motility of spermatozoa for ICSI procedures. However, the document does not contain information regarding the acceptance criteria, specific performance study results, sample sizes (training or test), expert qualifications, adjudication methods, or MRMC studies that would typically be detailed in a device's performance evaluation.
The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..."
This indicates that the device was cleared based on its substantial equivalence to a predicate device, rather than a detailed performance study against specific acceptance criteria. The FDA's 510(k) process often relies on demonstrating equivalence to an already approved device rather than requiring extensive de novo clinical trials with precise performance metrics and acceptance criteria.
Therefore, I cannot extract the requested information as it is not present in the provided text.
§ 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.