(112 days)
The product is intended to be used for the separation and purification of human sperm by density gradient centrifugation for intrauterine insemination (IUI).
The product PureSperm® is a based on a buffered salt solution which contains a colloidal suspension of silica particles, with hydrophilic silane covalently bound to the particles. The pH, osmolality and salts of PureSperm® are formulated to be compatible with human sperm during their centrifugal separation and purification. The product is packaged in three bottle sizes, 100, 250 and 1000 mL, and these bottles, being Type I borosilicate glass, are packaged individually in white virgin-fibre cartons. Both the bottles and the cartons have pharmaceutically approved labels showing batch number, production date and expiration date. In addition, every carton contains an insert with a full description of the product, including instructions for use and precautions.
The provided text is a 510(k) summary for the PureSperm® Sperm Separation Medium. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, it does not include detailed information regarding specific acceptance criteria, a comprehensive study outline with performance metrics, sample sizes, ground truth establishment, or any details about AI integration.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as this information is not present in the provided text.
Specifically, the document states:
- "The results of clinical trials and comparative testing against predicate products indicates that the new device is as safe and effective as the predicate devices."
- "Based on the similarity of composition, product testing results, and intended use, PureSperm® is substantially equivalent to the predicate devices named above."
These statements are high-level conclusions and do not provide the detailed scientific study parameters that you have requested in your prompt. There is no table of acceptance criteria, no reported device performance metrics (e.g., sensitivity, specificity, accuracy, or any performance on sperm separation quality), no sample sizes for test or training sets, no information on experts, no adjudication methods, no mention of MRMC studies or AI involvement, and no specifics on how ground truth was established beyond a general mention of "product testing 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.