(66 days)
Sperm Freeze is intended to be used as a cryopreservation medium for human sperm.
Not Found
The provided text is a 510(k) clearance letter from the FDA for a device named "Enhance Sperm Freeze" (later referred to as "Sperm Freeze"). This document does not contain any information about the acceptance criteria or a study that proves the device meets specific performance metrics.
Instead, this document focuses on:
- Substantial Equivalence: The FDA's determination that "Enhance Sperm Freeze" is substantially equivalent to legally marketed predicate devices, allowing it to be marketed.
- Regulatory Information: Details about regulatory classification (Class II), applicable regulations, and requirements for marketing the device.
- Indications for Use: Stating that "Sperm Freeze is intended to be used as a cryopreservation medium for human sperm."
Therefore, I cannot provide the requested information from this document regarding acceptance criteria, device performance, study details, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, or ground truth establishment. These details would typically be found in the 510(k) submission itself or a separate clinical/performance study report, not in the clearance letter.
§ 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.