(98 days)
Oil For Tissue Culture is used in covering tissue culture in in-vitro fertilization, embryo culture and micromanipulative procedures such as ICSI and assisted hatching.
Gradient System is used for separation and purification of human sperm for assisted reproduction procedures.
SpermFreeze is intended to be used as a cryopreservation medium for human sperm.
Oil For Tissue Culture is a colorless liquid paraffin.
Gradient System is a solution of silane-coated silica particles in Earle's Balanced Salts Solution (EBSS) with HEPES (pH buffer). Available in 45%, 90% and 100%.
SpermFreeze is a HEPES buffered freezing medium for use with human Sperm. It contains 0.4 % human serum albumin.
I am sorry, but based on the provided text, I cannot provide the requested information. The document focuses on a 510(k) summary for reproductive media devices (Oil for Tissue Culture, Gradient System, and SpermFreeze) and primarily discusses their equivalence to predicate devices and their intended indications for use.
The text does not contain any information about acceptance criteria, device performance metrics, study designs, sample sizes (for test or training sets), expert qualifications, ground truth establishment, or multi-reader multi-case studies.
Therefore, I cannot populate the table or answer the specific questions about the study that proves the device meets acceptance criteria.
§ 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.