(88 days)
Medium for handling and manipulating oocytes and embryos in ambient atmosphere.
MOPS buffered medium.
For oocyte collection after temperature equilibration at +37°C and ambient atmosphere.
For gamete and embryo manipulation after the addition of G-MM or HSA-solution and temperature equilibration at +37°C and ambient atmosphere.
This document is a 510(k) premarket notification summary for the G-MOPS(TM) Assisted Reproduction Media. It primarily focuses on demonstrating substantial equivalence to a predicate device and does not contain information about acceptance criteria or specific study data to prove device performance against such criteria.
Therefore, I cannot extract the requested information as it is not present in the provided text.
Specifically, the document does not include:
- A table of acceptance criteria and reported device performance.
- Details on sample sizes, data provenance for test sets, or ground truth establishment for test/training sets.
- Information about expert involvement or adjudication methods.
- Any multi-reader multi-case (MRMC) comparative effectiveness study or standalone algorithm performance.
- The type of ground truth used for performance evaluation.
§ 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.