(124 days)
LifeGlobal® Global® Total® w/HSA: Culture of embryos from zygote to blastocyst, embryo transfer
LifeGlobal® Global® Total® for Fertilization w/HSA: Oocyte culture and fertilization
LifeGlobal® Global® Total® w/HEPES w/HSA: Oocyte and embryo washing, manipulation, fertilization by intracytoplasmic sperm injection (ICSI), embryo transfer
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This document is a 510(k) premarket notification from the FDA, indicating clearance for a medical device. It does not contain information about the device's acceptance criteria, performance studies, sample sizes, expert qualifications, or ground truth establishment. These details are typically found in the submission's technical documentation, which is not part of this clearance letter.
Therefore, I cannot provide the requested information based on the provided text. The document confirms regulatory clearance but does not delve into the specific details of performance testing or clinical studies.
§ 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.