(276 days)
Global DMSO Blastocyst Vitrification Kit:
- Intended for the vitrification (ultra-rapid freezing) and cryostorage of . human blastocysts.
Global DMSQ Blastocyst Vitrification Warming Kit - . Intended for the recovery and rehydration of vitrified human blastocysts
- Intended for use with blastocysts that have been vitrified using the Global . DMSO Blastocyst Vitrification Kit.
Not Found
The provided text is a letter from the FDA regarding a 510(k) premarket notification for two devices: the "Global DMSO Blastocyst Vitrification Kit" and the "Global DMSO Blastocyst Vitrification Warming Kit." This document does not contain any information about acceptance criteria or a study that proves the device meets those criteria.
The letter is primarily an approval notice, stating that the FDA has determined the devices are "substantially equivalent" to legally marketed predicate devices. It outlines regulatory requirements and general information but does not delve into the specific performance data or studies that would typically be included in a 510(k) submission itself.
Therefore, I cannot fulfill your request to describe acceptance criteria and a study based on the provided input. The necessary information is not present in this document.
§ 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.