(221 days)
Medium for In Vitro Fertilization Procedures
Medium for embryo biopsy
Medium for In Vitro Fertilization Procedures
This document is a 510(k) premarket notification for the G-PGD™ Assisted Reproduction Media. It does not contain information about acceptance criteria, device performance, specific studies with sample sizes, ground truth establishment, or clinical performance metrics.
The document indicates that the device's technological characteristics are "essentially similar to those of the predicate device" (Embryo Biopsy Medium, K021358) and states that "None of these changes raise new questions of safety or effectiveness." This implies that the device achieved substantial equivalence based on its similarity to a previously approved device, rather than through extensive new performance studies detailed in this particular submission.
Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on substantial equivalence to a predicate device, rather than presenting detailed study data for the new device.
§ 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.