(151 days)
G-2TM v5/G-2TM v5 PLUS is intended for culture of embryos from day 3 to the blastocyst stage, and for embryo transfer.
The IVF Media GIII Series have been on the market for a number of years and Vitrolife Sweden AB has now made some product changes in order to further improve the robustness of these media. These improved media are called IVF Media G5 Series. G-2TM v5/G-2TM v5 PLUS is used for culture of embryos from day 3 to the blastocyst stage, and for embryo transfer.
This document is a 510(k) premarket notification for a new version of an IVF media, G-2TM v5/G-2TM v5 PLUS. The core assertion is that the new version is "substantially equivalent" to a predicate device, G-2TM version 3 (K021890).
However, the provided text does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria through testing.
Instead, the document focuses on:
- Device Description and Intended Use: G-2TM v5/G-2TM v5 PLUS is used for culture of embryos from day 3 to the blastocyst stage, and for embryo transfer.
- Technological Characteristics: The new device is a modification of the predicate device, and the manufacturer claims that "None of the differences between the predicate device and G-2™ v5/G-2™ v5 PLUS do raise any new questions of safety or effectiveness." This statement is key to the "substantial equivalence" claim for 510(k) clearance.
- FDA Clearance Letter: This confirms the FDA's finding of substantial equivalence to the predicate device, allowing the new device to be marketed.
Therefore, based solely on the provided text, I cannot produce the requested table and detailed information about acceptance criteria and a study proving device performance because that information is not present in the given document.
The document is a regulatory communication for a 510(k) submission, which relies on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a performance study with defined acceptance criteria for the new device itself. For reproductive media, "safety and effectiveness" are often evaluated by demonstrating that the new formulation performs comparably to the predicate for critical parameters like embryo development rates, blastocyst formation, and live birth rates, but the details of any such comparison study are not included here.
If a study was performed, its details would typically be in a separate section of the 510(k) submission, not in the provided fragments.
§ 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.