(232 days)
VitaVitro Vitrification Kit is intended for the vitrification of human blastocysts for assisted reproduction technologies (ART). This kit is designed for use with VitaVitro Warming Kit.
VitaVitro Warming Kit is intended for the warming of human blastocysts that have undergone vitrification using VitaVitro Vitrification Kit for ART procedures.
VitaVitro Straw Set is a cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human blastocyst stage embryos.
VitaVitro Vitrification and Warming Kits, and the VitaVitro Straw Set are used for vitrification, storage, and warming of blastocysts as part of human assisted reproduction technology (ART) procedures.
The VitaVitro Vitrification Kit includes three media components, Human Holding Medium (HHM), Human Vitrification Solution 1 (HV1) and Human Vitrification Solution 2 (HV2). All three media have the same base formulation, but HV1 and HV2 contain the cryoprotectants ethylene glycol and dimethyl sulfoxide in increasing concentrations. HV2 also includes sucrose as a non-permeating cryoprotectant. During the vitrification process, blastocysts are first equilibrated in HHM, and then exposed sequentially to HV1 and HV2. Using this methodology, the permeating cryoprotectants replace water in the blastocyst prior to vitrification and storage in liquid nitrogen. The VitaVitro Vitrification Kit includes single 1.0 ml vials of HHM, HV1, and HV2.
The VitaVitro Warming Kit includes three media used stepwise for warming and removing cryoprotectants from vitrified blastocysts. The VitaVitro Warming Kit includes Human Warming Solution 1 (HW1), Human Warming Solution 2 (HW2) and HHM. These media products are the same with the exception that HW1 and HW2 also include sucrose in decreasing concentrations to aid in the rehydration of the blastocysts. The VitaVitro Warming Kit includes two 1.5 ml vials of HW1, one 1.0 ml vial of HW2, and one 1.8 ml vial of HHM.
The VitaVitro Straw Set consists of two components, a straw that holds the blastocysts, and a container that is used to protect the straw. Both components are made from copolyester. The closed end of the container also includes a weight to aid in maintaining the orientation of the device in liquid nitrogen and prevent floating. During use, the container is pre-cooled by placing the closed end in liquid nitrogen with the open end extending above the level of the liquid nitrogen. Straw loading is done by placing the narrow tip of the straw in a 1 µl drop of vitrification media, which draws the media and blastocysts into the storage device. The straw component is then inserted into the pre-cooled container component to effect vitrification. The container component is then sealed to prevent contact between the samples and liquid nitrogen.
All of the products are provided sterile with a six-month shelf-life. The media in the vitrification and warming kits undergo aseptic filtration, while the storage devices are ethylene oxide sterilized.
This document describes the premarket notification (510(k)) for the VitaVitro Vitrification Kit, VitaVitro Warming Kit, and VitaVitro Straw Set, comparing it to a predicate device (Cryotop® Vitrification Kit and Cryotop® Thawing Kit, K160864).
1. Table of Acceptance Criteria and Reported Device Performance
| Feature | Acceptance Criteria (Subject Device: VitaVitro) | Reported Device Performance (VitaVitro) |
|---|---|---|
| Vitrification & Warming Kit Media | ||
| pH | 7.2 - 7.6 | pH: 7.2-7.6 for all solutions (met) |
| Osmolality (HHM) | 295-315 | Met (specific value not given, but stated to meet acceptance specifications) |
| Osmolality (HV1) | N/A (not specified in comparison table) | N/A (not specified in comparison table) |
| Osmolality (HV2) | N/A (not specified in comparison table) | N/A (not specified in comparison table) |
| Osmolality (HW1, diluted 1:1) | 600-850 | Met (specific value not given, but stated to meet acceptance specifications) |
| Osmolality (HW2) | 850-1000 | Met (specific value not given, but stated to meet acceptance specifications) |
| Endotoxin | Sterility Testing (met) | |
| Shelf-life | Maintain product specifications for pH, osmolality, MEA, endotoxin, and sterility over six months | Met (product specifications maintained over six-month shelf-life) |
| Straw Set (Cryopreservation Storage Device) | ||
| Cooling Rate | Not an acceptance criteria but a measured characteristic | 5,127 °C/min |
| Warming Rate | Not an acceptance criteria but a measured characteristic | 17,899 °C/min |
| Endotoxin |
§ 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.