(142 days)
This device is a vitrification storage device that is intended for use in vitrification procedures to contain and maintain human 4-8 cell or blastocyst stage embryos.
Cryotec is a cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human 4-8 cell or blastocyst stage embryos. It is designed to enable physicians and embryologists to preserve and to store vitrified embryos for assisted reproduction technology procedures. The Cryotec device is composed of a two piece assembly with a polyethylene terephthalate (PET) film sheet attached to a PET handle, and a weighted polyvinylchloride cap to cover the film sheet during handling and storage. During vitrification procedures, the film sheet is loaded with embryos, capped, and immersed in liquid nitrogen. The capped design creates a hermetic seal, resulting in a closed system keeping the film sheet and embryos isolated from liquid nitrogen. The cap is weighted to allow proper alignment in the storage container. The Cryotec device is provided sterile and is for single use only. The Cryotec device has been designed to maintain the integrity of the human embryos the freezing and thawing process.
The provided text describes the 510(k) premarket notification for the Cryotec device. This device is a cryopreservation storage device intended for use in vitrification procedures to contain and maintain human 4-8 cell or blastocyst stage embryos. The submission compares the Cryotec device to a legally marketed predicate device, the Kitazato CryotopUS (K153027), and presents non-clinical performance data to demonstrate substantial equivalence.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Appearance | Particle free, no cracks | All devices are particle free with no cracks; met specifications |
| Durability | No breakage, no liquid nitrogen inside the cap | No breakage of the stick or cap, no liquid nitrogen inside the cap; met specifications |
| Tensile Strength | $\geq 5N$ | Tensile strength to withstand 5N; met specifications |
| Endotoxin | $ |
§ 884.6160 Assisted reproduction labware.
(a)
Identification. Assisted reproduction labware consists of laboratory equipment or supplies intended to prepare, store, manipulate, or transfer human gametes or embryos for in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), or other assisted reproduction procedures. These include syringes, IVF tissue culture dishes, IVF tissue culture plates, pipette tips, dishes, plates, and other vessels that come into physical contact with gametes, embryos or tissue culture media.(b)
Classification. Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, and clinical testing). The device, when it is a dish or plate intended for general assisted reproduction technology procedures, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.