(279 days)
The Cryopette is a cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human blastocyst stage embryos.
The Cryopette consists of a cryostraw manufactured from polycarbonate-Lexan OQ-3820. This straw has a displacement bulb attached to one end of the cryostraw whose function is to aspirate and dispense the sample contained in the vitrification media in and out of the opposite (open) end of the cryostraw. The cryostraw is the only sample contacting portion of the Cryopette. The metering sheath provides structural rigidity for the Cryopette. The support ring provides a backstop and seal for the displacement bulb. The outer case encases the displacement bulb to provide a surface for labeling. The sealing mark, distal storage border and proximal storage border reference lines are found on the outside of the cryostraw.
The provided text describes the acceptance criteria and performance data for the Cryopette device. Here's a summary of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mouse Embryo Assay (MEA): >70% hatching at 96 hours | Hatching percentage well exceeded >70% at 96 hours (exact value not specified, but stated as "well exceeded") |
| Endotoxin (LAL) Levels: |
§ 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.