(192 days)
The Cryotop® Vitrification Kit is indicated for use in the preparation, and storage of promuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos.
The Cryotop® Thawing Kit is indicated for use in the preparation and thawing of vitrified pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos.
The Cryotop® Vitrification and Thawing Kits are composed of a set of five media to vitrify and warm pronuclear (PN) through blastocyst stage embryos for Assisted Reproductive Technologies (ART) procedures.
The Cryotop® Vitrification Kit includes two media components, Equilibration Solution (ES) and Vitrification Solution (VS), containing the cryoprotectants ethylene glycol and dimethyl sulfoxide. During the vitrification process, embryos are first exposed to ES and then in VS. Using this methodology, the permeating cryoprotectants can replace water in the PN through blastocyst stage embryos prior to vitrification and storage in liquid nitrogen. The Cryotop® Vitrification Kit comes pre-packaged with one 1.5 ml vial of ES, two 1.5 ml vials of VS, 4 Cryotop devices (Cryotop SC, or Cryotop US), and two Repro Plates.
The Cryotop® Thawing Kit is composed of three media used stepwise for thawing and removing cryoprotectants from vitrified PN through blastocyst stage embryos. The Cryotop® Thawing Kit is composed of TS (Thawing Solution), DS (Dilution Solution) and WS (Wash Solution). The Cryotop Thawing Kit comes pre-packaged with two 4.0 ml vials of thawing solution, one 4.0 ml vial of dilution solution, one 4.0 ml vial of washing solution, one Repro Plate, and two 35 mm dishes.
All of the media in the Cryotop® Vitrification Kit and Cryotop® Thawing Kit contain Gentamicin. The media in these kits undergo aseptic filtration, while storage devices are sterilized by radiation.
This document describes the Kitazato BioPharma Co., Ltd. Cryotop® Vitrification Kit and Cryotop® Thawing Kit, which are reproductive media and supplements used for the cryopreservation and thawing of pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos.
Here's an analysis of the provided information regarding acceptance criteria and the study:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Non-Clinical Performance Criteria | |
| Cleanliness and appearance: Free of turbidity and sedimentation | Passes |
| pH Testing: Average pH reading is from 7.2 – 7.6 | Passes (Average pH reading is from 7.2 – 7.6) |
| Endotoxin Testing: Endotoxin values conform to the value |
§ 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.