(225 days)
Dewin Vitrification Kit is intended for use in the vitrification of oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos.
Dewin Thawing Kit is intended for use in the thawing of vitrified oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos.
Dewin Vitrification Kit and Dewin Thawing Kit include a set of five media intended for use in the vitrification and thawing of oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos, and blastocyst stage embryos as part of InVitro Fertilization (IVF) procedures.
The Vitrification Kit and Thawing Kit media are offered in 2mL and 5mL volumes. Dewin Vitrification Kit includes two media components, Equilibration Solution (ES) and Vitrification Solution (VS), containing the cryoprotectants ethylene glycol, trehalose (only in VS), and dimethyl sulfoxide. During the vitrification process, embryos are first exposed to ES and then to VS. Using this methodology, the permeating cryoprotectants can replace water in the oocyte or PN through blastocyst stage embryos prior to vitrification and storage in liquid nitrogen.
Dewin Thawing Kit is composed of three media used stepwise for thawing and removing cryoprotectants from vitrified oocytes and PN through blastocyst stage embryos. It is composed of Thawing Solution (TS), Dilution Solution (DS) and Washing Solution (WS).
The primary ingredients of the vitrification and thawing media are water, sodium chloride, potassium chloride, sodium dihydrogen phosphate dihydrate, magnesium sulphate heptahydrate, calcium chloride, sodium bicarbonate, gentamicin sulfate, glucose, sodium-s-lactate, sodium pyruvate, alanyl glutamine, taurine, EDTA, phenol red, HEPES, HSA, trehalose, ethylene glycol, DMSO, non-essential amino acids. Cryoprotectants in the media include ethylene glycol (7.5% in ES, 15% in VS), DMSO (7.5% in ES, 15% in VS), and trehalose in VS, TS and DS.
The five solutions in the Dewin Vitrification Kit and Dewin Thawing Kit are aseptically filtered (storage vials sterilized by dry heat and radiation) and provided in glass bottles capped with a polypropylene screw-top cap. They are single-use only and have a shelf-life of 7 months when stored at 2-8°C.
The provided FDA clearance letter and 510(k) summary pertain to the Dewin Reproductive Media (Dewin Vitrification Kit, Dewin Thawing Kit). This document does not describe an AI/ML-enabled device or a study involving human readers or comparative effectiveness with AI. Therefore, most of the requested information (such as effect size of human readers with AI assistance, expert qualifications, and adjudication methods) is not applicable or cannot be extracted from the given text.
The information below focuses solely on the device and its testing as described in the provided document.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Dewin Reproductive Media are primarily based on physical, chemical, and biological performance measures. The reported device performance matches these criteria for the supported shelf-life.
| Acceptance Criteria | Reported Device Performance (at 7 months shelf-life) |
|---|---|
| Appearance: Clear, particulate free | Met |
| pH per USP : 7.20 - 7.60 (all solutions) | Met |
| **Osmolality per USP ** | |
| ES: 2300-3000 mOsm/Kg | Met |
| VS: 4900-6600 mOsm/Kg | Met |
| TS: 1255-1535 mOsm/Kg | Met |
| DS: 745-911 mOsm/Kg | Met |
| WS: 260-295 mOsm/Kg | Met |
| Sterility per USP : No microbial growth | Met |
| Bacterial Endotoxin per USP : |
§ 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.