(268 days)
Gems Vitrification Set is used for the vitrification of human blastocyst stage embryos for Assisted Reproductive Technology (ART) procedures.
Gems Warming Set is used for the warming of human blastocyst stage embryos that have undergone vitrification.
The Gems Vitrification Set and Gems Warming Set are intended for the vitrification and warming of human blastocysts as part of human ART procedures.
The Gems Vitrification Set is designed to facilitate dehydration of blastocysts before vitrification via rapid cooling in liquid nitrogen. Dehydration of the blastocysts is achieved by the step-wise use of increasing concentrations of cryoprotectants in the Gems Vitrification Set, which results in water being withdrawn from the cell. The cryoprotectants also protect the blastocysts by reducing the potential for ice crystal formation during the vitrification process.
The Gems Vitrification Set consists of three solutions (Vitsol 2, and Vitsol 3). The base formulation for Vitsol 1 and Vitsol 2 is a HEPES-buffered medium containing salts, energy substrates, amino acids, and human serum albumin. Vitsol 1 contains the cryoprotectant ethylene qlycol, while Vitsol 2 contains the cryoprotectants ethylene glycol and trehalose. Vitsol 3 consists of dimethyl sulphoxide (DMSO). The Gems Vitrification Set is not provided ready for use as Vitsol 3 must be added to the other vitrification solutions before use. Following DMSO addition to Vitsol 1 and 2, the final vitrification solutions for blastocyst vitrification procedures have the following properties:
- . Vitrification Solution 1 (Vitsol 1 + DMSO) - 8% ethylene glycol and 8% DMSO
- Vitrification Solution 2 (Vitsol 2 + DMSO) 16% ethylene glycol, 16% DMSO, and 0.57M trehalose ●
The Gems Warming Set consists of three warming solutions (Warmsol 2, and Warmsol 3), which are designed to facilitate the re-hydration (warming) of vitrified blastocysts. In the warming process, trehalose in the media manages the inflow of water into blastocysts as concentrations of DMSO and ethylene glycol are reduced during the rehydration process.
All three of the solutions in the Gems Warming Set consist of a HEPES-buffered medium containing salts, energy substrates, amino acids, and human serum albumin, with varying amounts of the cryoprotectant trehalose as described below:
- . Warmsol 1 - 1.0 M trehalose
- Warmsol 2 0.5 M trehalose ●
- Warmsol 3 - No trehalose
These media are single-use devices that are aseptically filled into sterilized bottles and have a sterility assurance level (SAL) of 10 3. The products are tested for pH, osmolality, embryotoxicity, endotoxin, and sterility before lot release.
The provided document describes the acceptance criteria and performance testing for the "Gems Vitrification Set and Gems Warming Set" (subject device) in comparison to a predicate device, the "Cook Sydney IVF Blastocyst Vitrification Kit and Cook Sydney IVF Blastocyst Warming Kit" (K143724).
Here's an analysis of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Parameter | Subject Device - Gems Vitrification Set and Gems Warming Set (K162409) Reported Performance | Predicate Device - COOK Sydney IVF Blastocyst Vitrification Kit and COOK Sydney IVF Blastocyst Warming Kit (K143724) | Comparison |
|---|---|---|---|
| Intended Use | Vitrification and warming of human blastocyst stage embryos for ART procedures. | Vitrification and warming of human blastocysts for ART procedures. | Same |
| Formulation | HEPES buffered physiologic media containing ethylene glycol, DMSO, trehalose, and human serum albumin in addition to normal physiological salts. DMSO provided separately. | HEPES buffered physiologic media containing ethylene glycol, DMSO, trehalose, human Serum albumin and gentamicin in addition to normal physiological salts. DMSO provided separately. | Similar (differences in gentamicin and some concentrations, deemed not to raise different S&E questions) |
| pH | 7.3-7.5 | 7.3-7.5 | Same |
| Osmolarity (mOsm/kg) | Warmsol 1: 1280-1320; Warmsol 2: 780-820; Warmsol 3: 295-305 (N/A for vitrification solutions) | K-SIBW-SOL1: 657-683; K-SIBW-SOL2: 500-520; K-SIBW-SOL3: 285-295 (Other values for vitrification solutions not directly comparable) | Different (higher in subject device for warming solutions due to cryoprotectant concentrations, deemed not to raise different S&E questions) |
| Mouse Embryo Assay (MEA) | 1-Cell MEA: ≥80% developed to blastocysts at 96h | 2-Cell MEA: ≥80% blastocyst formation at 72h | Similar |
| Endotoxin | Vitsol 1-2, Warmsol 1-3: and Endotoxin testing per USP . |
8. The sample size for the training set
This information is not applicable. The device is not an AI algorithm that requires a training set. The descriptions relate to the manufacturing and quality control testing of physical chemical media.
9. How the ground truth for the training set was established
This information is not applicable for the same reason as point 8.
§ 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.