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510(k) Data Aggregation
(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 <0.25 EU/mL | Passes (<0.25 EU/mL) |
| Osmolality Testing: Pass specification for each solution | Passes specification for each solution |
| Sterility Testing: No microbial growth from sterility testing | Passes |
| Mouse Embryo Assay: ≥80% of 1-cell control embryos develop at 96 hours | ≥80% blastocyst at 96 hours (one-cell MEA) |
| Package Integrity Testing | Passes |
| Clinical Performance Criteria (Effectiveness Indicators from Literature) | |
| Clinical pregnancies (from Literature 1) | 42% from total transfer number |
| Live births (from Literature 1) | 30% from total transfer number |
| Clinical pregnancies (from Literature 2) | 59% from number of cycles |
| Ongoing pregnancies (from Literature 2) | 48% from number of cycles |
| Clinical pregnancies (from Literature 3) | 49% from number of cycles |
| Ongoing pregnancies (from Literature 3) | 46% from number of cycles |
| Embryo survival rates | Consistent with normal ART procedures |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not explicitly state the sample sizes used for the non-clinical performance tests (e.g., number of vials for pH testing, number of mouse embryos for MEA).
For the clinical performance data, the provenance is clearly stated as retrospective data from published scientific literature. The countries of origin for the data are not explicitly stated, but the authors' affiliations in the cited literature might provide this information (e.g., "Minimal ovarian stimulation combind with elective single embryo transfer policy: age-specific results of a large, single-center, Japanese cohort" suggests Japanese data for Literature 1).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
For the non-clinical performance data, the "ground truth" is established by the specifications themselves, which are standard laboratory parameters. The testing would have been performed by qualified laboratory personnel following validated protocols. However, the exact number and qualifications of these experts are not explicitly mentioned in this summary.
For the clinical performance data, the "ground truth" is based on the outcomes reported in the published clinical studies (pregnancies, live births, survival rates). These outcomes were determined by the clinical teams involved in those studies. The document does not specify the number of experts (e.g., embryologists, reproductive endocrinologists) involved in each specific study or their qualifications, but it is implied that these are qualified professionals in the field of Assisted Reproductive Technologies (ART).
4. Adjudication Method for the Test Set
This information is not provided for either the non-clinical or clinical data. For non-clinical tests, results are typically determined by objective measurements against established specifications. For the clinical studies cited, the adjudication methods for clinical endpoints would be described within the individual publications, but are not summarized here.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or reported here. This type of study is typically used for diagnostic devices involving human interpretation against an AI algorithm. The Cryotop® Vitrification and Thawing Kit is a laboratory media kit, not a diagnostic device with an AI component.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This question is not applicable as the device is a laboratory media kit and does not involve an algorithm or AI component.
7. Type of Ground Truth Used
- Non-Clinical Data: The ground truth for non-clinical performance is based on established laboratory specifications and quantitative measurements (e.g., pH values, endotoxin levels, mouse embryo development).
- Clinical Data: The ground truth for clinical performance (pregnancy rates, live birth rates, embryo survival) is based on clinical outcomes data reported in peer-reviewed scientific literature.
8. Sample Size for the Training Set
This question is not applicable as the device is a laboratory media kit and does not involve an AI algorithm that requires a training set. The performance data is derived from specific tests and clinical use, not from an AI model.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable for the same reason as above; there is no training set for this type of device.
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