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510(k) Data Aggregation
(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: < 20 EU | Endotoxin levels < 20 EU |
| Mechanical Testing (Aspiration) | Aspirated samples appropriately; 100% (61/61) aspirated fluid as intended; 100% (61/61) delivered specimen to proper position |
| Mechanical Testing (Leakage) | No evidence of leakage following heat sealing; 100% (61/61) had intact seals and no leakage |
| Mechanical Testing (Intact after LN2) | 100% (61/61) remained intact after removing from liquid nitrogen |
| Blastocyst Survivability (Comparative) | Overall survival of mouse blastocysts for the Cryopette was 96% (compared to 84% for predicate) |
| Cooling Rates (Comparative) | -23,700 °C/min (equivalent to predicate device – exact value for predicate: -12,000 °C/min) |
| Warming Rates (Comparative) | 34,480 °C/min (equivalent to predicate device – exact value for predicate: 24,000 °C/min) |
| Sterilization Validation: SAL 10⁻⁶ | SAL of 10⁻⁶ |
| Shelf Life/Package Integrity | Maintained package integrity, sterility, and functionality for labeled shelf life (specific quantitative data not provided) |
2. Sample Size Used for the Test Set and Data Provenance:
- Mouse Embryo Assay (MEA), Endotoxin (LAL) Levels, Sterilization Validation, Shelf Life/Package Integrity: No specific sample sizes for these tests are explicitly stated in the provided text, but it mentions testing is performed "Each lot" for MEA and Endotoxin. The overall performance data pertains to the device's design verification rather than a specific "test set" in the context of an AI/human reader study.
- Mechanical Testing (Aspiration, Leakage, Intact after LN2): 61 Cryopettes were tested.
- Blastocyst Survivability (Comparative Testing): The sample size for the blastocyst survivability study is not explicitly stated in terms of number of blastocysts or replicates, but it compares the "overall survival of mouse blastocysts."
- Heating and Cooling Rates: Not specified.
- Data Provenance: The studies used mouse embryos/blastocysts, suggesting laboratory-based testing rather than clinical retrospective or prospective human data. The precise country of origin is not specified but the submission is for a US FDA 510(k).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. This device is a cryopreservation container, and the performance data relates to its physical and biological compatibility characteristics, not a diagnostic interpretation task that would involve human experts establishing ground truth for a test set. The performance is assessed via laboratory assays and mechanical tests.
4. Adjudication Method for the Test Set:
Not applicable, as the data collection does not involve human interpretation or adjudication in the context of diagnostic performance. The results are from objective laboratory tests and direct mechanical observations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation of images or other data, which is not the case for a cryopreservation container.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a physical container, not an algorithm or AI system.
7. The Type of Ground Truth Used:
The "ground truth" for the performance claims is based on:
- Laboratory Assay Results: For Mouse Embryo Assay (embryo viability/hatching), Endotoxin levels.
- Direct Observation/Measurement: For mechanical testing (aspiration, leakage, intactness, dimensions), and sterilization assurance level.
- Comparative Experimental Results: For blastocyst survivability and heating/cooling rates, compared against a predicate device using laboratory experimental setups.
8. The Sample Size for the Training Set:
Not applicable. This device is not an AI/ML algorithm that requires a training set. The descriptions are of device verification and validation tests.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this device.
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