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510(k) Data Aggregation
(123 days)
Origio a/s, a CooperSurgical Company
SynVitro® Hyadase is for the removal of the cumulus complex and corona radiata surrounding the oocyte in preparation for ICSI.
SynVitro® Hyadase is a modified version of the prior cleared SynVitro® Hyadase device and is used for removal of cumulus and corona radiata cells surrounding the oocytes (denudation) prior to intracytoplasmic sperm injection (ICSI).
SynVitro® Hyadase is a clear non-viscous hyaluronidase enzyme solution contained in a 2 ml transparent plastic bottles (containing 1 ml solution) with caps and provided in cardboard boxes containing five bottles. This product has a one-year shelf-life when stored as recommended and can be used for up to seven days after opening.
This document describes the acceptance criteria and the study that demonstrates the performance of the SynVitro® Hyadase device.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criterion | Reported Device Performance |
|---|---|---|
| pH | 7.150 - 7.449 | Met (tested at time zero, end of shelf-life (52 weeks), and after seven days of simulated vial opening) |
| Osmolality | 272 - 288 mOsm/kg | Met (tested at time zero, end of shelf-life (52 weeks), and after seven days of simulated vial opening) |
| Sterility | No growth | Met (tested at time zero, end of shelf-life (52 weeks), and after seven days of simulated vial opening) |
| Endotoxin | ≤ 0.5 EU/ml | Met (tested at time zero, end of shelf-life (52 weeks), and after seven days of simulated vial opening) |
| Mouse Embryo Assay (MEA) | ≥ 80% of one-cell stage embryos developed to blastocyst stage within 96 hours after a 15-second exposure to SynVitro® Hyadase | Met (tested at time zero, end of shelf-life (52 weeks), and after seven days of simulated vial opening). For a valid assay, at least 80% of one-cell stage control embryos developed to blastocyst stage within 96 hours. |
| Hyaluronidase enzyme activity | 40 - 120 IU/ml | Met (tested at time zero, end of shelf-life (52 weeks), and after seven days of simulated vial opening). The device is specified to contain 80 IU/ml. |
| Aseptic Processing Validation | Compliance with ISO 13408-1:2008 and ISO 13408-2:2018 | Report indicates "conducted per" the standards, implying compliance. |
| Shelf-Life | 52 weeks (unopened vial) and 7 days (open vial) | The shelf-life testing was conducted to ensure all product specifications (pH, Osmolality, One-cell MEA, Endotoxin concentration, Sterility testing, Hyaluronidase activity) are met at time zero, at the end of the 52-week shelf-life, and after seven days of simulated vial opening. The document concludes that "performance data demonstrate that the subject device is substantially equivalent to the predicate device," implying these criteria were met. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific "sample size" for each test in terms of number of units or replicates. For the Mouse Embryo Assay (MEA), the acceptance criterion mentions "at least 80% of the one-cell stage control embryos" which implies a set of embryos were used, but the exact number is not provided.
The data provenance is not specified. It is likely internal testing conducted by ORIGIO a/s, a CooperSurgical Company, given they are the manufacturer and submitter of the 510(k). The document does not indicate country of origin for data or if it was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This document describes the testing of a medical device (reproductive media) against established physical, chemical, and biological performance specifications, not an AI or diagnostic device that requires expert adjudication of images or clinical data. Therefore, the concept of "experts used to establish the ground truth" in the context of image interpretation or clinical diagnosis does not apply here. The "ground truth" for each test is the established scientific/regulatory standard or a biological outcome (e.g., embryo development to blastocyst stage).
4. Adjudication Method for the Test Set
Not applicable. As explained in point 3, this is not a study requiring expert adjudication of data or images. The tests described are laboratory analyses with objective endpoints.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This device is a reproductive media (hyaluronidase enzyme solution) and not a diagnostic or AI-assisted interpretation device that would involve human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
No, this is not an algorithm or AI-based device. The device itself is a chemical solution. The performance testing is a standalone evaluation of the solution's properties and efficacy as intended.
7. The Type of Ground Truth Used
The ground truth used for the tests is based on:
- Established scientific/regulatory standards: For pH (USP ), Osmolality (USP ), Sterility (USP ), and Endotoxin (USP ). Aseptic processing validation adheres to ISO standards.
- Biological efficacy defined by a specific outcome: For the Mouse Embryo Assay (MEA), the ground truth is the development of one-cell mouse embryos to the blastocyst stage within 96 hours.
- Quantitative measurement of active ingredient: For Hyaluronidase enzyme activity, the ground truth is the measured activity falling within a specified range (40-120 IU/ml), with the device specified at 80 IU/ml.
8. The Sample Size for the Training Set
Not applicable. This is not an AI or machine learning device that requires a "training set." The performance testing described evaluates the chemical and biological properties of the manufactured product.
9. How the Ground Truth for the Training Set was Established
Not applicable. Same as point 8.
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