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510(k) Data Aggregation
(230 days)
Sydney IVF Cryopreservation Kit is intended for use during in vitro fertilization procedures for cryopreservation of 1-cell to 8-cell embryos.
Sydney IVF Thawing Kit is intended for use during in vitro fertilization procedures for thawing of 1-cell to 8-cell embryos.
The Sydney IVF Cryopreservation and Thawing Kits are intended for cryopreservation and thawing of 1-cell to 8-cell human embryos. The Sydney IVF Cryopreservation and Thawing Kits provide users with the ability to cryopreserve supernumerary embryos created during the in vitro fertilization procedure and then to thaw them for use at a future point in time.
The Sydney IVF Cryopreservation Kit consists of three solutions containing increasing concentrations of cryoprotectant (both propanediol and sucrose are used). These buffers were designed to be used sequentially in order to remove water from embryos prior to cryopreservation. The removal of water prevents ice crystal formation inside the embryo thereby limiting damage and improving viability. It contains 12 mg/mL Human Serum Albumin (HSA) and 0.01mg/mL Gentamicin. Sydney IVF Cryopreservation Kit is designed for use with Sydney IVF Thawing Kit.
The Sydney IVF Thawing Kit consists of four solutions with decreasing concentrations of cryoprotectants (propanediol and sucrose) which are used sequentially throughout the thawing process. It contains 12 mg/mL Human Serum Albumin (HSA) and 0.01mg/mL Gentamicin. It is designed for use with Sydney IVF Cryopreservation Kit.
Sydney IVF Cryopreservation and Thawing Kits are provided in glass vials with Fluorotec coated rubber stoppers held in place with a tamper evident seal. Sydney IVF Cryopreservation Kit is packaged in a carton box containing 2 x 10mL and 1 x 20mL solutions per kit. The Sydney IVF Thawing Kit is packaged in a carton box containing 4 x 10mL solutions per kit.
The document provided is a 510(k) premarket notification for the Sydney IVF Cryopreservation Kit and Sydney IVF Thawing Kit. It outlines the similarities and differences with a predicate device and provides performance data primarily related to stability and shelf life, rather than clinical performance or a comparative effectiveness study.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Predicate Device) | Reported Device Performance (Sydney IVF Kits) |
|---|---|
| pH 7.3 - 7.5 | pH 7.3 - 7.5 |
| Osmolality 285 - 295 mOsm/kg | Osmolality 285 - 295 mOsm/kg |
| Endotoxin < 0.40 EU/mL | Endotoxin < 0.40 EU/mL |
| Sterility | Sterility |
| Mouse Embryo Assay (MEA): 1-cell MEA (96hrs) with ≥75% of control that develop to blastocyst | Mouse Embryo Assay (MEA): 2-cell MEA (72hrs) with ≥80% of control that develop to blastocyst |
| Shelf life: 6 weeks at 2-8°C | Shelf life: 20 weeks at 2-8°C |
Note: The document states that the product specifications for sterility, pH, osmolality, and endotoxin are the same for the proposed device and the predicate. The MEA test assay and specification have changed, as noted in the table.
2. Sample Size Used for the Test Set and Data Provenance
The document does not detail a specific "test set" for clinical performance. The studies mentioned are primarily stability studies and Mouse Embryo Assays (MEA).
- Sample Size: Not specified for the MEA or stability tests. The MEA mentions "control", but the number of embryos or replicates isn't provided.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). The submitting company is William A. Cook Australia Pty Ltd. The studies appear to be laboratory-based rather than clinical trials with human subjects.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. The document describes laboratory testing (MEA, stability) with defined endpoints and specifications, rather than a clinical study requiring expert assessment for ground truth.
4. Adjudication Method for the Test Set
Not applicable, as there's no mention of a human expert test set or adjudication process for the described studies.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document explicitly states: "The results of the testing provide reasonable assurance that the Sydney IVF Cryopreservation Kit & Sydney IVF Thawing Kit is as safe and effective as the predicate device and supports a determination of substantial equivalence." This indicates a non-clinical comparison for substantial equivalence, not a comparative effectiveness study with human readers/users. Therefore, no effect size for human readers with/without AI assistance is provided.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance
Not applicable. This device is a medical kit (media and reagents) used in IVF procedures, not an algorithm or AI-driven diagnostic device.
7. Type of Ground Truth Used
For the Mouse Embryo Assay (MEA), the "ground truth" is defined by the objective outcome measure: the percentage of control embryos that develop to blastocyst. For stability studies, it involves objective measurements of pH, osmolality, endotoxin, sterility, and concentrations of specific substances.
8. Sample Size for the Training Set
Not applicable. This device is a medical kit, not a machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As above, this is not a machine learning device.
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