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Blastocyst Vitrification Kit is intended for the vitrification of human blastocysts for assisted reproduction technologies (ART). This kit is designed for use with Blastocyst Warming Kit (K-SIBW-5000).

Blastocyst Warming Kit is intended for the warming of human blastocysts that have undergone vitrification using COOK Sydney IVF Vitrification Kit (K-SIBV-5000) for ART procedures.

COOK Sydney IVF Blastocyst Vitrification and Warming Kits are intended for the vitrification and warming of human blastocysts as part of human ART procedures. The COOK Sydney IVF Blastocyst Vitrification and Warming Kits provide users with the ability to cryopreserve supernumerary embryos created during the in vitro fertilization procedure and then to re-warm them for use at a future point in time.

The COOK Sydney IVF Blastocyst Vitrification Kit (K-SIBV-5000) consists of a series of 2-[4-(2-hydroxyethyl)piperazin1-yl] ethanesulfonic acid (HEPES)-buffered, physiological solutions containing increasing concentrations of functional cryoprotectants to which the embryo is sequentially exposed during cryopreservation. The first three solutions in the kit are all based upon the same formulation (known as "Cryobase buffer"), which is a 10 mM HEPES buffered media containing 20 mg/mL Human Serum Albumin (HSA) and 0.01 mg/mL Gentamicin. The fourth solution in the kit is dimethyl sulfoxide (DMSO) and does not contain HSA or Gentamicin. The DMSO is provided for the practitioner to add to Solution 2 and Solution 3 of the vitrification kit, as described in the Instructions for Use.

COOK Sydney IVF Blastocyst Warming Kit (K-SIBW-5000) consists of three solutions which are used sequentially throughout the warming process. The three media in the kit are all based upon the same formulation of Cryobase buffer, a 10 mM HEPES buffered media containing 20 mg/mL HSA and 0.01 mg/mL Gentamicin.

The COOK Sydney IVF Blastocyst Vitrification and Warming Kits are single use, sterile (aseptic filtration) devices.

These solutions contact the blastocyst during the vitrification and re-warming process. The solutions are removed by washing prior to embryo transfer back to the patient and are therefore non-patient contacting.

The provided document describes the COOK Sydney IVF Blastocyst Vitrification Kit and COOK Sydney IVF Blastocyst Warming Kit, and its comparison to a predicate device (K082363). The primary purpose of the submission is to justify an extended shelf-life from 8 weeks to 20 weeks for the updated device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document outlines performance specifications that are considered acceptance criteria for the device. The reported performance of the proposed device is stated to be the same as the predicate device for these parameters.

2. Sample Size Used for the Test Set and Data Provenance:

The document mentions that the shelf-life was validated "in stability studies." However, it does not provide any specific sample sizes for these stability studies (e.g., number of batches, number of vials tested per time point).

Regarding data provenance, the document does not explicitly state the country of origin for the data or whether the study was retrospective or prospective. Given that the manufacturer is William A. Cook Australia Pty Ltd and the submission is to the US FDA, it's likely the studies were conducted by the manufacturer, potentially in Australia or in collaboration with other labs. The nature of stability studies (testing products over time) inherently makes them prospective in terms of data collection from manufactured lots.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This information is not provided in the document. For device components like reproductive media, the "ground truth" for performance parameters (pH, osmolality, endotoxin, MEA) is typically established by laboratory testing against defined scientific standards and biological assays, not by expert consensus in the way a diagnostic imaging device might use radiologists. The MEA (Mouse Embryo Assay) is a biological test performed by trained embryologists or laboratory technicians, but the document doesn't specify the number or qualifications of these individuals involved in establishing the "ground truth" (i.e., the control performance).

4. Adjudication Method for the Test Set:

This information is not applicable to the type of device and testing described. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or performance evaluations where human interpretation of medical images or patient outcomes requires reconciliation among experts. For laboratory performance characteristics and stability testing of media, the results are quantitative and directly measured (e.g., pH, osmolality) or rely on established biological assay endpoints (e.g., MEA, sterility), not subjective expert judgment that requires adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance:

This information is not applicable and not present in the document. MRMC studies are relevant to diagnostic imaging devices or AI-assisted interpretation where human readers (e.g., radiologists) are involved in making decisions, and the AI's impact on their performance is being evaluated. The COOK Sydney IVF Blastocyst Vitrification and Warming Kits are reproductive media, not an AI diagnostic tool.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

This information is not applicable as the device is not an algorithm or AI. The performance evaluation focuses on the chemical and biological integrity of the media itself.

7. The Type of Ground Truth Used:

For the performance parameters and stability studies, the "ground truth" is established through:

• Laboratory measurements: For physical and chemical properties like pH, osmolality.
• Microbiological testing: For endotoxin and sterility.
• Biological assays: Specifically, the Mouse Embryo Assay (MEA), which is a standard biological control test to ensure that culture media and components are non-toxic and support embryonic development.
• Chemical assays: For concentrations of specific components like amino acids, pyruvate, ammonia, and HSA.

8. The Sample Size for the Training Set:

This information is not applicable and not provided. "Training set" refers to data used to train machine learning models. This device is not an AI/ML product. The document describes laboratory testing for product quality and stability.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable as there is no training set for an AI/ML model for this device. The ground truth for the device's characteristics (as outlined in point 7) is established through established laboratory methods and specifications.

In summary of the study proving the device meets acceptance criteria:

The primary study detailed (though without specific numerical sample sizes) is a stability study designed to validate the extended shelf-life of 20 weeks. This study involved testing critical device characteristics—pH, osmolality, endotoxin, MEA, sterility, and concentrations of specific chemical components (amino acids, pyruvate, ammonia, HSA)—over time at the specified storage conditions (2-8°C). The "conclusion" section states that "The results of the testing provide reasonable assurance that the COOK Sydney IVF Blastocyst Vitrification Kit & COOK Sydney IVF Blastocyst Warming Kit is as safe and effective as the predicate device and supports a determination of substantial equivalence." This implies that the measured values for these parameters remained within acceptable limits for the entire 20-week period, demonstrating that the device maintains its performance specifications for the extended shelf life.

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