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510(k) Data Aggregation
(27 days)
Sydney IVF PVP is intended for use as an aid in the immobilization of individual sperm cells prior to intracytoplasmic sperm injection (ICSI) procedures.
Sydney IVF PVP is a 10 % polyvinylpyrrolidine solution in a bicarbonate buffered media supplemented with 10 mg/mL Human Serum Albumin (HSA) and 0.01 mg/mL Gentamicin. Sydney IVF PVP is ready to use after equilibration to 37℃ and 6% CO2. It is designed to be used by professionals within Assisted Reproduction. This solution is an aseptically filtered sperm medium containing 10% polyvinylpyrrolidone. The PVP increases the viscosity of the solution to facilitate the capture of motile sperm for intracytoplasmic sperm injection (ICSI) procedures during Assisted Reproduction Techniques (ART) procedures. Sydney IVF PVP is provided in glass vials with FluroTec coated rubber stoppers held in place with a tamper evident seal. It is available in a 5 pack carton box with each vial containing 200 µL Sydney IVF PVP.
This document is a 510(k) premarket notification for a medical device called Sydney IVF PVP, which is a sperm immobilization medium. The purpose of the submission is to demonstrate that the new Sydney IVF PVP is substantially equivalent to a previously cleared predicate device (also named Sydney IVF PVP, K031304).
Based on the provided text, a conventional "study" to rigorously prove device performance against acceptance criteria in the manner of a clinical trial or AI model validation has not been performed or described for this specific submission. Instead, the submission relies on demonstrating substantial equivalence by comparing the technological characteristics and performance specifications of the new device to its predicate.
Here's an analysis of the requested information, understanding that "device performance" in this context refers to manufacturing and quality control parameters rather than a clinical outcome measure, and that the "study" is a stability study:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (from predicate similarity) | Reported Device Performance (from stability studies) |
|---|---|
| Endotoxin < 0.40 EU/mL | Endotoxin met criteria during stability studies. |
| Mouse Embryo Assay (MEA) for embryo toxicity | MEA met criteria ("screened the product for embryo toxicity"). |
| Sterility | Sterility met criteria during stability studies. |
| Concentrations of pyruvate (within expected range) | Pyruvate concentrations met criteria during stability studies. |
| HSA degradation by-product ammonia (within expected range) | Ammonia concentrations met criteria during stability studies. |
| Shelf-life: 20 weeks at 2-8°C | Validated to 20 weeks at 2-8°C through stability studies. |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the "sample size" for the stability studies in terms of number of lots or individual units tested for each time point or parameter. It refers to "stability studies" in the plural, implying multiple tests. The provenance of the data is implied to be from the manufacturer, William A. Cook Australia Pty Ltd. The studies are prospective in the sense that they are assessing the stability of the manufactured product over time.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable as the "ground truth" for these tests (e.g., endotoxin levels, sterility, MEA results) would be based on validated laboratory reference methods and defined thresholds, not expert consensus or clinical interpretation.
4. Adjudication method for the test set
Not applicable. Laboratory results are typically objective and either pass or fail predefined specifications.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI-powered diagnostic device, but a medical medium used in assisted reproduction.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithmic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the performance data (stability studies) is based on predefined analytical specifications and validated laboratory testing methods for parameters like endotoxin levels, sterility, and embryo toxicity (MEA).
8. The sample size for the training set
Not applicable. There is no concept of a "training set" for this type of medical device submission, as it does not involve machine learning or diagnostic algorithms.
9. How the ground truth for the training set was established
Not applicable, as there is no training set.
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