(54 days)
The Sydney IVF Culture Oil is intended for use as an oil overlay for culture of gametes, zygotes, or embryos in assisted reproduction technology (ART) and micromanipulation procedures.
Sydney IVF Culture Oil consists of colorless mineral oil, and is provided in glass vials with silicone rubber stoppers. The Sydney IVF Culture Oil will be available in 200 mL fill volumes.
The provided text describes a 510(k) premarket notification for the "Sydney IVF Culture Oil" device. However, it does not include detailed information regarding specific acceptance criteria, a formal study design, or quantitative performance data typically associated with studies demonstrating a device meets acceptance criteria.
The document primarily focuses on establishing substantial equivalence to a predicate device. It states, "The Sydney IVF Culture Oil was subjected to testing to assure satisfactory operating performance. The Sydney IVF Culture Oil passed the requirements of all tests." This is a general statement and lacks the specificity required to answer most of your detailed questions.
Therefore, for many of your points, the answer will be that the information is not provided in the given text.
Here's a breakdown based on the information available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated (general requirement to assure satisfactory operating performance) | "Passed the requirements of all tests." "Similar, with respect to intended use and technological characteristics, to the FDA published predicate device description." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not provided.
- Data Provenance: Not provided (e.g., country of origin, retrospective/prospective). While the device name includes "Sydney IVF," the document does not specify where the testing data originated or its nature (e.g., in-vitro studies, animal studies, human clinical data).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- This type of information is not applicable to the submission for this device. The submission does not describe a study involving expert assessment of a test set to establish ground truth. The device is a culture oil, not an diagnostic imaging device or an AI algorithm requiring human interpretation.
4. Adjudication Method for the Test Set
- Not applicable. See point 3.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size.
- No, an MRMC study was not done. This type of study is relevant for diagnostic devices where human readers interpret data, often with or without AI assistance. This device is a culture oil for IVF procedures.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done.
- Not applicable. This device is a culture oil, not an algorithm.
7. The Type of Ground Truth Used
- Not explicitly stated in terms of "ground truth" as typically understood in diagnostic studies. The "tests" mentioned likely refer to quality control tests relevant to a culture medium, such as sterility, pH, osmolality, and possibly performance in culturing gametes/embryos, but the specific metrics are not detailed. The "ground truth" would be objective measurements against predefined specifications for these quality parameters.
8. The Sample Size for the Training Set
- Not applicable. This device is a culture oil, not a machine learning model that requires a training set.
9. How the Ground Truth for the Training Set was Established
- Not applicable. See point 8.
Summary of Device and Approval:
The submission K022002 for "Sydney IVF Culture Oil" is a 510(k) premarket notification. The core of this submission is to demonstrate substantial equivalence to an already legally marketed predicate device (63 FR 48428, September 10, 1998, a reproductive media and supplement). The review process determined that the device is substantially equivalent based on intended use and technological characteristics. The document mentions that testing was conducted and the device "passed the requirements of all tests" to assure satisfactory operating performance, but it does not provide specifics about these tests, the acceptance criteria, or the study design and results in detail. This type of submission generally relies more on comparing the new device's specifications and performance to known characteristics of the predicate rather than presenting extensive, detailed clinical trials or performance studies with defined acceptance criteria in the way you've outlined.
§ 884.6180 Reproductive media and supplements.
(a)
Identification. Reproductive media and supplement are products that are used for assisted reproduction procedures. Media include liquid and powder versions of various substances that come in direct physical contact with human gametes or embryos (including water, acid solutions used to treat gametes or embryos, rinsing solutions, sperm separation media, supplements, or oil used to cover the media) for the purposes of preparation, maintenance, transfer or storage. Supplements are specific reagents added to media to enhance specific properties of the media (e.g., proteins, sera, antibiotics, etc.).(b)
Classification. Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, biocompatibility testing, and clinical testing). The device, when it is phosphate-buffered saline used for washing, and short-term handling and manipulation of gametes and embryos; culture oil used as an overlay for culture media containing gametes and embryos; and water for assisted reproduction applications, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.