(28 days)
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 micro-manipulation procedures.
Sydney IVF Culture Oil is designed to protect gametes and embryos during ART processing by providing a barrier between the embryo culture media and the air, thereby minimizing evaporation, and reducing fluctuations in osmolality. Sydney IVF Culture Oil consists of pharmaceutical grade mineral oil.
Sydney IVF Culture Oil is provided in glass vials (50 ml). This product is a single use, aseptically-filtered device.
The Sydney IVF Culture Oil is intended for use as an oil overlay for the culture of gametes, zygotes, or embryos in assisted reproduction technology (ART) and micromanipulation procedures. The study was conducted to expand the shelf-life of the device from 90 days to 20 weeks when stored at 2-8℃.
Here's a breakdown of the acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance (After 20 weeks at 2-8°C) |
|---|---|
| Mouse Embryo Assay (MEA): ≥80% 2-cell embryos expanded to blastocysts at 72 hours | Met (Specific percentage not provided, but stated as "met the following specifications") |
| Endotoxin (LAL): | Met (Specific value not provided, but stated as "met the following specifications") |
| Sterility: No growth in accordance with USP | Met (Specific observation not provided, but stated as "met the following specifications") |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify the exact number of units of Sydney IVF Culture Oil tested for the shelf-life study. It refers to a "real-time shelf-life study."
- Data Provenance: The study was conducted by William A. Cook Australia Pty Ltd in Australia. It is a prospective, real-time shelf-life study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. This device is not an AI/imaging diagnostic device requiring expert interpretation for ground truth. The acceptance criteria are based on standardized laboratory assays (MEA, LAL, Sterility).
4. Adjudication Method for the Test Set
Not applicable. As noted above, the ground truth is established by objective laboratory assays, not expert consensus requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. This device is a culture oil, not an AI diagnostic tool, and therefore human reader performance is not relevant.
6. Standalone Performance
Yes, a standalone performance study was done in the form of a real-time shelf-life study. This study evaluated the performance of the device (Sydney IVF Culture Oil) itself against pre-defined specifications without human intervention or interpretation as part of the primary outcome.
7. Type of Ground Truth Used
The ground truth used for the acceptance criteria are:
- Mouse Embryo Assay (MEA): A biological assay, an established standard for assessing the suitability of materials for embryo culture, providing an objective measure of embryo development.
- Endotoxin (LAL): A chemical assay (Limulus Amebocyte Lysate assay), a standard method for detecting bacterial endotoxins.
- Sterility: A microbiological test, an established standard for confirming the absence of viable microorganisms.
8. Sample Size for the Training Set
Not applicable. This device is not an AI/machine learning device that requires a training set. The study pertains to the physical and biological stability of a manufactured product over time.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
§ 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.