(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): <0.4 EU/ml in accordance with USP <85> | Met (Specific value not provided, but stated as "met the following specifications") |
| Sterility: No growth in accordance with USP <71> | 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.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 24, 2017
William A. Cook Australia Pty Ltd Gordana Pozvek, Ph.D. Senior Regulatory Affairs Specialist 95 Brandl Street Eight Mile Plains OLD 4113 Australia
K170257 Re:
Trade/Device Name: Sydney IVF Culture Oil Regulation Number: 21 CFR 884.6180 Regulation Name: Reproductive media and supplements Regulatory Class: Class II Product Code: MQL Dated: January 24, 2017 Received: January 27, 2017
Dear Dr. Gordana Pozvek:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must
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comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Charles Viviano -S
For Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K170257
Device Name Sydney IVF Culture Oil
Indications for Use (Describe)
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.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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K170257 Page 1 of 2
COOK®
MEDICAL
WILLIAM A. COOK AUSTRALIA PTY. LTD. 95 BRANDL STREET BRISBANE TECHNOLOGY PARK, EIGHT MILE PLAINS BRISBANE, QLD 4113, AUSTRALIA PHONE: 1800,777,222 FAX: +61,7,3841,1288 WWW.COOKMEDICAL.COM
510(k) Summary - K170257
SUBMITTED BY:
William A. Cook Australia Pty Ltd 95 Brandl Street Eight Mile Plains QLD 4113 Australia
| Contact Person: | Gordana Pozvek, Ph.D. |
|---|---|
| Tel: | +61 (7) 3841 1188 |
| Fax: | +61 (7) 3841 3905 |
| E-mail: | Gordana.Pozvek@CookMedical.com |
Date Prepared: February 24, 2017
DEVICE IDENTIFICATION:
| Trade Name: | Sydney IVF Culture Oil |
|---|---|
| Common Name: | IVF Culture Oil |
| Regulation No: | 21 CFR 884.6180, Reproductive Media and Supplements |
| Regulatory Class: | II |
| Product Code: | MQL - Media, Reproductive |
PREDICATE DEVICE:
Sydney IVF Culture Oil (K022002)
The predicate device has not been subject to a design related recall.
DEVICE DESCRIPTION:
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.
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INDICATIONS FOR USE:
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.
COMPARISON OF INTENDED USE AND TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE:
Sydney IVF Culture Oil has the same Indications for Use as the predicate device cleared under K022002. Therefore, the intended use of the subject device is the same as the predicate device.
Sydney IVF Culture Oil has similar technological characteristics to the predicate device. This 510(k) was submitted to expand the shelf-life from 90 days (predicate device shelf-life) to 20 weeks when stored at 2-8℃. The difference between subject and predicate devices does not impact substantial equivalence, as it does not raise different questions of safety and effectiveness.
PERFORMANCE DATA:
A real-time shelf-life study was conducted to demonstrate that the Sydney IVF Culture Oil met the following specifications at time zero (0) and after 20 weeks of storage at 2 - 8 °C:
- Mouse Embryo Assay (MEA): ≥80% 2-cell embryos expanded to blastocysts at 72 hours
- Endotoxin (LAL): <0.4 EU/ml in accordance with USP <85>
- Sterility: No growth in accordance with USP <71> ●
CONCLUSION:
The results of the testing demonstrate that the Sydney IVF Culture Oil is as safe and effective as the predicate device, and supports a determination of substantial equivalence.
§ 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.