Sydney IVF Culture Oil

K170257 · William A. Cook Australia Pty. , Ltd. · MQL · Feb 24, 2017 · Obstetrics/Gynecology

Device Facts

• Record ID: K170257
• Device Name: Sydney IVF Culture Oil
• Applicant: William A. Cook Australia Pty. , Ltd.
• Product Code: MQL · Obstetrics/Gynecology
• Decision Date: Feb 24, 2017
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 884.6180
• Device Class: Class 2

Intended 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 micro-manipulation procedures.

Device Story

Sydney IVF Culture Oil is a pharmaceutical-grade mineral oil used in assisted reproduction technology (ART) laboratories. It functions as a physical barrier overlay for culture media containing gametes, zygotes, or embryos. By separating the culture media from the incubator atmosphere, the oil minimizes evaporation and reduces osmolality fluctuations, protecting the biological samples during processing and incubation. The device is provided in 50 ml glass vials as a single-use, aseptically-filtered product. It is intended for use by trained embryologists or laboratory personnel in a clinical ART setting. The primary benefit is the maintenance of a stable environment for embryo development.

Clinical Evidence

Bench testing only. A real-time shelf-life study confirmed the device meets specifications after 20 weeks of storage at 2-8°C. Key metrics: Mouse Embryo Assay (MEA) ≥80% blastocyst development at 72 hours; Endotoxin (LAL) <0.4 EU/ml (USP <85>); Sterility (USP <71>) showed no growth.

Technological Characteristics

Pharmaceutical grade mineral oil. Provided in 50 ml glass vials. Aseptically-filtered. Single-use. Shelf-life validated for 20 weeks at 2-8°C. Testing standards: USP <85> (Endotoxin), USP <71> (Sterility).

Indications for Use

Indicated for use as an oil overlay for the culture of gametes, zygotes, or embryos during assisted reproduction technology (ART) and micromanipulation procedures.

Regulatory Classification

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.).

Special Controls

*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.

Predicate Devices

• Sydney IVF Culture Oil (K022002)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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: | [phone] |
| Fax: | [phone] |
| E-mail: | [e-mail] |

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.