MINERAL OIL

K160142 · Kitazato Biopharma Co., Ltd. · MQL · Apr 21, 2016 · Obstetrics/Gynecology

Device Facts

• Record ID: K160142
• Device Name: MINERAL OIL
• Applicant: Kitazato Biopharma Co., Ltd.
• Product Code: MQL · Obstetrics/Gynecology
• Decision Date: Apr 21, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.6180
• Device Class: Class 2

Intended Use

Mineral Oil is used as an overlay for culture of embryos, oocytes, and sperm in assisted reproduction technology (ART) and micromanipulation procedures.

Device Story

Mineral Oil serves as an overlay for culture media in ART and micromanipulation procedures; prevents evaporation of small media volumes; maintains stable osmolality and pH for embryos, oocytes, and sperm. Device is a high-purity paraffin oil available in light and heavy density types; colorless, tasteless, clear, non-fluorescent. Used in clinical laboratory settings by embryologists or laboratory technicians. Product is filter-sterilized and supplied in light-resistant glass bottles. Does not directly contact gametes or embryos. Benefits include maintenance of optimal culture environment conditions, supporting embryo development.

Clinical Evidence

Bench testing only. Performance data includes: sterility (USP <71>), endotoxin (< 0.25 EU/mL), Mouse Embryo Assay (MEA >80% development at 96h), peroxide value (< 0.1 meq/kg), and readily carbonizable substance testing (USP <271>).

Technological Characteristics

High-purity paraffin oil; two types: Light (density 0.8200-0.8400 g/mL, viscosity 8.850-11.70 mm²/s) and Heavy (density 0.8500-0.8700 g/mL, viscosity 41.90-44.10 mm²/s). Filter sterilized. Packaged in light-resistant glass bottles. No electronic or software components.

Indications for Use

Indicated for use as an overlay for culture of embryos, oocytes, and sperm in assisted reproduction technology (ART) and micromanipulation procedures for patients undergoing fertility treatment.

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

• Cook, 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

April 21, 2016

KITAZATO BioPharma Co., Ltd. % Diane Sudduth RA Consultant Emergo Global Consulting, LLC 816 Congress Avenue, Suite 1400 Austin, TX 78701

Re: K160142 Trade/Device Name: Mineral Oil Regulation Number: 21 CFR§ 884.6180 Regulation Name: Reproductive Media and Supplements Regulatory Class: II Product Code: MOL Dated: January 20, 2016 Received: January 21, 2016

Dear Diane Sudduth,

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.

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You must 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 vours.

# Herbert P. Lerner -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) K160142

Device Name Mineral Oil

Indications for Use (Describe)

Mineral Oil is used as an overlay for culture of embryos, oocytes, and sperm in assisted reproduction technology (ART) and micromanipulation procedures.

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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## 510(k) Summary

## MINERAL OIL

## K160142

#### 1. Submission Sponsor

KITAZATO Biopharma Co., Ltd. 81 Nakajima Fuji Shizuoka, 416-0907 Japan Phone number: [phone] Contact: Kyoko Izumi Title: Quality Assurance Manager

#### 2. Submission Correspondent

Emergo Global Consulting, LLC 816 Congress Avenue, Suite 1400 Austin, TX 78701 Cell Phone: [phone] Office Phone: [phone] Contact: Diana Sudduth, Senior Consultant, RA Email: [e-mail]

#### 3. Date Prepared

April 12, 2016

#### 4. Device Identification

| Trade/Proprietary Name: | Mineral Oil |
|-------------------------|-----------------------------------------|
| Common/Usual Name: | Mineral Oil |
| Classification Name: | Reproductive media and supplements |
| Regulation Number: | 21 CFR 884.6180 |
| Product Code: | MQL, Reproductive media and supplements |
| Device Class: | Class II |
| Classification Panel: | Obstetrics/Gynecology |

#### 5. Legally Marketed Predicate Device(s)

Cook, Sydney IVF Culture Oil, K022002

#### 6. Device Description

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Mineral Oil is used to cover medium during embryo, oocyte, and sperm culture in assisted reproduction technology (ART) and micro-manipulation procedures. Mineral Oil is recommended for use as an overlay for a small volume of medium to prevent evaporation stable osmolality and pH.

The material composition:

High Purity Paraffin Oil comes in two density types:

- Light type has a ratio between 0.8200 to 0.8400 g/mL (15°C) and a viscosity which is between 8.850 to 11.70mm²/s (37.78°C)
- Heavy type has a ratio between 0.8500 to 0.8700 g/mL (15°C) and a viscosity which is between 41.90 to 44.10mm²/s (37.78°C).

There are two types of products, Mineral Oil - Light and Mineral Oil - Heavy. Two different unit sizes (100mL and 50mL) are available for each type. Mineral oils are colorless, tasteless, clear oil fluids which do not produce fluorescence.

Both Mineral Oils (Heavy and Light) do not contact the ova or embryo during culture. Mineral Oil is filter sterilized and dispensed into sterile light-resistant glass bottles.

#### 7. Indication for Use Statement

Mineral Oil is used as an overlay for culture of embryos, oocytes, and sperm in assisted reproduction technology (ART) and micromanipulation procedures.

#### 8. Substantial Equivalence Discussion

The following Table 1 compares the Mineral Oil to the predicate device with respect to indications for use, principles of operation, technological characteristics, and performance testing. The comparison of the devices provides more detailed information regarding the basis for the determination of substantial equivalence.

| Manufacturer | Kitazato BioPharma Co., Ltd. | Cook | Significant<br>Differences |
|----------------------|---------------------------------------|---------------------------------------|----------------------------|
| Trade Name | Mineral Oil | Sydney IVF Culture Oil | - |
| 510(k)<br>Number | K160142 | K022002 | - |
| Product Code | MQL | MQL | Same |
| Regulation<br>Number | 884.6180 | 884.6180 | |
| Regulation<br>Name | Reproductive media and<br>supplements | Reproductive media and<br>supplements | Same |

| | | | Table 1 - Comparison of Characteristics |
|--|--|--|-----------------------------------------|
| | | | |

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| Clinical | | | |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Indications for<br>Use | Mineral Oil is used as an overlay<br>for culture of embryos, oocytes,<br>and sperm in assisted<br>reproduction technology (ART)<br>and micromanipulation<br>procedures. | The Sydney IVF Culture Oil is<br>intended for use as an oil<br>overlay for culture of gametes,<br>zygotes, or embryos in assisted<br>reproduction technology (ART)<br>and micromanupulation<br>procedures. | Similar |
| Patient<br>contact | This product does not contact<br>directly with gametes/embryos<br>as it is used as an overlay for<br>culturing in culture media. | This product does not<br>contact directly with<br>gametes/embryos as it is<br>used as an overlay for<br>culturing in culture media. | Same |
| Used in similar<br>population | The product is used for fertility<br>treatment of humans | The product is used for<br>fertility treatment of humans | Same |
| Technical | | | |
| MEA | ≥ 80%<br>(96h Blastocysts) | ≥ 80% | Same |
| Endotoxin | ≤ 0.25 EU/mL<br>(USP) | < 0.4 EU/mL | Similar |
| Sterilization<br>method | Aseptic filtration sterilization | Aseptic filtration sterilization | Same |
| Storage<br>method | 8-30 °C<br>Dark storage<br>Do not freeze | 2-8 °C<br>Do not freeze | Similar |
| Shelf life | 12 months | 8 weeks | Similar |
| Content | 100 mL<br>50 mL | 200 mL<br>50 mL | Similar |
| Composition | Mineral Oil | Mineral Oil | Same |

The technological characteristics of Mineral Oil are comparable to the predicate device. The subject device does not raise any new issues of safety or effectiveness based on the similarities to the predicate device.

#### 9. Non-Clinical Performance Data

As part of demonstrating safety and effectiveness of Mineral Oil and in showing substantial equivalence to the predicate devices that are subject to this 510(k) submission, KITAZATO BIOPHARMA completed a number of non-clinical performance tests as described below:

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- Appearance (color): clear, particle free -
- -Sterility: No microbial growth from sterility testing per USP <71>
- -Endotoxin Testing: Endotoxin values conform to the value < 0.25 EU/mL
- -MEA: >80% of 1-cell control embryos develop at 96 hours
- -Peroxide value (POV): < 0.1 meq/kg
- -Readily carbonizable substance test: no discoloration, color of sulfuric acid layer paler than control per USP <271>
- -Shelf-life testing

The Mineral Oil meets all the requirements for overall design, and sterilization results confirming that the design output meets the design inputs and specifications for the device.

#### 10. Statement of Substantial Equivalence

The results of the testing described above provide a reasonable assurance that Mineral Oil is as safe and effective as the predicate device and supports a determination of substantial equivalence.