PBS(-), Phosphate Buffered Saline

K160863 · Kitazato Biopharma Co., Ltd. · MQL · Jul 28, 2016 · Obstetrics/Gynecology

Device Facts

• Record ID: K160863
• Device Name: PBS(-), Phosphate Buffered Saline
• Applicant: Kitazato Biopharma Co., Ltd.
• Product Code: MQL · Obstetrics/Gynecology
• Decision Date: Jul 28, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.6180
• Device Class: Class 2

Intended Use

PBS(-), Phosphate Buffered Saline is intended for use in assisted reproductive procedures that involve the manipulation of gametes and embryos. These procedures include oocyte retrieval from ex vivo ovarian tissues, short term oocyte maintenance, and handling of fertilized embryos prior to embryo transfer.

Device Story

PBS(-) is a colorless, isotonic, buffered saline solution used in assisted reproductive technology (ART) laboratories. It serves as a medium for the manipulation of gametes and embryos, including oocyte retrieval from ex vivo ovarian tissues, short-term maintenance, and handling of fertilized embryos prior to transfer. The solution is provided in 100mL and 500mL PETG bottles with HDPE caps. It is intended for use by trained embryologists or clinical staff in a laboratory setting. By providing a controlled, physiological environment (pH 7.20-7.60; osmolality 279-295 mOsm/kg), the device supports the viability of gametes and embryos during clinical procedures, facilitating successful ART outcomes.

Clinical Evidence

Bench testing only. Testing included color, pH (7.20-7.60), osmolality (279-295 mOsm/kg), endotoxin (<0.25 EU/mL), sterility, and 1-cell Mouse Embryo Assay (MEA). MEA results showed ≥80% development to blastocyst at 96 hours. Shelf-life testing confirmed specifications maintained over six months.

Technological Characteristics

Isotonic buffered solution containing sodium chloride, potassium chloride, monopotassium phosphate, and di-sodium hydrogen phosphate anhydrous. pH 7.20-7.60; osmolality 279-295 mOsm/kg. Packaging: PETG bottle with HDPE cap. Sterility: Not specified (implied sterile).

Indications for Use

Indicated for use in assisted reproductive technology (ART) procedures involving gamete and embryo manipulation, including oocyte retrieval, short-term maintenance, and handling of fertilized embryos prior to transfer.

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

• Irvine Scientific, PBS 1X (K991342)

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

July 28, 2016

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

Re: K160863

> Trade/Device Name: PBS(-), Phosphate Buffered Saline Regulation Number: 21 CFR§ 884.6180 Regulation Name: Reproductive Media and Supplements Regulatory Class: II Product Code: MOL Dated: June 23, 2016 Received: June 27, 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.

# Benjamin R. Fisher -S

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) K160863

Device Name PBS(-), Phosphate Buffered Saline

#### Indications for Use (Describe)

PBS(-), Phosphate Buffered Saline is intended for use in assisted reproductive procedures that involve the manipulation of gametes and embryos. These procedures include oocyte retrieval from ex vivo ovarian tissues, short term oocyte maintenance, and handling of fertilized embryos prior to embryo transfer.

| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| <span style="font-size: 10pt;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size: 10pt;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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# 510(k) Summary (K160863)

#### 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 Regulatory Consultant Email: [e-mail]

#### 3. Date Prepared

07/27/2016

#### 4. Device Identification

| | Trade/Proprietary Name: PBS(-), Phosphate Buffered Saline |
|-----------------------|-----------------------------------------------------------|
| Common/Usual Name: | Phosphate Buffered Saline |
| 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)

Irvine Scientific, PBS 1X (K991342)

#### 6. Device Description

Phosphate Buffered Saline [PBS(-)] is a colorless isotonic buffered solution with a pH of 7.20-7.60.

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PBS(-) composition:

- Sodium Chloride
- · Potassium Chloride
- Monopotassium phosphate
- Di-sodium Hydrogen Phosphate Anhydrous

PBS(-) will be available in volumes of 100mL and 500mL. Packaging for PBS(-) consist of a PETG (Polyethylene Terephtalate Glycol-modified) bottle and HDPE (High Density Polyethylene) cap. PBS(-) has a six-month shelf-life.

## 7. Indication for Use

PBS(-). Phosphate Buffered Saline is intended for use in assisted reproductive procedures that involve the manipulation of gametes and embryos. These procedures include oocyte retrieval from ex vivo ovarian tissues, short term oocyte maintenance, and handling of fertilized embryos prior to embryo transfer.

### 8. Substantial Equivalence Discussion

Differences exist in the indications for use between the predicate and subject devices. Specifically, the predicate device is indicated for additional ART procedures (embryo transfer). This difference represents a narrower indication for use for the subject device and does not represent a new intended use as both devices are used for manipulation of gametes and embryos during ART procedures.

The subject and predicate devices have the same fundamental technological characteristics. Both are buffered solutions with similar pH and osmolality ranges meeting the physiological requirements of gametes and embryos. Although there are differences in the formulations of these devices, the differences do not represent a new technology as they do not raise different questions of safety and effectiveness.

#### 9. Performance Data

Non-clinical performance testing demonstrated that all product specifications were met as follows:

| ASSAY | SPECIFICATIONS |
|------------|----------------------------------------|
| Color | Clear, Particle Free |
| pH | 7.20-7.60 |
| Osmolality | 279-295mOsm/kg |
| Endotoxin | <0.25 EU/mL |
| Sterility | No Microbial Growth |
| 1-cell MEA | ≥80% developed to blastocyst at 96 hrs |

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Shelf-life testing demonstrated that PBS(-) maintained all specifications at the end of the sixmonth shelf-life period.

## 10. Conclusion

The subject and predicate devices have the same intended use and fundamental technological characteristics. The differences in technological characteristics do not raise different types of questions and can be assessed by bench performance testing. Performance data demonstrated that the subject device is substantially equivalent to the predicate device in terms of safety and effectiveness.