Cryotop US

K153027 · Kitazato Biopharma Co., Ltd. · MQK · Mar 14, 2016 · Obstetrics/Gynecology

Device Facts

• Record ID: K153027
• Device Name: Cryotop US
• Applicant: Kitazato Biopharma Co., Ltd.
• Product Code: MQK · Obstetrics/Gynecology
• Decision Date: Mar 14, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.6160
• Device Class: Class 2

Indications for Use

The Cryotop®US is a cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human 4-8 cell and blastocyst stage embryos.

Device Story

Cryotop®US is a single-use, sterile cryopreservation storage device for human embryos. It consists of an ABS handle shaft with a PET film tip for embryo loading and a polypropylene straw enclosure. During vitrification, embryos are loaded onto the film tip; the tip is then inserted into the straw enclosure, creating a hermetic seal that isolates the embryos from liquid nitrogen. The device is used in clinical laboratory settings by embryologists. The straw includes a weighted distal end for proper orientation in storage containers. By maintaining embryo integrity during freezing and thawing, the device facilitates successful cryopreservation, supporting assisted reproduction procedures.

Clinical Evidence

Bench testing only. Testing included cooling/warming rate verification, dimensional analysis, durability (liquid nitrogen immersion), mechanical tensile strength (5N), endotoxin levels (≤0.5 EU/device), sterility (no microbial growth), and mouse embryo assay (≥80% development at 96 hours). Shelf life and package integrity were also validated.

Technological Characteristics

Materials: ABS handle, PET film tip, polypropylene straw. Dimensions: specified outer diameter and length. Energy: passive storage in liquid nitrogen. Sterilization: radiation (SAL 10^-6). Single-use. Closed system design with hermetic seal.

Indications for Use

Indicated for use in vitrification procedures to contain and maintain human 4-8 cell and blastocyst stage embryos.

Regulatory Classification

Identification

Assisted reproduction labware consists of laboratory equipment or supplies intended to prepare, store, manipulate, or transfer human gametes or embryos for in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), or other assisted reproduction procedures. These include syringes, IVF tissue culture dishes, IVF tissue culture plates, pipette tips, dishes, plates, and other vessels that come into physical contact with gametes, embryos or tissue culture media.

Special Controls

*Classification.* Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, and clinical testing). The device, when it is a dish or plate intended for general assisted reproduction technology procedures, 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

• CRYOLOCK™ (K122982)

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

March 14, 2016

KITAZATO BioPharma Co., Ltd. % Richard A. Vincins, CBA, CQA, RAC (US,EU) Vice President, Quality Assurance Emergo Global Consulting, LLC 816 Congress Avenue, Suite 1400 Austin, TX 78701

Re: K153027

> Trade/Device Name: Cryotop® US Regulation Number: 21 CFR§ 884.6160 Regulation Name: Assisted Reproduction Labware Regulatory Class: II Product Code: MOK Dated: February 9, 2016 Received: February 12, 2016

Dear Richard A. Vincins.

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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# Page 2 - Richard A. Vincins, CBA, CQA, RAC (US,EU)

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) K153027

Device Name Cryotop®US

Indications for Use (Describe)

The Cryotop®US is a cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human 4-8 cell and blastocyst stage embryos.

| 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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# 510(k) Summary

# Cryotop®US

# K153027

#### 1. Submission Sponsor

KITAZATO BioPharma Co., Ltd.

81 Nakajima, Fuji-city

Shizuoka 416-0907

JAPAN

Phone number: +(81) 545-66-2202

Contact: Futoshi Inoue

Title: President

#### 2. Submission Correspondent

Emergo Global Consulting, LLC

816 Congress Avenue, Suite 1400

Austin, TX 78701

Office Phone: (512) 327 - 9997

Contact: Richard A. Vincins, Vice President, Quality Assurance/Regulatory Affairs

Email: [e-mail]

#### 3. Date Prepared

March 9, 2016

#### 4. Device Identification

| Trade/Proprietary Name: | Cryotop®US |
|-------------------------|---------------------------------|
| Common/Usual Name: | Cryopreservation Storage Device |
| Classification Name: | Assisted Reproduction Labware |
| Regulation Number: | 884.6160 |

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Product Code:

Device Class: Class II

Classification Panel: Obstetrics/Gynecology

MOK

### 5. Legally Marketed Predicate Device

K122982, CRYOLOCK™, BioTech Inc.

#### 6. Device Description

CryotopUS is a cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human 4-8 cell and blastocyst stage embryos. As part of the vitrification procedure, the cells to be stored are loaded on the tip of the CryotopUS device for subsequent storage.

The CryotopUS device is composed of an acrylonitrile butadiene styrene (ABS) handle shaft with a polyethylene terephthalate (PET) film tip and a polypropylene straw enclosure. The fine tip has a flat film area for loading embryos. The CryotopUS device has a "straw" enclosure system for when the unit is placed in the liquid nitrogen. The handle shaft is designed with a "stop" for inserting the film tip/shaft handle into the straw enclosure. A hermetic seal is created via a tapered shaft handle with a stop location integrated into the handle is placed into the straw enclosure this creates a closed system keeping the film tip isolated from the liquid nitrogen. The straw enclosure system has a weight at the distal end to place the straw and the shaft inside in a correct position in the liquid nitrogen. The CryotopUS device is provided sterile and is for single use only. The CryotopUS device has been designed to maintain the integrity of the human embryos through the freezing and thawing process.

#### 7. Indication for Use Statement

The Cryotop®US is a cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human 4-8 cell and blastocyst stage embryos.

#### 8. Substantial Equivalence Discussion

The following Table 1 compares the CryotopUS 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.

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| Manufacturer | Kitazato BioPharma Co.,<br>Ltd. | BioTech Inc. | Significant<br>Differences |
|---------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|
| Trade Name | Cryotop®US | CRYOLOCK™ | |
| 510(k) Number | Not assigned | K122982 | |
| Product Code | MQK | MQK | Same |
| Regulation Number | 884.6160 | 884.6160 | Same |
| Regulation Name | Assisted Reproduction<br>Labware | Assisted Reproduction<br>Labware | Same |
| Indications for Use | The Cryotop®US is a<br>cryopreservation storage<br>device that is intended<br>for use in vitrification<br>procedures to contain<br>and maintain human 4-8<br>cell and blastocyst stage<br>embryos | The CRYOLOCK™ is a<br>cryopreservation storage<br>device that is intended<br>for use in Vitrification<br>procedures to contain<br>and maintain human 1-<br>cell stage embryos | Similar; the<br>indications for use are<br>both for the<br>vitrification and<br>storage of human<br>embryos. |
| Mechanism of Action | Vitrification Method | Vitrification Method | Same |
| Technology<br>Overview | The CryotopUS is<br>designed to contain,<br>freeze and maintain<br>embryos. The device<br>consists of a two piece<br>assembly comprised of<br>the main part containing<br>the fine tip film area and<br>the "straw." The handle<br>shaft and straw are<br>designed to be closed<br>system. The straw is<br>weighted to allow proper<br>alignment in the storage<br>container. The<br>CryotopUS device is<br>packaged in a single<br>barrier sterilization<br>pouch. | The Cryolock is designed<br>to contain, freeze and<br>maintain embryos. The<br>device is a square shape<br>stick with four flat<br>surfaces. The device is<br>composed of two piece<br>assembly with the main<br>part for the embryo<br>placement and the<br>handle shaft and cap<br>designed to be a closed<br>system. The CryoLock<br>device is packaged in a<br>single barrier sterilization<br>pouch. | Same |
| Manufacturer | Kitazato BioPharma Co.,<br>Ltd. | BioTech Inc. | Significant<br>Differences |
| Trade Name | Cryotop®US | CRYOLOCK™ | |
| Material<br>Composition | PET, ABS, Polypropylene | PET, Polypropylene | Similar; both devices are made of medical grade plastics that are commonly used. |
| Sterile | Radiation, SAL 10-6 | Radiation, SAL 10-6 | Same |
| Single-Use | Yes | Yes | Same |
| Shelf Life | 3 years | 3 years | Same |
| Cooling Rate | 3,000°C/min | 1,494°C/min | Different; though the cooling rate is different, non-clinical performance testing from both devices support intended use. |
| Rewarming Rate | 44,000°C/min | 21,000°C/min | Different; though the warming rate is different, non-clinical performance testing from both devices support intended use. |
| Contact with<br>Warming Medium | The tip (film) and the shaft of CryotopUS are taken out from the straw. Directly immerse the tip (film) into thawing solution | The tip (film) and the shaft of Cryolock are taken out from the body. Directly immerse the tip (film) into thawing solution. | Same |
| Performance Testing | Passed | Passed | Same |
| Mouse Embryo<br>Testing | Passed | Passed | Same |
| Sterility Validation<br>Testing | Passed | Passed | Same |

## Table 1– Comparison of Characteristics

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The technological characteristics of the CryotopUS 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.

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#### 9. Non-Clinical Performance Data

As part of demonstrating substantial equivalence to the predicate device, Kitazato BioPharma completed a number of non-clinical performance tests. The CryotopUS device meets all the requirements for overall design, sterilization, and performance testing results, confirming that the design output meets the design inputs and specifications for the device.

The CryotopUS device passed all the testing in accordance with internal requirements and applicable standards that is shown below to support substantial equivalence of the subject device:

- . Cooling Rate Testing: Cooling rate of 3,000 °C/min passed
- . Warming Rate Testing: Warming rate of 44,000 °C/min passed
- Dimensional Testing: Passes outer diameter and length according to specifications
- . Durability Testing: No burst or liguid nitrogen inside the straw after 30 second immersion
- . Mechanical Tensile Testing: Tensile strength to withstand 5N
- . Endotoxin Testing: Endotoxin values conform to the value ≤0.5 EU/device
- . Sterility Testing: No microbial growth from sterility testing
- . Mouse Embryo Assay: ≥80% of 1-cell control embryos develop at 96 hours
- . Shelf life testing
- . Package integrity testing

Note: The performance testing, Mouse Embryo Assay (MEA), and sterility test are all performed on samples from routine manufactured lots; a Certificate of Analysis is provided with each lot of CryotopUS device.

#### 10. Conclusion

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