CRYOTOP

K112695 · Kitazato Biopharma Co;Ltd · MQK · Dec 12, 2012 · Obstetrics/Gynecology

Device Facts

• Record ID: K112695
• Device Name: CRYOTOP
• Applicant: Kitazato Biopharma Co;Ltd
• Product Code: MQK · Obstetrics/Gynecology
• Decision Date: Dec 12, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.6160
• Device Class: Class 2

Indications for Use

The Cryotop®CL 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

CryotopCL is a sterile, single-use cryopreservation storage device for human embryos. It consists of a PET plastic shaft with a fine tip featuring five depressed areas for embryo loading, a protective straw enclosure, and a pushing tool. During vitrification, embryos are loaded onto the tip, which is then inserted into the straw enclosure and heat-sealed by the user. The straw is weighted for alignment in storage containers. The device is used in clinical laboratory settings by embryologists. It facilitates the rapid cooling and rewarming of embryos during cryopreservation, helping to maintain embryo viability for future use.

Clinical Evidence

No clinical data was required. Substantial equivalence is supported by non-clinical bench testing, including cooling/warming rate verification, mechanical tensile strength testing (5N), dimensional analysis, endotoxin testing (≤0.5 EU/device), and Mouse Embryo Assay (≥80% development of 1-cell control embryos at 96 hours). Sterility was validated to SAL 10^-6.

Technological Characteristics

Materials: PET and Polypropylene. Form factor: Three-piece assembly (shaft with fine tip, straw, pushing tool). Cooling rate: 3,000°C/min. Rewarming rate: 40,000°C/min. Sterilization: Radiation. Single-use, sterile.

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

• Cryo Bio System, HSV Straw (K092398)

Submission Summary (Full Text)

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# 510(k) Summary

# DEC 1 2 2012

for

# Kitazato's Cryotop®CL, K112695

### 1. Submission Sponsor

KITAZATO BioPharma Co., Ltd. 81 Nakajima, Fuji Shizuoka 416-0907 JAPAN Phone: +(81) 545-66-2202 Fax: +(81) 545-60-5772 Contact: Futoshi Inoue, President

#### Submission Correspondent 2.

Emergo Group 611 West 5th Street, Third Floor Austin, TX 78701 Cell Phone: [phone] Office Phone: [phone] Fax: [phone] Contact: Richard Vincins, Vice President, QA Email: [e-mail]

#### 3. Date Prepared

7 December 2012

#### 4. Device Name

Cryotop®CL Trade/Proprietary Name: Cryotop Closed Common/Usual Name: Classification Name: Assisted Reproduction Labware Classification Regulation: 884.6160 Obstetrics/Gynecology Classification Panel: Product Code: MQK Device Class: ll

### 5. Predicate Devices

Cryo Bio System, HSV Straw, K092398

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#### Device Description 6.

CryotopCL 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.

The CryotopCL device is composed of PET plastic shaft with a fine tip and a straw cap. The fine tip has 5 rounded depressed areas for loading embryos. The CryotopCL device has a "straw" enclosure system for when the unit is placed in the liquid nitrogen. The straw cap is designed to be heat sealed by the user. The protective straw cap has a weighted end to allow proper alignment in the storage container. The CryotopCL device is provided sterile and is for single use only. The device is also provided with a pushing straw to aid in loading the sample holding component of the device into the "straw" enclosure system.

The CryotopCL device conforms to product quality test specifications of our company: appearance, dimension, durability, tensile strength, colorfastness, endotoxin and Mouse Embryo Assay. The sterilization dose of CryotopCL is validated by sterilization validation to maintain the sterility of the device through anticipated storage and handling.

#### 7. Indication for Use

The Cryotop®CL 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. Technological Characteristics and Substantial Equivalence

The following table compares Kitizato's CryotopCL to the predicate device with respect to intended use, technological characteristics, and principles of operation.

| Manufacturer | KITAZATO BioPharma Co., Ltd. | Cryo Bio System |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | Cryotop®CL | HSV Straw |
| 510(k) Number | K112695 | K092398 |
| Product Code | MQK | MQK |
| Regulation Number | 884.6160 | 884.6160 |
| Regulation Name | Assisted Reproduction Labware | Assisted Reproduction Labware |
| Indications for Use: | The CryotopCL is a<br>cryopreservation storage device<br>that is intended for use in<br>vitrification procedures to contain<br>and maintain human 4-8 cell and<br>blastocyst stage embryos. | The HSV Straw is a<br>cryopreservation storage device<br>that is intended for use in<br>vitrification procedures to contain<br>and maintain human 4-8 cell and<br>blastocyst stage embryos. |
| Overall Design | The device consists of a three<br>piece assembly comprised of the<br>main part containing the fine tip,<br>the protective "straw," and<br>pushing tool to assist in the proper<br>placement of the main part. The<br>straw is designed to be sealed. | The device consists of 3 parts: a<br>resin straw, a capillary tube with a<br>pre-formed gutter attached to a<br>colored handling rod, and a plastic<br>pushing tool to assist in the<br>proper placement of the capillary<br>tube. The straw is designed to be |

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| Manufacturer | KITAZATO BioPharma Co., Ltd. | Cryo Bio System |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | Cryotop®CL | HSV Straw |
| | The straw is weighted to allow<br>proper alignment in the storage<br>container. The CryotopCL device<br>is packaged in a single peel off<br>blister pack that is terminally<br>sterilized; 10 (ten) units are placed<br>in a secondary paper pouch for<br>storage purposes. | sealed. The HSV Straw is packaged<br>in a peel off blister pack. |
| Method of Action | Vitrification Method | Vitrification Method |
| Sterile | Radiation | Radiation |
| Cooling Rate | 3,000°C/min | 2,900°C/min |
| Rewarming Rate | 40,000°C/min | 25,000°C/min |
| Material Composition | PET, Polypropylene | Medical Grade Styrene-Butadiene<br>Copolymer |
| Contact with<br>Warming Medium | The tip (film) and the shaft of<br>CryotopCL are taken out from<br>straw. Directly immerse the tip<br>(film) into warming medium. | The curved spatula, containing the<br>cryopreserved embryo, is<br>immersed in warming medium<br>where thawing and dilution in the<br>warming medium occur<br>simultaneously. |
| Performance Testing<br>of Device | Passed | Passed |
| Mouse Embryo Test<br>Passed | ≥80% of 1-cell control embryos | ≥80% of 1-cell control embryos |
| Endotoxin Testing | ≤0.5 EU/device | ≤0.5 EU/device |
| Sterility Validation<br>Passed | No microbial growth, SAL 10-6 | No microbial growth, SAL 10-6 |

## 9. Non-Clinical Testing

The CryotopCL device has undergone cooling/warming rate testing, mechanical testing, The Cryolopce device has andergone obsing, wouse embryo assay testing, and endotoxin testing, dimensional testing, stermsy cosing, ""
Results support that all the specifications have met the acceptance criteria for the device.

- Cooling Rate Testing: Cooling rate of 3,000 °C/min passed �
- Cooling Rate Testing: Warming rate of 40,000 °C/min passed �
- warming nate Testing: Passes outer diameter, length, width of shaft, and spacing of .
- the embryo holding locations according to specifications
- Mechanical Tensile Testing: Tensile strength to withstand 5N .
- Mechanied Terror: Endotoxin values conform to the value ≤0.5 EU/device ●
- Sterility Testing: No microbial growth from sterility testing .
- Stenity Yesting 10 % of 1-cell control embryos develop at 96 hours .

The CryotopCL device passed all testing and supports the claims of substantial equivalence.

The CryotopCL device complies with the applicable voluntary standards for sterilization. The The Clyotopee de nee complise with national and international standards.
device passed all the testing in accordance with national and international standards.

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#### 10. Clinical Testing

There was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate devices. The substantial equivalence of the device is supported by the non-clinical testing. The validation testing of sterility testing and mouse embryo testing was found to acceptable and supports the claims of substantial equivalence.

#### 11. Conclusion

By definition, a device is substantially equivalent to a predicate device when the device has the same intended use and the same technological characteristics as the previously cleared predicate device. Or the device has the same intended use and different technological characteristics that can be demonstrated that the device is substantially equivalent to the predicate device, and that the new device does not raise different questions regarding its safety and effectiveness as compared to the predicate device.

It has been shown in this 510(k) submission that the difference between the CryotopCL device and the predicate devices do not raise any new types of questions regarding its safety and effectiveness. Kitazato's Cryotop®CL, as designed and manufactured, is determined to be substantially equivalent to the referenced predicate devices.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three stylized wing segments.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

## December 12, 2012

KITAZATO BioPharma Co., Ltd. % Mr. Richard Vincins, CQA, CBA, RAC (US, EU) Vice President, Quality Assurance Emergo Group 611 West 5th Street, Third Floor AUSTIN TX 78701

Re: K112695

Trade/Device Name: Cryotop®CL Regulation Number: 21 CFR§ 884.6160 Regulation Name: Assisted reproduction labware Regulatory Class: II Product Code: MQK Dated: November 21, 2012 Received: November 23, 2012

Dear Mr. 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 - Mr. Richard Vincins, CQA, CBA, 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

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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## Section 4 - Indications for Use Statement

510(k) Number (if known): K112695

Device Name: Cryotop®CL

Indications for Use:

The Cryotop®CL 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.

(Part 21 CFR 801 Subpart D) Prescription Use × 1 AND/OR Over-The-Counter Use ______________________________ (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Benjamin R. Fisher -S 2012.12.12 11/110:49 -05'00'

(Division Sign-Off) ision of Reproductive, Gastro-Renal, and logical Devices (k) Number