Cryotec

K162051 · Reprolife, Inc. · MQK · Dec 14, 2016 · Obstetrics/Gynecology

Device Facts

• Record ID: K162051
• Device Name: Cryotec
• Applicant: Reprolife, Inc.
• Product Code: MQK · Obstetrics/Gynecology
• Decision Date: Dec 14, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.6160
• Device Class: Class 2

Indications for Use

This device is a vitrification storage device that is intended for use in vitrification procedures to contain and maintain human 4-8 cell or blastocyst stage embryos.

Device Story

Cryotec is a cryopreservation storage device used in assisted reproduction technology (ART) clinics by embryologists and physicians. It consists of a two-piece assembly: a polyethylene terephthalate (PET) film sheet attached to a handle, and a weighted polyvinylchloride cap. During vitrification, embryos are loaded onto the film sheet, capped to create a hermetic seal, and immersed in liquid nitrogen. The closed system design isolates the embryos from direct contact with liquid nitrogen. The weighted cap ensures proper alignment in storage containers. The device is provided sterile for single use. By maintaining embryo integrity during freezing and thawing, the device facilitates the storage of vitrified embryos for later use in ART procedures.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing: cooling rate (1,500 °C/min), warming rate (42,000 °C/min), visual inspection, dimensional testing, durability (no breakage/leakage in liquid nitrogen), tensile strength (≥5N), endotoxin (<0.5 EU/device), sterility (no growth), and Mouse Embryo Assay (≥80% blastocyst development).

Technological Characteristics

Materials: PET film and handle, polyvinylchloride cap. Principle: Closed-system vitrification. Energy: Passive (liquid nitrogen immersion). Form factor: Square stick with handle and cap. Sterilization: Radiation (SAL 10^-6). Connectivity: None. Software: None.

Indications for Use

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

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

• Kitazato, CryotopUS (K153027)

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

December 14, 2016

Reprolife Inc. % Diane Sudduth Sr. Consultant, RA/QA Emergo Group 816 Congress Avenue, Suite 1400 Austin, TX 78701

Re: K162051

> Trade/Device Name: Cryotec Regulation Number: 21 CFR 884.6160 Regulation Name: Assisted Reproduction Labware Regulatory Class: Class II Product Code: MOK Dated: November 11, 2016 Received: November 14, 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. 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

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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,

# Joyce M. Whang -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)

K162051

Device Name Cryotec

Indications for Use (Describe)

This device is a vitrification storage device that is intended for use in vitrification procedures to contain and maintain human 4-8 cell or 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

## for

# CRYOTEC

# K162051

#### 1. Submission Sponsor

REPROLIFE Inc. 2-5-5-8F, Shinjuku Shinjuku-ku, Tokyo 160-0022 JAPAN Phone: +(81) 3-5925-8931 Contact: Koichi Takeda, Director, Global Certification Division

## 2. Submission Correspondent

Emergo Global Consulting, LLC 2500 Bee Cave Road Building 1, Suite 300 Austin, TX 78746 Office Phone: [phone] Contact: Diane Sudduth, Sr. Consultant RA/QA Email: [e-mail]

## 3. Date Prepared

12/12/2016

## 4. Device Identification

| Trade/Proprietary Name: | Cryotec |
|----------------------------|--------------------------------------|
| Common/Usual Name: | Cryopreservation storage device |
| Classification Regulation: | 884.6160 |
| Classification Name: | Assisted Reproduction Labware |
| Product Code: | MQK (Labware, Assisted Reproduction) |
| Device Class: | Class II |
| Classification Panel: | Obstetrics and Gynecology |

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

Kitazato, CryotopUS, K153027. The predicate device has not been subject to a design-related recall.

#### 6. Device Description

Cryotec is a cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human 4-8 cell or blastocyst stage embryos. It is designed to enable physicians and embryologists to preserve and to store vitrified embryos for assisted reproduction technology procedures.

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The Cryotec device is composed of a two piece assembly with a polyethylene terephthalate (PET) film sheet attached to a PET handle, and a weighted polyvinylchloride cap to cover the film sheet during handling and storage. During vitrification procedures, the film sheet is loaded with embryos, capped, and immersed in liquid nitrogen. The capped design creates a hermetic seal, resulting in a closed system keeping the film sheet and embryos isolated from liquid nitrogen. The cap is weighted to allow proper alignment in the storage container. The Cryotec device is provided sterile and is for single use only. The Cryotec device has been designed to maintain the integrity of the human embryos the freezing and thawing process.

The specifications for the Cryotec are as follows:

| Appearance: | Particle free, no cracks |
|-------------------|------------------------------------------------|
| Durability: | No breakage, no liquid nitrogen inside the cap |
| Tensile Strength: | $\geq 5N$ |
| Endotoxin: | $<$ 0.5 EU/device |
| Sterility: | No growth |
| MEA (1-cell): | $\geq$ 80% blastocyst |

## 7. Indication for Use Statement

This device is a vitrification storage device that is intended for use in vitrification procedures to contain and maintain human 4-8 cell or blastocyst stage embryos.

## 8. Substantial Equivalence Discussion

The following table compares the Cryotec to the predicate device (Cryotop®US) with respect to intended use, technological characteristics and principles of operation, providing more detailed information regarding the basis for the determination of substantial equivalence.

| Manufacturer | KITAZATO BioPharma Co., | REPROLIFE Inc. | |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Trade Name | Cryotop®US | Cryotec | Comparison |
| 510(k) Number | K153027 | K162051 | - |
| Product Code | MQK | MQK | - |
| Regulation Number | 884.6160 | 884.6160 | - |
| Regulation Name | Assisted Reproduction | Assisted Reproduction Labware | - |
| Indications for Use: | The CryotopUS is a<br>cryopreservation storage<br>device that is intended for<br>use in vitrification<br>procedures to contain and<br>maintain human 4-8 cell<br>and blastocyst stage<br>embryos. | This device is a vitrification<br>storage device that is<br>intended for use in<br>vitrification procedures to<br>contain and maintain human<br>4-8 cell or blastocyst stage<br>embryos. | Same |

## Comparison of Characteristics

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| Overall Design | The device consists of a two<br>piece assembly comprised of<br>the main part containing the<br>fine tip film area and the<br>"straw." The straw is designed<br>to be sealed. The straw is<br>weighted to allow proper<br>alignment in the storage<br>container. The CryotopUS<br>device is packaged in a single<br>barrier sterilization pouch. | The device is a square shape<br>stick with four flat surfaces. The<br>device is composed of two<br>piece assembly with the film for<br>embryo placement and handle<br>shaft and weighted cap<br>designed to be a closed system.<br>The Cryotec device is packaged<br>in a single barrier sterilization<br>pouch. | Similar |
|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Material<br>Composition | PET, ABS, Polypropylene | PET | Different |
| Sealing Mechanism | The shaft handle contains a<br>taper and stop. When inserted<br>into the straw, a hermetically<br>sealed closed system is<br>formed. | The shaft is inserted into straw<br>to form a hermetic seal creating<br>a closed system. | Same |
| Method of Action | Vitrification Method | Vitrification Method | Same |
| Sterilization method | Radiation, SAL 10-6 | Radiation, SAL 10-6 | Same |
| Cooling Rate | 3,000°C/min | 1500°C/min | Different |
| Rewarming Rate | 44,000°C/min | 42,000°C/min | Different |
| Rewarming method | The tip (film) and the shaft of<br>CryotopUS are taken out from<br>the straw. Directly immerse<br>the tip (film) into thawing<br>solution. | The tip (film) and the<br>shaft of<br>Cryotec are taken out from the<br>cap. Directly immerse the tip<br>(film) into thawing solution | Same |
| Shelf life | 3 years | 2 years | Different |
| Mouse Embryo | ≥80% blastocyst (1-cell) | ≥80% blastocyst (1-cell) | Same |
| Endotoxin | 0.5 EU/device | 0.5 EU/device | Same |

The subject and predicate device have the same intended use – vitrification and storage of 4-8 cell or blastocyst stage embryos.

The technological characteristics are different – the subject device has a different material composition, cooling rate, warming rate, and shelf life. However, different types of safety or effectiveness questions are not raised by these differences in technological characteristics. Nonclinical performance data has been provided to evaluate the effect of the different technological characteristics of the subject device.

## 9. Non-Clinical Performance Data

The Cryotec device conforms to product quality test specifications: appearance, dimension, durability, tensile strength, endotoxin and Mouse Embryo Assay. The Cryotec device has been evaluated for the cooling/warming rate, mechanically tested, sterility tested, and mouse embryo assay supporting that all the specifications have met the acceptance criteria for the device. The following testing has been performed to support substantial equivalence:

## Performance Testing

- Cooling Rate Testing: Cooling rate of 1,500 °C/min.; met specifications ●
- Warming Rate Testing: Warming rate of 42,000 °C/min.; met specifications ●
- Visual Inspection: All devices are particle free with no cracks; met specifications ●
- Dimensional Testing: Passes outer diameter and length according to specifications

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- . Durability Testing: Following immersion into liquid nitrogen, no breakage of the stick or cap, no liquid nitrogen inside the cap; met specifications
- Mechanical Tensile Testing: Tensile strength to withstand 5N; met specifications
- Endotoxin Testing: Endotoxin values conform to the value < 0.5 EU/device; met specifications
- Sterility Testing: No microbial growth from sterility testing; met specifications
- . Mouse Embryo Assay: ≥80% of 1-cell control embryos develop within 96 hours; met specifications
- . 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 Cryotec device.

## 11. Statement of Substantial Equivalence

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