CRYOLOCK

K122982 · Biotech, Inc. · MQK · Jan 9, 2014 · Obstetrics/Gynecology

Device Facts

• Record ID: K122982
• Device Name: CRYOLOCK
• Applicant: Biotech, Inc.
• Product Code: MQK · Obstetrics/Gynecology
• Decision Date: Jan 9, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.6160
• Device Class: Class 2

Indications for Use

The CRYOLOCK™ is a cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human 1-cell stage embryos.

Device Story

CRYOLOCK™ is a cryopreservation storage device used in assisted reproduction laboratories. It consists of a square-shaped stick with four flat surfaces, manufactured from medical-grade polystyrene. The device includes a body and a cap designed with matching coefficients of expansion to ensure secure coupling and efficient temperature conduction during vitrification. It is used to contain and maintain human 1-cell stage embryos during the freezing process. The device is handled by laboratory personnel using forceps, which grip the gaps on the extremes of the body and cap. By facilitating rapid cooling (-1,494°C/min) and warming (+21,000°C/min), the device enables the preservation of embryos for future clinical use, potentially benefiting patients undergoing fertility treatments.

Clinical Evidence

No clinical data. Evidence consists of non-clinical bench testing: mouse embryo assay (MEA) for cleavage and blastocyst rates, endotoxin titer screening, MEM elution, container/closure integrity (pressure/vacuum/immersion), accelerated aging, transportation testing (ASTM D4169-2009), and liquid nitrogen penetration testing.

Technological Characteristics

Material: Medical-grade polystyrene. Form factor: Square stick with 4 flat surfaces. Cooling rate: -1,494°C/min at -60°C. Warming rate: +21,000°C/min. Single-use. Sterilized. No electronic components or software.

Indications for Use

Indicated for use in vitrification procedures to contain and maintain human 1-cell 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

• HSV Straw (K041562)
• Rapid-I (K090832)

Submission Summary (Full Text)

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crolk) Traditiona BioTech, Inc. CRYOLOCK

JAN - 9 2014

K122982 Page 1 of 3

### 510(k) SUMMARY

510(k) Owner

Contact person

BioTech Inc. 11539 Park Woods Circle Suite 202 Alpharetta, GA 30005 TEL: [phone] FAX: [phone]

Robyn Scopis Regulatory Consultant to BioTech, Inc. Regulatory Specialists, Inc. 3722 Ave. Sausalito Irvine, CA 92606 TEL: [phone] FAX: [phone] EMAIL: [e-mail]

Date summary was prepared

December 9, 2014

| Name of device |
|---------------------|
| Common Name |
| Classification Name |
| Regulation |
| Product Code |
| Predicate |

CRYOLOCK™ Assisted Reproduction Devices Assisted Reproduction Labware 884.6160 MOK HSV Straw K041562 Rapid-I K090832

Description

The CRYOLOCK™ is a cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human 1-cell stage embryos.

The CRYOLOCK™ cooling rate: -1,494°C/min at -60°C The CRYOLOCK™ warming rate: +21,000°C /min

CRYQLOCK™ is a square shape stick, with 4 flat surfaces. Both the cap and body are produced from the same material (polystyrene medical grade). The cap and body possess the same coefficient of expansion, ensuring an equally secure coupling at room temperature as well as at low cryogenic temperatures facilitating an even temperature conduction from side to side of the device. Body and cap have gaps on their extremes that allow easy grip with forceps during handling.

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Intended Use

CRYOLOCK™ is intended for use as an assisted reproduction labware.

Indications for Use

The CRYOLOCK™ is a cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human 1-cell stage embryos.

Technological Characteristics

The predicates and the CRYOLOCK™ were compared in the following areas and found to have similar technological characteristics and to be equivalent:

Intended Use Principles of Use Fundamental Technology Biocompatibility Tip Marking Sinale Use Sterility Assurance Level (SAL) Endotoxin Test Mouse Embryo Assay (MEA) Loading Volume Survival Rate with One Cell Mouse Embryos Cleavage Rate Blastocyst Rate

The predicates and the CRYOLOCK™ were compared in the following areas and found to have minor different technological characteristics. The following differences have been determined to not have any impact on the safety or efficacy of the CRYOLOCK™:

System Components Packaging Materials Dimensions Cap Cooling Rate Warming Rate Colors Available Loading Method Closure System Accessories

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The following non-clinical performance tests were conducted:

VD Max Radiation Validation for CRYOLOCK™

One-cell mouse embryo development in extracted "embryo-tested" culture medium (5 test articles POOLED)

Endotoxin titer and interference screening using the Kinetic Turbidimetric method MEM Elution

CRYOLOCK™ Vitrification Device Temperature Profiles Closed Protocols

Comparison of survival of mouse zygotes after vitrification using two closed svstems

Accelerated Aging of Sterile Medical Device Packages for CRYOLOCK™ and its Associated Packaging

Container and Closure: Bacterial/Immersion Integrity Test Using Immersion, Pressure and Vacuum Final Report

Transportation and Distribution ASTM D4169-2009

Contamination Assessment of the Cryopreservation Device, the CRYOLOCK™ Container and Closure Integrity Test for CRYOLOCK™ Device Closed System Using Immersion in Contaminated Liquid Nitrogen

Dose Audit Summary Report for CRYOLOCK ™

CRYOLOCK™ Package Integrity - Shelf Life Real Time Aging Protocol Molding Process Validation

Liquid Nitrogen (LN) Penetration testing

Conclusions from non-clinical performance data

After performing non-clinical performance studies, the data shows that the CRYOLOCK™ is substantially equivalent to the predicates as an Assisted Reproduction Labware.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

#### Public Health Service

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

January 9, 2014

BioTech, Inc. % Robyn Scopis Regulatory Consultant Regulatory Specialist, Inc. 3722 Avenue Sausalito Irvine, CA 92606

Re: K122982

> Trade/Device Name: CRYOLOCK™ Regulation Number: 21 CFR§ 884.6160 Regulation Name: Assisted reproduction labware Regulatory Class: II Product Code: MQK Dated: December 26, 2013 Received: January 6, 2014

Dear Robyn Scopis,

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. Ilisting 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 - Robyn Scopis

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/CDRH/CDRHOffices/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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Benjamin 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known) K122982

#### Device Name CRYOLOCK™

#### Indications for Use (Describe)

The CR YOLOCK™ is a cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human 1-cell 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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FOR FOR FDA USE ONLY . 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ﺎ ﻓﻲ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ 。 . And . Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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FORM FDA 3881 (9/13)

PSC Publishing Services (30) 443-6710 EF

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

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