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 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.

AI/ML Overview

The provided text describes the CRYOLOCK™ cryopreservation storage device and its submission for 510(k) premarket notification. The document highlights that the device was found to be "substantially equivalent" to predicate devices, meaning it has similar technological characteristics, intended use, and is as safe and effective. However, it does not present specific acceptance criteria in a table format with numerical targets or thresholds for performance, nor does it detail a standalone clinical study on human subjects with a specified sample size, ground truth, or expert involvement to "prove" the device meets such criteria.

Instead, the submission focuses on demonstrating substantial equivalence through non-clinical performance tests and a comparison of technological characteristics with predicate devices.

Here's an analysis of the provided information, addressing your questions where possible:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with numerical targets. Instead, it states that the CRYOLOCK™ was compared to predicates in several areas and found to have "similar technological characteristics" or that "minor different technological characteristics have been determined to not have any impact on the safety or efficacy."

The key performance indicators implicitly considered and compared to predicates for equivalence are:

Performance Area	Acceptance Criteria Implied (Comparative)	Reported Device Performance (Comparative)
Intended Use	Equivalent to predicates	Similar to predicates
Principles of Use	Equivalent to predicates	Similar to predicates
Fundamental Technology	Equivalent to predicates	Similar to predicates
Biocompatibility	Equivalent to predicates	Similar to predicates
Tip Marking	Equivalent to predicates	Similar to predicates
Single Use	Equivalent to predicates	Similar to predicates
Sterility Assurance Level (SAL)	Equivalent to predicates	Similar to predicates
Endotoxin Test	Equivalent to predicates	Similar to predicates (Endotoxin titer and interference screening using Kinetic Turbidimetric method conducted)
Mouse Embryo Assay (MEA)	Equivalent to predicates (successful embryo development)	Similar to predicates ("One-cell mouse embryo development in extracted 'embryo-tested' culture medium" conducted)
Loading Volume	Similar to predicates	Minor differences, but no impact on safety/efficacy
Survival Rate (1-cell mouse)	Equivalent to predicates	Similar to predicates ("Comparison of survival of mouse zygotes after vitrification using two closed systems" conducted)
Cleavage Rate	Equivalent to predicates	Similar to predicates
Blastocyst Rate	Equivalent to predicates	Similar to predicates
Cooling Rate	Device specific rate to achieve desired cryopreservation conditions	-1,494°C/min at -60°C (Minor differences from predicates, but no impact on safety/efficacy)
Warming Rate	Device specific rate to achieve desired cryopreservation conditions	+21,000°C/min (Minor differences from predicates, but no impact on safety/efficacy)
Packaging Integrity	Maintain sterility and protection for shelf life	Achieved through "Accelerated Aging of Sterile Medical Device Packages," "Container and Closure: Bacterial/Immersion Integrity Test," "Transportation and Distribution ASTM D4169-2009," "CRYOLOCK™ Package Integrity - Shelf Life Real Time Aging Protocol"
Contamination Assessment	No contamination from device/system	"Contamination Assessment of the Cryopreservation Device, the CRYOLOCK™ Container and Closure Integrity Test for CRYOLOCK™ Device Closed System Using Immersion in Contaminated Liquid Nitrogen" conducted
LN Penetration	Prevent LN penetration	"Liquid Nitrogen (LN) Penetration testing" conducted

2. Sample Size Used for the Test Set and Data Provenance

The document mentions several non-clinical performance tests:

Mouse Embryo Assay: "One-cell mouse embryo development in extracted 'embryo-tested' culture medium (5 test articles POOLED)". This indicates a test sample of 5 pooled articles, likely involving multiple embryos per pool, but the exact number of embryos is not specified.
Survival of Mouse Zygotes: "Comparison of survival of mouse zygotes after vitrification using two closed systems." The sample size for this comparison is not explicitly stated.
Other tests (e.g., sterilization validation, packaging integrity) involve material or device units, not biological samples in a "test set" for performance metrics like accuracy.

Data Provenance: The studies appear to be laboratory-based non-clinical studies. The country of origin for the data is not specified, but the submission is to the US FDA. The studies are prospective in the sense that they were designed and executed to evaluate the device.

3. Number of Experts Used to Establish Ground Truth and Qualifications

The document does not describe the use of human experts to establish "ground truth" for the non-clinical performance tests mentioned. These are objective laboratory tests (e.g., measuring temperatures, assessing embryo development through standard biological assays, physical integrity tests). There is no mention of radiologists or similar clinical experts.

4. Adjudication Method for the Test Set

Not applicable. There is no mention of human-expert-based evaluation or adjudication for establishing ground truth in these non-clinical tests.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. The document describes a medical device for cryopreservation, not an AI or imaging diagnostic device. Therefore, an MRMC study is not relevant to this submission.

6. Standalone (Algorithm Only) Performance Study

No. This device is a physical cryopreservation tool, not an algorithm. The performance studies are focused on its physical and biological compatibility and function, not on a standalone algorithm's performance.

7. Type of Ground Truth Used

The "ground truth" for the non-clinical studies is based on:

Biological Endpoints: One-cell mouse embryo development, survival rate, cleavage rate, blastocyst rate (assessed through established biological assays).
Physical Measurements: Cooling rates, warming rates, endotoxin levels, sterility, package integrity (assessed through calibrated instruments and standardized test methods).
Comparative Equivalence: Performance similar to predicate devices.

8. Sample Size for the Training Set

Not applicable. This device is not an AI algorithm that requires a "training set." The listed non-clinical tests are for device validation, not model training.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of device.

Summary

{0}------------------------------------------------

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: 678 947 8173 FAX: 678 947 5580

Robyn Scopis Regulatory Consultant to BioTech, Inc. Regulatory Specialists, Inc. 3722 Ave. Sausalito Irvine, CA 92606 TEL: 949.422.3853 FAX: 949.552.2821 EMAIL: robyn@regulatoryspecialists.com

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

{1}------------------------------------------------

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

{2}------------------------------------------------

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.

{3}------------------------------------------------

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.

{4}------------------------------------------------

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 (800) 638-2041 or (301) 796-7100 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

{5}------------------------------------------------

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

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)

Image /page/5/Picture/11 description: The image contains the text 'Concurrence of Center for Devices and Radiological Health (CDRH) Signature'. The text appears to be a title or heading, possibly indicating the source or subject of the document or image. The text is in a clear, readable font, and the layout suggests it is an official or formal document.

Image /page/5/Picture/12 description: The image shows the name "Benjamin R. Fisher" in bold, black font. Below the name, the date "2014.01.09" and time "15:19:55" are printed. There is some additional text and graphics to the right of the name and date, but it is difficult to read.

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.

{6}------------------------------------------------

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration . Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Regulation Number and Section

§ 884.6160 Assisted reproduction labware.

(a)
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.(b)
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.