VitriGuard 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 Description

VitriGuard 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 VitriGuard device is composed of a two-piece polystyrene assembly that includes a hexagonal shaped stick and cap. As part of the vitrification procedure, the embryos to be stored are loaded on the tip, also referred to as the leaf, and capped with a pre-cooled cap for subsequent storage following vitrification. The leaf has a trough area for loading. maintaining, and securing the embryos. The stick and cap include a taper design that creates a hermetic seal, forming a closed system. Markings at the stick and the tip of the device provide visual aid for proper device orientation. The device is provided sterile and is for single use only. The VitriGuard has been designed as a cryopreservation storage device to maintain the integrity of human 4-8 cell and blastocyst stage embryos throughout the cooling. storage, and warming processes.

AI/ML Overview

Here's the information about the acceptance criteria and the study that proves the device meets them, extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Test/Parameter	Acceptance Criteria	Reported Device Performance
Gamma Sterilization Validation	(Implicit: Meets ISO 11137-1:2006/(R)2010 and 11137-2:2013)	Passed
Shipping and Distribution Testing	(Implicit: Meets ISTA 3A 2008)	Passed
Package Integrity Testing	(Implicit: Meets ASTM F1980-07(2011), AAMI/ANSI/ISO 11607-1:2006/A1:2014, 11607-2:2006/A1:2014, ASTM F929-15, ASTM F88/F88M-15, and ASTM F1886/F1886M-09(2013))	Passed
Endotoxin Evaluation	≤2.0 EU/device (Implicit: Meets ANSI/AAMI ST72:2011/(R)2016 and USP <85>)	≤2.0 EU/device (Passed)
Mouse Embryo Assay (MEA)	≥80% blastocyst at 96 hours (1-cell)	≥80% blastocyst at 96 hours (1-cell) (Passed)
Thermal Profile Evaluation (Cooling/Warming Rates)	Warming and cooling rates must be substantially equal to (or greater than in absolute value) to the predicate device.	Met acceptance criteria (Subject device cooling: -2,271°C/min; warming: 36,377°C/min; Predicate cooling: -1,494°C/min; warming: 21,000°C/min, indicating faster rates for the subject device)
Mouse Embryo Survival Evaluation	Survival rate must be ≥80% for all embryo stages.	Met acceptance criteria (≥80% survival rate for all embryo stages)
Mouse Embryo Development Evaluation	Blastocyst development rate must be ≥80% for all embryo stages.	Met acceptance criteria (≥80% blastocyst development rate for all embryo stages)
Container and Closure Integrity - Bacterial/Immersion	Negative for growth of the challenge organism.	Met acceptance criteria (Negative for growth)
Container and Closure Integrity Bacterial Contaminated LN2	Test samples do not show presence or growth of the challenge organism; no leakage of LN2.	Met acceptance criteria (No presence/growth; no leakage)
Durability Testing	Must not exhibit any cap expulsion during the process; no leakage of LN2.	Met acceptance criteria (No cap expulsion; no leakage)
Product Evaluation	Device passes the predetermined design requirements.	Met acceptance criteria
Shelf Life Testing (Accelerated Aging) - MEA	≥80% blastocyst at 96 hours (1-cell)	(Implicitly passed by passing overall MEA for aged samples)
Shelf Life Testing (Accelerated Aging) - Container and Closure Integrity Bacterial/Immersion	Negative for growth of the challenge organism.	(Implicitly passed by passing overall CCI for aged samples)
Shelf Life Testing (Accelerated Aging) - Container and Closure Integrity Bacterial Contaminated LN2	Test samples do not show presence or growth of the challenge organism; no leakage of LN2.	(Implicitly passed by passing overall CCI for aged samples)
Shelf Life Testing (Accelerated Aging) - Durability Testing	Must not exhibit any cap expulsion during the process; no leakage of LN2.	(Implicitly passed by passing overall Durability for aged samples)
Shelf Life Testing (Accelerated Aging) - Product Evaluation	Device passes the predetermined design requirements.	(Implicitly passed by passing overall Product Evaluation for aged samples)

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

The document does not explicitly state the specific numerical sample size (e.g., number of embryos or devices) used for each test. However, it indicates that "various mouse embryos" were used for the Mouse Embryo Survival and Development evaluations.

The data provenance is not explicitly detailed in terms of country of origin. The studies appear to be prospective in nature, as they involve conducting tests on the VitriGuard device according to specified protocols to evaluate its performance.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

The document does not mention the use of human experts to establish ground truth for the test set. The ground truth for the performance tests (e.g., survival rates, development rates, integrity checks) is established by direct measurement against predefined criteria or by observation of biological outcomes (mouse embryo survival/development).

4. Adjudication Method for the Test Set

Not applicable, as the evaluation methods described are objective measurements or biological assays rather than subjective human assessments requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The studies described are performance tests of the device itself, comparing its physical and biological performance characteristics to predefined criteria and to a predicate device.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

This question is not applicable. The VitriGuard is a cryopreservation storage device, not an AI algorithm. Its performance is evaluated through non-clinical laboratory testing.

7. The Type of Ground Truth Used

The ground truth used for the performance studies is a combination of:

Direct Measurement/Objective Criteria: For parameters like cooling/warming rates, endotoxin levels, sterility, and physical integrity (e.g., no leakage, no cap expulsion).
Biological Outcomes Data: Specifically for the Mouse Embryo Assay (MEA), Mouse Embryo Survival Evaluation, and Mouse Embryo Development Evaluation, where the "ground truth" is the observed biological response (e.g., percentage of blastocyst formation, survival rate). These are quantitative biological endpoints.

8. The Sample Size for the Training Set

Not applicable. The VitriGuard is a physical medical device, not an AI/machine learning algorithm that requires a training set.

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

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

Summary

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

February 16, 2017

ORIGIO a/s % Roaida Johnson Director, RA New Product Development CooperSurgical, Inc. 95 Corporate Drive Trumbull, CT 06611

Re: K162833 Trade/Device Name: VitriGuard™ Regulation Number: 21 CFR& 884.6160 Regulation Name: Assisted Reproduction Labware Regulatory Class: II Product Code: MQK Dated: January 17, 2017 Received: January 18, 2017

Dear Roaida Johnson:

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 mav 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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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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) K162833

Device Name VitriGuard™

Indications for Use (Describe)

VitriGuard 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 K162833 - VitriGuard™ Cryopreservation Storage Device

Submission Sponsor Information

Company Name:	ORIGIO a/s
Company Address:	Knardrupvej 22760 MåløvDenmark
	Telephone: +45 46790200
	Fax: +45 46790302

Submission Correspondent Information

Company Name:	CooperSurgical Inc.
Company Address:	95 Corporate DriveTrumbull, CT 06611
Telephone:	203-601-5200 (Ext. 3325)
Fax:	203-601-9870

Contact Person:	Roaida Johnson
Date Prepared:	February 15, 2017

Device Information

Trade Name:	VitriGuard™
Common Name:	Cryopreservation Storage Device
Device Class:	II
Classification Number:	21 CFR 884.6160
Classification Name:	Assisted Reproduction Labware
Product Code:	MQK (Labware, Assisted Reproduction)

Predicate Device Information

The CooperSurgical VitriGuard cryopreservation storage device is substantially equivalent to the following predicate:

Primary Predicate: CRYOLOCK™ cryopreservation storage device (K122982)

The predicate device has not been subject to a design-related recall.

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Device Description

Parameter	Specification
Cooling rate	-2,271°C/min
Warming rate	36,377°C/min
Sterilization	Radiation, SAL 10-6
Endotoxin	$\leq$ 2.0 EU/device
MEA	$\geq$ 80% blastocyst at 96 hours(1-cell)

Product specifications are listed in the table below:

Indications for Use

VitriGuard 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.

Substantial Equivalence Discussion

The substantial equivalence of the subject device to the predicate is discussed below in Table 1 in respect to: indications for use, principles of operation, technological characteristics, materials, and performance.

Table 1. Comparison of VitriGuard to the Predicate Device
Property	Subject DeviceVitriGuard™	PredicateCRYOLOCK™	SignificantDifferences
510(k) Number	K162833	K122982	N/A
Indications for Use	VitriGuard is acryopreservation storagedevice that is intended foruse in vitrificationprocedures to contain andmaintain human 4-8 celland blastocyst stageembryos	The CRYOLOCK™ isa cryopreservationstorage device that isintended for use invitrification proceduresto contain and maintainhuman 1-cell stageembryos	Similar. Althoughthe predicate deviceis only indicated foruse for 1-cell stageembryos, thepredicate and subjectdevice have the sameintended use –vitrification and
			storage of humanembryos.
TechnologyOverview	The device is designed tocontain, vitrify andmaintain human embryos.The device is composed ofa two-piece assembly withthe main stick containing afine tip area, called the"leaf," and a cap. Thehandle shaft and cap aredesigned to be ahermetically sealed closedsystem.	The device is designedto contain, vitrify andmaintain humanembryos. The device iscomposed of a two-piece assembly withthe main stickcontaining a fine tiparea, called the "leaf,"and a cap. The handleshaft and cap aredesigned to be ahermetically sealedclosed system.	Same
Sterility	Sterile, SAL 10-6	Sterile, SAL 10-6	Same
SterilizationMethod	Radiation	Radiation	Same
Number of Uses	Single Use, Disposable	Single Use, Disposable	Same
Shelf Life	2 Years	3 Years	Different. Thesubject device has ashorter shelf life,which does not raisedifferent questions ofsafety andeffectiveness.
MaterialComposition	Polystyrene	Polystyrene	Same
Cooling Rate	-2,271°C/min	-1,494°C/min	Different. However,both devices havecooling rates that aretypical for thesetypes of devices, anddo not raise differentquestions of safetyand effectiveness.
Rewarming Rate	36,377°C/min	21,000°C/min	Different. However,both devices havewarming rates thatare typical for thesetypes of devices, anddo not raise differentquestions of safetyand effectiveness.
Endotoxin Testing	≤2.0 EU/device	≤2.0 EU/device	Same
Mouse EmbryoTesting	≥80% blastocyst at 96hours (1 cell)	≥80% blastocyst at 96hours (1 cell)	Same

Table 1: Comparison of VitriGuard to the Predicate Device

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Non-Clinical Performance Testing

As part of demonstrating substantial equivalence to the predicate device, the following nonclinical performance tests were conducted. The VitriGuard device meets all requirements for overall design, sterilization, and performance testing results, confirming that the design outputs meet the design inputs and specifications for the device.

The VitriGuard device passed all the testing in accordance with internal requirements and applicable standards to support substantial equivalence of the subject device:

Gamma Sterilization Validation per ISO 11137-1:2006/(R)2010 and 11137-2:2013 .
. Shipping and Distribution Testing per ISTA 3A 2008
. Package Integrity Testing following accelerated aging per ASTM F1980-07(2011) per AAMI/ANSI/ISO 11607-1:2006/A1:2014 and 11607-2:2006/A1:2014, ASTM F929-15, ASTM F88/F88M-15, and ASTM F1886/F1886M-09(2013)
. Endotoxin Evaluation per ANSI/AAMI ST72:2011/(R)2016 and USP <85>
Mouse Embryo Assay (MEA) ●
Thermal Profile Evaluation .
- The purpose of this test was to evaluate the cooling and warming rates of the o subject device, and to demonstrate that these rates are equivalent, or faster, than the predicate device. Temperature recording and graphing equipment was used to record and document the temperature profile of the devices when used as prescribed in the Instructions for Use (IFU) throughout the cooling and warming portions of the vitrification process. The acceptance criteria were that the subject device warming and cooling rates must be substantially equal to (or greater than in absolute value) to the predicate device. The subject device met the acceptance criteria.
Mouse Embryo Survival Evaluation ●
- The purpose of this test was to evaluate post-warming survival rates of O various mouse embryos after vitrification using the subject device and predicate device. The vitrification process was performed on mouse embryos according to the device IFU. After warming, all embryos were evaluated for survival rate. The acceptance criteria were that the subject device survival rate must be ≥80% for all embryos stages. The subject device met the acceptance criteria.
Mouse Embryo Development Evaluation
- The purpose of this evaluation was to evaluate the post-warming development O competence of various mouse embryos after vitrification using the subject device and the predicate device. Embryos were cultured to the blastocyst stage. The acceptance criteria were that the subject device blastocyst development rate must be ≥80% for all embryo stages. The subject device met the acceptance criteria.
. Container and Closure Integrity - Bacterial/Immersion
- The purpose of this test was to evaluate the microbial barrier of the closure O system of the subject device and predicate device. Test samples were transferred to bacterial culture and transferred to an incubator for immersion. After immersion, test samples were removed and examined for growth/turbidity. The acceptance criteria were that the subject device must be

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negative for growth of the challenge organism. The subject device met the acceptance criteria.

Container and Closure Integrity Bacterial Contaminated LN2 .
- o The purpose of this test was to evaluate seal integrity through device exposure to bacterial contaminated Liquid Nitrogen (LN2). The samples were capped as prescribed in the IFU and transferred to contaminated LN5. Samples were incubated and observed for growth. The acceptance criteria were that the test samples do not show presence or growth of the challenge organism. The subject device met the acceptance criteria. No leakage of LN2 was observed in the device.
. Durability Testing
- The purpose of this test was to compare the seal integrity of the subject o device to the predicate device by characterizing the seal integrity through exposure to Liquid Nitrogen (LN2). The samples were assembled as prescribed in the IFU and submerged in LN2. The test samples were then exposed to 37℃ temperatures. The acceptance criteria were that the subject device must not exhibit any cap expulsion during this process. The subject device met the acceptance criteria. No leakage of LN2 was observed in the device.
Product Evaluation
- The purpose of this test was to evaluate the subject device with regards to o loading, vitrification, and unloading, following the steps prescribed by the IFU. The acceptance criteria were that that device passes the predetermined design requirements. The subject device met the acceptance criteria.
Shelf Life Testing - accelerated aging per ASTM F1980-07(2011)
- Mouse Embryo Assay (MEA) O
- Container and Closure Integrity Bacterial/Immersion о
- Container and Closure Integrity Bacterial Contaminated LN2 O
- Durability Testing O
- O Product Evaluation

Conclusion

The results of the testing described above demonstrate that the VitriGuard is as safe and effective as the predicate device and supports a determination of substantial equivalence.

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.