Blastocyst Vitrification Kit is intended for the vitrification of human blastocysts for assisted reproduction technologies (ART). This kit is designed for use with Blastocyst Warming Kit (K-SIBW-5000).

Blastocyst Warming Kit is intended for the warming of human blastocysts that have undergone vitrification using COOK Sydney IVF Vitrification Kit (K-SIBV-5000) for ART procedures.

Device Description

COOK Sydney IVF Blastocyst Vitrification and Warming Kits are intended for the vitrification and warming of human blastocysts as part of human ART procedures. The COOK Sydney IVF Blastocyst Vitrification and Warming Kits provide users with the ability to cryopreserve supernumerary embryos created during the in vitro fertilization procedure and then to re-warm them for use at a future point in time.

The COOK Sydney IVF Blastocyst Vitrification Kit (K-SIBV-5000) consists of a series of 2-[4-(2-hydroxyethyl)piperazin1-yl] ethanesulfonic acid (HEPES)-buffered, physiological solutions containing increasing concentrations of functional cryoprotectants to which the embryo is sequentially exposed during cryopreservation. The first three solutions in the kit are all based upon the same formulation (known as "Cryobase buffer"), which is a 10 mM HEPES buffered media containing 20 mg/mL Human Serum Albumin (HSA) and 0.01 mg/mL Gentamicin. The fourth solution in the kit is dimethyl sulfoxide (DMSO) and does not contain HSA or Gentamicin. The DMSO is provided for the practitioner to add to Solution 2 and Solution 3 of the vitrification kit, as described in the Instructions for Use.

COOK Sydney IVF Blastocyst Warming Kit (K-SIBW-5000) consists of three solutions which are used sequentially throughout the warming process. The three media in the kit are all based upon the same formulation of Cryobase buffer, a 10 mM HEPES buffered media containing 20 mg/mL HSA and 0.01 mg/mL Gentamicin.

The COOK Sydney IVF Blastocyst Vitrification and Warming Kits are single use, sterile (aseptic filtration) devices.

These solutions contact the blastocyst during the vitrification and re-warming process. The solutions are removed by washing prior to embryo transfer back to the patient and are therefore non-patient contacting.

AI/ML Overview

The provided document describes the COOK Sydney IVF Blastocyst Vitrification Kit and COOK Sydney IVF Blastocyst Warming Kit, and its comparison to a predicate device (K082363). The primary purpose of the submission is to justify an extended shelf-life from 8 weeks to 20 weeks for the updated device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document outlines performance specifications that are considered acceptance criteria for the device. The reported performance of the proposed device is stated to be the same as the predicate device for these parameters.

Acceptance Criteria	Reported Device Performance (Proposed Device)	Notes
pH	7.30 - 7.50	Same as predicate.
Osmolality (mOsm/kg)
K-SIBV-SOL1 (Vitrification Solution 1)	285 - 295	Same as predicate.
K-SIBV-SOL2 (Vitrification Solution 2)	N/A*	Same as predicate. *Not measurable due to high cryoprotectant concentration preventing freezing.
K-SIBV-SOL3 (Vitrification Solution 3)	N/A*	Same as predicate. *Not measurable due to high cryoprotectant concentration preventing freezing.
K-SIBW-SOL1 (Warming Solution 1)	657 - 683	Slight change from predicate (665-675). The document states this modification was "introduced to improve manufacturability and to ensure consistency with the other solutions in the kits" and "do not raise any safety concerns."
K-SIBW-SOL2 (Warming Solution 2)	500 - 520	Slight change from predicate (505-515). The document states this modification was "introduced to improve manufacturability and to ensure consistency with the other solutions in the kits" and "do not raise any safety concerns."
K-SIBW-SOL3 (Warming Solution 3)	285 - 295	Same as predicate.
2-cell MEA (Mouse Embryo Assay) at 72 hrs	≥ 80% of control	Same as predicate.
Endotoxin	< 0.40 EU/mL	Same as predicate.
Bioburden (In-process pre-filtration)	< 100 CFU/mL	Same as predicate.
Bioburden (Release Specification)	Not performed	Different from predicate (<1 CFU). The document states "Sterility was implemented as a release test, and therefore Bioburden testing as a release test was redundant."
Sterility (USP/EP/JP)	No Growth	Added compared to predicate ("Not performed"). The document states "The device is supplied sterile (aseptically filtered), therefore testing to the JP/EP/USP Pharmacopeia was implemented. Sterility testing makes bioburden testing redundant."
HSA Assay	10.00 - 40.00 mg/mL	Added compared to predicate ("Not performed"). The document states "Additional release test to assay Human Serum Albumin, included as an additional control to verify quality of the batch."
Shelf-life	20 weeks at 2 - 8°C	Extended from predicate (8 weeks at 2 - 8°C). This is the key modification justified by the stability study.

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

The document mentions that the shelf-life was validated "in stability studies." However, it does not provide any specific sample sizes for these stability studies (e.g., number of batches, number of vials tested per time point).

Regarding data provenance, the document does not explicitly state the country of origin for the data or whether the study was retrospective or prospective. Given that the manufacturer is William A. Cook Australia Pty Ltd and the submission is to the US FDA, it's likely the studies were conducted by the manufacturer, potentially in Australia or in collaboration with other labs. The nature of stability studies (testing products over time) inherently makes them prospective in terms of data collection from manufactured lots.

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

This information is not provided in the document. For device components like reproductive media, the "ground truth" for performance parameters (pH, osmolality, endotoxin, MEA) is typically established by laboratory testing against defined scientific standards and biological assays, not by expert consensus in the way a diagnostic imaging device might use radiologists. The MEA (Mouse Embryo Assay) is a biological test performed by trained embryologists or laboratory technicians, but the document doesn't specify the number or qualifications of these individuals involved in establishing the "ground truth" (i.e., the control performance).

4. Adjudication Method for the Test Set:

This information is not applicable to the type of device and testing described. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or performance evaluations where human interpretation of medical images or patient outcomes requires reconciliation among experts. For laboratory performance characteristics and stability testing of media, the results are quantitative and directly measured (e.g., pH, osmolality) or rely on established biological assay endpoints (e.g., MEA, sterility), not subjective expert judgment that requires adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance:

This information is not applicable and not present in the document. MRMC studies are relevant to diagnostic imaging devices or AI-assisted interpretation where human readers (e.g., radiologists) are involved in making decisions, and the AI's impact on their performance is being evaluated. The COOK Sydney IVF Blastocyst Vitrification and Warming Kits are reproductive media, not an AI diagnostic tool.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

This information is not applicable as the device is not an algorithm or AI. The performance evaluation focuses on the chemical and biological integrity of the media itself.

7. The Type of Ground Truth Used:

For the performance parameters and stability studies, the "ground truth" is established through:

Laboratory measurements: For physical and chemical properties like pH, osmolality.
Microbiological testing: For endotoxin and sterility.
Biological assays: Specifically, the Mouse Embryo Assay (MEA), which is a standard biological control test to ensure that culture media and components are non-toxic and support embryonic development.
Chemical assays: For concentrations of specific components like amino acids, pyruvate, ammonia, and HSA.

8. The Sample Size for the Training Set:

This information is not applicable and not provided. "Training set" refers to data used to train machine learning models. This device is not an AI/ML product. The document describes laboratory testing for product quality and stability.

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

This information is not applicable as there is no training set for an AI/ML model for this device. The ground truth for the device's characteristics (as outlined in point 7) is established through established laboratory methods and specifications.

In summary of the study proving the device meets acceptance criteria:

The primary study detailed (though without specific numerical sample sizes) is a stability study designed to validate the extended shelf-life of 20 weeks. This study involved testing critical device characteristics—pH, osmolality, endotoxin, MEA, sterility, and concentrations of specific chemical components (amino acids, pyruvate, ammonia, HSA)—over time at the specified storage conditions (2-8°C). The "conclusion" section states that "The results of the testing provide reasonable assurance that the COOK Sydney IVF Blastocyst Vitrification Kit & COOK Sydney IVF Blastocyst Warming Kit is as safe and effective as the predicate device and supports a determination of substantial equivalence." This implies that the measured values for these parameters remained within acceptable limits for the entire 20-week period, demonstrating that the device maintains its performance specifications for the extended shelf life.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the seal is a stylized image of three human profiles facing to the right, stacked on top of each other.

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

August 27, 2015

William A. Cook Australia Pty, Ltd.. Gordana Pozvek Senior Regulatory Affairs Specialist 95 Brandl Street Brisbane Technology Park, Eight Mile Plains Brisbane OLD 4113. Austrailia

K143724 Re:
Trade/Device Name: COOK Sydney IVF Blastocyst Vitrification Kit, COOK Sydney IVF Blastocyst Warming Kit Regulation Number: 21 CFR 884.6180 Regulation Name: Reproductive media and supplements Regulatory Class: II Product Code: MQL Dated: July 28, 2015 Received: July 31, 2015

Dear Gordana Pozvek,

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. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR

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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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 yours.

Joyce M. Whang -S

forBenjamin 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) K143724

Device Name

COOK Sydney IVF Blastocyst Vitrification Kit

Indications for Use (Describe)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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."

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Indications for Use

510(k) Number (if known) K143724

Device Name COOK Sydney IVF Blastocyst Warming Kit

Indications for Use (Describe)

Blastocyst Warming Kit is intended for the warming of human blastocysts that have undergone vitrification using COOK Sydney IVF Vitrification Kit (K-SIBV-5000) for ART procedures.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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.

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."

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Image /page/4/Picture/0 description: The image shows the logo for Cook Medical. The word "COOK" is in large, white, sans-serif font. Below the word "COOK" is a red banner with the word "MEDICAL" in white, sans-serif font. The background of the image is red.

WILLIAM A. COOK AUSTRALIA PTY. LTD. 95 BRANDL STREET BRISBANE TECHNOLOGY PARK, EIGHT MILE PLAINS BRISBANE, QLD 4113, AUSTRALIA PHONE: 1800.777.222 FAX: +61.7.3841.1288 WWW.COOKMEDICAL.COM ABN 79 005 526 723

510(k) Summary

SUBMITTED BY:

William A. Cook Australia Pty Ltd 95 Brandl Street Eight Mile Plains QLD 4113 Australia

Contact Person:	Gordana Pozvek Ph.D.
Tel:	+61 (7) 3841 1188
Fax:	+61 (7) 3841 3905
E-mail:	Gordana.Pozvek@CookMedical.com

Date Prepared: August 26, 2015

DEVICE IDENTIFICATION:

Trade Name:	COOK Sydney IVF Blastocyst Vitrification Kit (K-SIBV-5000)COOK Sydney IVF Blastocyst Warming Kit (K-SIBW-5000)
Common Name:	Blastocyst Vitrification & Warming Kits
Regulation No:	21 CFR 884.6180, Reproductive Media & Supplements
Regulatory Class:	II
Product Code:	MQL - Media, Reproductive

PREDICATE DEVICE:

COOK Sydney IVF Blastocyst Vitrification Kit & COOK Sydney IVF Blastocyst Warming Kit (product codes: K-SIBV-5000, K-SIBW-5000) (K082363).

DEVICE DESCRIPTION:

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embryo is sequentially exposed during cryopreservation. The first three solutions in the kit are all based upon the same formulation (known as "Cryobase buffer"), which is a 10 mM HEPES buffered media containing 20 mg/mL Human Serum Albumin (HSA) and 0.01 mg/mL Gentamicin. The fourth solution in the kit is dimethyl sulfoxide (DMSO) and does not contain HSA or Gentamicin. The DMSO is provided for the practitioner to add to Solution 2 and Solution 3 of the vitrification kit, as described in the Instructions for Use.

The COOK Sydney IVF Blastocyst Vitrification and Warming Kits are single use, sterile (aseptic filtration) devices

INDICATIONS FOR USE:

Blastocyst Warming Kit is intended for the warming of human blastocysts that have undergone vitrification using COOK Sydney IVF Vitrification Kit (K-SIBV-5000) for ART procedures.

The only differences in the intended use listed above and that of the predicate device are:

. An update to current indications for use for the Blastocyst Vitrification Kit, replacing "assisted reproduction procedures (ART)" with the proper acronym, "assisted reproduction technologies (ART)".
In the indications for use for the Blastocyst Warming Kit, "warming of human ● blastocysts" replaces "recovery of human blastocysts," which is used in the predicate device. This is an update to clarify the purpose of the device. There is no change to the clinical use of the device.

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE:

The COOK Sydney IVF Blastocyst Vitrification Kit & COOK Sydney IVF Blastocyst Warming Kit and the predicate device (K082363) have the same fundamental technology and many of the same technological characteristics including the following:

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Same chemical formulation
Same performance specifications:
- pH 7.3 7.5 —
- Osmolality 285 295 mOsm/kg (Cryobase Solution) -
- -Endotoxin < 0.40 EU/mL
- -2-cell MEA ≥ 80% of control at 72 hours
Same method of manufacturing process - aseptic filtration
Same packaging borosilicate type 1 vials with FluroTec stopper and tamper evident . seals

The modification that was made to the predicate device was a change in shelf-life from 8 weeks (for predicate device) to 20 weeks.

A full comparison is provided below in Table 1.

Device Name	Predicate Device(K082363):COOK Sydney IVFBlastocyst Vitrification Kit& COOK Sydney IVFBlastocyst Warming Kit	Proposed Device:COOK Sydney IVFBlastocyst Vitrification Kit& COOK Sydney IVFBlastocyst Warming Kit	Comparison
RegulationNumber	21 CFR 884.6180	21 CFR 884.6180	Same
Product Code	MQL	MQL	Same
Classification	Reproductive Media andSupplements	Reproductive Media andSupplements	Same
Indications forUse	Blastocyst Vitrification Kitis intended for thevitrification of humanblastocysts for assistedreproduction procedures(ART). This kit is designedfor use with BlastocystWarming Kit (K-SIBW-5000).	Blastocyst Vitrification Kitis intended for thevitrification of humanblastocysts for assistedreproduction technologies(ART). This kit is designedfor use with BlastocystWarming Kit (K-SIBW-5000).	Clerical update - replaced"assisted reproductionprocedures (ART)" with itsproper acronym "assistedreproduction technologies(ART)".
	Blastocyst Warming Kit isintended for the recovery ofhuman blastocysts that haveundergone vitrification usingCOOK Sydney IVFVitrification Kit (K-SIBV-5000) for ART procedures.	Blastocyst Warming Kit isintended for the warming ofhuman blastocysts that haveundergone vitrification usingCOOK Sydney IVFVitrification Kit (K-SIBV-5000) for ART procedures.	Current Intended use has thewording "warming" insteadof "recovery".This is an update to clarifythe purpose of the device, nochange to clinical use of thedevice.

	Predicate Device(K082363):	Proposed Device:
Device Name	COOK Sydney IVFBlastocyst Vitrification Kit& COOK Sydney IVFBlastocyst Warming Kit	COOK Sydney IVFBlastocyst Vitrification Kit& COOK Sydney IVFBlastocyst Warming Kit	Comparison
Principal ofOperation	Provides users with theability to cryopreservesupernumerary embryoscreated during the in vitrofertilization procedure andthen to re-warm them for useat a future point in time.	Provides users with theability to cryopreservesupernumerary embryoscreated during the in vitrofertilization procedure andthen to re-warm them for useat a future point in time.	Same
Formulation	HEPES buffered physiologicmedia containing ethyleneglycol, DMSO, trehalose,Human Serum Albumin &Gentamicin in addition tothe normal physiologicalsalts.	HEPES buffered physiologicmedia containing ethyleneglycol, DMSO, trehalose,Human Serum Albumin &Gentamicin in addition tothe normal physiologicalsalts.	Same
Packaging	Borosilicate type 1 vialswith Fluorotec coated butylrubber stoppers and tamper-evident aluminium seals.Sealed vials are packagedinto a cardboard outer box	Borosilicate type 1 vialswith Fluorotec coated butylrubber stoppers and tamper-evident aluminium seals.Sealed vials are packagedinto a cardboard outer box	Same
Shelf-life	8 weeks at 2 - 8°C	20 weeks at 2 - 8°C	The 8-week shelf life forIVF Media was extended to20 weeks from date ofmanufacture when stored at2 - 8℃. Stability testing wascarried out on the Cook IVFMedia suite to verify that theproperties of the device aremaintained during the entireshelf-life of 20 weeks.
Product Specification
pH	7.30 - 7.50	7.30 - 7.50	Same
Osmolality(mOsm/kg)	K-SIBV-SOL1: 285 - 295K-SIBV-SOL2: N/AK-SIBV-SOL3: N/A	K-SIBV-SOL1: 285 – 295K-SIBV-SOL2: N/AK-SIBV-SOL3: N/A	Same
	Predicate Device(K082363):	Proposed Device:
Device Name	COOK Sydney IVFBlastocyst Vitrification Kit& COOK Sydney IVFBlastocyst Warming Kit	COOK Sydney IVFBlastocyst Vitrification Kit& COOK Sydney IVFBlastocyst Warming Kit	Comparison
			A slight change was made tothe osmolality specificationsfor Blastocyst Warming KitSolutions 1 & 2.The modification wasintroduced to improvemanufacturability and toensure consistency with theother solutions in the kits.The modified osmolalityspecifications were notrelated to any changes in thedevice and do not raise anysafety concerns.
	K-SIBW-SOL1: 665 - 675K-SIBW-SOL2: 505 - 515K-SIBW-SOL3: 285 - 295	K-SIBW-SOL1: 657 - 683K-SIBW-SOL2: 500 - 520K-SIBW-SOL3: 285 - 295
2-cell MEA (72hrs)	≥ 80% of control	≥ 80% of control	Same
Endotoxin	< 0.40 EU/mL	< 0.40 EU/mL	Same
Bioburden	In-process pre-filtrationspecification:<100 CFU/mLRelease Specification:< 1 CFU	In-process pre-filtrationspecification:<100 CFU/mLRelease Specification:Not performed	In-process pre-filtrationbioburden specification:SameBioburden ReleaseSpecification:Sterility was implemented asa release test, and thereforeBioburden testing as arelease test was redundant.
Sterility(USP/EP/JP)	Not performed	No Growth	The device is supplied sterile(aseptically filtered),therefore testing to theJP/EP/USP Pharmacopeiawas implemented. Sterilitytesting makes bioburdentesting redundant.
Manufacturingprocess	Aseptic filtration	Aseptic filtration	Same
HSA Assay	Not performed	10.00 - 40.00 mg/mL	Additional release test toassay Human SerumAlbumin, included as anadditional control to verifyquality of the batch.

Table 1: Comparison of COOK Sydney IVF Blastocyst Vitrification Kit & COOK Sydney IVF Blastocyst Warming Kit with predicate device

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The osmometer measures osmolality by freezing samples and correlating the freeze point to the osmolality. The high concentration of cryoprotectants in K-SIBV-SOL2 and K-SIBV-SOL3 prevents freezing of the solutions, therefore it is not possible to measure the osmolality of these two solutions.

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PERFORMANCE DATA:

The product specifications for the COOK Sydney IVF Blastocyst Vitrification Kit & COOK Sydney IVF Blastocyst Warming Kit and the predicate device are the same regarding sterility, endotoxin, pH, and the MEA.

Stability & Shelf Life

The shelf-life of COOK Sydney IVF Blastocyst Vitrification Kit & COOK Sydney IVF Blastocyst Warming Kit has been validated in stability studies to 20 weeks at 2 - 8℃. Stability tests included pH, osmolality, endotoxin, MEA, sterility and the concentrations of amino acids (proline and lysine), pyruvate and ammonia.

CONCLUSION:

The results of the testing provide reasonable assurance that the COOK Sydney IVF Blastocyst Vitrification Kit & COOK Sydney IVF Blastocyst Warming Kit is as safe and effective as the predicate device and supports a determination of substantial equivalence.

Regulation Number and Section

§ 884.6180 Reproductive media and supplements.

(a)
Identification. Reproductive media and supplement are products that are used for assisted reproduction procedures. Media include liquid and powder versions of various substances that come in direct physical contact with human gametes or embryos (including water, acid solutions used to treat gametes or embryos, rinsing solutions, sperm separation media, supplements, or oil used to cover the media) for the purposes of preparation, maintenance, transfer or storage. Supplements are specific reagents added to media to enhance specific properties of the media (e.g., proteins, sera, antibiotics, etc.).(b)
Classification. Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, biocompatibility testing, and clinical testing). The device, when it is phosphate-buffered saline used for washing, and short-term handling and manipulation of gametes and embryos; culture oil used as an overlay for culture media containing gametes and embryos; and water for assisted reproduction applications, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.