Sydney IVF Blastocyst Cryopreservation Kit, Sydney IVF Blastocyst Thawing Kit

K152717 · William A. Cook Australia Pty. , Ltd. · MQL · May 6, 2016 · Obstetrics/Gynecology

Device Facts

• Record ID: K152717
• Device Name: Sydney IVF Blastocyst Cryopreservation Kit, Sydney IVF Blastocyst Thawing Kit
• Applicant: William A. Cook Australia Pty. , Ltd.
• Product Code: MQL · Obstetrics/Gynecology
• Decision Date: May 6, 2016
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 884.6180
• Device Class: Class 2

Intended Use

Sydney IVF Blastocyst Cryopreservation Kit is intended for use in assisted reproduction technologies for cryopreservation of blastocysts. Sydney IVF Blastocyst Thawing Kit is intended for use in assisted reproduction technologies for thawing of cryopreserved blastocysts.

Device Story

Kits consist of sequential chemical solutions for cryopreservation and thawing of human blastocysts; used in IVF laboratories by embryologists. Cryopreservation kit uses increasing concentrations of cryoprotectants (glycerol, sucrose) to dehydrate embryos, preventing intracellular ice crystal formation. Thawing kit uses decreasing concentrations of sucrose to rehydrate embryos. Solutions contain Human Serum Albumin (HSA) and Gentamicin. Provided in borosilicate glass vials with Fluorotec-coated rubber stoppers. Enables storage of supernumerary embryos for future use; improves embryo viability post-thaw by mitigating cryo-damage.

Clinical Evidence

Bench testing only. Stability studies validated a 20-week shelf-life at 2-8°C. Performance metrics include pH (7.3-7.5), osmolality (285-295 mOsm/kg), endotoxin (< 0.40 EU/mL), and sterility. Embryo toxicity screened via 2-cell Mouse Embryo Assay (72hrs) with ≥80% of control developing to blastocyst.

Technological Characteristics

Chemical solutions containing glycerol, sucrose, 12 mg/mL HSA, and 0.01 mg/mL Gentamicin. Packaging: Borosilicate type 1 glass vials with Fluorotec-coated rubber stoppers and tamper-evident seals. Manufacturing: Aseptic filtration. Shelf-life: 20 weeks at 2-8°C.

Indications for Use

Indicated for use in assisted reproduction technologies for the cryopreservation and subsequent thawing of human blastocysts.

Regulatory Classification

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.).

Special Controls

*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.

Predicate Devices

• Sydney IVF Blastocyst Cryopreservation Kit & Sydney IVF Blastocyst Thawing Kit (K030441)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of three human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the largest and the bottom profile being the smallest.

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

May 6, 2016

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

Re: K152717

> Trade/Device Name: Sydney IVF Blastocyst Cryopreservation Kit Sydney IVF Blastocyst Thawing Kit Regulation Number: 21 CFR 884.6180 Regulation Name: Reproductive Media and Supplements Regulatory Class: Class II Product Code: MQL Dated: April 6, 2016 Received: April 8, 2016

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 [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 yours.

# Benjamin R. 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

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

K152717

Device Name

Sydney IVF Blastocyst Cryopreservation Kit

Indications for Use (Describe)

Sydney IVF Blastocyst Cryopreservation Kit is intended for use in assisted reproduction technologies for cryopreservation of blastocysts.

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

K152717

Device Name Sydney IVF Blastocyst Thawing Kit

Indications for Use (Describe)

Sydney IVF Blastocyst Thawing Kit is intended for use in assisted reproduction technologies for thawing of cryopreserved blastocysts.

| 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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Image /page/4/Picture/0 description: The image shows the logo for Cook Medical. The logo consists of the word "COOK" in white, block letters, with a registered trademark symbol to the right of the word. Below the word "COOK" is the word "MEDICAL" in white, block letters. The background of the logo is a solid red color.

WILLIAM A. COOK AUSTRALIA PTY. LTD. 95 BRANDL STREET BRISBANE TECHNOLOGY PARK, EIGHT MILE PLAINS BRISBANE, QLD 4113, AUSTRALIA PHONE: [phone] FAX: [phone] WWW.COOKMEDICAL.COM

# Special 510(k) Summary - K152717

#### SUBMITTED BY:

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

| Contact Person: | Gordana Pozvek Ph.D. |
|-----------------|--------------------------------|
| Tel: | [phone] |
| Fax: | [phone] |
| E-mail: | [e-mail] |

Date Prepared: May 5, 2016

## DEVICE IDENTIFICATION:

| Trade Name: | Sydney IVF Blastocyst Cryopreservation Kit (K-SIBF-5000) &<br>Sydney IVF Blastocyst Thawing Kit (K-SIBT-5000) |
|-------------------|---------------------------------------------------------------------------------------------------------------|
| Common Name: | Cryopreservation & Thawing Kits |
| Regulation No: | 21 CFR 884.6180, Reproductive Media & Supplements |
| Regulatory Class: | II |
| Product Code: | MQL - Media, Reproductive |

#### PREDICATE DEVICE:

Sydney IVF Blastocyst Cryopreservation Kit & Sydney IVF Blastocyst Thawing Kit (K030441), cleared August 29, 2003.

## DEVICE DESCRIPTION:

The Sydney IVF Blastocyst Cryopreservation and Thawing Kits are intended for cryopreservation and thawing of human blastocysts. The Sydney IVF Blastocyst Cryopreservation and Thawing Kits provide users with the ability to cryopreserve supernumerary embryos created during the in vitro fertilization procedure and then to thaw them for use at a future point in time.

The Sydney IVF Blastocyst Cryopreservation Kit consists of three solutions containing increasing concentrations of cryoprotectant (both glycerol and sucrose are used). These buffers were designed to be used sequentially in order to remove water from embryos prior

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to cryopreservation. The removal of water prevents ice crystal formation inside the embryo thereby limiting damage and improving viability. It contains 12 mg/mL Human Serum Albumin (HSA) and 0.01mg/mL Gentamicin. Sydney IVF Blastocyst Cryopreservation Kit is designed for use with Sydney IVF Blastocyst Thawing Kit.

The Sydney IVF Blastocyst Thawing Kit consists of four solutions with decreasing concentrations of cryoprotectants (sucrose) which are used sequentially throughout the thawing process. It contains 12 mg/mL Human Serum Albumin (HSA) and 0.01mg/mL Gentamicin. It is designed for use with Sydney IVF Blastocyst Cryopreservation Kit.

Sydney IVF Blastocyst Cryopreservation and Thawing Kits are provided in glass vials with Fluorotec® coated rubber stoppers held in place with a tamper evident seal. Sydney IVF Blastocyst Cryopreservation Kit is packaged in a carton box containing 3 x 20mL solutions per kit. The Sydney IVF Blastocyst Thawing Kit is packaged in a carton box containing 4 x 20mL solutions per kit.

## INDICATIONS FOR USE:

Sydney IVF Blastocyst Cryopreservation Kit is intended for use in assisted reproduction technologies for cryopreservation of blastocysts.

Sydney IVF Blastocyst Thawing Kit is intended for use in assisted reproduction technologies for thawing of cryopreserved blastocysts.

The indications for use statements are identical to the predicate device.

## COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE:

The Sydney IVF Blastocyst Cryopreservation Kit & Sydney IVF Blastocyst Thawing Kit and the predicate device (K030441) have the same fundamental technology and similar technological characteristics including the following:

- Similar chemical formulation
- . Similar performance specifications:
- pH 7.3 7.5 -
- -Osmolality 285 - 295 mOsm/kg
- Endotoxin < 0.40 EU/mL —
- -A Mouse Embryo Assay (MEA) is used to screen the product for embryo toxicity.
- Same method of manufacturing process aseptic filtration. ●
- Same packaging borosilicate type 1 vials with FluroTec coated stopper and tamper . evident seals.

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The modification that was made to the predicate device was a change in shelf-life from 8 weeks at 2-8°C (for predicate device) to 20 weeks at 2-8°C. In addition, minor changes were made to the formulation and specifications.

The technological characteristics of Sydney IVF Blastocyst Cryopreservation Kit & Sydney IVF Blastocyst Thawing Kit are comparable to the predicate device.

#### PERFORMANCE DATA:

The product specifications for the Sydney IVF Blastocyst Cryopreservation Kit & Sydney IVF Blastocyst Thawing Kit and the predicate device are the same regarding sterility, pH, osmolality and endotoxin.

The MEA is used for both the predicate and the proposed device but the test assay and specification has changed from 1-cell MEA (96hrs) with ≥75% of control that develop to blastocyst (predicate) to 2-cell MEA (72hrs) with ≥80% of control that develop to blastocyst.

## Stability & Shelf Life

The shelf-life of Sydney IVF Blastocyst Cryopreservation Kit & Sydney IVF Blastocyst Thawing Kit has been validated in stability studies to 20 weeks at 2 - 8°C. Stability tests included MEA, endotoxin, osmolality, pH, sterility and the concentrations of the amino acid proline and the HSA degradation by-product ammonia.

#### CONCLUSION:

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