COOK Sydney IVF Blastocyst Vitrification Kit, COOK Sydney IVF Blastocyst Warming Kit
Device Facts
| Record ID | K143724 |
|---|---|
| Device Name | COOK Sydney IVF Blastocyst Vitrification Kit, COOK Sydney IVF Blastocyst Warming Kit |
| Applicant | William A. Cook Australia Pty. , Ltd. |
| Product Code | MQL · Obstetrics/Gynecology |
| Decision Date | Aug 27, 2015 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 884.6180 |
| Device Class | Class 2 |
Intended Use
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 Story
Kits consist of HEPES-buffered physiological solutions containing cryoprotectants (ethylene glycol, DMSO, trehalose), Human Serum Albumin, and Gentamicin; used for cryopreservation of supernumerary embryos created during IVF. Vitrification kit involves sequential exposure of blastocysts to solutions with increasing cryoprotectant concentrations; warming kit involves sequential re-warming process. Solutions are non-patient contacting; removed by washing prior to embryo transfer. Used in clinical ART laboratories by embryologists. Benefits include ability to cryopreserve embryos for future use.
Clinical Evidence
Bench testing only. Stability studies validated 20-week shelf-life at 2-8°C, testing pH, osmolality, endotoxin, MEA, sterility, and concentrations of amino acids, pyruvate, and ammonia. Performance specifications (pH 7.3-7.5, MEA ≥ 80% of control, endotoxin < 0.40 EU/mL) match the predicate.
Technological Characteristics
HEPES-buffered media containing ethylene glycol, DMSO, trehalose, 20 mg/mL Human Serum Albumin, and 0.01 mg/mL Gentamicin. Supplied in borosilicate type 1 vials with Fluorotec-coated butyl rubber stoppers and tamper-evident aluminum seals. Sterilization via aseptic filtration. Shelf-life 20 weeks at 2-8°C.
Indications for Use
Indicated for vitrification and warming of human blastocysts for assisted reproduction technologies (ART) procedures.
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
- COOK Sydney IVF Blastocyst Vitrification Kit & COOK Sydney IVF Blastocyst Warming Kit (K082363)
Related Devices
- K073522 — VITRIFICATION KIT & VITRIFICATION WARMING KIT · Sage In-Vitro Fertilization, Inc. · Oct 10, 2008
- K152717 — Sydney IVF Blastocyst Cryopreservation Kit, Sydney IVF Blastocyst Thawing Kit · William A. Cook Australia Pty. , Ltd. · May 6, 2016
- K093273 — VIT KIT - FREEZE AND THAW · Irvine Scientific Sales Co., Inc. · Mar 3, 2010
- K082363 — COOK SYDNEY IVF BLASTOCYST VITRIFICATION (K-SIBV-5000), WARMING (K-SIBW-5000) KITS · William A. Cook Australia Pty. , Ltd. · Apr 29, 2009
- K171748 — Vitrification Kit and Thawing Kit · Kitazato Corporation · Dec 14, 2017
Submission Summary (Full Text)
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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)
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).
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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### 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.*
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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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)<br>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:
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
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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.
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.
### INDICATIONS FOR USE:
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.
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<br>(K082363):<br>COOK Sydney IVF<br>Blastocyst Vitrification Kit<br>& COOK Sydney IVF<br>Blastocyst Warming Kit | Proposed Device:<br>COOK Sydney IVF<br>Blastocyst Vitrification Kit<br>& COOK Sydney IVF<br>Blastocyst Warming Kit | Comparison |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulation<br>Number | 21 CFR 884.6180 | 21 CFR 884.6180 | Same |
| Product Code | MQL | MQL | Same |
| Classification | Reproductive Media and<br>Supplements | Reproductive Media and<br>Supplements | Same |
| Indications for<br>Use | Blastocyst Vitrification Kit<br>is intended for the<br>vitrification of human<br>blastocysts for assisted<br>reproduction procedures<br>(ART). This kit is designed<br>for use with Blastocyst<br>Warming Kit (K-SIBW-<br>5000). | Blastocyst Vitrification Kit<br>is intended for the<br>vitrification of human<br>blastocysts for assisted<br>reproduction technologies<br>(ART). This kit is designed<br>for use with Blastocyst<br>Warming Kit (K-SIBW-<br>5000). | Clerical update - replaced<br>"assisted reproduction<br>procedures (ART)" with its<br>proper acronym "assisted<br>reproduction technologies<br>(ART)". |
| | Blastocyst Warming Kit is<br>intended for the recovery of<br>human blastocysts that have<br>undergone vitrification using<br>COOK Sydney IVF<br>Vitrification Kit (K-SIBV-<br>5000) for ART procedures. | Blastocyst Warming Kit is<br>intended for the warming of<br>human blastocysts that have<br>undergone vitrification using<br>COOK Sydney IVF<br>Vitrification Kit (K-SIBV-<br>5000) for ART procedures. | Current Intended use has the<br>wording "warming" instead<br>of "recovery".<br>This is an update to clarify<br>the purpose of the device, no<br>change to clinical use of the<br>device. |
| | | | |
| | Predicate Device<br>(K082363): | Proposed Device: | |
| Device Name | COOK Sydney IVF<br>Blastocyst Vitrification Kit<br>& COOK Sydney IVF<br>Blastocyst Warming Kit | COOK Sydney IVF<br>Blastocyst Vitrification Kit<br>& COOK Sydney IVF<br>Blastocyst Warming Kit | Comparison |
| Principal of<br>Operation | Provides users with the<br>ability to cryopreserve<br>supernumerary embryos<br>created during the in vitro<br>fertilization procedure and<br>then to re-warm them for use<br>at a future point in time. | Provides users with the<br>ability to cryopreserve<br>supernumerary embryos<br>created during the in vitro<br>fertilization procedure and<br>then to re-warm them for use<br>at a future point in time. | Same |
| Formulation | HEPES buffered physiologic<br>media containing ethylene<br>glycol, DMSO, trehalose,<br>Human Serum Albumin &<br>Gentamicin in addition to<br>the normal physiological<br>salts. | HEPES buffered physiologic<br>media containing ethylene<br>glycol, DMSO, trehalose,<br>Human Serum Albumin &<br>Gentamicin in addition to<br>the normal physiological<br>salts. | Same |
| Packaging | Borosilicate type 1 vials<br>with Fluorotec coated butyl<br>rubber stoppers and tamper-<br>evident aluminium seals.<br>Sealed vials are packaged<br>into a cardboard outer box | Borosilicate type 1 vials<br>with Fluorotec coated butyl<br>rubber stoppers and tamper-<br>evident aluminium seals.<br>Sealed vials are packaged<br>into a cardboard outer box | Same |
| Shelf-life | 8 weeks at 2 - 8°C | 20 weeks at 2 - 8°C | The 8-week shelf life for<br>IVF Media was extended to<br>20 weeks from date of<br>manufacture when stored at<br>2 - 8℃. Stability testing was<br>carried out on the Cook IVF<br>Media suite to verify that the<br>properties of the device are<br>maintained during the entire<br>shelf-life of 20 weeks. |
| Product Specification | | | |
| pH | 7.30 - 7.50 | 7.30 - 7.50 | Same |
| Osmolality<br>(mOsm/kg) | K-SIBV-SOL1: 285 - 295<br>K-SIBV-SOL2: N/A*<br>K-SIBV-SOL3: N/A* | K-SIBV-SOL1: 285 – 295<br>K-SIBV-SOL2: N/A*<br>K-SIBV-SOL3: N/A* | Same |
| | Predicate Device<br>(K082363): | Proposed Device: | |
| Device Name | COOK Sydney IVF<br>Blastocyst Vitrification Kit<br>& COOK Sydney IVF<br>Blastocyst Warming Kit | COOK Sydney IVF<br>Blastocyst Vitrification Kit<br>& COOK Sydney IVF<br>Blastocyst Warming Kit | Comparison |
| | | | A slight change was made to<br>the osmolality specifications<br>for Blastocyst Warming Kit<br>Solutions 1 & 2.<br><br>The modification was<br>introduced to improve<br>manufacturability and to<br>ensure consistency with the<br>other solutions in the kits.<br>The modified osmolality<br>specifications were not<br>related to any changes in the<br>device and do not raise any<br>safety concerns. |
| | K-SIBW-SOL1: 665 - 675<br>K-SIBW-SOL2: 505 - 515<br>K-SIBW-SOL3: 285 - 295 | K-SIBW-SOL1: 657 - 683<br>K-SIBW-SOL2: 500 - 520<br>K-SIBW-SOL3: 285 - 295 | |
| 2-cell MEA (72<br>hrs) | ≥ 80% of control | ≥ 80% of control | Same |
| Endotoxin | < 0.40 EU/mL | < 0.40 EU/mL | Same |
| Bioburden | In-process pre-filtration<br>specification:<br><100 CFU/mL<br>Release Specification:<br>< 1 CFU | In-process pre-filtration<br>specification:<br><100 CFU/mL<br>Release Specification:<br>Not performed | In-process pre-filtration<br>bioburden specification:<br>Same<br><br>Bioburden Release<br>Specification:<br>Sterility was implemented as<br>a release test, and therefore<br>Bioburden testing as a<br>release test was redundant. |
| Sterility<br>(USP/EP/JP) | Not performed | No Growth | The device is supplied sterile<br>(aseptically filtered),<br>therefore testing to the<br>JP/EP/USP Pharmacopeia<br>was implemented. Sterility<br>testing makes bioburden<br>testing redundant. |
| Manufacturing<br>process | Aseptic filtration | Aseptic filtration | Same |
| HSA Assay | Not performed | 10.00 - 40.00 mg/mL | Additional release test to<br>assay Human Serum<br>Albumin, included as an<br>additional control to verify<br>quality 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.
