(230 days)
Sydney IVF Cryopreservation Kit is intended for use during in vitro fertilization procedures for cryopreservation of 1-cell to 8-cell embryos.
Sydney IVF Thawing Kit is intended for use during in vitro fertilization procedures for thawing of 1-cell to 8-cell embryos.
The Sydney IVF Cryopreservation and Thawing Kits are intended for cryopreservation and thawing of 1-cell to 8-cell human embryos. The Sydney IVF 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 Cryopreservation Kit consists of three solutions containing increasing concentrations of cryoprotectant (both propanediol and sucrose are used). These buffers were designed to be used sequentially in order to remove water from embryos prior 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 Cryopreservation Kit is designed for use with Sydney IVF Thawing Kit.
The Sydney IVF Thawing Kit consists of four solutions with decreasing concentrations of cryoprotectants (propanediol and 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 Cryopreservation Kit.
Sydney IVF Cryopreservation and Thawing Kits are provided in glass vials with Fluorotec coated rubber stoppers held in place with a tamper evident seal. Sydney IVF Cryopreservation Kit is packaged in a carton box containing 2 x 10mL and 1 x 20mL solutions per kit. The Sydney IVF Thawing Kit is packaged in a carton box containing 4 x 10mL solutions per kit.
The document provided is a 510(k) premarket notification for the Sydney IVF Cryopreservation Kit and Sydney IVF Thawing Kit. It outlines the similarities and differences with a predicate device and provides performance data primarily related to stability and shelf life, rather than clinical performance or a comparative effectiveness study.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Predicate Device) | Reported Device Performance (Sydney IVF Kits) |
|---|---|
| pH 7.3 - 7.5 | pH 7.3 - 7.5 |
| Osmolality 285 - 295 mOsm/kg | Osmolality 285 - 295 mOsm/kg |
| Endotoxin < 0.40 EU/mL | Endotoxin < 0.40 EU/mL |
| Sterility | Sterility |
| Mouse Embryo Assay (MEA): 1-cell MEA (96hrs) with ≥75% of control that develop to blastocyst | Mouse Embryo Assay (MEA): 2-cell MEA (72hrs) with ≥80% of control that develop to blastocyst |
| Shelf life: 6 weeks at 2-8°C | Shelf life: 20 weeks at 2-8°C |
Note: The document states that the product specifications for sterility, pH, osmolality, and endotoxin are the same for the proposed device and the predicate. The MEA test assay and specification have changed, as noted in the table.
2. Sample Size Used for the Test Set and Data Provenance
The document does not detail a specific "test set" for clinical performance. The studies mentioned are primarily stability studies and Mouse Embryo Assays (MEA).
- Sample Size: Not specified for the MEA or stability tests. The MEA mentions "control", but the number of embryos or replicates isn't provided.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). The submitting company is William A. Cook Australia Pty Ltd. The studies appear to be laboratory-based rather than clinical trials with human subjects.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. The document describes laboratory testing (MEA, stability) with defined endpoints and specifications, rather than a clinical study requiring expert assessment for ground truth.
4. Adjudication Method for the Test Set
Not applicable, as there's no mention of a human expert test set or adjudication process for the described studies.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document explicitly states: "The results of the testing provide reasonable assurance that the Sydney IVF Cryopreservation Kit & Sydney IVF Thawing Kit is as safe and effective as the predicate device and supports a determination of substantial equivalence." This indicates a non-clinical comparison for substantial equivalence, not a comparative effectiveness study with human readers/users. Therefore, no effect size for human readers with/without AI assistance is provided.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance
Not applicable. This device is a medical kit (media and reagents) used in IVF procedures, not an algorithm or AI-driven diagnostic device.
7. Type of Ground Truth Used
For the Mouse Embryo Assay (MEA), the "ground truth" is defined by the objective outcome measure: the percentage of control embryos that develop to blastocyst. For stability studies, it involves objective measurements of pH, osmolality, endotoxin, sterility, and concentrations of specific substances.
8. Sample Size for the Training Set
Not applicable. This device is a medical kit, not a machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As above, this is not a machine learning device.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a serpent entwined around it. The logo also includes the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 5, 2016
Willian A. Cook Australia Pty Ltd Gordana Pozvek Senior Regulatory Affairs Specialist 95 Brandl Street Brisbane Technology Park, Eight Mile Plains Brisbane, QLD 4113, Australia
Re: K152682
Trade/Device Name: Sydney IVF Cryopreservation Kit, Sydney IVF Thawing Kit Regulation Number: 21 CFR 884.6180 Regulation Name: Reproductive Media and Supplements Regulatory Class: Class II Product Code: MOL Dated: April 5, 2016 Received: April 7, 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 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. 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
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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 yours,
Image /page/1/Picture/8 description: The image shows the name "Herbert P. Lerner -S" in a large, sans-serif font. The text is black and appears to be the main focus of the image. There is a faint, watermark-like design in the background, but it is not easily discernible.
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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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)
Device Name Sydney IVF Cryopreservation Kit
Indications for Use (Describe)
Sydney IVF Cryopreservation Kit is intended for use during in vitro fertilization procedures for cryopreservation of 1-cell to 8-cell 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)
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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Form Approved: OMB No. 0910-0120
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name Sydney IVF Thawing Kit
Indications for Use (Describe)
Sydney IVF Thawing Kit is intended for use during in vitro fertilization procedures for thawing of 1-cell to 8-cell 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)
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 large, bold, white letters against a red background. To the right of the word "COOK" is a small, superscripted "R" inside a circle, indicating a registered trademark. Below the word "COOK" is the word "MEDICAL" in smaller, white letters, positioned on a red angled shape.
WILLIAM A. COOK AUSTRALIA PTY. LTD. 95 BRANDL STREET BRISBANE TECHNOLOGY PARK, EIGHT MILE PL BRISBANE, QLD 4113, AUS HONE: 1800.777.222 FAX: +61.7.38 WWW.COOKMEDICAL
Special 510(k) Summary - K152682
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: May 3, 2016
DEVICE IDENTIFICATION:
| Trade Name: | Sydney IVF Cryopreservation Kit (K-SICS-5000) & |
|---|---|
| Sydney IVF Thawing Kit (K-SITS-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:
Cook IVF Cryopreservation Kit & Cook IVF Thaw Kit (K011157), cleared May 3, 2001.
DEVICE DESCRIPTION:
The Sydney IVF Cryopreservation and Thawing Kits are intended for cryopreservation and thawing of 1-cell to 8-cell human embryos. The Sydney IVF 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 Cryopreservation Kit consists of three solutions containing increasing concentrations of cryoprotectant (both propanediol and sucrose are used). These buffers were designed to be used sequentially in order to remove water from embryos prior 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
AORTIC CRITICAL WOMEN'S INTERVENTIONAL LEAD SURGERY UROLOGY ENDOSCOPY INTERVENTION MANAGEMENT INTERVENTION HEALTH CARE RADIOLOGY William A. Cook Australia Pty Ltd K152682 Page 1 of 3
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Albumin (HSA) and 0.01mg/mL Gentamicin. Sydney IVF Cryopreservation Kit is designed for use with Sydney IVF Thawing Kit.
The Sydney IVF Thawing Kit consists of four solutions with decreasing concentrations of cryoprotectants (propanediol and 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 Cryopreservation Kit.
Sydney IVF Cryopreservation and Thawing Kits are provided in glass vials with Fluorotec coated rubber stoppers held in place with a tamper evident seal. Sydney IVF Cryopreservation Kit is packaged in a carton box containing 2 x 10mL and 1 x 20mL solutions per kit. The Sydney IVF Thawing Kit is packaged in a carton box containing 4 x 10mL solutions per kit.
INDICATIONS FOR USE:
Sydney IVF Cryopreservation Kit is intended for use during in vitro fertilization procedures for cryopreservation of 1-cell to 8-cell embryos.
Sydney IVF Thawing Kit is intended for use during in vitro fertilization procedures for thawing of 1-cell to 8-cell embryos.
The only differences in the indications for use listed above and that of the predicate device are:
- An update to clarify the intended use of the device as the original statements refers to "zygotes or embryos", and this has been updated to "1-cell to 8-cell embryos". The update serves to describe the intended use more accurately than the previous statement. There is no change to the clinical use of the device.
This clarification does not represent a new intended use nor does it pose any safety or effectiveness issues.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE:
The Sydney IVF Cryopreservation Kit & Sydney IVF Thawing Kit and the predicate device (K011157) have the same fundamental technology and similar technological characteristics including the following:
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- Similar chemical formulation
- Similar performance specifications: ●
- pH 7.3 7.5 ー
- Osmolality 285 - 295 mOsm/kg
- ー 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.
The modification that was made to the predicate device was a change in shelf-life from 6 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 Cryopreservation Kit & Sydney IVF Thawing Kit are comparable to the predicate device.
PERFORMANCE DATA:
The product specifications for the Sydney IVF Cryopreservation Kit & Sydney IVF 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 Cryopreservation Kit & Sydney IVF 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 Cryopreservation Kit & Sydney IVF Thawing Kit is as safe and effective as the predicate device and supports a determination of substantial equivalence.
§ 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.