(228 days)
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 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 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.
The provided text describes a Special 510(k) submission for the Sydney IVF Blastocyst Cryopreservation Kit and Sydney IVF Blastocyst Thawing Kit (K152717). This submission is for reproductive media, not an AI/ML medical device. Therefore, many of the requested categories pertaining to AI/ML device studies (e.g., sample size for test set, data provenance, ground truth experts, adjudication methods, MRMC studies, standalone performance) are not applicable to this document.
However, I can extract information related to the device's performance, stability, and comparison to its predicate.
Here's the information that can be extracted:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Predicate Device (K030441) Specification | Proposed Device (K152717) Specification | Performance (K152717) |
|---|---|---|---|
| pH | 7.3 - 7.5 | 7.3 - 7.5 | The product specifications are the same as the predicate. |
| Osmolality | 285 - 295 mOsm/kg | 285 - 295 mOsm/kg | The product specifications are the same as the predicate. |
| Endotoxin | < 0.40 EU/mL | < 0.40 EU/mL | The product specifications are the same as the predicate. |
| Mouse Embryo Assay (MEA) | 1-cell MEA (96hrs) with ≥75% of control that develop to blastocyst | 2-cell MEA (72hrs) with ≥80% of control that develop to blastocyst | Pass (validated by stability studies) |
| Sterility | Not explicitly stated but implied as part of "product specifications" and "aseptic filtration" | Not explicitly stated but implied as part of "product specifications" and "aseptic filtration" | The product specifications are the same as the predicate. |
| Shelf-life | 8 weeks at 2-8°C | 20 weeks at 2-8°C | 20 weeks at 2-8°C (validated by stability studies) |
| Proline concentration | Not specified (tested during stability) | Not specified (tested during stability) | Tested during stability studies. |
| Ammonia concentration | Not specified (tested during stability) | Not specified (tested during stability) | Tested during stability studies. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The stability studies and MEA tests would have involved specific sample sizes, but these are not disclosed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable as the device is reproductive media, not an AI/ML diagnostic tool requiring expert ground truth in the context of image interpretation or similar.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the MEA, the "ground truth" is the observation of embryo development to blastocyst stage, compared to a control group. For the chemical and physical properties (pH, osmolality, endotoxin, sterility), the ground truth is established by standard laboratory testing and measurements.
8. The sample size for the training set
Not applicable; this is not an AI/ML device with a 'training set'.
9. How the ground truth for the training set was established
Not applicable.
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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 (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.
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)
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)
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: 1800.777.222 FAX: +61.7.3841.1288 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: | +61 (7) 3841 1188 |
| Fax: | +61 (7) 3841 3905 |
| E-mail: | Gordana.Pozvek@CookMedical.com |
Date Prepared: May 5, 2016
DEVICE IDENTIFICATION:
| Trade Name: | Sydney IVF Blastocyst Cryopreservation Kit (K-SIBF-5000) &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.
§ 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.