(257 days)
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No
The device description and performance studies focus on the chemical composition and functional properties of a buffer solution, with no mention of AI or ML technologies.
No
The device is a solution used to wash and store gametes, not to treat a disease or condition in a patient.
No
This device is a buffer solution used to wash and store gametes, not to diagnose a condition or disease. It facilitates the IVF process rather than identifying medical states.
No
The device description clearly indicates it is a physical solution packaged in glass vials, which is a hardware component, not software.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "to physically wash and store gametes in preparation for the IVF process." While it's a preparation step, it's directly related to the in vitro fertilization process, which involves handling biological samples (gametes) outside the body.
- Device Description: The description details a "HEPES buffered physiologic solution" used to "wash gametes." This is a reagent or solution specifically designed for use with biological samples in a laboratory setting for a diagnostic or therapeutic process (in this case, IVF).
- Functional Testing: The performance studies include functional tests like the "two-cell MEA and Human Sperm Survival Assay (HSSA)." These are biological assays performed in vitro to assess the suitability and performance of the buffer with biological samples (embryos and sperm). This type of testing is characteristic of IVD devices.
- Predicate Device: The predicate device listed, "G-IVFIM PLUS (K081116)," is also likely an IVD related to IVF procedures, further supporting the classification of this device.
While the device itself isn't performing a diagnostic test on the gametes to identify a disease or condition, it is a critical reagent used in vitro as part of a complex process (IVF) that ultimately leads to a clinical outcome. The regulatory definition of an IVD can be broad and includes reagents and solutions used in laboratory procedures involving biological samples.
Therefore, the Sydney IVF Gamete Buffer fits the criteria of an IVD.
N/A
Intended Use / Indications for Use
Sydney IVF Gamete Buffer is used to physically wash and store gametes in preparation for the IVF process.
Product codes
MOL
Device Description
Sydney IVF Gamete Buffer is a HEPES buffered physiologic solution used to physically wash gametes in preparation for the fertilization step in the IVF process. Sydney IVF Gamete Buffer can be used for both sperm and oocytes. This solution can be used to wash oocytes of excess blood following aspiration and also as a short term storage solution until transfer to a fertilisation medium. Sydney IVF Gamete Buffer is based upon the formulation of a 20 mM HEPES buffered media containing salts, non-essential amino acids, glucose, 10 mg/mL Human Serum Albumin (HSA) and 0.01 mg/mL Gentamicin.
Sydney IVF Gamete Buffer is packaged in 20, 50 or 100 mL borosilicate Type I glass vials with Fluorotec coated rubber stoppers held in place with a tamper evident seal. These products are single use, sterile (aseptic filtration) devices. It has a shelf life of 20 weeks when stored at 2 - 8 °C.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Bench testing of the Sydney IVF Gamete Buffer included pH, osmolality, endotoxin, bioburden, and sterility.
The two-cell MEA and Human Sperm Survival Assay (HSSA) were also conducted. These functional tests provide assurance that the Sydney IVF Gamete Buffer functions in accordance with its intended use with regards to oocyte and sperm wash procedure.
Successful results in these tests provide evidence of reproducible conformance to specifications.
Stability of the device was tested through MEA, Endotoxin, HSSA, Osmolality, pH, sterility, pyruvate, ammonia and amino acid (proline) testing of the product over the proposed shelf life.
Key Metrics
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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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 features a stylized eagle with three heads in profile, representing the department's mission to protect the health of all Americans. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 15, 2016
William A. Cook Australia PTY. LTD. Gordana Pozvek, Ph.D. Senior Regulatory Affairs Specialist 95 Brandl Street Eight Mile Plains, Queensland 4113 Australia
Re: K153478 Trade/Device Name: Sydney IVF Gamete Buffer Regulation Number: 21 CFR§ 884.6180 Regulation Name: Reproductive Media and Supplements Regulatory Class: II Product Code: MOL Dated: July 13 2015 Received: July 15, 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 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.
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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-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 vours.
Douglas Silverstein -S 2016.08.15 11:17:47 -04'00'
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 Gamete Buffer
Indications for Use (Describe)
Sydney IVF Gamete Buffer is used to physically wash and store gametes in preparation for the IVF process.
| 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/3/Picture/0 description: The image shows the logo for Cook Medical. The logo is set against a red background. The word "COOK" is written in large, white, sans-serif font at the top. Below that, the word "MEDICAL" is written in a smaller, white, sans-serif font.
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
510(k) Summary - K153478
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: August 11, 2016
DEVICE IDENTIFICATION:
| Trade Name: | Sydney IVF Gamete Buffer |
|---|---|
| Model Numbers: | K-SIGB-20-AA, K-SIGB-50-AA, K-SIGB-100-AA |
| Common Name: | IVF Media |
| Regulation No: | 21 CFR 884.6180, Reproductive Media and Supplement |
| Regulatory Class: | II |
| Product Code: | MQL - Media, Reproductive |
PREDICATE DEVICE:
G-IVFIM PLUS (K081116) manufactured by Vitrolife Sweden AB, cleared September 2, 2008.
DEVICE DESCRIPTION:
Sydney IVF Gamete Buffer is a HEPES buffered physiologic solution used to physically wash gametes in preparation for the fertilization step in the IVF process. Sydney IVF Gamete Buffer can be used for both sperm and oocytes. This solution can be used to wash oocytes of excess blood following aspiration and also as a short term storage solution until transfer to a fertilisation medium. Sydney IVF Gamete Buffer is based upon the formulation of a 20 mM HEPES buffered media containing salts, non-essential amino acids, glucose, 10 mg/mL Human Serum Albumin (HSA) and 0.01 mg/mL Gentamicin.
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Sydney IVF Gamete Buffer is packaged in 20, 50 or 100 mL borosilicate Type I glass vials with Fluorotec coated rubber stoppers held in place with a tamper evident seal. These products are single use, sterile (aseptic filtration) devices. It has a shelf life of 20 weeks when stored at 2 - 8 °C.
INDICATIONS FOR USE:
Sydney IVF Gamete Buffer is used to physically wash and store gametes in preparation for the fertilization step in the IVF process.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE:
Sydney IVF Gamete Buffer and the predicate (K081116) are based on similar technology, principal of operation and equivalent intended use/indications for use. Both Sydney IVF Gamete Buffer and the predicate are buffered physiological formulations containing HSA, Non-Essential Amino Acids and Gentamicin used to wash and prepare gametes for fertilization during the IVF process.
Sydney IVF Gamete Buffer and the predicate device have the same fundamental technology and similar technological characteristics including the following:
- Similar chemical formulation
- o Similar performance specifications
- pH: 7.3 7.5 ।
- Osmolality: 285 295 ।
- Endotoxin: