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.

AI/ML Overview

This document describes the Sydney IVF Gamete Buffer and its substantial equivalence to a predicate device. However, it does not contain the information you requested regarding the acceptance criteria and a study proving a new device's performance against those criteria in the context of an AI/human-in-the-loop system.

This document is a 510(k) summary for a medical device (a buffer solution for IVF), not for a device that involves AI, image analysis, or human reader performance. The "performance data" section refers to bench testing for the buffer solution itself (pH, osmolality, endotoxin, etc.), and functional tests like the 2-cell Mouse Embryo Assay (MEA) and Human Sperm Survival Assay (HSSA) to confirm its suitability for its intended use. It's a comparison to ensure the new buffer is as safe and effective as an existing one, not a study of algorithm performance.

Therefore, I cannot extract the requested information from the provided text.

Here's why each point you asked for cannot be answered from this document:

A table of acceptance criteria and the reported device performance: While the document lists performance specifications (pH, osmolality, endotoxin, MEA, HSSA) for the Sydney IVF Gamete Buffer and implies they are similar to the predicate, it doesn't present them in a formal acceptance criteria and reported performance table for a new device's diagnostic or AI performance.
Sample size used for the test set and the data provenance: Not applicable. The "test set" here refers to samples of the buffer solution or biological assays, not a set of clinical data for an AI system.
Number of experts used to establish the ground truth... and their qualifications: Not applicable. Ground truth for an AI system is established by human experts, not through chemical and biological assays of a buffer solution.
Adjudication method: Not applicable.
If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable. This type of study is for evaluating human performance with and without AI assistance, which is not relevant to a gamete buffer solution.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used: Not applicable in the context of AI. The "ground truth" for the buffer solution's performance is derived from standardized laboratory tests (e.g., pH meter readings, osmolality measurements, biological assay results).
The sample size for the training set: Not applicable. There is no AI model being trained.
How the ground truth for the training set was established: Not applicable.

In summary, the provided document describes a medical device of a completely different nature than what your questions target.

Summary

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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)

K153478

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)
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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

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:

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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: < 0.40 EU/mL ।
- 2-cell Mouse Embryo Assay (MEA) ≥ 80% blastocyst at 72 hours ।
- Human Sperm Survival Assay (HSSA) ।
Same method of manufacturing process aseptic filtration ●
Similar packaging ●
Similar shelf life ●
Identical storage temperature

Technological characteristics such as formulation, shelf-life, pH, osmolality, MEA, endotoxin, and HSSA specifications of Sydney IVF Gamete Buffer are similar to the predicate device, and differences do not impact substantial equivalence as they do not raise different questions of safety or effectiveness.

PERFORMANCE DATA:

Bench testing of the Sydney IVF Gamete Buffer included pH, osmolality, endotoxin, bioburden, and sterility.

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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.

CONCLUSION:

The results of the testing provide reasonable assurance that Sydney IVF Gamete Buffer has been designed and tested to assure conformance to the requirements for its intended use, is as safe and effective as the predicate device and supports a determination of substantial equivalence.

Regulation Number and Section

§ 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.