The Gems Oocyte Retrieval Buffer is an assisted reproduction medium used for removal of oocytes from ovarian follicles. It consists of salts, energy substrates, amino acids buffering agents, stabilizers and antibiotics. This device has direct contact with the patients and oocytes.

This product is a single-use device that is aseptically filled into sterilized bottles and has a sterility assurance level (SAL) of 10-3. It is tested for pH, osmolality, embryotoxicity, endotoxin and sterility before lot release and has a shelf-life of 30 weeks.

AI/ML Overview

The provided text does not contain information about an AI device or a study comparing AI with human readers. It describes a submission for a medical device called "Genea Biomedx Gems Oocyte Retrieval Buffer ORB-20, ORB-50," which is a reproductive medium used for oocyte retrieval.

Therefore, I cannot provide the requested information regarding acceptance criteria and studies related to an AI device or human-in-the-loop performance. The document focuses on demonstrating the substantial equivalence of the Oocyte Retrieval Buffer to a legally marketed predicate device through non-clinical performance testing.

However, I can extract the acceptance criteria and a summary of the non-clinical performance testing for the described Genea Biomedx Gems Oocyte Retrieval Buffer device.

Acceptance Criteria and Reported Device Performance (Table for the Oocyte Retrieval Buffer)

Acceptance Criteria	Reported Device Performance (at release and end of shelf-life)
pH	7.3-7.5 (comparable to predicate)
Osmolality	280-290 mOsm/kg (comparable to predicate)
1-cell MEA (Mouse Embryo Assay)	≥80% developed to the blastocyst stage at 96 hours
Endotoxin	<0.4 EU/ml (LAL)
Sterility	No microbiological growth (Sterility Assurance Level (SAL) of 10-3)
Cytotoxicity	Met requirements per ISO 10993-5:2009
Sensitization	Met requirements per ISO 10993-10:2010 (Guinea Pig Maximization)
Intracutaneous Reactivity	Met requirements per ISO 10993-10:2010
Aseptic Processing	Met requirements in ISO 13408-2:2003

Study Details (for the Oocyte Retrieval Buffer):

The document describes non-clinical performance testing to support the substantial equivalence of the "Genea Biomedx Gems Oocyte Retrieval Buffer ORB-20, ORB-50" to a predicate device. This is not a study involving AI or human readers.

Sample size used for the test set and the data provenance: The document does not specify a "test set" in the context of an AI algorithm. For the MEA (Mouse Embryo Assay), "one-cell mouse embryos" were used. The exact number of embryos or experimental replicates is not provided in this summary. The data provenance (country of origin, retrospective/prospective) for these non-clinical tests is not detailed, though Genea Biomedx Pty Ltd is based in Australia.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is not an AI study requiring expert ground truth for image interpretation or similar tasks.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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. No AI component is described.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. No AI algorithm is described.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the performance tests listed, the "ground truth" or reference was based on established scientific and regulatory standards/methods (e.g., USP <71> for sterility, USP <85> for endotoxin, ISO standards for biocompatibility, and a pre-defined blastocyst development rate for MEA).
The sample size for the training set: Not applicable. This document pertains to a medical product, not an AI model requiring a training set.
How the ground truth for the training set was established: Not applicable.

Summary

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Image /page/0/Picture/2 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of three faces in profile, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 28, 2017

Genea Biomedx Pty Ltd % Roger Grav VP. Ouality Assurance and Regulatory Donawa Lifescience Consulting Srl Piazza Albania 10 00153 Rome Italy

Re: K170498

Trade/Device Name: Genea Biomedx Gems Oocyte Retrieval Buffer ORB-20, ORB-50 Regulation Number: 21 CFR§ 884.6180 Regulation Name: Reproductive Media and Supplements Regulatory Class: II Product Code: MQL Dated: August 28, 2017 Received: August 30, 2017

Dear Roger Gray:

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.

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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 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 (DICE) 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 (DICE) 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,

Charles Viviano -S

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

510(k) Number (if known)

K170498

Device Name

Genea Biomedx Gems Oocyte Retrieval Buffer ORB-20, ORB-50

Indications for Use (Describe)

Gems Oocyte Retrieval Buffer is used in the removal of oocytes from ovarian follicles.

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."

Type of Use (Select one or both, as applicable)

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Image /page/3/Picture/1 description: The image contains the logo for Genea Biomedx. The logo consists of a green square with a white curved line inside, followed by the text "Genea" in gray and "BIOMEDX" in green. The logo is simple and modern, with a focus on the company's name.

510(k) Summary (K170498)

l. General Information on Submitter

Submitter/Address:Contact person:Phone:Fax:	Genea Biomedx Pty LtdLevel 2, 321 Kent StreetSydneyNSW 2000AustraliaMs. Kea Dent+61 2 8484 7677+61 2 9229 6478
Correspondent:Phone:Fax:Email:	Mr. Roger GrayVP, Quality and RegulatoryDonawa Lifescience Consulting SrlPiazza Albania 1000153 RomeItaly+39 06 578 2665+39 06 574 3786rgray@donawa.com

II. Date Prepared: September 28, 2017

III. General Information on Devices

Device Name:	Gems Oocyte Retrieval Buffer ORB-20, ORB-50
Common Name:	Embryo Culture Media
Classification Name:	Reproductive Media and Supplements (21 CFR 884.6180)
Product code:	MQL (Media, Reproductive)
Regulatory Class:	II

IV. Predicate Device

Cook Sydney IVF Follicle Flushing Buffer (K002385), manufactured by Cook Ob/Gyn. This predicate device has not been subject to any design related recalls.

V. Device Description

VI. Indications for Use:

Gems Oocyte Retrieval Buffer is used in the removal of oocytes from ovarian follicles.

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Image /page/4/Picture/1 description: The image shows the logo for Genea Biomedx. The logo consists of a green square with a white curved line inside, followed by the text "Genea" in gray and "BIOMEDX" in green. The logo is clean and modern, with a focus on the company's name and brand.

VII. Comparison of Intended Use and Technological Characteristics of the Subject and Predicate Devices

Device/PredicateDevices	Subject device - Gems Oocyte RetrievalBuffer	Predicate device - Cook IVF Follicle FlushingBuffer (K002385)
Indications for Use	Gems Oocyte Retrieval Buffer is used inthe removal of oocytes from ovarianfollicles.	Cook IVF follicle flushing buffer is intendedfor use during in vitro fertilization proceduresfor follicle flushing and oocyte collection.
pH	7.3-7.5	Similar
Osmolality	280-290 mOsm/kg	Similar
Formulation	Comparable
The subject and predicate devices have the same intended use – removal of the oocytes from ovarian follicles. Thesubject and predicate devices also have comparable pH, osmolality, and formulations. In addition, they havecomparable specifications for MEA, endotoxin, and sterility. There may be minor differences in technologicalcharacteristics between the subject and predicate devices, but these differences do not raise different questions of

safety and effectiveness.

VIII. Summary of Non-clinical Performance Testing

The following studies have been performed to support substantial equivalence to the predicate devices:

pH
. Osmolality
Aseptic Processing Validation testing that met the requirements in ISO 13408-2:2003 ●
. Sterility testing per USP <71>
Endotoxin testing per USP <85>
Mouse embryo assay (MEA)

One-cell mouse embryos were exposed to subject devices and cultured at 37°C in an atmosphere containing 5% CO2. The percent of embryos developed to the expanded blastocyst stage within 96 hours were assessed in comparison with the control group.

. Biocompatibility studies, as follows:
- - Cytotoxicity testing per 10993-5:2009
- - Guinea Pig Maximization Sensitization testing per ISO 10993-10:2010
- - Intracutaneous Reactivity testing per ISO 10993-10:2010
Shelf-life studies (real-time and accelerated) were conducted to ensure that the following product specifications are met at time zero and the end of shelf-life.
- - pH - See tables above
- - Osmolality - See tables above
- - 1-cell MEA - ≥80% developed to the blastocyst stage at 96 hours
- - Endotoxin - <0.4 EU/ml (LAL)
- - Sterility - No microbiological growth

IX. Conclusion

The subject and predicate devices have the same intended use and comparable technological characteristics. The differences in technological characteristics between subject and predicate devices do not raise different questions of safety and effectiveness. The performance data demonstrate that the subject device is substantially equivalent to the predicate device.

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.