The Gems Vitrification Set is designed to facilitate dehydration of blastocysts before vitrification via rapid cooling in liquid nitrogen. Dehydration of the blastocysts is achieved by the step-wise use of increasing concentrations of cryoprotectants in the Gems Vitrification Set, which results in water being withdrawn from the cell. The cryoprotectants also protect the blastocysts by reducing the potential for ice crystal formation during the vitrification process.

The Gems Vitrification Set consists of three solutions (Vitsol 2, and Vitsol 3). The base formulation for Vitsol 1 and Vitsol 2 is a HEPES-buffered medium containing salts, energy substrates, amino acids, and human serum albumin. Vitsol 1 contains the cryoprotectant ethylene qlycol, while Vitsol 2 contains the cryoprotectants ethylene glycol and trehalose. Vitsol 3 consists of dimethyl sulphoxide (DMSO). The Gems Vitrification Set is not provided ready for use as Vitsol 3 must be added to the other vitrification solutions before use. Following DMSO addition to Vitsol 1 and 2, the final vitrification solutions for blastocyst vitrification procedures have the following properties:

. Vitrification Solution 1 (Vitsol 1 + DMSO) - 8% ethylene glycol and 8% DMSO
Vitrification Solution 2 (Vitsol 2 + DMSO) 16% ethylene glycol, 16% DMSO, and 0.57M trehalose ●

The Gems Warming Set consists of three warming solutions (Warmsol 2, and Warmsol 3), which are designed to facilitate the re-hydration (warming) of vitrified blastocysts. In the warming process, trehalose in the media manages the inflow of water into blastocysts as concentrations of DMSO and ethylene glycol are reduced during the rehydration process.

All three of the solutions in the Gems Warming Set consist of a HEPES-buffered medium containing salts, energy substrates, amino acids, and human serum albumin, with varying amounts of the cryoprotectant trehalose as described below:

. Warmsol 1 - 1.0 M trehalose
Warmsol 2 0.5 M trehalose ●
Warmsol 3 - No trehalose

These media are single-use devices that are aseptically filled into sterilized bottles and have a sterility assurance level (SAL) of 10 3. The products are tested for pH, osmolality, embryotoxicity, endotoxin, and sterility before lot release.

AI/ML Overview

The provided document describes the acceptance criteria and performance testing for the "Gems Vitrification Set and Gems Warming Set" (subject device) in comparison to a predicate device, the "Cook Sydney IVF Blastocyst Vitrification Kit and Cook Sydney IVF Blastocyst Warming Kit" (K143724).

Here's an analysis of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria / Parameter	Subject Device - Gems Vitrification Set and Gems Warming Set (K162409) Reported Performance	Predicate Device - COOK Sydney IVF Blastocyst Vitrification Kit and COOK Sydney IVF Blastocyst Warming Kit (K143724)	Comparison
Intended Use	Vitrification and warming of human blastocyst stage embryos for ART procedures.	Vitrification and warming of human blastocysts for ART procedures.	Same
Formulation	HEPES buffered physiologic media containing ethylene glycol, DMSO, trehalose, and human serum albumin in addition to normal physiological salts. DMSO provided separately.	HEPES buffered physiologic media containing ethylene glycol, DMSO, trehalose, human Serum albumin and gentamicin in addition to normal physiological salts. DMSO provided separately.	Similar (differences in gentamicin and some concentrations, deemed not to raise different S&E questions)
pH	7.3-7.5	7.3-7.5	Same
Osmolarity (mOsm/kg)	Warmsol 1: 1280-1320; Warmsol 2: 780-820; Warmsol 3: 295-305 (N/A for vitrification solutions)	K-SIBW-SOL1: 657-683; K-SIBW-SOL2: 500-520; K-SIBW-SOL3: 285-295 (Other values for vitrification solutions not directly comparable)	Different (higher in subject device for warming solutions due to cryoprotectant concentrations, deemed not to raise different S&E questions)
Mouse Embryo Assay (MEA)	1-Cell MEA: ≥80% developed to blastocysts at 96h	2-Cell MEA: ≥80% blastocyst formation at 72h	Similar
Endotoxin	Vitsol 1-2, Warmsol 1-3: < 0.40 EU/mL; DMSO: <0.05 EU/ml	< 0.40 EU/mL	Similar
Sterilization Method	Aseptic Filtration, SAL 10⁻³	Aseptic Filtration	Same
Shelf-Life	20 weeks	20 weeks	Same

2. Sample size(s) used for the test set and the data provenance

The document does not specify exact sample sizes for all non-clinical tests. However, for the Mouse Embryo Assay (MEA), it states: "One-cell mouse embryos were exposed sequentially to subject devices in the Vitrification and Warming Sets followed by culture at 37°C in an atmosphere containing 5% CO₂. The percent of embryos developed to the expanded blastocyst stage at 96 hours were assessed in comparison with the control group."

The provenance of this data is a non-clinical study, likely conducted internally by Genea Biomedx Pty Ltd, or by a contract research organization. There is no mention of country of origin of the data or if it was retrospective or prospective in the context of human embryos. Given it's a non-clinical study using mouse embryos, these distinctions are less relevant than for human clinical trials.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. The studies are non-clinical (MEA, chemical analyses, sterility, endotoxin) and likely rely on laboratory measurements and protocols rather than expert consensus for ground truth on individual test items. For the MEA, the "ground truth" would be the observed development of mouse embryos to the blastocyst stage.

4. Adjudication method for the test set

This information is not provided. Given the nature of the non-clinical tests (quantitative measurements and adherence to specified limits), a formal adjudication method by experts is not typically 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

No, an MRMC comparative effectiveness study was not done. This document describes the testing of reproductive media (Gems Vitrification Set and Gems Warming Set), which are medical devices used for in-vitro fertilization procedures, not imaging or diagnostic AI software that would typically involve human readers. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This question is not applicable as the device is not an AI algorithm. It is a set of chemical media. The performance assessed is the biological effectiveness (embryo development) and chemical/physical characteristics of the media themselves in standalone non-clinical tests.

7. The type of ground truth used

The ground truth for the non-clinical performance testing involved:

Quantitative laboratory measurements: For pH, osmolality, endotoxin levels, and sterility. These are objective measurements against established scientific standards and limits.
Biological endpoint observation: For the Mouse Embryo Assay (MEA), the ground truth is the observed development of 1-cell mouse embryos to the expanded blastocyst stage within 96 hours. This is an objective biological outcome.
Validation against standards: Aseptic Processing Validation met requirements in ISO 13408-2:2003. Sterility testing was per USP <71> and Endotoxin testing per USP <85>.

8. The sample size for the training set

This information is not applicable. The device is not an AI algorithm that requires a training set. The descriptions relate to the manufacturing and quality control testing of physical chemical media.

9. How the ground truth for the training set was established

This information is not applicable for the same reason as point 8.

Summary

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring a stylized representation of three human profiles facing right, with flowing lines suggesting movement or connection.

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

May 24, 2017

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

Re: K162409

Trade/Device Name: Gems Vitrification Set and Gems Warming Set Regulation Number: 21 CFR§ 884.6180 Regulation Name: Reproductive Media and Supplements Regulatory Class: II Product Code: MQL Dated: April 21, 2017 Received: April 24, 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.

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

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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 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,

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) K162409

Device Name

Gems Vitrification Set and Gems Warming Set

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

Indications for Use (Describe)

Gems Vitrification Set is used for the vitrification of human blastocyst stage embryos for Assisted Reproductive Technology (ART) procedures.

Gems Warming Set is used for the warming of human blastocyst stage embryos that have undergone vitrification.

	Over-The-Counter Use (21 CFR 801 Subpart C) X Prescription Use (Part 21 CFR 801 Subpart D)
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	DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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Image /page/3/Picture/0 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 word "Genea" in gray and "BIOMEDX" in green. The logo is simple and modern, and the colors are eye-catching.

510(k) Summary

l. Submitter Information

Submitter/Address:	Genea Biomedx Pty LtdLevel 2, 321 Kent StreetSydneyNSW 2000Australia
Phone:	+61 2 8484 7677
Fax:	+61 2 9229 6478
Correspondent:	Mr. Roger GrayVP, Quality and RegulatoryDonawa Lifescience Consulting SrlPiazza Albania 1000153 RomeItaly
Phone:	+39 06 578 2665
Fax:	+39 06 574 3786
Email:	rgray@donawa.com
Date Prepared:	May 22, 2017

II. Date Prepared:

III. General Information on Devices

Device Name:	Gems Vitrification Set and Gems Warming Set
Common Name:	Vitrification and Warming Media
Classification Name:	Reproductive Media and Supplements (21 CFR 884.6180)
Product code:	MQL (Media, Reproductive)
Regulatory Class:	II

IV. Predicate Devices

Cook Sydney IVF Blastocyst Vitrification Kit and Cook Sydney IVF Blastocyst Warming Kit (K143724)

These predicate devices have not been subject to any design-related recalls.

V. Indications for Use

Gems Vitrification Set is used for the vitrification of human blastocyst stage embryos for Assisted Reproductive Technology (ART) procedures.

Gems Warming Set is used for the warming of human blastocyst stage embryos that have undergone vitrification.

VI. Device Description

The Gems Vitrification Set and Gems Warming Set are intended for the vitrification and warming of human blastocysts as part of human ART procedures.

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Image /page/4/Picture/0 description: The image contains the logo for Genea BIOMEDX. The logo consists of a green square with rounded corners and a white curved line inside, resembling a stylized "D". To the right of the square, the word "Genea" is written in gray, and below it, "BIOMEDX" is written in green.

. Vitrification Solution 1 (Vitsol 1 + DMSO) - 8% ethylene glycol and 8% DMSO
Vitrification Solution 2 (Vitsol 2 + DMSO) 16% ethylene glycol, 16% DMSO, and 0.57M trehalose ●

. Warmsol 1 - 1.0 M trehalose
Warmsol 2 0.5 M trehalose ●
Warmsol 3 - No trehalose

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

Parameter	Subject Device - GemsVitrification Set andGems Warming Set(K162409)	Predicate Device - COOKSydney IVF BlastocystVitrification Kit and COOKSydney IVF BlastocystWarming Kit (K143724)	Comparison
Indicationfor Use	Gems Vitrification Set isused for the vitrification ofhuman blastocyst stageembryos for AssistedReproductive Technology(ART) procedures.Gems Warming Set isused for the warming ofhuman blastocyst stageembryos that haveundergone vitrification.	Blastocyst Vitrification Kit isintended for the vitrificationof human blastocysts forassisted reproductiontechnologies (ART). This kitis designed for use withBlastocyst Warming Kit (K-SIBW-5000).Blastocyst Warming Kit isintended for the warming ofhuman blastocysts that haveundergone vitrification usingCOOKSydney IVF Vitrification Kit(K-SIBV-5000) for ARTprocedures.	Same Intended Use -vitrification and warming ofhuman blastocyst stageembryos.

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Image /page/5/Picture/0 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 and a clean design.

Parameter	Subject Device - GemsVitrification Set andGems Warming Set(K162409)	Predicate Device - COOKSydney IVF BlastocystVitrification Kit and COOKSydney IVF BlastocystWarming Kit (K143724)	Comparison
Formulation	HEPES bufferedphysiologicmedia containing ethyleneglycol, DMSO, trehalose,and human serumalbumin in addition tonormal physiologicalsalts.DMSO provided in aseparate vial and must beadded to vitrificationmedia before use.	HEPES buffered physiologicmedia containing ethyleneglycol, DMSO, trehalose,human Serum albumin andgentamicin in addition tonormal physiologicalsalts.DMSO provided in aseparate vial and must beadded to vitrification mediabefore use.	Different - Formulas for thevitrification and WarmingVitrification Solutions are similar,consisting of the samecomponents with the exceptionof gentamicin (not in subjectdevice). Some differences inconcentrations.Differences noted above do notraise different questions ofsafety and effectiveness (S&E).
pH	7.3-7.5	7.3-7.5	Same
Osmolarity(mOsm/kg)	Not applicable (N/A) forvitrification solutionsWarmsol 1 – 1280-1320Warmsol 2 – 780-820Warmsol 3 - 295-305	K-SIBV-SOL1: 285 - 295K-SIBV-SOL2: N/AK-SIBV-SOL3: N/AK-SIBW-SOL1: 657 - 683K-SIBW-SOL2: 500 - 520K-SIBW-SOL3: 285 - 295	Different: Osmolality values arehigher in the subject device thanin the predicate device due todifferences in cryoprotectantconcentrations in the subjectdevice. Differences in osmolalitydo not raise different questionsof S&E.
MEA	1-Cell MEA: ≥80%developed to blastocystsat 96h	2-Cell MEA: ≥80%blastocyst formation at 72h	Similar
Endotoxin	Vitsol 1-2, Warmsol 1-3< 0.40 EU/mLDMSO <0.05 EU/ml	< 0.40 EU/mL	Similar
SterilizationMethod	Aseptic FiltrationSAL 10-3	Aseptic Filtration	Same
Shelf-Life	20 weeks	20 weeks	Same

As noted in the table above, the devices have intended use and are technologically comparable. Differences in technological characteristics noted above do not raise different questions of safety or 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 sequentially to subject devices in the Vitrification and Warming Sets followed by culture at 37°C in an atmosphere containing 5% CO₂. The percent of embryos developed to the expanded blastocyst stage at 96 hours were assessed in comparison with the control group.

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Image /page/6/Picture/0 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 simple and modern, with a focus on the company's name.

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 7.3-7.5 *
- - Osmolality - See technological comparison table above for specifications
- - 1-cell MEA – ≥80% developed to the blastocyst stage at 96 hours
- - Endotoxin - <0.4 EU/ml (LAL) for Vitsol 1-2, and Warmsol 1-3
- - Sterility - No microbiological growth

IX. Conclusions

The results of the performance testing conducted on the subject device demonstrate that it is as safe and effective as the predicate device and supports 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.