Gems Fertilisation Medium is used to provide a suitable environment for both oocytes and sperm and support in vitro fertilisation. This medium can be used for transfer of zygotes into the uterus.

Gems Cleavage Medium is for in vitro culture of embryos following fertilization to the 4-8 cell stage. This medium can be used for transfer of cleavage stage embryos into the uterus.

Gems Blastocyst Medium is for in vitro culture of embryos from the cleavage stage to the blastocyst stage of development. This medium can be used for transfer of blastocyst stage embryos into the uterus.

Gems Geri Medium is for in vitro culture of embryos from fertilization to the blastocyst stage of development. This medium can be used for transfer of embryos into the uterus.

Gems VitBase is used to maintain embryos for a short period of time in a non-gassed environment during embryo vitrification and warming procedures. The embryos can be placed in this medium for a maximum of 10 minutes.

Device Description

The subject devices are culture media consisting of salts, energy substrates, amino acids, buffering agents, nutrients supplements and antibiotics, with or without L-Carnitine and/or human serum albumin. These devices have different applications in Assisted Reproduction Technology (ART) procedures in a hospital environment. These media are single-use devices that are aseptically filled into the 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

This document describes the Genea Biomedx Genea Embryo Culture Media and its associated performance testing for substantial equivalence to predicate devices, as reviewed by the FDA.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for several key parameters are presented, primarily for shelf-life studies and comparison to predicate devices/literature.

Parameter	Acceptance Criteria (Internal/Comparative)	Reported Device Performance
pH	Varies by medium (e.g., Gems Fertilisation: 7.5-7.7, Gems Cleavage: 7.4-7.6, Gems Blastocyst: 7.6-7.80, Gems Geri: 7.4-7.6, Gems VitBase: 7.3-7.5)	Similar to predicate devices, met internal specifications. Included in shelf-life studies.
Osmolality	Varies by medium (e.g., Gems Fertilisation: 295-305 mOsm/kg, Gems Cleavage: 285-295 mOsm/kg, Gems Blastocyst: 285-295 mOsm/kg, Gems Geri: 285-295 mOsm/kg, Gems VitBase: 295-305 mOsm/kg)	Similar to predicate devices, met internal specifications. Included in shelf-life studies.
1-cell MEA (Mouse Embryo Assay)	≥80% developed to the blastocyst stage at 96 hours	Met acceptance criteria (implied by "performance data demonstrate that the subject devices are substantially equivalent"). Included in shelf-life studies.
Endotoxin	<0.4 EU/ml (LAL)	Met acceptance criteria (implied). Included in shelf-life studies.
Sterility	No microbiological growth	Met acceptance criteria (implied). Included in shelf-life studies.
Pregnancy Rate (Primary Clinical Endpoint)	Comparable to CDC data for relevant age groups (comparator)	Comparable to CDC data.
Fertilization Rate (Secondary Clinical Endpoint)	Comparable to published literature (comparator)	Comparable to published literature.
Cleavage Rate (Secondary Clinical Endpoint)	Comparable to published literature (comparator)	Comparable to published literature.
Blastulation Rate (Secondary Clinical Endpoint)	Comparable to published literature (comparator)	Comparable to published literature.
Live Birth Rate (Additional Clinical Endpoint)	Comparable to CDC data for relevant age groups (comparator)	Comparable to CDC data.
Biocompatibility	Per ISO 10993 standards (e.g., cytotoxicity, sensitization, intracutaneous reactivity, genotoxicity)	All tests met the requirements (implied by non-clinical testing summary).
Aseptic Processing	Met requirements in ISO 13408-2:2003	Met requirements.

2. Sample Sizes Used for the Test Set and Data Provenance

A single-site clinical trial was conducted for performance testing.

Test Set Sample Size:
- Embryos:
  - Test Group (Subject Devices): 641 embryos used
  - Control Group (Genea in-house media): 598 embryos used
- Embryo Transfer Procedures:
  - Test Group: 569 procedures
  - Control Group: 531 procedures
- The sample sizes for MEA, endotoxin, sterility, and biocompatibility tests are not explicitly stated, but standard procedures typically involve sufficient numbers for statistical validity.
Data Provenance: The clinical trial was conducted at the Genea Clinic (Sydney, Australia). The study was prospective as it was a controlled, double-blinded, single-site clinical trial designed to evaluate safety and effectiveness.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not specify the number or qualifications of experts involved in establishing the ground truth for the clinical trial endpoints (pregnancy rate, fertilization rate, cleavage rate, blastulation rate, live birth rate). These outcome measures are typically objectively determined through established medical protocols and laboratory analyses in an IVF clinic setting. The "ground truth" for clinical outcomes in this context would be the objective clinical data recorded (e.g., ultrasound confirmation of fetal heartbeat, successful fertilization observed microscopically, embryo development stages).

4. Adjudication Method for the Test Set

The document states it was a "controlled, double-blinded, single-site clinical trial." This implies that neither the patients nor the clinicians/researchers directly involved in assessing outcomes were aware of whether the specific subject device or the control media was used. This blinding inherently serves as a form of adjudication against bias in outcome assessment. However, a specific "adjudication method" (like 2+1 reads for imaging) is not applicable or described for these types of clinical outcomes.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. This type of study is typically relevant for interpretative diagnostic devices where human reader performance is a direct output. This document describes embryo culture media, and its effectiveness is measured by biological outcomes, not human interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

This question is not applicable. The device is a "Reproductive Media and Supplements" – an in-vitro diagnostic/culture medium, not an algorithm or AI device. Its performance is inherent to its biochemical properties and biological effect on embryos, assayed through laboratory and clinical endpoints.

7. The Type of Ground Truth Used

The ground truth for the clinical study was based on:

Outcomes Data:
- Primary Endpoint: Fetal heartbeat at 6-8 weeks post-embryo transfer (objective clinical outcome).
- Secondary Endpoints: Fertilization rate, cleavage rate, and blastulation rate (observable biological outcomes assessed in the lab).
- Additional Analysis: Live birth rate (objective clinical outcome).
Comparative Data: The study compared its clinical outcomes to:
- Published literature for fertilization, cleavage, and blastulation rates.
- Assisted Reproductive Technology National Summary Report published by the Centers for Disease Control and Prevention (CDC) for pregnancy and live birth rates.
- Genea in-house media in the control group for direct comparison within the trial.

8. The Sample Size for the Training Set

This information is not provided. The document describes pre-market notification (510(k)) for substantial equivalence, which focuses on demonstrating safety and effectiveness for a device, typically through testing and comparison, rather than an "algorithm training" process. The media formulations and manufacturing processes would have been developed and optimized, but not necessarily through a formal "training set" in the sense of machine learning algorithms.

9. How the Ground Truth for the Training Set Was Established

This information is not provided. As mentioned above, the concept of a "training set" with established "ground truth" in the statistical learning sense is not directly applicable to the development of embryo culture media as described in this document. The development and optimization of such media would involve extensive R&D, experimentation, and quality control, ensuring optimal conditions for embryo development, but this is distinct from establishing ground truth for a machine learning model.

Summary

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

May 12, 2017

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

Re: K161261

Trade/Device Name: Gems Fertilisation Medium, Gems Cleavage Medium, Gems Blastocyst Medium, Gems Geri Medium, Gems VitBase Regulation Number: 21 CFR§ 884.6180 Regulation Name: Reproductive Media and Supplements Regulatory Class: II Product Code: MQL Dated: April 25, 2017 Received: April 28, 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.

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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/Resourcesfor You/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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Indications for Use

510(k) Number (if known) K161261

Device Name

Gems Fertilisation Medium, Gems Cleavage Medium, Gems Blastocyst Medium, and Geri Medium, and Gems VitBase

Indications for Use (Describe)

Gems Fertilisation Medium is used to provide a suitable environment for both oocytes and sperm and support in vitro fertilisation. This medium can be used for transfer of zygotes into the uterus.

Gems Cleavage Medium is for in vitro culture of embryos following fertilization to the 4-8 cell stage. This medium can be used for transfer of cleavage stage embryos into the uterus.

Gems Geri Medium is for in vitro culture of embryos from fertilization to the blastocyst stage of development. This medium can be used for transfer of embryos into the uterus.

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

☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/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.

510(k) Summary

I. General Information on Submitter

Submitter/Address:Phone:Fax:	Genea Biomedx Pty LtdLevel 2, 321 Kent StreetSydneyNSW 2000Australia+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:	May 11, 2017

III. General Information on Devices

Device Name:	Gems Fertilisation Medium, Gems Cleavage Medium, Gems BlastocystMedium, Gems Geri Medium, and Gems VitBase
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 Devices

1. Sydney IVF Fertilization Medium, Sydney IFV Cleavage Medium and Sydney IVF Blastocyst Medium (K153290), manufactured by William A. Cook Australia Pty Ltd
1. G-TI (K133568), manufactured by Vitrolife, Inc.
1. Cook Sydney IVF Blastocyst Vitrification Kit, Cook Sydney IVF Blastocyst Warming Kit (K143724), manufactured by William A. Cook Australia Pty Ltd

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

V. Device Description

. The Gems Fertilisation Medium is intended for in vitro fertilization and transfer of embryos to the uterus.
. The Gems Cleavage Medium is intended for culture of embryos from fertilization to cleavage stage and transfer of embryos to the uterus.

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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 a white curved line inside, followed by the text "Genea" in gray and "BIOMEDX" in green. The green square is on the left side of the logo, and the text is on the right side.

The Gems Blastocyst Medium is intended for culture of embryos from cleavage stage to blastulation stage and transfer of embryos to the uterus.

The Gems Geri Medium is intended for culture of embryos from fertilization stage and transfer of embryos to the uterus.
. The Gems VitBase is intended for culture of embryos (up to 10 minutes) during embryo vitrification/warming procedures.

These media are single-use devices that are aseptically filled into the 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.

Devices	Indications for Use
Gems Fertilisation Medium	Gems Fertilisation Medium is used to provide a suitable environment for both oocytesand sperm and support in vitro fertilisation. This medium can be used for transfer ofzygotes into the uterus.
Gems Cleavage Medium	Gems Cleavage Medium is for in vitro culture of embryos following fertilization to the 4-8cell stage. This medium can be used for transfer of cleavage stage embryos into theuterus.
Gems Blastocyst Medium	Gems Blastocyst Medium is for in vitro culture of embryos from the cleavage stage to theblastocyst stage of development. This medium can be used for transfer of blastocyststage embryos into the uterus.
Gems Geri Medium	Gems Geri Medium is for in vitro culture of embryos from fertilization to the blastocyststage of development. This medium can be used for transfer of embryos into the uterus.
Gems VitBase	Gems VitBase is used to maintain embryos for a short period of time in a non-gassedenvironment during embryo vitrification and warming procedures. The embryos can beplaced in this medium for a maximum of 10 minutes.

VI. Indications for Use:

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

Device/PredicateDevices	Subject device - Gems FertilisationMedium	Predicate device - Sydney IVF FertilizationMedium (K153290)
Indications for Use	Gems Fertilisation Medium is used toprovide a suitable environment for bothoocytes and sperm and support in vitrofertilization. This medium can be used fortransfer of zygotes into the uterus.	Sydney IVF Fertilization Medium is intendedfor use during in vitro procedures forinsemination and incubation of oocytes.
pH	7.5-7.7	Similar
Osmolality	295-305 mOsm/kg	Similar
Formulation	Base formulations are comparable, while the subject device contains additional ingredients.

The subject and predicate devices have the similar indications – culture media for in vitro fertilization. The subject device is also indicated for transfer of zygotes into the uterus, while the predicate for transfer procedures. This difference does not represent a new intended use as both devices are for the treatment of infertility which requires transfer of embryos into the uterus, and is in-line with other devices cleared under this regulation/product code that are used for both culture and embryo transfer.

The subject and predicate devices have comparable base formulations; however, the subject device includes additional ingredients. In addition, the pH, osmolality, MEA, endotoxin and sterility specifications for the subject and predicate devices are comparable. The differences in formulation noted above do not raise different questions of safety or effectiveness.

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Device/PredicateDevices	Subject device – Gems CleavageMedium	Predicate device – Sydney IVF CleavageMedium (K153290)
Indications for Use	Gems Cleavage Medium is for in vitroculture of embryos following fertilization tothe 4-8 cell stage. This medium can beused for transfer of cleavage stageembryos into the uterus.	Sydney IVF Cleavage Medium is intended foruse during in vitro fertilization procedures forculture and transfer of cleavage stageembryos.
pH	7.4-7.6	Similar
Osmolality	285-295 mOsm/kg	Similar
Formulation	Base formulations are comparable, while the subject device contains additional ingredients.

The subject and predicate devices have similar indications – culture of embryos from fertilization to the cleavage stage of development and transfer of cleavage stage embryos into the uterus. However, the predicate device can also be used for in vitro fertilization procedures, which is different than the subject device. This narrower indication for the subject device does not represent a new intended use.

Device/PredicateDevices	Subject device – Gems BlastocystMedium (K161261)	Predicate device – Sydney IVF BlastocystMedium (K153290)
Indications for Use	Gems Blastocyst Medium is for in vitroculture of embryos from the cleavagestage to the blastocyst stage ofdevelopment. This medium can be usedfor transfer of blastocyst stage embryosinto the uterus.	Sydney IVF Blastocyst Medium is intended foruse during in vitro fertilization procedures forextended culture and transfer of embryos.
pH	7.6-7.80	Similar
Osmolality	285-295 mOsm/kg	Similar
Formulation	Base formulations are comparable, while the subject device contains additional ingredients

formulations are comparable, while the subject device contains additional ingredien The subject and predicate devices have the similar indications – in vitro culture of embryos from cleavage stage to

blastocyst stage and transfer of embryos to the uterus. Unlike the predicate device is not intended for in vitro fertilization, representing a narrower indication but not a new intended use.

The subject and predicate devices have comparable base formulations: however, the subject device includes additional ingredients. In addition, the pH, osmolality, MEA, endotoxin and sterility specifications for the subject and predicate devices are comparable. The differences in formulation noted above do not raise different questions of safety or effectiveness.

Device/PredicateDevices	Subject device – Gems Geri Medium	Predicate device - G-TL (K133568)
Indications for Use	Gems Geri Medium is for in vitro cultureof embryos from fertilization to theblastocyst stage of development. Thismedium can be used for transfer ofembryos into the uterus.	Medium for culture of embryos from fertilizationto blastocyst stage.
pH	7.4-7.6	7.2-7.4
Osmolality	285-295 mOsm/kg	265-275 mOsm/kg
Formulation	Base formulations are comparable, while the subject device contains additional ingredientsand does not include some ingredients that are present in the predicate device.

The subject and predicate devices have similar indications - in vitro culture of embryos from fertilization to blastocyst stage. The subject device is also indicated for transfer of blastocysts into the predicate device is not indicated for transfer procedures. This difference does not represent a new intended use as both devices are for the treatment of infertility which requires transfer of embryos into the uterus, and is in-line with other devices cleared under this regulation/product code that are used for both culture and embryo transfer.

The subject and predicate devices have comparable base formulations. However, the subject device includes additional ingredients and does not contain some ingredients that are present in the predicate device formulation. In addition, the pH, osmolality, MEA, endotoxin and sterility specifications for the subject and predicate devices are

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	comparable. The differences in formulation noted above do not raise different questions of safety or effectiveness.

Device & PredicateDevice(s):	Subject device - Gems VitBase	Predicate device - Cryobase solution includedin Cook Sydney IVF Blastocyst Vitrification Kitand COOK Sydney IVF Blastocyst Warming Kit(K143724)
Indications for Use	Gems VitBase is used to maintainembryos for a short period of time in anon-gassed environment duringembryo vitrification and warmingprocedures. The embryos can beplaced in this medium for a maximumof 10 minutes.	Blastocyst Vitrification Kit is intended for thevitrification of human blastocysts for assistedreproduction technologies (ART). This kit isdesigned for use with Blastocyst Warming Kit.Blastocyst Warming Kit is intended for thewarming of human blastocysts that haveundergone vitrification using COOK Sydney IVFVitrification Kit for ART procedures.
pH	7.3-7.5	7.3-7.5
Osmolality	295-305 mOsm/kg	285-295 mOsm/kg
Formulation	Base formulations are comparable, while the subject device does not contain gentamicinthat is present in the subject device.
The subject device and the Cryobase solution in the predicate devices have similar indications – temporary culture of

embryos during embryo vitrification/warming procedures. Therefore, the subject and predicate devices have comparable intended uses.

The subject and predicate devices have comparable base formulations; however, the subject device does not contain gentamicin that is present in the predicate device formulation. In addition, the pH, osmolality, MEA, endotoxin and sterility specifications for the subject and predicate devices are comparable. The differences in formulation noted above do not raise different questions of safety or effectiveness.

In addition to pH and osmolality, the specifications for MEA, endotoxin, and sterility for each version of the subject device are comparable to that of their respective predicate device.

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
- - Genotoxicity testing - Bacterial Reverse Mutation Assay per ISO 10993-3:2003
- - Genotoxicity testing - Mouse Lymphoma Assay per ISO 10993-3:2014
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

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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. Summary of Clinical Performance Testing

A controlled, double-blinded, single-site clinical trial was conducted at the Genea Clinic (Sydney, Australia) to evaluate the safety and effectiveness of the subject devices. The comparator devices used in this study were Genea in-house media. However, for the purpose of determining substantial equivalence, the results of the subject media were compared to the published literature and the Assisted Reproductive Technology National Summary Report published by the Centers for Disease Control and Prevention (CDC).

In the test group, a total of 641 embryos were used in 569 embryo transfer procedures. In the control group. a total of 598 embryos were used in 531 embryo transfer procedures. The primary endpoint was pregnancy rate as indicated by fetal heartbeat at 6-8 weeks post-embryo transfer. The secondary endpoints were fertilization rate, cleavage rate and blastulation rate. The additional analysis was live birth rate. The pregnancy rate and live birth rate were evaluated based on patient ages and compared to the CDC data. The secondary outcomes were compared with the literature reports. Data analysis was based on the outcome of all embryos transferred.

The results demonstrated that the primary endpoint of pregnancy rate was comparable to CDC data whereas the secondary endpoints of fertilization rate, cleavage rate and blastulation rate were comparable to those found in the published literature. Finally, the live birth rate was also comparable to CDC data.

X. Conclusion

The subject and predicate devices have the same intended uses. Although there are differences in technological characteristics between the subject and predicate devices, these differences do not raise different questions of safety or effectiveness. The performance data demonstrate that the subject devices are substantially equivalent to the predicate devices.

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.