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

{0}------------------------------------------------ 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, representing the department's commitment to health, human services, and science. The eagle is positioned to the right of the department's name, which is arranged in a circular pattern around the logo. 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. {1}------------------------------------------------ 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 {2}------------------------------------------------ # 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 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. Type of Use (Select one or both, as applicable) | <span> <span style="font-size: 10pt;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> | |-----------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------| |-----------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------| # CONTINUE ON A SEPARATE PAGE IF NEEDED. 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General Information on Submitter | Submitter/Address:<br>Phone:<br>Fax: | Genea Biomedx Pty Ltd<br>Level 2, 321 Kent Street<br>Sydney<br>NSW 2000<br>Australia<br>+61 2 8484 7677<br>+61 2 9229 6478 | |--------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Correspondent:<br>Phone:<br>Fax:<br>Email: | Mr. Roger Gray<br>VP, Quality and Regulatory<br>Donawa Lifescience Consulting Srl<br>Piazza Albania 10<br>00153 Rome<br>Italy<br>+39 06 578 2665<br>+39 06 574 3786<br>rgray@donawa.com | | II. Date Prepared: | May 11, 2017 | # III. General Information on Devices | Device Name: | Gems Fertilisation Medium, Gems Cleavage Medium, Gems Blastocyst<br>Medium, 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 - 2. G-TI (K133568), manufactured by Vitrolife, Inc. - 3. 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 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, as follows: - . 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. {4}------------------------------------------------ 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 oocytes<br>and sperm and support in vitro fertilisation. This medium can be used for transfer of<br>zygotes into the uterus. | | | | | Gems Cleavage Medium | Gems Cleavage Medium is for in vitro culture of embryos following fertilization to the 4-8<br>cell stage. This medium can be used for transfer of cleavage stage embryos into the<br>uterus. | | | | | Gems Blastocyst Medium | Gems Blastocyst Medium is for in vitro culture of embryos from the cleavage stage to the<br>blastocyst stage of development. This medium can be used for transfer of blastocyst<br>stage embryos into the uterus. | | | | | Gems Geri Medium | Gems Geri Medium is for in vitro culture of embryos from fertilization to the blastocyst<br>stage 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-gassed<br>environment during embryo vitrification and warming procedures. The embryos can be<br>placed 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/Predicate<br>Devices | Subject device - Gems Fertilisation<br>Medium | Predicate device - Sydney IVF Fertilization<br>Medium (K153290) | |-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------| | Indications for Use | Gems Fertilisation Medium is used to<br>provide a suitable environment for both<br>oocytes and sperm and support in vitro<br>fertilization. This medium can be used for<br>transfer of zygotes into the uterus. | Sydney IVF Fertilization Medium is intended<br>for use during in vitro procedures for<br>insemination 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. {5}------------------------------------------------ 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. | Device/Predicate<br>Devices | Subject device – Gems Cleavage<br>Medium | Predicate device – Sydney IVF Cleavage<br>Medium (K153290) | |-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for Use | Gems Cleavage Medium is for in vitro<br>culture of embryos following fertilization to<br>the 4-8 cell stage. This medium can be<br>used for transfer of cleavage stage<br>embryos into the uterus. | Sydney IVF Cleavage Medium is intended for<br>use during in vitro fertilization procedures for<br>culture and transfer of cleavage stage<br>embryos. | | 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. 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/Predicate<br>Devices | Subject device – Gems Blastocyst<br>Medium (K161261) | Predicate device – Sydney IVF Blastocyst<br>Medium (K153290) | |-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------| | Indications for Use | Gems Blastocyst Medium is for in vitro<br>culture of embryos from the cleavage<br>stage to the blastocyst stage of<br>development. This medium can be used<br>for transfer of blastocyst stage embryos<br>into the uterus. | Sydney IVF Blastocyst Medium is intended for<br>use during in vitro fertilization procedures for<br>extended 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/Predicate<br>Devices | Subject device – Gems Geri Medium | Predicate device - G-TL (K133568) | |-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------| | Indications for Use | Gems Geri Medium is for in vitro culture<br>of embryos from fertilization to the<br>blastocyst stage of development. This<br>medium can be used for transfer of<br>embryos into the uterus. | Medium for culture of embryos from fertilization<br>to 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 ingredients<br>and 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 {6}------------------------------------------------ Image /page/6/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. | | comparable. The differences in formulation noted above do not raise different questions of safety or effectiveness. | |--|---------------------------------------------------------------------------------------------------------------------| | | | | | | | | | | | | | Device & Predicate<br>Device(s): | Subject device - Gems VitBase | Predicate device - Cryobase solution included<br>in Cook Sydney IVF Blastocyst Vitrification Kit<br>and COOK Sydney IVF Blastocyst Warming Kit<br>(K143724) | |-----------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for Use | Gems VitBase is used to maintain<br>embryos for a short period of time in a<br>non-gassed environment during<br>embryo vitrification and warming<br>procedures. The embryos can be<br>placed in this medium for a maximum<br>of 10 minutes. | Blastocyst Vitrification Kit is intended for the<br>vitrification of human blastocysts for assisted<br>reproduction technologies (ART). This kit is<br>designed for use with Blastocyst Warming Kit.<br>Blastocyst Warming Kit is intended for the<br>warming of human blastocysts that have<br>undergone vitrification using COOK Sydney IVF<br>Vitrification 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 gentamicin<br>that 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 {7}------------------------------------------------ Image /page/7/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 text is aligned to the right of the square. - 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.