Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and intended use clearly define the devices as culture media, which are chemical formulations used in ART procedures. There is no mention of any computational or analytical components that would suggest the use of AI or ML. The performance studies focus on biological outcomes (pregnancy rate, fertilization rate, etc.) and compare them to existing data and literature, not on the performance of an AI/ML algorithm.

Therapeutic

Yes
The device is described as a culture medium used for in vitro fertilization and culturing embryos before transfer into the uterus, directly impacting reproductive health by facilitating a medical procedure.

Diagnostic

No

The devices are culture media used for in vitro fertilization and embryo transfer, which are therapeutic and supportive procedures, not diagnostic.

SaMD (Software as a Medical Device)

No

The device description explicitly states the devices are "culture media consisting of salts, energy substrates, amino acids, buffering agents, nutrients supplements and antibiotics," which are physical substances, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, the devices described are not IVDs (In Vitro Diagnostics).

Here's why:

Intended Use: The intended use is to provide a suitable environment for oocytes and sperm for fertilization and to support the culture of embryos for transfer into the uterus. This is a direct intervention in the process of reproduction, not a diagnostic test performed in vitro on a sample from the body to provide information about a patient's health status.
Device Description: The devices are culture media used in Assisted Reproduction Technology (ART) procedures. While these procedures involve in vitro steps (fertilization and embryo culture), the media themselves are facilitating biological processes, not performing a diagnostic test.
Lack of Diagnostic Purpose: The description and performance studies focus on the success of fertilization, embryo development, pregnancy rate, and live birth rate. These are outcomes of the ART procedure, not diagnostic markers of a patient's condition.
No Mention of Diagnostic Information: There is no indication that these media are used to diagnose a disease, condition, or to monitor a patient's health status.

IVDs are typically used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. These devices are facilitating a biological process outside the body that is then used for therapeutic purposes (embryo transfer).

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes (comma separated list FDA assigned to the subject device)

MQL

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:

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

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Hospital environment

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-clinical Performance Testing:

Study Type: Laboratory testing
Tests performed: pH, Osmolality, Aseptic Processing Validation (ISO 13408-2:2003), Sterility testing (USP ), Endotoxin testing (USP ), Mouse embryo assay (MEA), Biocompatibility studies (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.
Key Results: 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. The studies ensured that product specifications (pH, Osmolality, 1-cell MEA - >=80% developed to the blastocyst stage at 96 hours, Endotoxin -

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.

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.

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)

☑ 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 Ltd
Level 2, 321 Kent Street
Sydney
NSW 2000
Australia
+61 2 8484 7677
+61 2 9229 6478 |
|--------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Correspondent:
Phone:
Fax:
Email: | Mr. Roger Gray
VP, Quality and Regulatory
Donawa Lifescience Consulting Srl
Piazza Albania 10
00153 Rome
Italy
+39 06 578 2665
+39 06 574 3786
rgray@donawa.com |
| II. Date Prepared: | May 11, 2017 |

III. General Information on Devices

| Device Name: | Gems Fertilisation Medium, Gems Cleavage Medium, Gems Blastocyst
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
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 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.

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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 oocytes
and sperm and support in vitro fertilisation. This medium can be used for transfer of
zygotes into the uterus.
Gems Cleavage Medium	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	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	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	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.

VI. Indications for Use:

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

| Device/Predicate
Devices | Subject device - Gems Fertilisation
Medium | Predicate device - Sydney IVF Fertilization
Medium (K153290) |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | Gems Fertilisation Medium is used to
provide a suitable environment for both
oocytes and sperm and support in vitro
fertilization. This medium can be used for
transfer of zygotes into the uterus. | Sydney IVF Fertilization Medium is intended
for use during in vitro procedures for
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.

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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.

| Device/Predicate
Devices | Subject device – Gems Cleavage
Medium | Predicate device – Sydney IVF Cleavage
Medium (K153290) |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | 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. | Sydney IVF Cleavage Medium is intended for
use during in vitro fertilization procedures for
culture and transfer of cleavage stage
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
Devices | Subject device – Gems Blastocyst
Medium (K161261) | Predicate device – Sydney IVF Blastocyst
Medium (K153290) |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | 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. | Sydney IVF Blastocyst Medium is intended for
use during in vitro fertilization procedures for
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

Devices	Subject device – Gems Geri Medium	Predicate device - G-TL (K133568)
Indications for Use	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.	Medium for culture of embryos from fertilization
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
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

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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
Device(s): | Subject device - Gems VitBase | Predicate device - Cryobase solution included
in Cook Sydney IVF Blastocyst Vitrification Kit
and COOK Sydney IVF Blastocyst Warming Kit
(K143724) |
|-----------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | 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. | Blastocyst Vitrification Kit is intended for the
vitrification of human blastocysts for assisted
reproduction technologies (ART). This kit is
designed for use with Blastocyst Warming Kit.
Blastocyst Warming Kit is intended for the
warming of human blastocysts that have
undergone vitrification using COOK Sydney IVF
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
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 ●
Endotoxin testing per USP .
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 -