(156 days)
Not Found
No
The summary describes a time-lapse incubator with imaging capabilities and associated software for controlling settings and patient information. There is no mention of image analysis, pattern recognition, or any other function that would typically involve AI/ML. The performance studies focus on the physical and functional aspects of the incubator and dish, not on any analytical capabilities of the imaging system.
No
The device provides an environment and imaging for embryo development but does not actively treat a disease or condition. Its function is supportive and diagnostic (imaging), not interventional or restorative on the patient.
No.
Explanation: The device is described as an incubator for embryo development with integrated imaging for viewing and monitoring embryos, but it is not stated that the device itself performs any diagnostic function or analysis that leads to a medical diagnosis. Its primary function is to provide an optimal environment and imaging for observation.
No
The device description clearly states it is a benchtop incubator with physical components like heating elements, a camera, optics, and filters. While it includes firmware and software, it is not solely software.
Based on the provided information, the Geri Embryo Incubator and Geri Dish are not IVD (In Vitro Diagnostic) devices.
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Geri System's Function: The Geri Embryo Incubator and Geri Dish are used to culture and image human embryos outside the body. While this process is part of assisted reproduction, it's not about analyzing a specimen from the body for diagnostic purposes. The imaging is for observing the development of the embryo itself, not for diagnosing a condition in the patient.
- Intended Use: The intended use clearly states providing an environment for embryo development and imaging. It doesn't mention analyzing a specimen for diagnostic information.
- Device Description: The description focuses on the incubator's environmental controls and imaging capabilities for the embryos.
- Performance Studies: The performance studies focus on the functionality of the incubator and dish (temperature, gas, imaging, embryo development in the device), not on the accuracy of a diagnostic test.
- Predicate Devices: The predicate devices are also embryo incubators with time-lapse imaging, further supporting their classification outside of IVD.
Therefore, the Geri Embryo Incubator and Geri Dish are considered medical devices used in assisted reproduction procedures, but they do not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Geri Embryo Incubator is intended to provide an environment with controlled temperature and mixed gas (CO2 and other gases) for the development of embryos. The Geri Embryo Incubator has an integrated camera and optics for imaging and viewing embryos during incubation, for a maximum time of 120 hours.
The Geri Dish is intended to be used for preparation, storage and imaging of human embryos. The Geri Dish is intended to be used only with the Geri Embryo Incubator.
Product codes
MOG, MOK, MTX
Device Description
The Geri Embryo Incubator is a benchtop incubator with six modular incubation chambers each with its own temperature control capability and separate gas inlet feed. Each chamber contains heating elements in its lid and base, together with an orange light source (591 nm) and camera with integrated optics that take time-lapse images of embryos and allows operators to view embryos without removing them from the incubation chamber. Inside each chamber is a filter the gas mixture entering the incubation chamber from the gas supply. The gas is supplied from standard premixed medical gas cylinders.
The Geri Embryo Incubator includes firmware to control the incubator settings, and software to control patient information and settings.
The embryos are maintained in Geri Dishes that are supplied separately. The Geri Dish is an optically-clear polystyrene dish designed to be compatible with the Geri Embryo Incubator. Up to 16 embryos can be stored in one Geri Dish. Geri Dishes are supplied sterile with a sterility assurance level (SAL) of 10-9, and have a shelf-life of 12 months.
The Geri Embryo Incubator and Geri Dish are intended to be used together for embryo imaging purposes. The Geri Dish is not compatible with other embryo time-lapse incubators. However, other assisted reproduction culture dishes may be used in the Geri Embryo Incubator in separate non-time-lapse positions located within each chamber.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CMOS microscope camera
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Bench performance tests that met design specifications described in Section VII, as follows:
- Gas maintenance testing to ensure that gas flow rates, gas recovery rates and CO2 levels in chambers meet design specifications
- Temperature control testing to ensure that culture chamber temperature conditions were within defined ranges and were stable over time.
- Time-lapse testing to demonstrate that all design specifications of time-lapse function are met (dish presence detection, dish position accuracy, image quality and resolution, imaging of embryos in all wells on Geri Dishes within time and focal plane settings)
- Embryo development test demonstrating that >=70% mouse 1-cell embryos developed to blastocyst on day 5 following exposure to the maximum time lapse exposure conditions.
- Embryo light energy exposure testing comparing the potential for light toxicity associated with time-. lapse imaging under worst-case exposure conditions (maximum light exposure over the full duration of use [120 hours]) to that of total light exposure during in assisted reproduction procedures (IVF and ICSI) using typical laboratory microscopes. Results showed total light energy exposure following time-lapse imaging should not exceed levels associated with typical assisted reproduction imaging procedures.
Testing for Geri Dish:
- Radiation sterilization validation testing per ISO 11137-2:2009
- Package integrity testing:
- Dye Penetration Test per ASTM F1929-12
- Peel strength testing ASTM F88/F88M-09
- Endotoxin testing per USP and ANSI/AAMI ST72: 2011. The testing demonstrated that the device met the specification of =80% embryos developed to blastocyst in 96 hours."
- Shelf-life testing (accelerated) demonstrating that visual requirements, media fill volume, timelapse alignment and MEA met design specifications before and after aging
Key Metrics
- Embryo development test: >=70% mouse 1-cell embryos developed to blastocyst on day 5 following exposure to the maximum time lapse exposure conditions.
- Endotoxin testing: =80% embryos developed to blastocyst in 96 hours.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 884.6120 Assisted reproduction accessories.
(a)
Identification. Assisted reproduction accessories are a group of devices used during assisted reproduction procedures, in conjunction with assisted reproduction needles and/or assisted reproduction catheters, to aspirate, incubate, infuse, and/or maintain temperature. This generic type of device may include:(1) Powered aspiration pumps used to provide low flow, intermittent vacuum for the aspiration of eggs (ova).
(2) Syringe pumps (powered or manual) used to activate a syringe to infuse or aspirate small volumes of fluid during assisted reproduction procedures.
(3) Collection tube warmers, used to maintain the temperature of egg (oocyte) collection tubes at or near body temperature. A dish/plate/microscope stage warmer is a device used to maintain the temperature of the egg (oocyte) during manipulation.
(4) Embryo incubators, used to store and preserve gametes and/or embryos at or near body temperature.
(5) Cryopreservation instrumentation and devices, used to contain, freeze, and maintain gametes and/or embryos at an appropriate freezing temperature.
(b)
Classification. Class II (special controls) (design specifications, labeling requirements, and clinical testing). The device, when it is a simple embryo incubator with only temperature, gas, and humidity control; a syringe pump; a collection tube warmer; a dish/plate/microscope stage warmer; a controlled-rate cryopreservation freezer; or an assisted reproduction laminar flow workstation is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 15, 2017
Genea Biomedx Pty Ltd % Roger Gray VP, Quality Assurance and Regulatory Affairs Donawa Lifescience Consulting Srl Piazza Albania 10 00153 Rome Italy
Re: K171736
Trade/Device Name: Geri Embryo Incubator and Geri Dish Regulation Number: 21 CFR& 884.6120 Regulation Name: Assisted Reproduction Accessories Regulatory Class: II Product Code: MOG, MOK, MTX Dated: October 12, 2017 Received: October 16, 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 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 (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
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) K171736
Device Name
Geri Embryo Incubator and Geri Dish
Indications for Use (Describe)
The Geri Embryo Incubator is intended to provide an environment with controlled temperature and mixed gas (CO2 and other gases) for the development of embryos. The Geri Embryo Incubator has an integrated camera and optics for imaging and viewing embryos during incubation, for a maximum time of 120 hours.
The Geri Dish is intended to be used for preparation, storage and imaging of human embryos. The Geri Dish is intended to be used only with the Geri Embryo Incubator.
| 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 (K171736)
I. General Information on Submitter
| Submitter/Address:
Contact person:
Phone:
Fax: | Genea Biomedx Pty Ltd
Level 2, 321 Kent Street
Sydney
NSW 2000
Australia
Ms. Kea Dent
+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: November 14, 2017
III. General Information on Devices
| Device Name: | Geri Embryo Incubator and Geri Dish | |
|---|---|---|
| Common Name: | Embryo Incubator | |
| Classification Name: | Assisted Reproduction Accessories (21 CFR 884.6120) | |
| Product code: | MQG (Accessory, Assisted Reproduction), MQK (Labware, Assisted | |
| Reproduction, MTX (Microscope and Microscope Accessories, | ||
| Reproduction, Assisted) | ||
| Regulatory Class: | II |
IV. Predicate Device
EmbryoScope (Version D) and EmbryoViewer Software (K113075) and EmbryoScope and EmbryoSlide (K092183), which are manufactured by Unisense FertillTech A/S. The predicate devices have not been subject to any design related recalls.
V. Device Description
The Geri Embryo Incubator is a benchtop incubator with six modular incubation chambers each with its own temperature control capability and separate gas inlet feed. Each chamber contains heating elements in its lid and base, together with an orange light source (591 nm) and camera with integrated optics that take time-lapse images of embryos and allows operators to view embryos without removing them from the incubation chamber. Inside each chamber is a filter the gas mixture entering the incubation chamber from the gas supply. The gas is supplied from standard premixed medical gas cylinders.
The Geri Embryo Incubator includes firmware to control the incubator settings, and software to control patient information and settings.
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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 logo is simple and modern, with a focus on the company's name.
The embryos are maintained in Geri Dishes that are supplied separately. The Geri Dish is an optically-clear polystyrene dish designed to be compatible with the Geri Embryo Incubator. Up to 16 embryos can be stored in one Geri Dish. Geri Dishes are supplied sterile with a sterility assurance level (SAL) of 10-9, and have a shelf-life of 12 months.
The Geri Embryo Incubator and Geri Dish are intended to be used together for embryo imaging purposes. The Geri Dish is not compatible with other embryo time-lapse incubators. However, other assisted reproduction culture dishes may be used in the Geri Embryo Incubator in separate non-time-lapse positions located within each chamber.
VI. Indications for Use:
The Geri Embryo Incubator is intended to provide an environment with controlled temperature and mixed gas (CO2 and other gases) for the development of embryos. The Geri Embryo Incubator has an integrated camera and optics for imaging and viewing embryos during incubation, for a maximum time of 120 hours.
The Geri Dish is intended to be used for preparation, storage and imaging of human embryos. The Geri Dish is intended to be used only with the Geri Embryo Incubator.
VII. Comparison of Intended Use and Technological Characteristics of the Subject and Predicate Devices
| Device/Predicate
Devices | Subject device - Geri Embryo
Incubator | Predicate device - EmbryoScope (Version D)
and EmbryoViewer Software (K113075) |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The Geri Embryo Incubator is intended
to provide an environment with
controlled temperature and mixed gas
(CO2 and other gases) for the
development of embryos. The Geri
Embryo Incubator has an integrated
camera and optics for imaging and
viewing embryos during incubation, for
a maximum time of 120 hours. | The Embryoscope (Version D) provides an
environment with controlled temperature, CO2
(and other gases) for the development of
embryos. This model has an integrated inverted
microscope and imaging system for embryo
viewing. Device use is limited to five days (120
hr) covering the time from post-fertilization to day
5 of development.
EmbryoViewer is an optional accessory software
package for use in displaying, comparing, storing,
and transferring EmbryoScope (Version D)
generated images. The software includes a user
annotation function for capturing information on
embryo development parameters, treatment data,
and outcome data. The EmbryoViewer software
does not control any hardware components in the
EmbryoScope (Version D) device. |
| Incubation chamber
heating | Heated aluminium stage and lid | Heated chamber with recirculation |
| Incubation humidity | Same as predicate | No chamber humidification |
| Gas supply type | Premixed blend of 6% CO2, 5% O2,
89% N2 or high purity 6% CO2 | Internally regulated mixture of CO2, O2 and N2 |
| Gas supply pressure | 150 ± 15 kPa (218 ± 2.2 psi) | Unclear |
| Gas flow rate capability | 10 mL/min per chamber. Purge at 160
mL/min per chamber for 3 min | Unclear |
| Gas flow rate accuracy | ±15% of flow per chamber (normal
flow) and ±10 mL/min per chamber
(purge) | Unclear |
| HEPA Filter | Same as predicate | Retains 99.97% of particles >0.3 µm |
| Chamber temperature
capability | 35.0-40.0°C in 0.1°C increments at 20-
28°C. At set point of 37°C, the ambient
temperature range is 18-30°C | 30-45 ± 0.2°C |
| Chamber temperature
accuracy | ±0.2°C at calibration point | During incubation ±0.1°C |
Comparison of Geri Embryo Incubator with predicate device
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Image /page/5/Picture/0 description: The image shows the logo for Genea Biomedx. The logo consists of a green square with a white curve on the left side, 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 - Geri Embryo
Incubator | Predicate device - EmbryoScope (Version D)
and EmbryoViewer Software (K113075) |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------|-----------------------------------------------------------------------------------|
| Microscope/camera | CMOS microscope camera (2560×1928
pixels monochrome | CCD camera (1280×1024 pixels monochrome) |
| Image resolution | 2 pixels/um | 3 pixels/um |
| Image acquisition
frequency | 5 min | 10 min |
| Illumination | Single orange LED (591nm) | Single red LED (635nm) |
| Number of image focal
planes | 11 | 7 |
| Light exposure | ~45s/day | Unclear |
| The subject and predicate devices have intended use - culturing embryos and capturing, storing and
viewing embryo images. They also have the same fundamental technology - incubator with temperature and gas | | |
control and integrated microscope/camera for time-lapse imaging. There are differences in design and performance specifications between the subject and predicate devices. However, these different questions of safety and effectiveness.
Comparison of Geri Dish with predicate device
| Device/Predicate
| Devices | Subject device – Geri Dish | Predicate device – EmbryoSlide (K092183) |
|---|---|---|
| Indications for Use | The Geri Dish is intended to be used | |
| for preparation, storage and imaging of | ||
| human embryos. The Geri Dish is | ||
| intended to be used only with the Geri | ||
| Embryo Incubator. | Preparing, storing, and transferring human embryos. | |
| To be used only with the EmbryoScope device. | ||
| Fundamental design | Same as predicate | Dish with multiple microwells intended to house |
| individual embryos | ||
| Design feature | 16 culture wells | |
| Well base diameter 0.43mm | ||
| Well depth 0.4mm | ||
| 3 outer rings for wash or rinse media | ||
| Fill volume 40-80µl | ||
| Optically clear with a lid | Unclear | |
| Material | Same as predicate | Polystyrene |
| The subject and predicate devices have the same intended use - preparing and storing human embryos undergoing |
preparing and storing human devices have the same intended use time-lapse imaging procedures. They also have the same fundamental technology – culture dishes with multiple small microwells intended to house individual embryos. The subject device is different from the predicate device regarding microwell number, dimensions, and fill volume. However, these different questions of safety and effectiveness.
VIII. Summary of Non-clinical Performance Testing
The following studies have been performed to support substantial equivalence to the predicate devices:
Testing for Geri Embryo Incubator
- Electrical safety testing per IEC 61010-1:2010 ●
- Electromagnetic Compatibility testing per IEC 61326-1:2012 .
- Software verification and validation testing that met the requirements of the FDA Guidance . Document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices Document" issued on May 11, 2005
- Cleaning and disinfection validation testing per FDA Guidance Document, "Reprocessing Medical . Devices in Health Care Settings: Validation Methods and Labeling: Guidance for Industry and Food and Drug Administration" issued on March 17, 2015
- Bench performance tests that met design specifications described in Section VII, as follows:
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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 clean and modern, with a focus on the company's name and a simple graphic element.
- Gas maintenance testing to ensure that gas flow rates, gas recovery rates and CO2 levels in chambers meet design specifications
-
- Temperature control testing to ensure that culture chamber temperature conditions were within defined ranges and were stable over time.
-
- Time-lapse testing to demonstrate that all design specifications of time-lapse function are met (dish presence detection, dish position accuracy, image quality and resolution, imaging of embryos in all wells on Geri Dishes within time and focal plane settings)
- Embryo development test demonstrating that ≥70% mouse 1-cell embryos developed to blastocyst ● on day 5 following exposure to the maximum time lapse exposure conditions.
- Embryo light energy exposure testing comparing the potential for light toxicity associated with time-. lapse imaging under worst-case exposure conditions (maximum light exposure over the full duration of use [120 hours]) to that of total light exposure during in assisted reproduction procedures (IVF and ICSI) using typical laboratory microscopes. Results showed total light energy exposure following time-lapse imaging should not exceed levels associated with typical assisted reproduction imaging procedures.
Testing for Geri Dish
- Radiation sterilization validation testing per ISO 11137-2:2009 ●
- . Package integrity testing:
-
- Dye Penetration Test per ASTM F1929-12
-
- Peel strength testing ASTM F88/F88M-09
-
- Endotoxin testing per USP and ANSI/AAMI ST72: 2011. The testing demonstrated that the ● device met the specification of