(77 days)
Not Found
No
The summary describes a time-lapse imaging system within an incubator but does not mention any AI/ML algorithms used for image analysis, embryo assessment, or decision support. The performance studies focus on the physical and functional aspects of the incubator and dish, not on the performance of any image analysis algorithms.
Yes.
The Geri Embryo Incubator provides a controlled environment for the development of embryos, which is a therapeutic function in the context of assisted reproductive procedures.
No
The Geri Embryo Incubator is intended to provide an environment for the development of embryos and allows for imaging and viewing during incubation. It does not perform any diagnostic function on the embryo, but rather facilitates its development and observation.
No
The device is a physical incubator with integrated hardware components (heating elements, camera, optics, filters, gas inlets) and relies on a separate physical dish. 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 derived from the human body (like blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Geri System Function: The Geri Embryo Incubator and Geri Dish are used to provide a controlled environment for the development and imaging of human embryos outside the body. They are tools used in assisted reproduction procedures (like IVF), but they are not analyzing a specimen from the body to diagnose a condition.
- Intended Use: The intended use clearly states providing an environment for embryo development and imaging. It does not mention diagnosis, treatment, or prevention of disease based on analysis of a bodily specimen.
- Device Description: The description focuses on the physical components and functions related to maintaining the environment for the embryos and capturing images.
- Performance Studies: The performance studies focus on the functionality of the device itself (temperature control, gas levels, imaging quality, embryo development rate in a mouse model) and not on the diagnostic accuracy of analyzing a human specimen.
Therefore, while these devices are used in a clinical setting related to human reproduction, their function does not align with the definition of an In Vitro Diagnostic device. They are considered medical devices used in the process of assisted reproduction.
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 (comma separated list FDA assigned to the subject device)
MQG, MQK, 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. Each chamber can also contain an optional water bottle (Geri Water Bottle) to generate humidity. The Geri Water Bottle is supplied sterile with a sterility assurance level (SAL) of 10°, and has a shelf-life of three years. The Geri Water Bottle is designed to be used with the Geri Embryo Incubator only.
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°, and have a shelflife 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.
The Geri Embryo Incubator includes firmware to control the incubator settings, and software to control patient information and settings.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Optical imaging (integrated camera and optics)
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
- The following studies that were provided in the predicate submission (K171736) were leveraged in the current submission as the additional humidity control system did not impact the ability of these studies to support substantial equivalence:
Testing for Geri Embryo Incubator
- Electrical safety testing per IEC 61010-1:2010
- Electromagnetic Compatibility testing per IEC 61326-1:2012
- 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:
- 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 timelapse 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 timelapse 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 testing 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, time-lapse alignment and MEA met design specifications before and after aging
- The following studies on the subject device have been conducted to support the addition of the humidity control system to the Geri Embryo Incubator:
Testing for Geri Embryo Incubator:
- 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
- Humidity control testing to ensure that the humidity levels in chambers meet design specifications
Testing for Geri Water Bottle:
- Radiation sterilization validation testing per ISO 11137-2:2013
- Package integrity testing:
- Dye penetration testing per ASTM F1929-15
- Seal strength testing per ASTM F88/F88M-15
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Embryo development test: >=70% mouse 1-cell embryos developed to blastocyst on day 5.
Mouse embryo assay (MEA): "1-cell MEA >=80% embryos developed to blastocyst in 96 hours."
Endotoxin testing:
§ 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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April 20, 2018
Genea Biomedx Pty Ltd % Roger Grav VP, Quality Assurance and Regulatory Affairs Donawa Lifescience Consulting Srl Piazza Albania, 10 00153 Rome ITALY
Re: K180304
Trade/Device Name: Geri Embryo Incubator and Geri Dish Regulation Number: 21 CFR 884.6120 Regulation Name: Assisted reproduction accessories Regulatory Class: Class II Product Code: MQG, MQK, MTX Dated: March 19, 2018 Received: March 22, 2018
Dear Roger Gray:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Charles Viviano -S
For
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K180304
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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510(k) Summary (K180304)
I. General Information on Submitter
| Submitter/Address: | Genea Biomedx Pty Ltd
Level 2, 321 Kent Street
Sydney
NSW 2000
Australia |
|--------------------|-------------------------------------------------------------------------------------------------------------------------------|
| Contact person: | Ms. Kea Dent |
| Phone: | +61 2 8484 7677 |
| Fax: | +61 2 9229 6478 |
| Correspondent: | Mr. Roger Gray
VP, Quality and Regulatory
Donawa Lifescience Consulting Srl
Piazza Albania 10
00153 Rome
Italy |
| Phone: | +39 06 578 2665 |
| Fax: | +39 06 574 3786 |
| Email: | rgray@donawa.com |
II. Date Prepared: April 19, 2018
III. General Information on Devices
| Device Name: | Geri Embryo Incubator and Geri Dish |
|---|---|
| Common Name: | Embryo Incubator |
| Regulation Number: | 21 CFR 884.6120 |
| Regulation Name: | Assisted Reproduction Accessories |
| Product Code: | MQG (Accessory, Assisted Reproduction), MQK (Labware, Assisted |
| Reproduction), MTX (Microscope and Microscope Accessories, Reproduction, | |
| Assisted) | |
| Regulatory Class: | II |
IV. Predicate Device
Geri Embryo Incubator (K171736) manufactured by Genea Biomedx, Australia. The predicate device has 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. Each chamber can also contain an optional water bottle (Geri Water Bottle) to generate humidity. The Geri Water Bottle is supplied sterile with a sterility assurance level (SAL) of 10°, and has a shelf-life of three years. The Geri Water Bottle is designed to be used with the Geri Embryo Incubator only.
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
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Image /page/4/Picture/0 description: The image contains the logo for Genea BIOMEDX. The logo consists of a green square with rounded corners and a white curved line inside. To the right of the square, the word "Genea" is written in gray, and below it, the word "BIOMEDX" is written in green.
one Geri Dish. Geri Dishes are supplied sterile with a sterility assurance level (SAL) of 10°, and have a shelflife 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.
The Geri Embryo Incubator includes firmware to control the incubator settings, and software to control patient information and settings.
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 Device and Predicate Device
| Parameter | Subject device (K180304) | Predicate device (K171736) |
|---|---|---|
| Indications for Use | Same as the predicate device | 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. |
| Number of incubation chamber | Same as the predicate device | Six |
| Incubation chamber heating | Same as the predicate device | Heated aluminium stage and lid |
| Incubation chamber gas supply | Same as the predicate device | Flow controlled positive pressure system with fast purge
flow rate for rapid recovery |
| Incubation chamber humidity | Disposable water bottle to
generate humidity (~80% RH) in
each incubation chamber | N/A |
| Gas supply type | Same as the predicate device | Premixed blend of 6% CO2, 5% O2, 89% N2 or high purity
6% CO2 |
| Gas supply pressure | Same as the predicate device | $150 \pm 15$ kPa ( $218 \pm 2.2$ psi) |
| Gas flow rate capability | Same as the predicate device | 10 mL/min per chamber. Purge at 160 mL/min per
chamber for 3 min |
| Gas flow rate accuracy | Same as the predicate device | $\pm$ 15% of flow per chamber (normal flow) and $\pm$ 10 mL/min
per chamber (purge) |
| HEPA Filter | Same as the predicate device | Retains 99.97% of particles >0.3 µm |
| Chamber temperature capability | Same as the predicate device | 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 |
| Chamber temperature accuracy | Same as the predicate device | $\pm$ 0.2°C at calibration point |
| Microscope/camera | Same as the predicate device | CMOS microscope camera (2560x1928 pixels
monochrome ) |
| Image resolution | Same as the predicate device | 2 pixels/µm |
| Image acquisition frequency | Same as the predicate device | 5 min |
| Illumination | Same as the predicate device | Single orange LED (591nm) |
| Number of image focal planes | Same as the predicate device | 11 |
| Light exposure | Same as the predicate device | ~45s/day |
| Alarm (for out of range) | Same as the predicate device,
with additional alarm for humidity | Chamber temperature, CO2 concentration, CO2 pressure
O2 concentration, N2 pressure, Load door open >30s |
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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 on the left, and the text "Genea" in gray above the text "BIOMEDX" in green on the right. The logo is clean and modern, with a focus on the company name and a simple graphic element.
| Parameter | Subject device (K180304) | Predicate device (K171736) |
|---|---|---|
| Culture dish (Geri Dish) | Same as the predicate device | 16-well culture dish (40-80 $\mu$ l fill volume/well) made of |
| polystyrene. Each incubation chamber can hold one dish |
The subject and predicate devices have the same Intended Use for preparing and storing human embryos undergoing time-lapse imaging procedures. They also have the same technological characteristics, except that the subject device has an additional humidity control system, including a water container, humidity sensor, and software component to manage this new feature. The addition of humidification system to the device does not raise different questions of safety and effectiveness as compared to the predicate device. In addition, similar humidification systems are present on other cleared devices of this type.
VIII. Summary of Non-Clinical Performance Testing
- The following studies that were provided in the predicate submission (K171736) were leveraged in the current submission as the additional humidity control system did not impact the ability of these studies to support substantial equivalence:
Testing for Geri Embryo Incubator
- Electrical safety testing per IEC 61010-1:2010
- Electromagnetic Compatibility testing per IEC 61326-1:2012 ●
- . 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: ●
- o Gas maintenance testing to ensure that gas flow rates, gas recovery rates and CO2 levels in chambers meet design specifications
- o 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 O (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 timelapse 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 timelapse 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 testing per ASTM F1929-12 O
- Peel strength testing ASTM F88/F88M-09 o
- Endotoxin testing per USP and ANSI/AAMI ST72: 2011. The testing demonstrated that the ● device met the specification of