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.

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.

AI/ML Overview

The provided text is a 510(k) summary for the Geri Embryo Incubator and Geri Dish. It details the device, its intended use, comparison to predicate devices, and a summary of non-clinical performance testing. However, it does not include detailed acceptance criteria tables or specific reported device performance values for the Geri Embryo Incubator and Geri Dish.

Specifically, while it mentions "Bench performance tests that met design specifications described in Section VII" and lists some parameters like "Gas maintenance testing," "Temperature control testing," and "Time-lapse testing," it generally states that these tests "met design specifications" without providing the actual acceptance criteria values (e.g., specific CO2 levels, temperature ranges, or image resolution thresholds) and the precise device performance results.

Therefore, I cannot create a table of acceptance criteria and reported device performance from the provided text. The document describes the types of tests performed and generally states that the device met the specifications, but it does not quantify those specifications or the observed performance.

Similarly, the document provides limited information on most of the other requested criteria for a study proving the device meets acceptance criteria, as it is a 510(k) summary, not a detailed study report.

Here's an assessment based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

Cannot be created from the provided text. The document states that "Bench performance tests that met design specifications described in Section VII" and lists categories like "Gas maintenance testing," "Temperature control testing," and "Time-lapse testing." It also provides a specific acceptance criterion for the Geri Dish's Mouse Embryo Assay: "1-cell MEA ≥80% embryos developed to blastocyst in 96 hours." However, the actual numerical design specifications (acceptance criteria) and the measured device performance for gas, temperature, and time-lapse functions are not provided.

2. Sample Size Used for the Test Set and Data Provenance:

Sample size for test set: Not explicitly stated for most tests. For the mouse embryo assays, it implies a comparative group ("in comparison with the control group"), but the number of embryos or dishes tested is not given.
Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). This is typically lab-based bench testing.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not applicable / Not specified. This document describes performance testing for an incubator and dish, which are physical devices with measurable parameters (temperature, gas, imaging). The "ground truth" for these tests would be established through calibrated instruments and established scientific principles, not typically by expert consensus in the way, for example, medical image analysis AI models use expert radiologists. The "Embryo development test" and "Mouse embryo assay" are biological assays, where the "ground truth" is typically the observed biological outcome (blastocyst development), assessed by trained laboratory personnel, but no expert qualifications or numbers are mentioned.

4. Adjudication Method for the Test Set:

Not applicable / Not specified. Adjudication is relevant for subjective assessments, particularly in clinical studies involving interpretation. The tests described are primarily objective benchtop and biological assays.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No. An MRMC study is relevant for AI-assisted diagnostic devices where human readers interpret medical images. This document describes a medical device (incubator and dish) that does not directly involve human image interpretation in its primary function, nor does it describe AI assistance to human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance):

Not applicable. This device is hardware with integrated software for control and imaging; it's not a standalone AI algorithm for interpretation. Its performance is inherent to the device's function.

7. Type of Ground Truth Used:

For physical parameters (gas, temperature, imaging functions): Measured values against design specifications using calibrated instruments.
For biological assays (mouse embryo development): Observed biological outcomes (e.g., blastocyst formation).

8. Sample Size for the Training Set:

Not applicable. This is a hardware device with integrated control/imaging software, not a machine learning model that requires a "training set" in the conventional AI sense for learning patterns from data. The software mentioned ("Software verification and validation testing") refers to traditional software engineering V&V, not AI model training.

9. How Ground Truth for Training Set Was Established:

Not applicable. (As explained above, no separate training set for an AI model is described.)

Summary

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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.

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You must comply with all the Act's requirements. including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting 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

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Indications for Use

510(k) Number (if known) K171736

Device Name

Geri Embryo Incubator and Geri Dish

Indications for Use (Describe)

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 LtdLevel 2, 321 Kent StreetSydneyNSW 2000AustraliaMs. Kea Dent+61 2 8484 7677+61 2 9229 6478
Correspondent:Phone:Fax:Email:	Mr. Roger GrayVP, Quality and RegulatoryDonawa Lifescience Consulting SrlPiazza Albania 1000153 RomeItaly+39 06 578 2665+39 06 574 3786rgray@donawa.com

II. Date Prepared: 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, AssistedReproduction, 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 includes firmware to control the incubator settings, and software to control patient information and settings.

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VI. 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.

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

Device/PredicateDevices	Subject device - Geri EmbryoIncubator	Predicate device - EmbryoScope (Version D)and EmbryoViewer Software (K113075)
Indications for Use	The Geri Embryo Incubator is intendedto provide an environment withcontrolled temperature and mixed gas(CO2 and other gases) for thedevelopment of embryos. The GeriEmbryo Incubator has an integratedcamera and optics for imaging andviewing embryos during incubation, fora maximum time of 120 hours.	The Embryoscope (Version D) provides anenvironment with controlled temperature, CO2(and other gases) for the development ofembryos. This model has an integrated invertedmicroscope and imaging system for embryoviewing. Device use is limited to five days (120hr) covering the time from post-fertilization to day5 of development.EmbryoViewer is an optional accessory softwarepackage for use in displaying, comparing, storing,and transferring EmbryoScope (Version D)generated images. The software includes a userannotation function for capturing information onembryo development parameters, treatment data,and outcome data. The EmbryoViewer softwaredoes not control any hardware components in theEmbryoScope (Version D) device.
Incubation chamberheating	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 160mL/min per chamber for 3 min	Unclear
Gas flow rate accuracy	±15% of flow per chamber (normalflow) and ±10 mL/min per chamber(purge)	Unclear
HEPA Filter	Same as predicate	Retains 99.97% of particles >0.3 µm
Chamber temperaturecapability	35.0-40.0°C in 0.1°C increments at 20-28°C. At set point of 37°C, the ambienttemperature range is 18-30°C	30-45 ± 0.2°C
Chamber temperatureaccuracy	±0.2°C at calibration point	During incubation ±0.1°C

Comparison of Geri Embryo Incubator with predicate device

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Device/PredicateDevices	Subject device - Geri EmbryoIncubator	Predicate device - EmbryoScope (Version D)and EmbryoViewer Software (K113075)
Microscope/camera	CMOS microscope camera (2560×1928pixels monochrome	CCD camera (1280×1024 pixels monochrome)
Image resolution	2 pixels/um	3 pixels/um
Image acquisitionfrequency	5 min	10 min
Illumination	Single orange LED (591nm)	Single red LED (635nm)
Number of image focalplanes	11	7
Light exposure	~45s/day	Unclear
The subject and predicate devices have intended use - culturing embryos and capturing, storing andviewing 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/PredicateDevices	Subject device – Geri Dish	Predicate device – EmbryoSlide (K092183)
Indications for Use	The Geri Dish is intended to be usedfor preparation, storage and imaging ofhuman embryos. The Geri Dish isintended to be used only with the GeriEmbryo 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 houseindividual embryos
Design feature	16 culture wellsWell base diameter 0.43mmWell depth 0.4mm3 outer rings for wash or rinse mediaFill volume 40-80µlOptically 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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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 <85> and ANSI/AAMI ST72: 2011. The testing demonstrated that the ● device met the specification of <20 EU/device.
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. The testing demonstrated that the device met acceptance criterion of "1-cell MEA ≥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

IX. Conclusion

The subject and predicate devices have the same intended use and fundamental technological characteristics. The differences in technological characteristics between subject and predicate devices do not raise different questions of safety and effectiveness. The performance data demonstrate that the subject device is substantially equivalent to the predicate device.

Regulation Number and Section

§ 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.