Embryo Real-time Incubator (TLS301), Embryo Real-time Culture Dish (MC 2004)

K232493 · Wuhan Huchuang Union Technology Co., Ltd. · MQG · May 7, 2024 · Obstetrics/Gynecology

Device Facts

• Record ID: K232493
• Device Name: Embryo Real-time Incubator (TLS301), Embryo Real-time Culture Dish (MC 2004)
• Applicant: Wuhan Huchuang Union Technology Co., Ltd.
• Product Code: MQG · Obstetrics/Gynecology
• Decision Date: May 7, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.6120
• Device Class: Class 2

Intended Use

The Embryo Real-time Incubator (TLS301) is intended to provide an environment with controlled temperature and mixed gas (CO2 and other gases) for the development of embryos. The Embryo Real-time Incubator (TLS301) has an integrated camera and optics for imaging and viewing embryos during incubation, for a maximum time of 120 hours. The Embryo Real-time Culture Dish (MC 2004) is intended for preparing, storing and transferring human embryos. It is intended to be used only with the Embryo Real-time Incubator (TLS301). Embryo Realtime 2S Software and Embryo Realtime 3E Software accessories for the Embryo Realtime Incubator (TLS301). The Embryo Realtime 2S Software is intended to store, archive and transfer data. In addition, the Embryo Realtime 2S Software includes functions for managing models and performing calculations based on image data and embryo development parameters. Embryo Realtime 3E Software is intended for viewing and recording embryo development events from images captured using the Embryo Real-time Incubator (TLS301). Embryo Realtime 3E Software includes a user annotation for capturing information on embryo development parameters and a user-defined modeling function that allows the user to combine annotated information on embryo development parameters to aid in embryo selection. Embryo Realtime 2S Software and Embryo Realtime 3E Software do not control any hardware components in the Embryo Real-time Incubator (TLS301). Embryo Realtime 2S Software and Embryo Realtime 3E Software are provided in different software package and must be used together.

Device Story

Benchtop tri-gas incubator (CO2, N2, air) with integrated inverted microscope and camera for time-lapse imaging of embryos. System includes Embryo Real-time Incubator (TLS301), Embryo Real-time Culture Dish (MC 2004), and two software packages (2S and 3E). Incubator maintains temperature and gas concentrations; camera captures images at multiple focal planes using 635 nm red LED illumination. Images are transmitted to a workstation for display, storage, and analysis. Embryologists use software to annotate embryo development events and apply user-defined models to assist in embryo selection. Software does not control incubator hardware. Used in clinical embryology laboratories. Benefits include continuous monitoring of embryo development without removing dishes from the controlled environment, potentially aiding in selection of viable embryos for transfer.

Clinical Evidence

Bench testing only. Includes electrical safety (IEC 61010-1, 61010-2-010), EMC (IEC 60601-1-2), software validation, cybersecurity, and performance testing (temperature/gas stability, imaging, auto-focus). Culture dish testing includes radiation sterilization (ISO 11137-2), transportation (ASTM D4169), shelf-life (ASTM F1980), endotoxin (USP <85>), and Mouse Embryo Assay (MEA) showing ≥80% blastocyst development at 96 hours.

Technological Characteristics

Benchtop tri-gas incubator; heating via aluminum container/lid; gas control via HEPA/VOC filters. Imaging: inverted microscope, monochrome CMOS camera, 20x magnification, 635 nm red LED. Connectivity: workstation-based. Culture dish: polystyrene, radiation sterilized. Software: non-hardware controlling, used for data management, annotation, and modeling.

Indications for Use

Indicated for the culture and monitoring of human embryos in Assisted Reproductive Technology (ART) procedures for a maximum duration of 120 hours.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• EmbryoScope+ (K173264)

Submission Summary (Full Text)

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May 7, 2024

Wuhan Huchuang Union Technology Co., Ltd. % Ivy Wang Technical Manager Shanghai Sungo Management Consulting Company Limited 14th Floor, 1500# Central Avenue Shanghai, Shanghai 200122 CHINA

Re: K232493 Trade/Device Name: Embryo Real-time Incubator (TLS301), Embryo Real-time Culture Dish (MC 2004) Regulation Number: 21 CFR 884.6120 Regulation Name: Assisted Reproduction Accessories Regulatory Class: II Product Code: MQG, MQK, MTX Dated: April 7, 2024 Received: April 8, 2024

Dear Ivy Wang:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510/k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the

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Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Michael T. Bailey -S

For Monica D. Garcia, PhD Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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#### Indications for Use

510(k) Number (if known) K232493

#### Device Name

Embryo Real-time Incubator (TLS301), Embryo Real-time Culture Dish (MC 2004)

#### Indications for Use (Describe)

The Embryo Real-time Incubator (TLS301) is intended to provide an environment with controlled temperature and mixed gas (CO2 and other gases) for the development of embryos. The Embryo Real-time Incubator (TLS301) has an integrated camera and optics for imaging and viewing embryos during incubation, for a maximum time of 120 hours.

The Embryo Real-time Culture Dish (MC 2004) is intended for preparing, storing and transferring human embryos. It is intended to be used only with the Embryo Real-time Incubator (TLS301).

Embryo Realtime 2S Software and Embryo Realtime 3E Software accessories for the Embryo Realtime Incubator (TLS301).

The Embryo Realtime 2S Software is intended to store, archive and transfer data. In addition, the Embryo Realtime 2S Software includes functions for managing models and performing calculations based on image data and embryo development parameters.

Embryo Realtime 3E Software is intended for viewing and recording embryo development events from images captured using the Embryo Real-time Incubator (TLS301). Embryo Realtime 3E Software includes a user annotation for capturing information on embryo development parameters and a user-defined modeling function that allows the user to combine annotated information on embryo development parameters to aid in embryo selection.

Embryo Realtime 2S Software and Embryo Realtime 3E Software do not control any hardware components in the Embryo Real-time Incubator (TLS301). Embryo Realtime 2S Software and Embryo Realtime 3E Software are provided in different software package and must be used together.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------------|------------------------------------------------------------|
| <span style="font-size:100%;">☑ Prescription Use (Part 21 CFR 801 Subpart D)</span> | <span>☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> |

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# 510(k) Summary

# K232493

#### I. Submitter Information

Name: Wuhan Huchuang Union Technology Co., Ltd. Address: Building10, No.818 Gaoxin Avenue Wuhan Hubei 430206 China Name of contact person: Zhan Yuanyuan Tel: [phone] E-Mail: [e-mail]

## II. Date Prepared

May 7, 2024

## III.Subject Device Information

Device trade name: Embryo Real-time Incubator (TLS301), Embryo Real-time Culture Dish (MC 2004) Common Name: Embryo Incubator Regulation number: 21 CFR 884.6120 Regulation Name: Assisted Reproduction Accessories Regulation class: II Product code: MQG (Accessory, Assisted Reproduction), MQK (Labware, Assisted Reproduction), MTX (Microscope and Microscope Accessories, Reproduction, Assisted)

# IV. Predicate Device

EmbryoScope+ (K173264) manufactured by Vitrolife A/S

The predicate device has not been subject to any design related recalls.

#### V. Device Description

The Embryo Real-time Incubator (TLS301) consists of the following components:

- Embryo Real-time Incubator, integrated with temperature control system, gas ● supply control system and time-lapse imaging system.
- Image capture software
- Workstation, composed of server and workstation software. ●
- Embryo Real-time Culture Dish (MC 2004) ●

The Embryo Real-time Incubator (TLS301) is a benchtop tri-gas (CO2, N2, and air) embryo incubator with a built-in microscope for time-lapse imaging intended to be used for the culture and monitoring of embryos used in Assisted Reproductive Technology (ART) procedures. It provides temperature control, gas control, and time-lapse imaging at multiple focal planes. The incubator chamber has the capacity to hold up to ten

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Embryo Real-time Culture Dishes (MC 2004). Each chamber contains a heating plate to maintain chamber temperatures. Gas (CO2, N2, and air) is mixed in a mixing chamber and passed through a HEPA/VOC filter prior to delivery to the incubation chamber. The built-in microscope consists of an illumination unit (red LED, 635 nm) and an inverted microscope/camera unit. The imaging system is mobile and is controlled through moving guide rail to automatically position the camera to the designated culture plate/well. The camera can acquire images in multiple focal planes. The time-lapse imaging system in the incubator along with the image capture software capture timelapse images of the embryos and transmit captured images to the computer for display and storage. The image capture software also reads the patient labels on the Embryo Real-time Culture Dish (MC 2004) and incorporates patient information into the imaging record.

The workstation includes a server and workstation software (Embryo Realtime 3E Software). It includes graphical user interface and receives and stores images. It also supports query, retrieval and display of the embryo images. The workstation software allows for manual annotation of the series of images obtained through time-lapse imaging into a user-defined model for the assessment of embryo's development. In addition, the server software (Embryo Realtime 2S Software), that does not include a graphical user interface, is designed to archive, transfer and store images of embryos from the time lapse incubator and performs user model management and calculations based on image data and user inputted embryo development parameters. The two software are used together.

The Embryo Real-time Culture Dish (MC 2004) is a single use, single-patient, polystyrene, radiation sterilized culture dish intended for preparing, storing, and transferring human embryos. It is intended to be used only with the Embryo Real-time Incubator (TLS301). It contains two types of wells for rinsing and handling the embryos before or after incubation and 16 wells for culturing the embryos during incubation. Each culture well is used to culture one embryo and a total of 16 embryos from a single patient can be cultured on one dish. The culture and rinsing wells have a volume of 30 µL and 50 µL, respectively. There is a central depression in the center of each culture well, where the embryo resides. The Embryo Real-time Culture Dishes (MC 2004) has a label area for unique identification of the culture dish.

#### VI. Indications for Use

The Embryo Real-time Incubator (TLS301) is intended to provide an environment with controlled temperature and mixed gas (CO2 and other gases) for the development of embryos. The Embryo Real-time Incubator (TLS301) has an integrated camera and optics for imaging and viewing embryos during incubation, for a maximum time of 120 hours.

The Embryo Real-time Culture Dish (MC 2004) is intended for preparing, storing and transferring human embryos. It is intended to be used only with the Embryo Real-time

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Incubator (TLS301).

Embryo Realtime 2S Software and Embryo Realtime 3E Software are optional software accessories for the Embryo Real-time Incubator (TLS301).

The Embryo Realtime 2S Software is intended to store, archive and transfer data. In addition, the Embryo Realtime 2S Software includes functions for managing models and performing calculations based on image data and embryo development parameters.

Embryo Realtime 3E Software is intended for viewing and recording embryo development events from images captured using the Embryo Real-time Incubator (TLS301). Embryo Realtime 3E Software includes a user annotation for capturing information on embryo development parameters and a user-defined modeling function that allows the user to combine annotated information on embryo development parameters to aid in embryo selection.

Embryo Realtime 2S Software and Embryo Realtime 3E Software do not control any hardware components in the Embryo Real-time Incubator (TLS301). Embryo Realtime 2S Software and Embryo Realtime 3E Software are provided in different software package and must be used together.

| Attribute | Subject device<br>(K232493) | Predicate device<br>(K173264) | Comparison |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The Embryo Real-time<br>Incubator (TLS301) is<br>intended to provide an<br>environment with<br>controlled temperature<br>and mixed gas (CO2 and<br>other gases) for the<br>development of embryos.<br>The Embryo Real-time<br>Incubator (TLS301) has<br>an integrated camera and<br>optics for imaging and<br>viewing embryos during<br>incubation, for a<br>maximum time of 120<br>hours.<br>The Embryo Real-time | The EmbryoScope+<br>incubator provides an<br>environment with<br>controlled temperature and<br>gas concentrations (CO2<br>and O2) for the<br>development of embryos at<br>or near body temperature.<br>Use of the EmbryoScope+<br>incubator is limited to five<br>days (120 hr) covering the<br>time from post insemination<br>to day five of development.<br><br>The EmbryoSlide+ culture<br>dish is intended for<br>preparing, storing, and<br>transferring human | The indications for<br>use statements for<br>the subject and<br>predicate devices<br>are not identical;<br>however, their<br>intended uses are<br>the same (i.e.,<br>time-lapse imaging<br>of embryos<br>maintained in a<br>device-specific<br>culture dish). |
| Culture Dish (MC 2004)<br>is intended for preparing,<br>storing and transferring<br>human embryos. It is<br>intended to be used only<br>with the Embryo Real-<br>time Incubator (TLS301). | embryos. The<br>EmbryoSlide+ culture dish<br>must be used together with<br>the EmbryoScope+<br>incubator. | | |
| Embryo Realtime 2S<br>Software and Embryo<br>Realtime 3E Software are<br>optional software<br>accessories for the<br>Embryo Real-time<br>Incubator (TLS301). | The EmbryoViewer<br>software is intended for<br>displaying, comparing,<br>storing, and transferring<br>images generated by the<br>EmbryoScope+ incubator.<br>This software includes a<br>user annotation function for<br>capturing information on<br>embryo development<br>parameters as well as a<br>user-defined modeling<br>function, which allows the<br>user to combine annotated<br>information on embryo<br>development parameters to<br>aid in embryo selection.<br>The EmbryoViewer<br>software does not control<br>any hardware components<br>in the EmbryoScope+<br>incubator. | | |
| The Embryo Realtime 2S<br>Software is intended to<br>store, archive and transfer<br>data. In addition, the<br>Embryo Realtime 2S<br>Software includes<br>functions for managing<br>models and performing<br>calculations based on<br>image data and embryo<br>development parameters. | The ES Server software is<br>intended to store, archive<br>and transfer data. In<br>addition, this software<br>includes functions for<br>managing models and<br>performing calculations<br>based on image data and<br>embryo development<br>parameters. | | |
| Embryo Realtime 3E<br>Software is intended for<br>viewing and recording<br>embryo development<br>events from images<br>captured using the<br>Embryo Real-time<br>Incubator (TLS301).<br>Embryo Realtime 3E<br>Software includes a user<br>annotation function for<br>capturing information on<br>embryo development<br>parameters and a user-<br>defined modeling<br>function that allows the | The EmbryoScope+<br>incubator, EmbryoViewer<br>software, and ES Server<br>software must be used | | |
| | user to combine<br>annotated information on<br>embryo development<br>parameters to aid in<br>embryo selection.<br><br>Embryo Realtime 2S<br>Software and Embryo<br>Realtime 3E Software do<br>not control any hardware<br>components in the<br>Embryo Real-time<br>Incubator (TLS301).<br>Embryo Realtime 2S<br>Software and Embryo<br>Realtime 3E Software are<br>provided in different<br>software package and<br>must be used together. | together to export embryo<br>images from the<br>EmbryoScope+ incubator.<br>The EmbryoViewer<br>software and ES Server<br>software must be used<br>together to analyze the<br>embryo images. | |
| | Incubator, integrated computer and microscopy system | | |
| Culture dish<br>capacity | 10 dishes | 15 dishes | Different |
| Heating<br>mechanism | Heated aluminum<br>container and lid | Direct heat transfer | Different |
| Temperature range | 35-40 °C | 36-39 °C | Similar |
| Temperature<br>accuracy | $\pm$ 0.2 °C | $\pm$ 0.2 °C | Similar |
| CO2 accuracy | $\pm$ 0.1% for CO2<br>concentration at 6.0%,<br>$\pm$ 0.2% for other CO2<br>concentration | $\pm$ 0.3 % | Different |
| O2 accuracy | $\pm$ 0.1% for O2<br>concentration at 5.0%,<br>$\pm$ 0.2% for other O2<br>concentration | $\pm$ 0.5 % | Different |
| Recirculation rate | 150ml $\pm$ 7.5ml/min (full<br>purification of gas<br>volume every 6.3 min) | >100 L/h (full<br>purification of gas<br>volume every 6 min) | Different |
| Recovery time | CO2 (6% $\pm$ 0.3%) $\leq$ 90<br>seconds<br>O2(5% $\pm$ 0.3%) $\leq$ 90 | CO2 (5% $\pm$ 0.3 %) < 5 min<br>O2 (5% $\pm$ 0.5 %) <3 min | Different |
| | | load door opening | |
| | closed after a 15-second<br>load door opening (single<br>chamber) | | |
| Control of<br>temperature and<br>gas | Firmware | Firmware | Same |
| Computer | Integrated | Integrated | Same |
| Microscope | Inverted microscope | Inverted microscope | Same |
| Type of camera | Monochrome CMOS | Monochrome CMOS | Same |
| Magnification | 20× | 16× | Different |
| Focusing | Fully automated dish<br>detection and embryo<br>focusing | Fully automated dish<br>detection and embryo<br>focusing | Same |
| Numerical aperture | 0.45 | 0.5 | Similar |
| Number of pixels | 2048 × 1088 pixels | 2048 × 1088 pixels | same |
| Resolution | ≥ 2.7 pixels per µm | 3 pixels per µm | Different |
| Light source (for<br>imaging) | Low-power red LED 635<br>nm | Low-power red LED 627<br>nm | Similar |
| Time-lapse system | Time-lapse imaging<br>(Hoffman Modulation<br>Contrast Objective). 10<br>Min cycle time for 11<br>focal planes | Time-lapse imaging<br>(Hoffman Modulation<br>Contrast Objective). 10<br>Min cycle time for 11<br>focal planes for up to 5<br>days | Same |
| Embryo Realtime 2S Software and Embryo Realtime 3E Software | | | |
| Image display | High-resolution time-<br>lapse images of single<br>embryos | High-resolution time-<br>lapse images of single<br>embryos | Same |
| Data handling | Export, storage and<br>transfer of embryo data | Export, storage and<br>transfer of embryo data | Same |
| Embryo annotation<br>and data analysis | • Embryo annotation<br>tools which assist the user<br>in selecting embryos<br>• Model designer | • Embryo annotation<br>tools which assist the user<br>in selecting embryos<br>• Model designer<br>• Model management<br>• Data analysis using<br>user-defined modeling<br>function | Different |
| Incubation<br>condition<br>monitoring | Inspection of incubation<br>details, such as<br>temperature and gas<br>conditions | Inspection of incubation<br>details, such as<br>temperature and gas<br>conditions | Same |
| | Embryo Real-time Culture Dish (MC 2004) | | |
| General design | Optically clear culture dish with a lid | Optically clear culture dish with a lid | Same |
| Material | Polystyrene | Polystyrene | Same |
| Culture wells on the dish | 16 wells for individual embryo incubation | 16 wells for individual embryo incubation…