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 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.

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 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.

AI/ML Overview

The provided text pertains to the FDA 510(k) premarket notification for the "Embryo Real-time Incubator (TLS301)" and "Embryo Real-time Culture Dish (MC 2004)" and their associated software.

Based on the provided information, the acceptance criteria and study details are primarily focused on the non-clinical performance and substantial equivalence to a predicate device, rather than a clinical study evaluating diagnostic accuracy or reader performance with AI. The device does not appear to be an AI-based diagnostic tool in the typical sense, but rather an incubator with an integrated imaging system and software that aids in embryo selection.

Here's a breakdown of the requested information based on the document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes various performance tests and their acceptance criteria, predominantly for the hardware components (incubator, optics, culture dish) and basic software functionalities.

Test/Parameter	Acceptance Criteria	Reported Device Performance
Electrical Safety	Compliance with IEC 61010-1:2010 + A1: 2016 and IEC 61010-2-010: 2019	Met
Electromagnetic Compatibility (EMC)	Compliance with 2022 FDA Guidance and IEC 60601-1-2:2020	Met
Software Validation	In accordance with 2023 FDA guidance "Content of Premarket Submissions for Device Software Functions."	Met
Cybersecurity	Evaluated per 2023 FDA guidance "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions."	Met
Incubator Temperature Control	Temperature stability under normal working, power-off, and cold-start conditions; heating and cooling times in different environments. (Specific parameters like ±0.2 °C were mentioned in comparison to predicate, implying they are met criteria.)	Met design specifications (e.g., Temperature accuracy ± 0.2 °C, Temperature range 35-40 °C)
Incubator Gas Concentration	Gas concentration stability under normal working, alarm, power-off, and cold-start conditions; gas consumption over time. (Specific parameters like CO2 accuracy ±0.1% at 6.0%, ±0.2% for others; O2 accuracy ±0.1% at 5.0%, ±0.2% for others, were mentioned in comparison to predicate, implying they are met criteria.)	Met design specifications (e.g., CO2 accuracy, O2 accuracy)
Microscope Performance: Light Exposure Safety	Wavelength and intensity of illumination source, exposure time, time-lapse worst-case imaging simulation with mouse embryo assay.	Met
Microscope Performance: Image Quality	Not explicitly stated numeric acceptance criteria, but tested.	Met
Microscope Performance: Auto-positioning and Auto-focus	Tested for functionality.	Met
Culture Dish: Radiation Sterilization	Compliance with ISO 11137-2: 2006 and 2024 FDA guidance.	Validated
Culture Dish: Transportation Simulation	In accordance with ASTM D4169-22.	Performed
Culture Dish: Endotoxin Testing (Shelf-life)	≤0.5 EU/device.	Met specification of ≤0.5 EU/device.
Culture Dish: Mouse Embryo Assay (MEA) (Shelf-life)	"1-cell MEA ≥80% embryos developed to blastocyst in 96 hours."	Met acceptance criterion.
Culture Dish: Visual Assessment (Appearance)	Transparent, smooth, no cracks, no scratches, no dust, no oil.	Met
Culture Dish: Package Integrity (Dye Penetration Test)	Per ASTM F1929-15.	Performed
Culture Dish: Package Integrity (Peel Strength Testing)	Per ASTM F88/F88M-21.	Performed
Culture Dish: Package Integrity (Visual Assessment)	Per ASTM F1886/F1886M-16.	Performed

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

The document describes non-clinical bench testing.

Sample Size: Not explicitly quantified for each specific test in terms of individual units. The "Mouse embryo assay (MEA)" involved embryos, but a specific number is not given.
Data Provenance: The studies are described as "Non-clinical bench testing." There is no mention of human clinical data, retrospective or prospective studies, or country of origin for such data. The MEA, by its nature, would use animal (mouse) embryos.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:

This type of information is generally relevant for AI/diagnostic devices that require expert human labels for ground truth. The provided document describes non-clinical bench testing to verify hardware and software performance against specifications. As such, there is no mention of experts establishing a "ground truth" in the diagnostic sense, nor their qualifications. The closest would be implicit expertise in conducting the various standardized tests (e.g., electrical safety, sterility, MEA).

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set:

Not applicable. The tests described are objective non-clinical performance and safety tests, not subjective interpretations requiring adjudication among experts.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No MRMC comparative effectiveness study was mentioned. The device's software (Embryo Realtime 3E Software) includes a "user-defined modeling function that allows the user to combine annotated information on embryo development parameters to aid in embryo selection." However, the document does not describe any study evaluating the comparative effectiveness or improvement in human reader performance (e.g., embryologists) with or without this AI assistance. The focus is on the software's functionality and validation rather than its clinical impact on human decision-making.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

The document does not describe a standalone performance evaluation of the "user-defined modeling function" or any other algorithm. The software functions aid in embryo selection, implying a human-in-the-loop process. The "Embryo Realtime 2S Software... includes functions for managing models and performing calculations based on image data and embryo development parameters," but no standalone performance metrics are provided for these calculations.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For the specific tests mentioned:

Hardware and Software Performance: Ground truth is defined by objective engineering specifications and scientific standards (e.g., temperature ranges, gas concentrations, electrical safety standards, image quality parameters, sterility levels, endotoxin limits, mouse embryo development rates).
Mouse Embryo Assay (MEA): The "ground truth" for this test is the biological outcome of mouse embryo development to blastocyst (≥80% development in 96 hours), an accepted standard for assessing device biocompatibility.

8. The Sample Size for the Training Set:

The document does not describe any machine learning or AI model training. Therefore, there is no mention of a training set sample size. The software's "user-defined modeling function" suggests that users create or define models based on annotated information, rather than the device coming with a pre-trained model.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as no machine learning training set or associated ground truth establishment process is described.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of an eagle, while the FDA name on the right is written in blue and consists of the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION".

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.

{1}------------------------------------------------

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

{2}------------------------------------------------

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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

{3}------------------------------------------------

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 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).

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{4}------------------------------------------------

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: +86-13554695434 E-Mail: hc@huchuang.com

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) ●

{5}------------------------------------------------

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.

VI. Indications for Use

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

{6}------------------------------------------------

Incubator (TLS301).

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

Attribute	Subject device(K232493)	Predicate device(K173264)	Comparison
Indications for Use	The Embryo Real-timeIncubator (TLS301) isintended to provide anenvironment withcontrolled temperatureand mixed gas (CO2 andother gases) for thedevelopment of embryos.The Embryo Real-timeIncubator (TLS301) hasan integrated camera andoptics for imaging andviewing embryos duringincubation, for amaximum time of 120hours.The Embryo Real-time	The EmbryoScope+incubator provides anenvironment withcontrolled temperature andgas concentrations (CO2and O2) for thedevelopment of embryos ator near body temperature.Use of the EmbryoScope+incubator is limited to fivedays (120 hr) covering thetime from post inseminationto day five of development.The EmbryoSlide+ culturedish is intended forpreparing, storing, andtransferring human	The indications foruse statements forthe subject andpredicate devicesare not identical;however, theirintended uses arethe same (i.e.,time-lapse imagingof embryosmaintained in adevice-specificculture dish).
Culture Dish (MC 2004)is intended for preparing,storing and transferringhuman embryos. It isintended to be used onlywith the Embryo Real-time Incubator (TLS301).	embryos. TheEmbryoSlide+ culture dishmust be used together withthe EmbryoScope+incubator.
Embryo Realtime 2SSoftware and EmbryoRealtime 3E Software areoptional softwareaccessories for theEmbryo Real-timeIncubator (TLS301).	The EmbryoViewersoftware is intended fordisplaying, comparing,storing, and transferringimages generated by theEmbryoScope+ incubator.This software includes auser annotation function forcapturing information onembryo developmentparameters as well as auser-defined modelingfunction, which allows theuser to combine annotatedinformation on embryodevelopment parameters toaid in embryo selection.The EmbryoViewersoftware does not controlany hardware componentsin the EmbryoScope+incubator.
The Embryo Realtime 2SSoftware is intended tostore, archive and transferdata. In addition, theEmbryo Realtime 2SSoftware includesfunctions for managingmodels and performingcalculations based onimage data and embryodevelopment parameters.	The ES Server software isintended to store, archiveand transfer data. Inaddition, this softwareincludes functions formanaging models andperforming calculationsbased on image data andembryo developmentparameters.
Embryo Realtime 3ESoftware is intended forviewing and recordingembryo developmentevents from imagescaptured using theEmbryo Real-timeIncubator (TLS301).Embryo Realtime 3ESoftware includes a userannotation function forcapturing information onembryo developmentparameters and a user-defined modelingfunction that allows the	The EmbryoScope+incubator, EmbryoViewersoftware, and ES Serversoftware must be used
	user to combineannotated information onembryo developmentparameters to aid inembryo selection.Embryo Realtime 2SSoftware and EmbryoRealtime 3E Software donot control any hardwarecomponents in theEmbryo Real-timeIncubator (TLS301).Embryo Realtime 2SSoftware and EmbryoRealtime 3E Software areprovided in differentsoftware package andmust be used together.	together to export embryoimages from theEmbryoScope+ incubator.The EmbryoViewersoftware and ES Serversoftware must be usedtogether to analyze theembryo images.
	Incubator, integrated computer and microscopy system
Culture dishcapacity	10 dishes	15 dishes	Different
Heatingmechanism	Heated aluminumcontainer and lid	Direct heat transfer	Different
Temperature range	35-40 °C	36-39 °C	Similar
Temperatureaccuracy	$\pm$ 0.2 °C	$\pm$ 0.2 °C	Similar
CO2 accuracy	$\pm$ 0.1% for CO2concentration at 6.0%,$\pm$ 0.2% for other CO2concentration	$\pm$ 0.3 %	Different
O2 accuracy	$\pm$ 0.1% for O2concentration at 5.0%,$\pm$ 0.2% for other O2concentration	$\pm$ 0.5 %	Different
Recirculation rate	150ml $\pm$ 7.5ml/min (fullpurification of gasvolume every 6.3 min)	>100 L/h (fullpurification of gasvolume every 6 min)	Different
Recovery time	CO2 (6% $\pm$ 0.3%) $\leq$ 90secondsO2(5% $\pm$ 0.3%) $\leq$ 90	CO2 (5% $\pm$ 0.3 %) < 5 minO2 (5% $\pm$ 0.5 %) <3 min	Different
		load door opening
	closed after a 15-secondload door opening (singlechamber)
Control oftemperature andgas	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 dishdetection and embryofocusing	Fully automated dishdetection and embryofocusing	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 (forimaging)	Low-power red LED 635nm	Low-power red LED 627nm	Similar
Time-lapse system	Time-lapse imaging(Hoffman ModulationContrast Objective). 10Min cycle time for 11focal planes	Time-lapse imaging(Hoffman ModulationContrast Objective). 10Min cycle time for 11focal planes for up to 5days	Same
Embryo Realtime 2S Software and Embryo Realtime 3E Software
Image display	High-resolution time-lapse images of singleembryos	High-resolution time-lapse images of singleembryos	Same
Data handling	Export, storage andtransfer of embryo data	Export, storage andtransfer of embryo data	Same
Embryo annotationand data analysis	• Embryo annotationtools which assist the userin selecting embryos• Model designer	• Embryo annotationtools which assist the userin selecting embryos• Model designer• Model management• Data analysis usinguser-defined modelingfunction	Different
Incubationconditionmonitoring	Inspection of incubationdetails, such astemperature and gasconditions	Inspection of incubationdetails, such astemperature and gasconditions	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	Same
Rinsing wells in the dish	3 wells	4 wells	Different
Sterile	Yes	Yes	Same

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

{7}------------------------------------------------

{8}------------------------------------------------

{9}------------------------------------------------

{10}------------------------------------------------

As noted in the table above, the subject and predicate devices do not have identical indication for use statements; however, their intended use are the same (i.e., time-lapse imaging of embryos maintained in a device-specific culture dish). In addition, there are differences in the technological characteristics between the subject and predicate devices, including culture dish capacity, heating mechanism, gas recirculation rate, gas/temperature recovery time, gas accuracy specifications, microscope magnification, camera resolution, and number of dish rinsing wells. The technological differences between the subject and predicate devices do not raise different questions of safety and effectiveness.

Summary of Non-clinical Performance VIII.

Non-clinical bench testing for the Embryo Real-time Incubator (TLS301) with the Embryo Realtime 2S Software and Embryo Realtime 3E Software was conducted to verify that the subject device met all design specifications, demonstrated their performance, and to demonstrate substantial equivalence to the predicate device. The following tests were conducted:

. Electrical safety testing per IEC 61010-1:2010 + A1: 2016 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements and IEC 61010-2-010: 2019 Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-010: Particular requirements for laboratory equipment for the heating of materials
Electromagnetic compatibility testing per 2022 FDA Guidance Electromagnetic . Compatibility (EMC) of Medical Devices and IEC 60601-1-2:2020 Medical electrical equipment—Part 1-2: General requirements for basic safety and essential performance -Collateral Standard: Electromagnetic disturbances – Requirements and tests
. Software validation was conducted in accordance with the 2023 FDA guidance "Content of Premarket Submissions for Device Software Functions."
Cybersecurity was evaluated per the 2023 FDA guidance "Cybersecurity in Medical ● Devices: Quality System Considerations and Content of Premarket Submissions."
Bench performance testing to evaluate that the device met all the specifications listed . in the table in Section VII:
- Temperature control performance to evaluate temperature stability under o normal working, power-off and cold-start conditions, and heating and cooling times in different environments.

{11}------------------------------------------------

Gas concentration performance to evaluate gas concentration stability under O normal working, alarm, power-off and cold-start conditions and gas consumption over time.
Microscope performance testing to evaluate light exposure safety of embryo O (wavelength and intensity of illumination source, exposure time, time-lapse worst-case imaging simulation with mouse embryo assay), image quality, and auto-positioning and auto-focus functions.
Performance testing conducted on the Embryo Real-time Culture Dish (MC2004) to ● support substantial equivalence to the predicate device:
- Radiation sterilization and validation testing per ISO 11137-2: 2006 and the o 2024 FDA guidance "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile Guidance for Industry and Food and Drug Administration Staff".
- Transportation simulation testing in accordance with ASTM D4169-22 o
- Shelf-life testing (accelerated aging) per ASTM F1980:2016, including the o following assessments:
  - 트 Endotoxin testing per USP <85> and ANSI/AAMI ST72:2019. The testing demonstrated that the device met the specification of ≤0.5 EU/device.
  - . Mouse embryo assay (MEA) per the 2021 FDA guidance document "Mouse Embryo Assay for Assisted Reproduction Technology Devices" before and after accelerated aging-

The testing demonstrated that the device met acceptance criterion of "1cell MEA ≥80% embryos developed to blastocyst in 96 hours."

Visual assessment for appearance of the product (transparent, smooth, no cracks, no scratches, no dust, no oil).
트 Package integrity testing after accelerated aging:
- . Dye penetration test per ASTM F1929-15
- Peel strength testing per ASTM F88/F88M-21
- Visual assessment per ASTM F1886/F1886M-16 ●

IX. Conclusions

The results of the performance testing described above demonstrate that subject device is as safe and effective as the predicate device and supports a determination of substantial equivalence.

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.