(264 days)
Not Found
No
The software description mentions "managing models and performing calculations based on image data and 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." This suggests rule-based or statistical modeling based on user input and image data, but there is no explicit mention of AI or ML algorithms, training data, or performance metrics typically associated with AI/ML systems. The modeling appears to be user-defined and based on annotated parameters rather than learned from data.
Yes.
The device, through its components (incubator, culture dish), provides an environment for the development and handling of embryos, which is a key part of Assisted Reproductive Technology (ART) procedures. While it doesn't directly treat a disease, it supports a physiological process (embryo development) for therapeutic purposes (ART for infertility).
Yes
The device aids in embryo selection by allowing users to combine annotated information on embryo development parameters, which can be used to assess the embryo's viability or health, thus serving a diagnostic purpose in the context of reproductive medicine.
No
The device description clearly states that the system includes hardware components such as the incubator, integrated temperature control system, gas supply control system, time-lapse imaging system (including camera and optics), and a workstation with a server. While the software components are described as accessories and are stated not to control hardware, the overall device is a system that includes significant hardware.
Based on the provided information, the Embryo Real-time Incubator (TLS301) system, including the incubator, culture dish, and associated software, is likely considered an In Vitro Diagnostic (IVD) device or a device used in conjunction with IVD procedures.
Here's why:
- Intended Use: The primary intended use is to provide a controlled environment for the development of embryos. While the incubator itself is a piece of equipment, its function is directly tied to the process of culturing and observing embryos, which are biological samples.
- Role in ART Procedures: The device is explicitly stated as being used in Assisted Reproductive Technology (ART) procedures. ART procedures often involve the manipulation and assessment of gametes and embryos in vitro for diagnostic and therapeutic purposes related to infertility.
- Imaging and Assessment: The integrated camera and software are used for imaging and viewing embryos during incubation and for recording embryo development events. The software also includes functions for managing models and performing calculations based on image data and 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. This suggests the device is used to gather information about the embryo's development, which can be used to make decisions about the embryo's viability or suitability for transfer.
- Mouse Embryo Assay (MEA): The performance testing includes a Mouse Embryo Assay (MEA). This is a common test used to assess the suitability of materials and devices for use in embryo culture, which is a key component of IVD procedures in ART. The acceptance criterion of "greater than or equal to 80% embryos developed to blastocyst in 96 hours" is a measure of the device's ability to support healthy embryo development in vitro.
- Predicate Device: The predicate device listed, K173264 EmbryoScope+, is also a time-lapse embryo incubator used in ART, and such devices are typically regulated as medical devices, often falling under the scope of IVD or devices used in IVD procedures.
While the device itself is an incubator and imaging system, its specific intended use in supporting and monitoring embryo development in vitro for ART procedures strongly aligns with the definition and scope of devices used in IVD. The information gathered from the device (embryo development parameters, images) is used to inform clinical decisions related to embryo selection and transfer, which are diagnostic and therapeutic steps in addressing infertility.
Therefore, it is highly probable that this device is considered an IVD or a device used in conjunction with IVD procedures by regulatory bodies.
N/A
Intended Use / 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 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.
Product codes (comma separated list FDA assigned to the subject device)
MQG, MQK, MTX
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
No
Input Imaging Modality
Not Found
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)
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 and IEC 61010-2-010: 2019.
- Electromagnetic compatibility testing per 2022 FDA Guidance Electromagnetic Compatibility (EMC) of Medical Devices and IEC 60601-1-2:2020.
- 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 normal working, power-off and cold-start conditions, and heating and cooling times in different environments.
- Gas concentration performance to evaluate gas concentration stability under normal working, alarm, power-off and cold-start conditions and gas consumption over time.
- Microscope performance testing to evaluate light exposure safety of embryo (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 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.
- Shelf-life testing (accelerated aging) per ASTM F1980:2016, including the following assessments:
- Endotoxin testing per USP 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).
- 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
Key results: 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
EmbryoScope+ (K173264)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 884.6120 Assisted reproduction accessories.
(a)
Identification. Assisted reproduction accessories are a group of devices used during assisted reproduction procedures, in conjunction with assisted reproduction needles and/or assisted reproduction catheters, to aspirate, incubate, infuse, and/or maintain temperature. This generic type of device may include:(1) Powered aspiration pumps used to provide low flow, intermittent vacuum for the aspiration of eggs (ova).
(2) Syringe pumps (powered or manual) used to activate a syringe to infuse or aspirate small volumes of fluid during assisted reproduction procedures.
(3) Collection tube warmers, used to maintain the temperature of egg (oocyte) collection tubes at or near body temperature. A dish/plate/microscope stage warmer is a device used to maintain the temperature of the egg (oocyte) during manipulation.
(4) Embryo incubators, used to store and preserve gametes and/or embryos at or near body temperature.
(5) Cryopreservation instrumentation and devices, used to contain, freeze, and maintain gametes and/or embryos at an appropriate freezing temperature.
(b)
Classification. Class II (special controls) (design specifications, labeling requirements, and clinical testing). The device, when it is a simple embryo incubator with only temperature, gas, and humidity control; a syringe pump; a collection tube warmer; a dish/plate/microscope stage warmer; a controlled-rate cryopreservation freezer; or an assisted reproduction laminar flow workstation is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.
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Image /page/0/Picture/0 description: The image 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 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) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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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) ●
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
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.
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
6
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
(K232493) | Predicate device
(K173264) | Comparison |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 | The EmbryoScope+
incubator provides an
environment with
controlled temperature and
gas concentrations (CO2
and O2) for the
development of embryos at
or near body temperature.
Use of the EmbryoScope+
incubator is limited to five
days (120 hr) covering the
time from post insemination
to day five of development.
The EmbryoSlide+ culture
dish is intended for
preparing, storing, and
transferring human | The indications for
use statements for
the subject and
predicate devices
are not identical;
however, their
intended uses are
the same (i.e.,
time-lapse imaging
of embryos
maintained in a
device-specific
culture dish). |
| 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). | embryos. The
EmbryoSlide+ culture dish
must be used together with
the EmbryoScope+
incubator. | | |
| Embryo Realtime 2S
Software and Embryo
Realtime 3E Software are
optional software
accessories for the
Embryo Real-time
Incubator (TLS301). | The EmbryoViewer
software is intended for
displaying, comparing,
storing, and transferring
images generated by the
EmbryoScope+ incubator.
This software includes a
user annotation function for
capturing information on
embryo development
parameters as well as a
user-defined modeling
function, which allows the
user to combine annotated
information on embryo
development parameters to
aid in embryo selection.
The EmbryoViewer
software does not control
any hardware components
in the EmbryoScope+
incubator. | | |
| 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. | The ES Server software is
intended to store, archive
and transfer data. In
addition, this 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 function for
capturing information on
embryo development
parameters and a user-
defined modeling
function that allows the | The EmbryoScope+
incubator, EmbryoViewer
software, and ES Server
software must be used | | |
| | 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. | together to export embryo
images from the
EmbryoScope+ incubator.
The EmbryoViewer
software and ES Server
software must be used
together to analyze the
embryo images. | |
| | Incubator, integrated computer and microscopy system | | |
| Culture dish
capacity | 10 dishes | 15 dishes | Different |
| Heating
mechanism | Heated aluminum
container and lid | Direct heat transfer | Different |
| Temperature range | 35-40 °C | 36-39 °C | Similar |
| Temperature
accuracy | $\pm$ 0.2 °C | $\pm$ 0.2 °C | Similar |
| CO2 accuracy | $\pm$ 0.1% for CO2
concentration at 6.0%,
$\pm$ 0.2% for other CO2
concentration | $\pm$ 0.3 % | Different |
| O2 accuracy | $\pm$ 0.1% for O2
concentration at 5.0%,
$\pm$ 0.2% for other O2
concentration | $\pm$ 0.5 % | Different |
| Recirculation rate | 150ml $\pm$ 7.5ml/min (full
purification of gas
volume every 6.3 min) | >100 L/h (full
purification of gas
volume every 6 min) | Different |
| Recovery time | CO2 (6% $\pm$ 0.3%) $\leq$ 90
seconds
O2(5% $\pm$ 0.3%) $\leq$ 90 | CO2 (5% $\pm$ 0.3 %) 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.