(212 days)
Not Found
No
The document describes software for displaying, storing, and transferring images, and includes a "user-defined modeling function" to aid in embryo selection based on user-annotated parameters. This does not indicate the use of AI or ML for automated analysis or decision-making.
No
The device provides an environment for the development of embryos and tools for viewing and managing images and data, but it does not directly treat or diagnose any medical condition. Its purpose is to aid in the in vitro fertilization (IVF) process by providing controlled conditions and monitoring capabilities for embryos.
No
The "Intended Use / Indications for Use" section states, "The EmbryoViewer software neither controls any hardware components in the EmbryoScope+ incubator nor performs any diagnostics." While it aids in embryo selection by allowing users to combine annotated information, it explicitly disclaims diagnostic capabilities.
No
The device described is a system that includes both hardware components (incubator, culture dish) and software components (EmbryoViewer, ES Server). While the software components are part of the system, the overall device is not software-only.
Based on the provided information, the EmbryoScope+ system, as a whole, is an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The primary intended use is for the development of human embryos in vitro (outside the body) in a controlled environment. This directly aligns with the definition of an IVD, which involves examining specimens derived from the human body (in this case, embryos) in vitro to provide information for medical purposes.
- Components: The system includes components specifically designed for handling and culturing human embryos in vitro (EmbryoSlide+ culture dish) and providing the necessary environment for their development (EmbryoScope+ incubator).
- Purpose: While the software components primarily handle data and imaging, their function is directly tied to the in vitro process of embryo development and assessment. The EmbryoViewer software, in particular, aids in embryo selection based on observed development parameters, which is a crucial step in assisted reproductive technologies.
- Regulatory Context: The mention of predicate devices (K133712 EmbryoScope time-lapse incubator and K150961 EmbryoSlide culture dish) which are also likely IVDs, further supports the classification of this system as an IVD. The non-clinical performance testing also includes tests relevant to devices used in a clinical laboratory setting (e.g., electrical safety, EMC, software validation, MEA testing).
While the software components themselves might not perform direct diagnostic tests on the embryo in the traditional sense (like analyzing biomarkers), their role in facilitating and assessing the in vitro development of the embryo for the purpose of selection and potential implantation falls under the scope of IVD regulation. The system provides information about the embryo's development in vitro that is used to make decisions about its suitability for clinical use.
N/A
Intended Use / Indications for Use
EmbryoScope+ consists of the following devices with the following indications for use:
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 embryos. The EmbryoSlide+ culture dish must be used together with the EmbryoScope+ incubator.
The Embryo Viewer software is intended for displaying, storing, and transferring images generated by the EmbryoScope+ incubator. This software includes a user annotation 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 Viewer software does not control any hardware components in the EmbryoScope+ incubator.
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.
The EmbryoScope+ incubator, EmbryoViewer software, and ES Server software must be used together to export embryo images from the EmbryoScope+ incubator. The EmbryoViewer software must be used together to analyze the embryo images.
Product codes (comma separated list FDA assigned to the subject device)
MOG, MOK, MTX
Device Description
EmbryoScope+ consists of the following devices: EmbryoScope+ incubator, EmbryoSlide+ culture dish, EmbryoViewer software, and ES Server software.
The EmbryoScope+ incubator is a bench top embryo incubator with a time-lapse imaging function. It provides temperature control, and time-lapse microscopy at multiple focal planes. This device can hold up to 15 culture dishes (EmbryoSlide+ culture dish) in the incubation chamber. The culture dishes are placed on the dish holder in the EmbryoScope+ incubator. The holder provides direct heat transfer to the EmbryoSlide+ culture dish. The built-in microscope consists of an LED illumination unit and an inverted microscope/camera unit. During image acquisition, each culture dish located on the culture dish holder is rotated to the microscopy system and individual image stacks are acquired from all individual embryos in each culture dish.
The EmbryoSlide+ culture dish is a radiation-sterilized polystyrene culture dish containing two separate reservoirs. Each reservoir has eight culture well is used to culture one embryo. Therefore, a total of 16 embryos can be cultured on one dish. Each dish includes four special wells that are only used for rinsing and handling the embryos either before or after incubation. An adhesive barcode label printed from the EmbryoViewer software is used to mark each dish. The barcode label contains two different 2D data matrices that provide information on the patient ID, treatment ID, and insemination time). The EmbryoSlide+ culture dish has a sterility assurance level of 10° and a shelf-life of four years. This device is subject to mouse embryo assay (MEA) and endotoxin testing before lot release.
The EmbryoViewer software is used for displaying, comparing, storing, and transferring images generated by the EmbryoScope+ incubator. The data that can be viewed using this software includes embryo images, incubation details, alarms, log files and other instrument parameters. This software also includes a user annotation 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 neither controls any hardware components in the EmbryoScope+ incubator nor performs any diagnostics.
The ES Server software allows users to update and view common data. The server acts as the central unit, which stores data and controls the data flow to and from the connected devices. The server can be connected to multiple EmbryoScope+ incubators and computers with the EmbryoViewer software installed.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
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)
The following studies have been conducted on the EmbryoScope+ incubator, EmbryoViewer software, and ES Server software to support substantial equivalence to the predicate device:
- Electrical safety testing per IEC 60601-1:2005 (Third Edition) + C1:2006 + C2:2007 + A1:2012 ● (IEC 60601-1:2012 reprint)
- Electromagnetic compatibility testing per EN/IEC 60601-1-2:2007 .
- . Software verification and validation testing that met the requirements of the FDA Guidance Document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued on May 11, 2005
- . Bench performance tests that met design specifications described in Section 7, as follows:
-
- Gas maintenance testing to ensure that gas levels, flow rates, and gas recovery rates in chambers meet design specifications
-
- Temperature control testing to ensure that culture chamber temperature conditions were within defined ranges and stable over time
-
- Time-lapse testing to demonstrate that all design specifications of time-lapse function (image acquisition, quality, and resolution) are met
-
- Light intensity testing to determine the maximum light dose embryos will be exposed to during device use, which was shown to be lower than the predicate device.
-
The following studies have been conducted on the EmbryoSlide+ culture dish to support substantial equivalence to the predicate device:
- . Radiation sterilization validation testing per ISO 11137-2:2013
- . Transportation simulation testing that met the requirements of ASTM D4169-16
- . Package integrity testing after accelerated aging:
-
- Bubble test per ASTM F2096-11
-
- Peel strength testing ASTM F88/F88M-09
-
- Endotoxin testing per USP and ANSI/AAMI ST72:2002. The testing demonstrated that the . device met the specification of ≤20 EU/device.
- . Mouse embryo assay (MEA) before and after accelerated aging:
One-cell mouse embryos were exposed to subject devices and cultured at 37°C in an atmosphere containing 5% CO2. The percent of embryos developed to the expanded blastocyst stage within 96 hours were assessed in comparison with the control group. The testing demonstrated that the device met acceptance criterion of "1-cell MEA ≥80% embryos developed to blastocyst in 96 hours."
In addition, the cleaning and disinfection information provided in cleared K133712 was leveraged in the current submission to support substantial equivalence to the predicate device.
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.
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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and reads "FDA U.S. FOOD & DRUG ADMINISTRATION".
May 11, 2018
Vitrolife A/S Belinda Dueholm Regulatory Affairs Specialist Jens Juuls Vej 20 DK-8260 Viby J Denmark
Re: K173264
Trade/Device Name: EmbryoScope+ Regulation Number: 21 CFR§ 884.6120 Regulation Name: Assisted Reproduction Accessories Regulatory Class: II Product Code: MOG, MOK, MTX Dated: April 6, 2018 Received: April 12, 2018
Dear Belinda Dueholm:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.
1
You must comply with all the Act's requirements. including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Charles Viviano -S
For Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K173264
Device Name EmbryoScope+
Indications for Use (Describe)
EmbryoScope+ consists of the following devices with the following indications for use:
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 embryos. The EmbryoSlide+ culture dish must be used together with the EmbryoScope+ incubator.
The Embryo Viewer software is intended for displaying, storing, and transferring images generated by the EmbryoScope+ incubator. This software includes a user annotation 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 Viewer software does not control any hardware components in the EmbryoScope+ incubator.
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.
The EmbryoScope+ incubator, EmbryoViewer software, and ES Server software must be used together to export embryo images from the EmbryoScope+ incubator. The EmbryoViewer software must be used together to analyze the embryo images.
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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3
510(k) Summary (K173264)
1. Submitter Information
| Submitter | Vitrolife A/S
Jens Juuls Vej 20
DK-8260 Viby J
Denmark |
|---------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person:
Telephone: | Ms. Belinda Dueholm
+45 7221 7900 (main)
+45 2076 3707 (direct) |
| 2. Date Prepared: | May 11, 2018 |
| 3. Device Information | |
| Proprietary Name:
Common Name:
Regulation Number: | EmbryoScope+
Embryo Incubator
21 CFR 884.6120 |
| Regulation Name:
Product Code: | Assisted Reproduction Accessories
MQG (Accessory, Assisted Reproduction), MQK (Labware, Assisted
Reproduction), MTX (Microscope and Microscope Accessories,
Reproduction, Assisted) |
| Regulatory Class | II |
4. Predicate devices
EmbryoScope time-lapse incubator (K133712) manufactured by Unisense FertiliTech A/S and EmbryoSlide culture dish (K150961) manufactured by Vitrolife A/S. These predicate devices have not been subject to any design related recalls.
5. Device Description
EmbryoScope+ consists of the following devices: EmbryoScope+ incubator, EmbryoSlide+ culture dish, EmbryoViewer software, and ES Server software.
The EmbryoScope+ incubator is a bench top embryo incubator with a time-lapse imaging function. It provides temperature control, and time-lapse microscopy at multiple focal planes. This device can hold up to 15 culture dishes (EmbryoSlide+ culture dish) in the incubation chamber. The culture dishes are placed on the dish holder in the EmbryoScope+ incubator. The holder provides direct heat transfer to the EmbryoSlide+ culture dish. The built-in microscope consists of an LED illumination unit and an inverted microscope/camera unit. During image acquisition, each culture dish located on the culture dish holder is rotated to the microscopy system and individual image stacks are acquired from all individual embryos in each culture dish.
The EmbryoSlide+ culture dish is a radiation-sterilized polystyrene culture dish containing two separate reservoirs. Each reservoir has eight culture well is used to culture one embryo. Therefore, a total of 16 embryos can be cultured on one dish. Each dish includes four special wells that are only used for rinsing and handling the embryos either before or after incubation. An adhesive barcode label printed from the EmbryoViewer software is used to mark each dish. The barcode label contains two different 2D data matrices that provide information on the patient ID, treatment ID, and insemination time). The EmbryoSlide+ culture dish has a sterility assurance level of 10° and a shelf-life of four years. This device is subject to mouse embryo assay (MEA) and endotoxin testing before lot release.
4
The EmbryoViewer software is used for displaying, comparing, storing, and transferring images generated by the EmbryoScope+ incubator. The data that can be viewed using this software includes embryo images, incubation details, alarms, log files and other instrument parameters. This software also includes a user annotation 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 neither controls any hardware components in the EmbryoScope+ incubator nor performs any diagnostics.
The ES Server software allows users to update and view common data. The server acts as the central unit, which stores data and controls the data flow to and from the connected devices. The server can be connected to multiple EmbryoScope+ incubators and computers with the EmbryoViewer software installed.
6. Indications for Use
EmbryoScope+ consists of the following devices with the following indications for use:
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, and transferring human embryos. The EmbryoSlide+ culture dish must be used together with the EmbryoScope+ incubator.
The EmbryoViewer software is intended for displaying, 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 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.
The EmbryoScope+ incubator, EmbryoViewer software, and ES Server software must be used 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.
7. Comparison of Intended Use and Technological Characteristics of the Subject and Predicate Devices
Intended Use
| Devices | Subject device (K173264) | Predicate device (K133712) | Predicate device (K150961) |
|---|---|---|---|
| Indications | |||
| for Use | EmbryoScope+ consists of the following devices | ||
| with the following indications for use: |
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 EmbryoScope (Version D)
provides an environment with
controlled temperature, CO2 (and
other gases) for the development
of embryos. This model has an
integrated inverted microscope
and imaging system for embryo
viewing. Device use is limited to
five days (120 hr) covering the
time from post-fertilization to day
5 of development.
The EmbryoViewer software is
an optional accessory software | The EmbryoSlide
culture dish is
intended for
preparing, storing,
and transferring
human embryos. It
is intended to be
used only with the
EmbryoScope
device. |
5
| embryos. The EmbryoSlide+ culture dish must be
used together with the EmbryoScope+ incubator.
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 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.
The EmbryoScope+ incubator, EmbryoViewer
software, and ES Server software must be used
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. | package for use in displaying,
comparing, storing, and
transferring images generated by
the EmbryoScope time-lapse
incubator (Version D). The
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 time-lapse
incubator (Version D). |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Substantial equivalence discussion: | |
Both subject and predicate devices are intended for culturing embryos, handling embryo data, annotating embryos, and analyzing embryo parameters to aid in embryo selection using user-defined modeling function. Therefore, the subject and predicate devices have the same intended uses.
Technological Characteristics
| EmbryoScope+ incubator, EmbryoViewer software, and ES Server software | |||
|---|---|---|---|
| Devices | Subject device (K173264) | Predicate device (K133712) | |
| EmbryoScope+ incubator | |||
| Culture dish capacity | 15 dishes | 6 dishes | |
| Heating mechanism | Same as the predicate | Direct heat transfer | |
| Temperature range | 36-39°C | 30-45°C | |
| Temperature accuracy | +/- 0.2°C | +/- 0.1°C | |
| CO2 accuracy | +/- 0.3 % | +/- 0.2 % | |
| O2 accuracy | +/- 0.5 % | +/- 0.3 % | |
| Recirculation rate | >100 L/h (full purification of gas | ||
| volume every 6 min) | >60 L/h (full purification of gas volume every 20 | ||
| min) | |||
| Recovery times when the load | |||
| door is closed after a 30-second | |||
| load door opening | CO2 (5% ± 0.3 %) and ANSI/AAMI ST72:2002. The testing demonstrated that the . device met the specification of ≤20 EU/device. |
- . Mouse embryo assay (MEA) before and after accelerated aging:
One-cell mouse embryos were exposed to subject devices and cultured at 37°C in an atmosphere containing 5% CO2. The percent of embryos developed to the expanded blastocyst stage within 96 hours were assessed in comparison with the control group. The testing demonstrated that the device met acceptance criterion of "1-cell MEA ≥80% embryos developed to blastocyst in 96 hours."
In addition, the cleaning and disinfection information provided in cleared K133712 was leveraged in the current submission to support substantial equivalence to the predicate device.
9. Conclusion
The subject and predicate devices have the same intended use and fundamental technological characteristics. The differences in technological characteristics between subject and predicate devices do not raise different questions of safety and effectiveness. The performance data demonstrate that the subject devices are substantially equivalent to the predicate devices.