EMBRYOVIEWER SOFTWARE by UNISENSE FERTILITECH A/S

The EmbryoScope® time-lapse incubator (version D) provides an environment with controlled temperature, CO2 (and other gasses) 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 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).

Device Description

The EmbryoScope® time-lapse incubator is a tri-gas incubator, which acquires a series of unattended measurements on individual embryos during their development. The measurements include: time-lapse microscopy at multiple focal planes and logging of incubation conditions. Separate processing units control the incubation environment and data acquisition to ensure safe and reliable operation. Up to 72 embryos (6 EmbryoSlide® culture dishes with 12 embryos in each culture dish) can be incubated simultaneously.

The purpose of the EmbryoViewer™ software is to assist the embryologist in selecting embryos for transfer or freezing. This is obtained by allowing the embryologist to inspect high-resolution time-lapse images of embryo development, to use detailed annotation tools and to inspect the running conditions of the EmbryoScope® time-lapse system. The EmbryoViewer™ software does not perform any diagnostics, but only shows data from the EmbryoScope® time-lapse system and data entered by the user.

AI/ML Overview

The provided text describes the 510(k) summary for the "EmbryoScope time-lapse incubator (Version D) and EmbryoViewer software." However, it does not contain specific acceptance criteria, a detailed quantitative study proving the device meets acceptance criteria, or information on human reader performance with or without AI assistance, or details about the training set.

Instead, it states that the device is considered substantially equivalent to a predicate device (K113075) based on an evaluation of tests performed on previous versions, with additional tests for new features. The document explicitly states that "No clinical testing was performed" for the EmbryoViewer software and "No clinical testing was performed" for the EmbryoScope time-lapse incubator.

Therefore, many of the requested details cannot be extracted from the provided text.

Here is an attempt to address the request based only on the information available:

A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria with specific quantitative targets. Instead, it relies on substantial equivalence to a predicate device (K113075). The reported "performance" for the EmbryoScope time-lapse incubator is that the "test results have been evaluated and it has been concluded to accept the test results; the EmbryoScope time-lapse incubator is substantially equivalent to the predicate device." For the EmbryoViewer software, "Test results have been evaluated and it has been concluded to accept the test results; the EmbryoViewer software is as safe, as effective and performs as well or better than the EmbryoViewer software included in the submission K113075."

Acceptance Criteria	Reported Device Performance
EmbryoScope time-lapse incubator (Version D):
Substantial equivalence to predicate device (K113075) based on evaluation of tests performed on previous version (GB) and additional tests for new features (EGS).Incubation conditions and image quality not adversely affected by changes.New features do not raise new types of safety and effectiveness questions.Underwent and passed electrical safety, electromagnetic compatibility, environmental, and operating performance testing in accordance with IEC 60601-1:2005.	Test results evaluated and accepted; device is substantially equivalent to the predicate device. Incubation conditions and image quality are not adversely affected. New features do not raise new types of safety and effectiveness questions.Passed electrical safety, electromagnetic compatibility, environmental, and operating performance testing in accordance with IEC 60601-1:2005. Tests with and without mouse embryos confirm gas system component (EGS) is equivalent to gas system component (GB) in predicate device. No adverse effects of image acquisition were observed.
EmbryoViewer™ software:
Substantial equivalence to predicate device (K113075) based on evaluation of tests performed on previous version and additional tests for new features.Fulfilling the requirements of the IEC 62304 standard according to software testing.New features (models and Compare & Select) do not impact incubation conditions or require changes to the EmbryoScope time-lapse incubator and do not raise new types of safety and effectiveness questions.	Test results evaluated and accepted; software is as safe, as effective, and performs as well or better than the predicate device's software. Fulfills the requirements of the IEC 62304 standard according to software testing. New features have no impact on incubation conditions and do not raise new safety and effectiveness questions.

Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify a distinct "test set" in terms of number of cases (e.g., embryos or patients). The testing for substantial equivalence for both the EmbryoScope incubator and EmbryoViewer software primarily refers to "an evaluation of tests performed on previous version" with "addition of tests related to new features." There's mention of "Tests with and without mouse embryos" for the incubator, but no sample size or specific provenance for these. No information is provided about data provenance or whether any data was retrospective or prospective.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable (N/A). The document states "No clinical testing was performed" for either device. Therefore, no ground truth was established by experts in a clinical study context for this submission.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable (N/A). As "No clinical testing was performed," there was no clinical test set requiring adjudication.
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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states "No clinical testing was performed." The EmbryoViewer software includes a "user-defined modeling function" to "aid in embryo selection," but no study on its effectiveness or the improvement of human readers is presented.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done
The document describes the EmbryoViewer software's functionality, including "a user annotation function" and a "user-defined modeling function." It explicitly states that the "EmbryoViewer™ software does not perform any diagnostics, but only shows data from the EmbryoScope® time-lapse system and data entered by the user." This implies it's designed as an assistive tool for human-in-the-loop use, rather than a standalone diagnostic algorithm. No standalone performance metrics are provided.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable (N/A). As "No clinical testing was performed," there is no mention of ground truth types derived from studies for this submission. The EmbryoViewer software stores "patient details, treatment data and outcome data," but this refers to data input by the user and stored in the database, not ground truth used to evaluate the device itself for this submission.
The sample size for the training set
Not applicable (N/A). No explicit training set is mentioned as part of the device's development or evaluation in this submission. The software's "user-defined modeling function" allows users to define models, which implies the models are user-trained or configured, but no internal training set used by the manufacturer is described.
How the ground truth for the training set was established
Not applicable (N/A). As no training set is described for the manufacturer's algorithm development in this document, no information on how its ground truth was established is provided.

Summary

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the word "FertiliTech" in bold black font. To the left of the word is a small, circular graphic that appears to be a stylized image of a seed or plant embryo. The text and graphic are the only elements in the image, and they are centered horizontally. ## 510(k) Summary – EmbryoScope time-lapse incubator (Version D) and ### EmbryoViewer software #### Administrative information | Name: | Unisense FertiliTech A/S | |-------------------|------------------------------------------| | Address: | Tueager 1 DK-8200 Aarhus N Denmark | | Contact person: | Henrik Wahlgren, QA Manager | | Telephone Number: | +45 29 33 36 85 | | Fax Number: | +45 89 44 95 49 | | E-mail: | hew@fertilitech.com | | Date of summary: | 8-August-2014 | #### Device name and predicate device name | Trade name | Common name | Device | Class | CFR Reference | Product code | Predicate device K number | |--------------------------------------------------------------------------|-------------------------------|-----------------------------------------------------------------------------------|-------|---------------|--------------|---------------------------| | EmbryoScope® time-lapse incubator (Version D) and EmbryoViewer™ software | EmbryoScope time-lapse system | Assisted reproduction accessories and Picture archiving and communications system | II | 884.6120 | MQG | 113075 | {1}------------------------------------------------ Image /page/1/Picture/0 description: The image contains the logo for "FertiliTech". The logo consists of a stylized graphic to the left of the company name. The graphic is a circular shape with an abstract design inside. The text "FertiliTech" is in a bold, sans-serif font. K133712 Page 2 of 9 #### Indications for Use EmbryoScope time-lapse incubator (Version D) and EmbryoViewer software The EmbryoScope® time-lapse incubator (version D) provides an environment with controlled temperature, CO2 (and other gasses) 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 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). #### Device description EmbryoScope® time-lapse incubator (Version D) The EmbryoScope® time-lapse incubator is a tri-gas incubator, which acquires a series of unattended measurements on individual embryos during their development. The measurements include: time-lapse microscopy at multiple focal planes and logging of incubation conditions. Separate processing units control the incubation environment and data acquisition to ensure safe and reliable operation. Up to 72 embryos (6 EmbryoSlide® culture dishes with 12 embryos in each culture dish) can be incubated simultaneously. | | EmbryoScope | EmbryoScope (K113075) | |---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for use | The EmbryoScope® time-lapse incubator (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 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. | #### Indications for use EmbryoScope® time-lapse incubator (Version D) Unisense FertiliTech A/S Tueager 1 DK-8200 Aarhus N Denmark Page 2 of 9 {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the word "FertiliTech" in bold, black font. To the left of the word is a small, abstract graphic that appears to be a stylized depiction of a plant or seed. The text is the primary focus of the image, with the graphic serving as a visual element to complement the brand name. #### Summary of Performance testing EmbryoScope® time-lapse incubator (Version D) For the EmbryoScope time-lapse incubator software and gas system component (EGS), the test cases that have been performed to verify and validate requirements are an evaluation of tests performed on previous version of the EmbryoScope time-lapse incubator software and gas system component (GB), with addition of tests related to new features described in this submission. Test results have been evaluated and it has been concluded to accept the test results; the EmbryoScope time-lapse incubator is substantially equivalent to the predicate device. | | EmbryoScope | EmbryoScope (K113075) | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for use | The EmbryoScope® timelapse incubator (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 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. | | Design features | Gas system component (EGS) providing an environment with controlled temperature, CO2 (and other gases) for the development of embryos. An integrated inverted microscope and imaging system for embryo viewing. IR-cut off filter enabling reduced exposure times and increased image acquisition frequency | Gas system component (GB) providing an environment with controlled temperature, CO2 (and other gases) for the development of embryos. An integrated inverted microscope and imaging system for embryo viewing. | | | | | | Treatment ID should be specified for all EmbryoSlide culture dishes Integrated computer running Microsoft Windows 7 Load door LEDs (red/green) indicating the status of the load door lock Optional barcode reader | Integrated computer running Microsoft Windows Vista | | | Non-Clinical Tests performed for Determination of Substantial Equivalence | The tests described in the software test plan for the EmbryoScope time-lapse incubator software and gas system component (EGS), derived from the Software Requirements Specification and technical specification, are an evaluation of tests performed on previous version on the EmbryoScope time-lapse incubator software and gas system component (GB), with addition of tests related to new features described in this submission Underwent and passed electrical safety electromagnetic compatibility environmental and operating performance testing in accordance with IEC 60601-1:2005 | Underwent and passed electrical safety electromagnetic compatibility environmental and operating performance testing in accordance with IEC 60601-1:1998 | | Clinical Tests performed | No clinical testing was performed. Tests with and without mouse embryos have been performed to confirm that | Clinical data show that the EmbryoScope (Version D) performs according to the intended use of the device. | | system component (EGS) is equivalent to the gas system component (GB) in the predicate device. | No adverse effects of image acquisition were observed. | | | No adverse effects of image acquisition were observed. | | | #### Comparison to Predicate Device EmbryoScope® time-lapse incubator (Version D) Unisense FertiliTech A/S Tueager 1 DK-8200 Aarhus N Denmark Phone: +45 89 44 95 00 Fax: +45 89 44 95 49 sales@fertilitech.com www.fertilitech.com {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for FertiliTech. The logo consists of a stylized symbol to the left of the word "FertiliTech". The symbol appears to be a stylized representation of a seed or a cell, with a swirling design inside a circular shape. The text "FertiliTech" is written in a bold, sans-serif font. Page 4 of 9 {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for "FertiliTech". The logo consists of a stylized plant or seed sprouting icon to the left of the company name. The text "FertiliTech" is written in a bold, sans-serif font, with each letter clearly legible. The indications for use for the EmbryoScope time-lapse incubator have not changed as a consequence of the change in design features described above. To the name EmbryoScope, the description time-lapse incubator has been added. The components in the EmbryoScope time-lapse incubator are considered equivalent to the components in the predicate device included in the submission K113075. Incubation conditions and image quality are not adversely affected by the above changes. The addition of the features described above to the EmbryoScope time-lapse incubator does not raise new types of safety and effectiveness questions. #### Device description EmbryoViewer™ software The purpose of the EmbryoViewer™ software is to assist the embryologist in selecting embryos for transfer or freezing. This is obtained by allowing the embryologist to inspect high-resolution time-lapse images of embryo development, to use detailed annotation tools and to inspect the running conditions of the EmbryoScope® time-lapse system. The EmbryoViewer™ software does not perform any diagnostics, but only shows data from the EmbryoScope® time-lapse system and data entered by the user. The EmbryoViewer™ software provides: - · High-resolution time-lapse images of single embryos - Embryo annotation tools which assist the user in selecting embryos - Option to design a set of models that can be used for scoring embryos - Inspection of incubation details, e.g. temperature and gas conditions - Export of data for statistical analysis The EmbryoViewer™ software is an optional accessory package to the EmbryoScope® timelapse system. The time-lapse system provides a controlled culture environment that allows continuous monitoring and observation of up to 72 embryos at a time. The data from the EmbryoScope® time-lapse system can be seen in the EmbryoViewer™ software. This includes embryo images, incubation details, alarms, log files and other Page 5 of 9 {5}------------------------------------------------ fech instrument parameters. The EmbryoViewer™ software can be used to review and compare synchronized time-lapse movies of various embryos. In addition, the EmbryoViewer™ software contains a database which enables the user to annotate time-lapse images for e.g. cleavage times, fragmentation, multinucleation, pronuclei and other characteristics used for selecting embryos for transfer. Annotations are saved in the database and can be exported to an Excel file for statistical analysis. The EmbryoViewer™ software also enables input of patient details, treatment data and outcome data. This data is stored in the database and can be exported to an Excel file complete with annotations. | | EmbryoViewer | EmbryoViewer (K113075) | |---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for Use | The EmbryoScope® time- lapse system (version D) provides an environment with controlled temperature, CO2 (and other gasses) 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 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 | EmbryoViewer is an optional accessory software package for use in displaying, comparing, storing, and transferring EmbryoScope (Version D) generated images. The software includes a user annotation function for capturing information on embryo development parameters, treatment data, and outcome data. The EmbryoViewer software does not control any hardware components in the EmbryoScope (Version D) device. | #### Indications for use EmbryoViewer™ software Page 6 of 9 Phone: +45 89 44 95 00 Fax: +45 89 44 95 49 sales@fertilitech.com www.fertilitech.com {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for "FertiliTech". The logo consists of a stylized graphic to the left of the company name. The company name is in a bold, sans-serif font. #### Summary of Performance testing EmbryoViewer™ software For the EmbryoViewer software, the test cases that have been performed to verify and validate requirements are an evaluation of tests performed on previous version on the EmbryoViewer software, with addition of tests related to new features described in this submission. Test results have been evaluated and it has been concluded to accept the test results; the EmbryoViewer software is as safe, as effective and performs as well or better than the EmbryoViewer software included in the submission K113075. #### Comparison to Predicate Device EmbryoViewer™ software | Indications for Use | EmbryoViewer | EmbryoViewer (K113075) | |------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | The EmbryoScope® time-lapse system (version D) provides an environment with controlled temperature, CO2 (and other gasses) 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. | EmbryoViewer is an optional accessory software package for use in displaying, comparing, storing, and transferring EmbryoScope (Version D) generated images. The software includes a user annotation function for capturing information on embryo development parameters, treatment data, and outcome data. The EmbryoViewer software does not control any hardware components in the EmbryoScope (Version | | | The EmbryoViewer™ software is an optional | | | | | | | | 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). | | | Design features | Displaying, comparing, storing, and transferring EmbryoScope time-lapse incubator generated images and an annotation function. In the Model Designer, the user can define models applied in the Compare & Select view where embryos are listed together with the score from the applied model | Displaying, comparing, storing, and transferring EmbryoScope (Version D) generated images and an annotation function. | | Non-Clinical Tests performed for Determination of Substantial Equivalence | The EmbryoViewer software is fulfilling the requirements of the IEC 62304 standard according to software testing. The tests described in the software test plan for the EmbryoViewer software, derived from the Software Requirements Specification, are an evaluation of tests performed on previous version on the EmbryoViewer | The EmbryoViewer software is fulfilling the requirements of the IEC 62304 standard according to software testing. | | | software, with addition of tests related to new features described in this submission | | | Clinical Tests performed | This section does not apply. No clinical testing was performed | This section does not apply. No clinical testing was performed | Substantial equivalence is claimed to legally marketed device and accessory covered by K113075, the EmbryoViewer software from Unisense FertiliTech A/S. Page 7 of 9 {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for FertiliTech. The logo consists of a stylized graphic to the left of the word "FertiliTech". The graphic is a circular design with a small extension at the top. Page 8 of 9 {8}------------------------------------------------ Image /page/8/Picture/0 description: The image contains the word "FertiliTech" in a sans-serif font. The text is dark gray, and there is a light gray graphic to the left of the word. The graphic appears to be a stylized leaf or plant. The background is white. The addition of the features models and Compare & Select result in a new Indications for Use for the EmbryoViewer software. The update of the EmbryoViewer software has no impact on incubation conditions in the EmbryoScope time-lapse incubator.The new features models and Compare & Select in the EmbryoViewer software does not introduce or require changes to the EmbryoScope timelapse incubator. As the EmbryoViewer software does not control any functions on the EmbryoScope timelapse incubator it can not affect the operation of the EmbryoScope time-lapse incubator. The addition of the features models and Compare & Select to the EmbryoViewer software does not raise new types of safety and effectiveness questions. #### Conclusion The subject device is substantially equivalent to the predicate device. Unisense FertiliTech A/S Tueager 1 DK-8200 Aarhus N Denmark Page 9 of 9 Phone: +45 89 44 95 00 Fax: +45 89 44 95 49 sales@fertilitech.com www.fertilitech.com {9}------------------------------------------------ Image /page/9/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three lines forming its body and head. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 August 8, 2014 Unisense FertiliTech A/S Henrik Wahlgren QA & RA Manager Tueager 1 Aarhus N DK-8200 Denmark Re: K133712 > Trade/Device Name: EmbryoScope time-lapse incubator (Version D) and EmbryoViewer software Regulation Number: 21 CFR§ 884.6120 Regulation Name: Assisted reproduction accessories Regulatory Class: II Product Code: MQG Dated: July 14, 2014 Received: July 17, 2014 Dear Henrik Wahlgren, 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. {10}------------------------------------------------ Page 2 - Henrik Wahlgren You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, # Herbert P. Lerner -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 {11}------------------------------------------------ # Indications for Use 510(k) Number (if known): K133712 Device Name: EmbryoScope time-lapse incubator (Version D) and EmbryoViewer software Indications For Use: The EmbryoScope® time-lapse incubator (version D) provides an environment with controlled temperature, CO2 (and other gasses) 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 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). × Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of Center for Devices and Radiological Health (CDRH) Herbert P. Lerner -S 2014.08.08 13:09:58 -04'00' Page 1 of 1 __________________________________________________________________________________________________________________________________________________________________

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.