EMBRYO VIEWER SOFTWARE
Device Facts
| Record ID | K113075 |
|---|---|
| Device Name | EMBRYO VIEWER SOFTWARE |
| Applicant | Unisense Fertilitech A/S |
| Product Code | MQG · Obstetrics/Gynecology |
| Decision Date | Dec 21, 2011 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 884.6120 |
| Device Class | Class 2 |
Indications for Use
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. 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.
Device Story
EmbryoScope (Version D) is an embryo incubator with integrated inverted microscope for time-lapse imaging; logs incubation conditions and captures images of embryos during 5-day development. EmbryoViewer is an optional accessory software for displaying, comparing, storing, and transferring these time-lapse images. Software includes manual annotation tools for embryologists to record development parameters, treatment data, and outcomes. Device used in clinical embryology labs; operated by trained personnel. Software does not control hardware; acts as a viewing and data management platform. Output allows clinicians to inspect high-resolution images and track embryo development, facilitating clinical decision-making regarding embryo selection for transfer.
Clinical Evidence
Bench testing only. Software validation testing conducted to verify data transfer and annotation accuracy. Electrical safety, electromagnetic compatibility, and environmental/operating performance testing performed per IEC 60601-1.
Technological Characteristics
Incubator with integrated inverted microscope for time-lapse imaging. Software: EmbryoViewer accessory for image display and manual annotation. Compliance: IEC 60601-1 (electrical/EMC), EN 62304 (software lifecycle).
Indications for Use
Indicated for embryos in an assisted reproduction environment requiring controlled incubation (temperature, CO2/gases) and time-lapse imaging for up to 120 hours post-fertilization to day 5 of development.
Regulatory Classification
Identification
Assisted reproduction accessories are a group of devices used during assisted reproduction procedures, in conjunction with assisted reproduction needles and/or assisted reproduction catheters, to aspirate, incubate, infuse, and/or maintain temperature. This generic type of device may include:(1) Powered aspiration pumps used to provide low flow, intermittent vacuum for the aspiration of eggs (ova). (2) Syringe pumps (powered or manual) used to activate a syringe to infuse or aspirate small volumes of fluid during assisted reproduction procedures. (3) Collection tube warmers, used to maintain the temperature of egg (oocyte) collection tubes at or near body temperature. A dish/plate/microscope stage warmer is a device used to maintain the temperature of the egg (oocyte) during manipulation. (4) Embryo incubators, used to store and preserve gametes and/or embryos at or near body temperature. (5) Cryopreservation instrumentation and devices, used to contain, freeze, and maintain gametes and/or embryos at an appropriate freezing temperature.
Special Controls
*Classification.* Class II (special controls) (design specifications, labeling requirements, and clinical testing). The device, when it is a simple embryo incubator with only temperature, gas, and humidity control; a syringe pump; a collection tube warmer; a dish/plate/microscope stage warmer; a controlled-rate cryopreservation freezer; or an assisted reproduction laminar flow workstation is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.
Predicate Devices
Submission Summary (Full Text)
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DEC 2 1 2011
Image /page/0/Picture/1 description: The image shows the logo for UNISENSE FERTILITECH. The logo features a stylized graphic of cells or molecules connected by a line, positioned above the company name. The text "UNISENSE" is in a bold, sans-serif font, with a circled "R" indicating a registered trademark. Below "UNISENSE" is the word "FERTILITECH", also in a bold, sans-serif font.
## K113075
## 510(k) Summary - EmbryoScope (Version D) and EmbryoViewer software
## Administrative information:
| Name:<br>Address: | Unisense FertiliTech A/S<br>Tueager 1<br>DK-8200 Aarhus N<br>Denmark |
|---------------------------------------------|----------------------------------------------------------------------|
| Contact person: | Mette Munch, QA Consultant |
| Telephone Number:<br>Fax Number:<br>E-mail: | +45 89449500<br>+45 89449549<br>mm@unisense.com |
| Date of summary: | 19-Dec-2011 |
Propose of submission: The propose of this submission is to add the optional accessory EmbryoViewer software.
Device name :
| Trade name | Common name | Class | CFR Reference | Procode |
|--------------------------------------------------------------|--------------------------------|-------|---------------|---------|
| EmbryoScope<br>(Version D) and<br>EmbryoViewerTM<br>software | Embryo<br>monitoring<br>system | II | 884.6120 | 85 MQG |
## Indications for Use:
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.
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.
Phone: +45 89 44 95 00 Fax: +45 89 44 95 49 sales@fertilitech.com www.fertilitech.com
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Image /page/1/Picture/0 description: The image shows a logo for a company called UNISENSE FERTILITECH. The logo features the company name in bold, uppercase letters, with the word "UNISENSE" appearing above the word "FERTILITECH". To the top of the company name is a graphic of three circles, with a line going through one of the circles. The "R" symbol is to the right of the word UNISENSE.
## Device Description:
The EmbryoScope 1M - (Version D) is an embryo incubator, which performs timelapse microscopy at multiple planes and logging of incubation conditions on individual embryos during their development. The EmbryoScope (Version D) included in this submission is identical to that cleared in previous 510(k) submissions (K092183 and K111715).
The EmbryoViewer software is an accessory to the EmbryoScope (Version D). The Embryo Viewer™ software does not perform any diagnostics, but only shows data from the EmbryoScope™ (Version D) and data filled in by the user. The EmbryoViewer™ software assists the user by allowing for inspection of high resolution time-lapse images of embryo development, detailed annotation tools and inspection of EmbryoScope™ (version D) running conditions.
### Comparison to Predicate Device:
Table 1: Comparison of EmbryoScope (Version D) and EmbryoViewer™ software to EmbryoScope (Version D) -- K092183 and K111715.
| | EmbryoScope (Version D) and<br>EmbryoViewer software | EmbryoScope (Version D) |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for<br>use | The EmbryoScope (Version<br>D) provides an environment<br>with controlled<br>temperature, CO2 (and<br>other gases) for the<br>development of embryos.<br>This model has an<br>integrated inverted<br>microscope and imaging<br>system for embryo viewing.<br>Device use is limited to five<br>days (120 hr) covering the<br>time from post-fertilization<br>to day 5 of development.<br><br>EmbryoViewer is an<br>optional accessory software<br>package for use in<br>displaying, comparing,<br>storing, and transferring<br>EmbryoScope (Version D)<br>generated images. The<br>software includes a user<br>annotation function for<br>capturing information on<br>embryo development<br>parameters, treatment data,<br>and outcome data. The<br>EmbryoViewer software | The EmbryoScope (Version<br>D) provides an<br>environment with<br>controlled temperature,<br>CO2 (and other gases) for<br>the development of<br>embryos. This model has<br>an integrated inverted<br>microscope and imaging<br>system for embryo viewing.<br>Device use is limited to<br>five days (120 hr) covering<br>the time from post-<br>fertilization to day 5 of<br>development. |
Phone: +45 89 44 95 00 Fax: +45 89 44 95 49 sales@fertilitech.com www.fertilitech.com
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Image /page/2/Picture/0 description: The image shows the logo for UNISENSE FERTILITECH. The logo consists of the words "UNISENSE" and "FERTILITECH" stacked on top of each other. Above the words is a graphic of three circles connected together with a line going through them. The logo is in black and white.
| Discussion of<br>NonClinical<br>Tests performed<br>for the<br>determination of<br>Substantial<br>Equivalence | does not control any<br>hardware components in<br>the EmbryoScope (Version<br>D) device.<br>Underwent and passed<br>electrical safety<br>electromagnetic<br>compatibility,<br>environmental and<br>operating performance<br>testing. Classification<br>according to IEC 60601-1.<br>The EmbryoViewer<br>software is fulfilling the<br>requirements of the EN<br>62304 standard according<br>to software testing. | Underwent and passed<br>electrical safety<br>electromagnetic<br>compatibility,<br>environmental and<br>operating performance<br>testing. Classification<br>according to IEC 60601-1. |
|--------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|--------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
Summary of comparison to predicate device:
The current submission includes addition of the optional EmbryoViewer to be used with the predicate device The EmbryoScope (Version D). This extension results in a new Indication for Use reflection the addition of annotation tool.
The EmbryoViewer software does not introduce changes to the EmbryoScope (Version D) thus the components in this device are identical in the predicate device.
As the EmbryoViewer software does not control any functions on the EmbryoScope (Version D) device it can not affect the operation of the EmbryoScope (Version D) device.
The purpose of the EmbryoViewer software is to view images generated by the EmbryoScope (version D), and software validation testing has been conducted to verify data transfer.
The annotation functions of the device do not raise any concerns because the information inputted by the physician is the same that would typically be collected by an embryologist and maintained on paper patient records. Also, software testing has been conducted to verify correct annotation for a specific patient/embryo.
In the event of a software malfunction, there will be no affect on the EmbryoScope device.
Conclusion: The addition of the optional EmbryoViewer software to the EmbryoScope (Version D) does not raise new types of safety and effectiveness questions.
Phone: +45 89 44 95 00 Fax: +45 89 44 95 49 sales@fertilitech.com www.fertilitech.com
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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter of the circle. Inside the circle is a stylized image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
DEC 2 1 2011
Mette Munch, Ph.D. QA Consultant Unisense FertiliTech A/S Tueager 1 DK-8200 AARHUS N DENMARK
Re: K113075
Trade/Device Name: EmbryoScope (Version D) and EmbryoViewer Software Regulation Number: 21 CFR\$ 884.6120 Regulation Name: Assisted reproduction accessories Regulatory Class: II Product Code: MQG Dated: October 14, 2011 Received: October 24, 2011
Dear Dr. Munch:
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. 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
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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/ReportaProblem/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,
Hubert Lemmer MD
Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
#### Enclosure
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# Indications for Use
510(k) Number (if known):
Device Name: EmbryoScope (Version D) and EmbryoViewer software
Indications For Use:
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.
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.
X Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Tom Whing
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