EMBRYOSCOPE

K111715 · Unisense Fertilitech A/S · MQG · Aug 11, 2011 · Obstetrics/Gynecology

Device Facts

• Record ID: K111715
• Device Name: EMBRYOSCOPE
• Applicant: Unisense Fertilitech A/S
• Product Code: MQG · Obstetrics/Gynecology
• Decision Date: Aug 11, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.6120
• Device Class: Class 2

Intended Use

To provide 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.

Device Story

EmbryoScope™ (Version D) is an IVF incubator providing controlled temperature and gas environment for embryo development. Device features integrated inverted microscope and imaging system for time-lapse microscopy at multiple planes. System performs unattended measurements and logs incubation conditions for up to 72 individual embryos housed in six sterile disposable EmbryoSlides™ (12 embryos each). Red light source used for imaging. Separate processing units manage incubation environment and data acquisition. Clinicians use the system to monitor embryo development; output allows observation of development stages without removing embryos from the controlled environment. Extended incubation duration (up to 120 hours) supports monitoring from post-fertilization through day 5 of development, potentially benefiting patient outcomes by maintaining stable culture conditions.

Clinical Evidence

Clinical data compared 5-day incubation (120 hours) to 3-day incubation (72 hours). Results showed no significant difference in ongoing pregnancy rates between the two groups. No adverse effects related to image acquisition were observed.

Technological Characteristics

Embryo incubator with integrated inverted microscope and red light source. Capacity for 72 embryos in 6 EmbryoSlides™. Controlled temperature and gas (CO2) environment. Electrical safety and EMC compliance per IEC 60601-1. Software-controlled data acquisition and incubation environment management.

Indications for Use

Indicated for the incubation of embryos in an environment with controlled temperature and gas composition (CO2) for up to 5 days (120 hours) post-fertilization. Intended for use in assisted reproduction settings.

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

• EmbryoScope™ (Version D) (K092183)

Submission Summary (Full Text)

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AUG 1 1 2011

Image /page/0/Picture/1 description: The image contains the logo for UNISENSE FERTILITECH, which is written in bold, capitalized letters. Above the company name is a graphic of three circles connected together with a line going through them. To the right of the logo is the text "pg 1 of 2" in handwritten font. The image appears to be a document or page from a larger set of materials.

## 510(k) Summary - K111715

Administrative information:

| Name: | Unisense FertiliTech A/S | |
|-------------------|------------------------------------------|--|
| Address: | Tueager 1<br>DK-8200 Aarhus N<br>Denmark | |
| Contact person: | Mette Munch, QA Consultant | |
| Telephone Number: | [phone] | |
| Fax Number: | [phone] | |
| E-mail: | [e-mail] | |
| Date of summary: | 24-July-2011 | |

Propose of submission: Change in Indication for Use to allow device use for up to 5 days (120 hr) of culture. Device design has not been changed from the device cleared under K092183.

Device name:

| Trade name | Common name | Device | Class | CFR Reference | Procode |
|-----------------------------|---------------|-----------------------------------------|-------|---------------|---------|
| EmbryoScope™<br>(Version D) | IVF Incubator | Assisted<br>reproduction<br>accessories | II | 884.6120 | 85 MQG |

EmbryoScope™ - (Version D):

Indication for Use: To provide 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.

Device Description:

The EmbryoScope™ - (Version D) is an embryo incubator, which performs a series of unattended measurements including time-lapse microscopy at multiple planes and logging of incubation conditions on individual embryos during their development. The device has a build-in microscope within a red light source. Separate processing units control the incubation environment and the data acquisition to ensure safe and reliable operation. The Device allows incubation of up to 72 individual embryos in six sterile disposable EmbryoSlides™ each with capacity for 12 embryos.

Phone: [phone] Fax: [phone] [e-mail] www.fertilitech.com

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Image /page/1/Picture/0 description: The image shows a logo for UNISENSE FERTILITECH with a graphic of three circles connected by lines above the text. To the right of the logo are handwritten notes that say K111715 and pg. 2 of 2. The text UNISENSE FERTILITECH is in bold, with UNISENSE on top and FERTILITECH on the bottom.

Table 1: Comparison of EmbryoScope™ - (Version D) K 092183 to Embry - (Version D) K 111715:

| | EmbryoScope™<br>(Version D)<br>K092183 | EmbryoScope™<br>(Version D)<br>K111715 |
|--------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for use | To provide an environment<br>with controlled temperature,<br>CO2 (and other gases) for the<br>development of embryos.<br>This model has an integrated<br>inverted microscope and<br>imaging system for embryo<br>viewing. Device use is limited<br>to three days (72 hr) covering<br>the time from post-<br>fertilization to day 3 of<br>development. | To provide an environment<br>with controlled temperature,<br>CO2 (and other gases) for the<br>development of embryos.<br>This model has an integrated<br>inverted microscope and<br>imaging system for embryo<br>viewing. Device use is<br>limited to five days (120 hr)<br>covering the time from post-<br>fertilization to day 5 of<br>development. |
| Discussion of Non-Clinical<br>Tests performed for<br>Determination of Substantial<br>Equivalence | Underwent and passed<br>electrical safety<br>electromagnetic<br>compatibility, environmental<br>and operating performance<br>testing. Classification<br>according to IEC 60601-1 | Underwent and passed<br>electrical safety<br>electromagnetic<br>compatibility, environmental<br>and operating performance<br>testing. Classification<br>according to IEC 60601-1 |

Summary: The differences between the EmbryoScope™ - (Version D) used for 5 days incubation do not alter the safety and effectiveness of the device. The EmbryoScope™ - (Version D) is similar, with respect to the FDA published predicate device description.

## Clinical Testing:

Clinical data showed that the EmbryoScope™ - (Version D) performs according to the intended use of the device. No significant difference was found between the rates of ongoing pregnancies in the EmbryoScope™ -- (Version D) with 5 days of incubation compared to three days of incubation. No adverse effects of image acquisition were observed.

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Image /page/2/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. Inside the circle is an image of an eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Dr. Mette Munch QA Consultant Unisense FertiliTech A/S Tueager l DK-8200 AARHUS N DENMARK

AUG 1 1 2011

Re: K111715

Trade/Device Name: EmbryoScope™ - (Version D) Regulation Number: 21 CFR§ 884.6120 Regulation Name: Assisted reproduction accessories Regulatory Class: II Product Code: MQG Dated: June 15, 2011 Received: June 20, 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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## Page 2

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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

http://www.fda.gov/MedicalDevices/ResourceforYou/Industry/default.htm.

Sincerely vours,

Hubert Lenoir 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):

EmbryoScope™ - (Version D) Device Name:

Indications For Use:

To provide an environment with controlled temperature, CO2 (and other gases) for the development of embryos. This model has an 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.

ਮ 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)

Aonath

Page 1 of

(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K111715