Who is the manufacturer of EMBRYOSCOPE AND EMBRYOSLIDE?

Unisense Fertilitech A/S filed the 510(k) submission for EMBRYOSCOPE AND EMBRYOSLIDE (K092183).

What is the FDA product code for EMBRYOSCOPE AND EMBRYOSLIDE?

MQG. It is classified under 21 CFR 884.6120 as a Class 2 device in the Obstetrics/Gynecology panel.

What is the regulatory pathway for EMBRYOSCOPE AND EMBRYOSLIDE?

510(k) clearance (submission type: Traditional).

What are the predicate devices for EMBRYOSCOPE AND EMBRYOSLIDE?

COOK Mini-Incubator (K983642); Nunc IVF 4-Well Dish (K070047).

Who can help prepare an FDA 510(k) submission like EMBRYOSCOPE AND EMBRYOSLIDE?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

EMBRYOSCOPE AND EMBRYOSLIDE

K092183 · Unisense Fertilitech A/S · MQG · Jan 11, 2011 · Obstetrics/Gynecology

Device Facts

Record ID	K092183
Device Name	EMBRYOSCOPE AND EMBRYOSLIDE
Applicant	Unisense Fertilitech A/S
Product Code	MQG · Obstetrics/Gynecology
Decision Date	Jan 11, 2011
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 884.6120
Device Class	Class 2
Attributes	Real-World Evidence

Real-World Evidence

Submission	Device	Sponsor	RWD Sources	RWE Use Summary	Key Tags
K092183 · Jan 11, 2011	EMBRYOSCOPE AND EMBRYOSLIDE	Unisense Fertilitech A/S	Clinical IVF clinic data	Clinical data was used to demonstrate that the EmbryoScope performs according to its intended use by comparing ongoing pregnancy rates between the device and standard incubators.	IVF; Pregnancy rates; Clinical performance

Clinical Evidence

Study Design	Population	Comparator	Key Endpoints
Comparative clinical assessment	Patients undergoing IVF procedures	Standard incubator	Ongoing pregnancy rates

Indications 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 three days (72 hr) covering the time from post-fertilization to day 3 of development.

Device Story

EmbryoScope (Version D) is an IVF incubator providing controlled temperature and gas (CO2/O2) environment for embryo development. Device features integrated inverted microscope and imaging system for time-lapse microscopy at multiple planes. Operates with sterile disposable EmbryoSlides (12-well capacity, 72 embryos total). Used in IVF clinics by embryologists. Device performs unattended measurements and logs incubation conditions. Integrated imaging allows viewing of embryo development without removing slides from the controlled environment, minimizing disturbance. Output consists of time-lapse images and incubation data, enabling monitoring of embryo development. Benefits include stable incubation environment and reduced embryo handling/disturbance compared to conventional incubators.

Clinical Evidence

Clinical data compared EmbryoScope (Version D) to standard incubators. Results showed no significant difference in ongoing pregnancy rates. No adverse effects from image acquisition were observed. Bench testing included electrical safety (IEC 60601-1), electromagnetic compatibility, and environmental/operating performance testing. EmbryoSlides passed LAL (non-pyrogenic), cytotoxicity, and mouse embryo assay (MEA) testing.

Technological Characteristics

Incubator with direct heating, integrated inverted microscope, and gas control (CO2/O2). EmbryoSlides made of polystyrene, E-beam sterilized (SAL 10^-6), tested per ISO 11137. Connectivity includes data logging of incubation conditions. Software controls incubation environment and data acquisition. Dimensions/form factor: 6-slide capacity (72 embryos).

Indications for Use

Indicated for the incubation of human embryos from post-fertilization to day 3 of development (72 hours) in an environment with controlled temperature and gas composition.

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

COOK Mini-Incubator (K983642)
Nunc IVF 4-Well Dish (K070047)

Reference Devices

MidAtlantic Diagnostics, Inc. Custom products IVF Workstation (K991216)
Forma Scientific Incubator (K991408)

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for UNISENSE FERTILITECH. The logo consists of the words "UNISENSE" and "FERTILITECH" stacked on top of each other, with the trademark symbol to the right of "UNISENSE". Above the words is a graphic of what appears to be a cell with a needle inserted into it. ## 510(k) Summary JAN 1 1 2011 Administrative information: | Name: | Unisense FertiliTech A/S | |-------------------|------------------------------------------| | Address: | Tueager I DK-8200 Aarhus N Denmark | | Contact person: | Mette Munch, QA Manager | | Telephone Number: | +45 89449500 | | Fax Number: | +45 89449549 | | E-mail: | mm@unisense.com | | Date of summary: | 05-January-2011 | #### Device name: | Trade name | Common name | Device | Class | CFR Reference | Procode | |------------------------------|----------------------------|-----------------------------------------|-------|------------------|---------| | EmbryoScopeTM (Version D) | IVF Incubator | Assisted reproduction accessories | II | 884.6120 | 85 MQG | | EmbryoSlideTM (FT-S-ES-D) | IVF incubator accessory | Assisted reproduction labware | II | 884.6160 | 85 MQK | # 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 three days (72 hr) covering the time from post-fertilization to day 3 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. Unisense FertiliTech A/S Tueager 1 DK-8200 Aarhus N Denmark {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows the logo for UNISENSE FERTILITECH. The logo consists of the words "UNISENSE" in large, bold letters, with a registered trademark symbol to the right of the word. Below this is the word "FERTILITECH" in a smaller, bold font. Above the words is a graphic of two circles connected together, with a line going through them. EmbryoSlide™ (FT-S-ES-D): Indication for Use: Preparing, storing, and transferring human embryos. To be used only with the EmbryoScope device. Device Description: The EmbryoSlide™ (FT-S-ES-D) is designed to fit the EmbryoScope™ – (Version D) incubator arm in order to control temperature. The EmbryoSlides are made of polystyrene, E-beam sterilized (SAL of 106) and tested according to the ISO 11137 standard and relevant bioassays are performed. The slides are tested non-pyrogenic by Limulus Amebocyte Lysate (LAL), have passed the cytotoxicity test and are nonembryotoxic as tested by the mouse embryo assay (MEA). #### Comparison to Predicate Device: The Cook Mini-Incubator is the device identified by Unisense FertiliTech A/S for the substantial equivalence comparison .This is based on the fact that both incubators use direct heating which is considered as an important parameter according to intended use. | | EmbryoScope™ (Version D) | COOK Mini-Incubator K983642 | |--------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------| | 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 three days (72 hr) covering the time from post- fertilization to day 3 of development. | The COOK Mini-Incubator is intended to be used to store and preserve gametes and/or embryos at or near body temperature. | | Discussion of Non-Clinical Tests performed for Determination of Substantial Equivalence | Underwent and passed electrical safety electromagnetic compatibility, environmental and operating performance testing. Classification according to IEC 60601-1 | Subjected to electrical safety, electromagnetic compatibility acceptability and operating performance. The incubator passed all these tests. | Table 1: Comparison of EmbryoScope™ - (Version D) to COOK Mini-Incubator -K983642 Unisense FertiliTech A/S Tueager I DK-8200 Aarhus N Denmark {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the logo for UNISENSE FERTILITECH. The logo consists of a graphic element above the text. The graphic element appears to be a stylized representation of cells or biological structures with a line extending from the top right. Below the graphic is the word "UNISENSE" in bold, followed by the registered trademark symbol. Underneath "UNISENSE" is the word "FERTILITECH," also in bold. | | EmbryoSlide™ | Nunc IVF 4-Well Dish K070047 | |--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indication for use | Preparing, storing, and transferring human embryos. To be used only with the EmbryoScope device. | In vitro fertilization techniques, cell culture. | | Contraindication | N/A | N/A | | Patient / embryo contact material | Polystyrene surface | Polystyrene surface | | Design features | The slide is optimised optically clear. The lid and slide have a marking which requires that the lid always has the same orientation; thus cross contamination can be minimized. The lid can be handled by one hand while other lab equipment can be handled by the other hand. The wells are numbered. | The bottom of the plate is optimised flat and optically clear. The lid and plate have a cut off corner which requires that the lid always has the same orientation; thus cross contamination can be minimized. The lid can be handled by one hand while other lab equipment can be handled by the other hand. The plates can be stacked. | | Safety features | N/A | N/A | | Other relevant characteristics | Sterile (SAL 10-6) • Tested non- pyrogenic by LAL • Passed 1-cell mouse embryo | Sterile (SAL 10-6) • Tested non- pyrogenic by LAL • Passed 1-cell mouse embryo test (MEA) | Table 2: Comparison of EmbryoSlide™ to Nunc IVF 4-well Dish. #### Summary of comparison to predicate devices: The EmbryoScope™ - (Version D) and the COOK Mini-Incubator incubator are both incubators controlling the environment according to primarily gas and temperature. The devices enhance safety by continuously monitoring the critical functions. Both incubators use direct heating of the culture dish. This principle is shown to be very effective in order to control the temperature as "the direct heat transfer culture incubator has superior temperature maintenance compared to a large volume air convection incubator" in: Cooke et al., "Objective Assessments of Temperature Maintenance Using In Vitro Culture techniques". 2002, Journal of Assisted Reproduction and Genetics, Vol 19, p. 368-375. The EmbryoScope™ - (version D) has a build in microscope. This feature is not an option in the predicate device but the light intensity is compared to conventional light microscopes used in the IVF clinic and the data shows that it is comparable and thus safe for the embryos and in addition the embryo disturbance is minimized as the EmbryoSlides stay in the controlled incubation environment during microscopy. The Unisense FertiliTech A/S Tueager I DK-8200 Aarhus N Denmark {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for UNISENSE FERTILITECH. The logo consists of a graphic of three circles connected together with a line going through them. Below the graphic, the words "UNISENSE" and "FERTILITECH" are written in bold, stacked on top of each other. The logo appears to be for a company in the fertility technology industry. concept with a build-in microscope is not new but an option in workstations as " Custom products IVF Workstation" from MidAtlantic Diagnostics, Inc - K991216. It should also be noted that microscopes for use in general assisted reproductive procedures are classified as Class I exempt products under 21 CFR 884.6190. Assisted Reproductive Microscopes and Microscope Accessories). In the EmbryoScope™ - (Version D) the oxygen range (3-20%) can be controlled. The concept of controlling Oxygen levels in incubators is not new. Ex.: The Forma Scientific Incubator - K991408) allows for the direct control of oxygen levels (2-20%). By using an oil overlay and a dedicated slide lid increased humidity is avoided in the EmbryoScope™ – (Version D) thus reducing the contamination risk. This is different from the Predicate Device. The EmbryoSlides™ and the Nunc IVF 4-Well Dish have similar applications, which include cell culturing and IVF. Both devices are sterile (SAL of 106), non-pyrogenic, and non-embryotoxic. They are made of the same material, polystyrene and are similar in configuration, with each well having optically clear surface. The design as such is different as each EmbryoSlide "" has 12 wells and other well dimensions, but the embryo survival rate is shown to be comparable to the Predicate Device. Summary: The differences between the EmbryoScope™ ~ (Version D), EmbryoSlide™ and the Predicate Devices do not alter the safety and effectiveness of the device. The EmbryoScope™ - (Version D) and related accessory the EmbryoSlide "" are similar, with respect to the FDA published predicate device description. #### Clinical Testing: Clinical data showed that the EmbryoScope TM - (Version D) performs according to the intended use of the device. No significant difference was found between the rates of ongoing pregnancies in a standard incubator and the EmbryoScope™ - (Version D). No adverse effects of image acquisition were observed. Unisense FertiliTech A/S Tueager 1 DK-8200 Aarhus N Denmark {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three tail feathers, representing the three levels of government: federal, state, and local. The eagle is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement. The seal is black and white. Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002 Ms. Mette Munch QA Manager Unisense FertiliTech A/S Brendstrupgaardsvej 21F DK-8200 Aarhus N DENMARK Re: K092183 Trade Name: EmbryoScope™ (Version D) EmbryoSlide™ Regulation Number: 21 CFR §884.6120 Regulation Name: Assisted reproduction accessories Regulatory Class: II Product Code: MOG, MOK, MTX Dated: January 5, 2011 Received: January 7, 2011 JAN 1 1 2011 Dear Ms. 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 {5}------------------------------------------------ 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/Resourcesfor You/Industry/default.htm. Sincerely yours, Hubert H. Humphrey 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 {6}------------------------------------------------ # Indications for Use Form JAN 1 1 2011 510(k) Number (if known): _ K092183 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 integrated inverted microscope and imaging system for embryo viewing. Device use is limited to three days (72 hr) covering the time from post-fertilization to day 3 of development. Prescription Use _____________________________________________________________________________________________________________________________________________________________ Prescription Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Division Sign-Off Office of to Vitro Diagnostic Device Evaluation and Safety 510AK) Norma M. White (Division Sign Off) Division of Reproductive, Gastro-Renal, and Urological Devices 510(k) Number K092183 Page 1 of {7}------------------------------------------------ # Indications for Use Form JAN 1 1 2011 510(k) Number (if known): _ K092183 EmbryoSlide™ Device Name: _ Indications for Use: Preparing, storing, and transferring human embryos. To be used only with the EmbryoScope device. Prescription Use _____________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) (Division Sign-Off) Division of Reproductive, Gastro-Renal, and Urological Devices 510(k) Number K092183 Page 1 of

EMBRYOSCOPE AND EMBRYOSLIDE

Device Facts

Real-World Evidence

Clinical Evidence

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Special Controls

Predicate Devices

Reference Devices

Submission Summary (Full Text)

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EMBRYOSCOPE AND EMBRYOSLIDE

Device Facts

Real-World Evidence

Clinical Evidence

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

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Special Controls

Predicate Devices

Reference Devices

Submission Summary (Full Text)

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