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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the EmbryoScope™ (Version D) and EmbryoSlide™ devices, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The documents describe the EmbryoScope™ (Version D) as an IVF incubator and the EmbryoSlide™ (FT-S-ES-D) as an IVF incubator accessory. The acceptance criteria primarily revolve around demonstrating substantial equivalence to predicate devices. This means the new devices perform as safely and effectively as existing legally marketed devices.

The "acceptance criteria" are not explicitly stated in numerical thresholds but are implied by the comparison to predicate devices and the clinical testing outcome. The "reported device performance" is the statement of equivalence and the finding of comparable outcomes.

Acceptance Criteria (Implied)	Reported Device Performance
EmbryoScope™ (Version D) - Functionality and Safety equivalent to predicate incubator (COOK Mini-Incubator K983642)	Underwent and passed electrical safety, electromagnetic compatibility, environmental, and operating performance testing. Classification according to IEC 60601-1.
EmbryoScope™ (Version D) - Image acquisition feature (integrated inverted microscope) safe for embryos and comparable to conventional microscopy.	Light intensity is comparable to conventional light microscopes used in IVF clinics, indicating safety for embryos. Embryo disturbance minimized as slides remain in the controlled incubation environment during microscopy.
EmbryoScope™ (Version D) - Oxygen control function in line with existing technology.	The concept of controlling Oxygen levels (3-20%) is not new and comparable to devices like the Forma Scientific Incubator (K991408).
EmbryoScope™ (Version D) - Maintains humidity and reduces contamination risk.	Uses an oil overlay and a dedicated slide lid to avoid increased humidity, thereby reducing contamination risk (different from predicate).
EmbryoScope™ (Version D) - Overall safety and effectiveness equivalent to predicate, despite design differences (e.g., integrated microscope).	"The differences between the EmbryoScope™ ~ (Version D)... and the Predicate Devices do not alter the safety and effectiveness of the device."
EmbryoScope™ (Version D) - Clinical performance (ongoing pregnancy rates) comparable to standard incubators.	"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."
EmbryoSlide™ (FT-S-ES-D) - Functionality, safety/sterility, and embryotoxicity equivalent to predicate labware (Nunc IVF 4-Well Dish K070047).	Sterile (SAL 10-6), tested non-pyrogenic by LAL, and passed 1-cell mouse embryo test (MEA). Made of polystyrene, optically clear.
EmbryoSlide™ (FT-S-ES-D) - Embryo survival rate comparable to predicate, despite design differences (e.g., number of wells).	"The embryo survival rate is shown to be comparable to the Predicate Device."
EmbryoSlide™ (FT-S-ES-D) - Overall safety and effectiveness equivalent to predicate, despite design differences (e.g., number of wells).	"The differences between the ... EmbryoSlide™ and the Predicate Devices do not alter the safety and effectiveness of the device." "EmbryoSlide™ are similar, with respect to the FDA published predicate device description."

2. Sample Size Used for the Test Set and Data Provenance

The document mentions "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)."

Sample Size for Test Set: The exact sample size for the clinical study is not specified in the provided text.
Data Provenance: The provenance (country of origin, retrospective/prospective) is not specified. It refers to "Clinical data," implying a human clinical study. Given the company's address in Denmark, it's possible the study was conducted there or in another European country. The context of a 510(k) submission to the FDA suggests the data must meet FDA's requirements for demonstrating safety and effectiveness.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document does not specify the number of experts used to establish ground truth or their qualifications for the clinical study. The "ground truth" for the clinical study appears to be the "rates of ongoing pregnancies," which would typically be determined by medical professionals in an IVF setting.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method for the clinical study results. It simply states the finding of "no significant difference" in ongoing pregnancy rates.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

MRMC Study: No, an MRMC comparative effectiveness study was not performed or described in the provided text.
Effect Size (Human Readers with/without AI): Not applicable, as this device (EmbryoScope) is an incubator and imaging system, not an AI-assisted diagnostic tool that aids human readers in interpretation. The "imaging system" is for embryo viewing, not AI-driven analysis for human interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Standalone Performance: Not applicable in the context of the primary function of these devices. The EmbryoScope™ is an incubator with an integrated imaging system for embryo viewing, and the EmbryoSlide™ is an accessory. There isn't an "algorithm" performing a diagnostic or interpretive function in a standalone capacity described in the documentation. The device's performance relates to maintaining a suitable environment for embryo development and enabling imaging, not making automated diagnoses.

7. The Type of Ground Truth Used

For the clinical study of the EmbryoScope™ (Version D), the type of ground truth used was outcomes data, specifically "rates of ongoing pregnancies."

For the EmbryoSlide™ (FT-S-ES-D), the ground truth for its biological compatibility was established through:

Sterility testing (SAL 10-6)
Non-pyrogenic testing by Limulus Amebocyte Lysate (LAL)
Non-embryotoxic testing by the 1-cell mouse embryo assay (MEA)
"Embryo survival rate" comparable to the predicate device.

8. The Sample Size for the Training Set

The document does not mention or imply any training set, as these devices are not described as employing machine learning or AI models that would require a dedicated training set. The "testing" referred to is for device performance, safety, and clinical outcomes.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as no training set is described for these devices.

Summary

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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 IDK-8200 Aarhus NDenmark
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	CFRReference	Procode
EmbryoScopeTM(Version D)	IVF Incubator	Assistedreproductionaccessories	II	884.6120	85 MQG
EmbryoSlideTM(FT-S-ES-D)	IVF incubatoraccessory	Assistedreproductionlabware	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:

Unisense FertiliTech A/S Tueager 1 DK-8200 Aarhus N Denmark

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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-IncubatorK983642
Indication for use	To provide an environmentwith controlled temperature,CO2 (and other gases) for thedevelopment of embryos.This model has an integratedinverted microscope andimaging system for embryoviewing. Device use is limitedto three days (72 hr) coveringthe time from post-fertilization to day 3 ofdevelopment.	The COOK Mini-Incubator isintended to be used to storeand preserve gametes and/orembryos at or near bodytemperature.
Discussion of Non-ClinicalTests performed forDetermination of SubstantialEquivalence	Underwent and passedelectrical safetyelectromagneticcompatibility, environmentaland operating performancetesting. Classificationaccording to IEC 60601-1	Subjected to electrical safety,electromagneticcompatibility acceptabilityand operating performance.The incubator passed allthese tests.

Table 1: Comparison of EmbryoScope™ - (Version D) to COOK Mini-Incubator -K983642

Unisense FertiliTech A/S Tueager I DK-8200 Aarhus N Denmark

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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 DishK070047
Indication for use	Preparing, storing, andtransferring humanembryos. To be used onlywith the EmbryoScopedevice.	In vitro fertilizationtechniques, cell culture.
Contraindication	N/A	N/A
Patient / embryo contactmaterial	Polystyrene surface	Polystyrene surface
Design features	The slide is optimisedoptically clear. The lidand slide have a markingwhich requires that the lidalways has the sameorientation; thus crosscontamination can beminimized. The lid can behandled by one handwhile other lab equipmentcan be handled by theother hand. The wells arenumbered.	The bottom of the plate isoptimised flat and opticallyclear. The lid and platehave a cut off corner whichrequires that the lid alwayshas the same orientation;thus cross contaminationcan be minimized. The lidcan be handled by one handwhile other lab equipmentcan be handled by the otherhand. The plates can bestacked.
Safety features	N/A	N/A
Other relevantcharacteristics	Sterile (SAL 10-6)• Tested non-pyrogenic byLAL• Passed 1-cellmouse embryo	Sterile (SAL 10-6)• Tested non-pyrogenic by LAL• Passed 1-cellmouse 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

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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

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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

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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/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

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Indications for Use Form

JAN 1 1 2011

510(k) Number (if known): _ K092183

EmbryoScope™ - (Version D) Device Name:

Indications for Use:

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

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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

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.