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 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.

AI/ML Overview

The provided document describes a 510(k) submission for the EmbryoScope (Version D) and EmbryoViewer software. The purpose of the submission is to add the optional accessory EmbryoViewer software to the existing EmbryoScope (Version D) device.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (the EmbryoScope (Version D) without the EmbryoViewer software). It does not present a study with specific acceptance criteria and reported device performance metrics in the way one might expect for a new diagnostic or AI-driven decision support system. Instead, the "study" is a comparison to the predicate device and validation of the software's functionality.

Therefore, the requested information must be interpreted within the context of software validation and a demonstration of substantial equivalence rather than a traditional performance study against clinical endpoints.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or reported device performance metrics in terms of clinical accuracy, sensitivity, specificity, etc., for the EmbryoViewer software. The "performance" being validated is primarily related to the software's functionality and its non-interference with the predicate device.

Acceptance Criteria (Implied)	Reported Device Performance
Software Functionality:
Fulfills EN 62304 standard (software testing)	Yes, underwent and passed software testing according to EN 62304.
Correctly displays, compares, stores, and transfers images.	Software validation testing has been conducted to verify data transfer.
Correctly handles user annotations for a specific patient/embryo.	Software testing has been conducted to verify correct annotation.
Does not control hardware components of EmbryoScope (Version D).	Verified; "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."
Does not introduce new safety or effectiveness questions.	Concluded: "The addition of the optional EmbryoViewer software to the EmbryoScope (Version D) does not raise new types of safety and effectiveness questions."
Electrical Safety/EMC:
Underwent and passed electrical safety, electromagnetic compatibility, environmental, and operating performance testing, classification according to IEC 60601-1.	Underwent and passed (Inherited from predicate, as the EmbryoViewer doesn't change the hardware).

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

Test Set Sample Size: The document does not specify a quantitative "test set sample size" in terms of number of embryos or images used for software validation. The validation appears to be functional testing.
Data Provenance: Not specified. The document outlines general software testing and validation rather than a clinical study involving patient data.

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

Number of Experts: Not specified.
Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable/not specified. The validation described is software functionality testing, not a clinical study with subjective interpretations requiring adjudication.

5. 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

MRMC Study: No, an MRMC comparative effectiveness study was not described. The EmbryoViewer software is an image display and annotation tool, not an AI-driven diagnostic or decision support system intended to improve human reader performance.

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

Standalone Performance: Not applicable. The EmbryoViewer is an accessory software package for displaying data and enabling user annotation; it does not perform any diagnostic or analytical tasks autonomously.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

Type of Ground Truth: For the software validation, the "ground truth" would be the expected behavior and output of the software based on its design specifications and user inputs. For annotations, the "ground truth" would be the intended user input being correctly recorded and associated. It does not involve "expert consensus, pathology, or outcomes data" in a clinical sense.

8. The Sample Size for the Training Set

Training Set Sample Size: Not applicable. The EmbryoViewer software is not described as involving machine learning or AI that would require a "training set."

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

Ground Truth Establishment for Training Set: Not applicable, as there is no described training set.

Summary Conclusion from the Document:

The K113075 submission for the EmbryoViewer software focuses on demonstrating that this optional accessory solely provides features for displaying and annotating images generated by the predicate EmbryoScope device. The key argument for acceptance (substantial equivalence) is that the software does not control any hardware, does not affect the operation of the main device, and its functions (display, storage, annotation) have been validated through standard software testing (EN 62304) to ensure data integrity and correct functionality. The document explicitly states that the EmbryoViewer "does not perform any diagnostics." Therefore, the validation approach is centered on safety and functional performance rather than clinical efficacy or diagnostic accuracy studies.

Summary

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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:Address:	Unisense FertiliTech A/STueager 1DK-8200 Aarhus NDenmark
Contact person:	Mette Munch, QA Consultant
Telephone Number:Fax Number:E-mail:	+45 89449500+45 89449549mm@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(Version D) andEmbryoViewerTMsoftware	Embryomonitoringsystem	II	884.6120	85 MQG

Indications for Use:

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:

Comparison to Predicate Device:

Table 1: Comparison of EmbryoScope (Version D) and EmbryoViewer™ software to EmbryoScope (Version D) -- K092183 and K111715.

	EmbryoScope (Version D) andEmbryoViewer software	EmbryoScope (Version D)
Indications foruse	The EmbryoScope (VersionD) provides an environmentwith controlledtemperature, CO2 (andother gases) for thedevelopment of embryos.This model has anintegrated invertedmicroscope and imagingsystem for embryo viewing.Device use is limited to fivedays (120 hr) covering thetime from post-fertilizationto day 5 of development.EmbryoViewer is anoptional accessory softwarepackage for use indisplaying, comparing,storing, and transferringEmbryoScope (Version D)generated images. Thesoftware includes a userannotation function forcapturing information onembryo developmentparameters, treatment data,and outcome data. TheEmbryoViewer software	The EmbryoScope (VersionD) provides anenvironment withcontrolled temperature,CO2 (and other gases) forthe development ofembryos. This model hasan integrated invertedmicroscope and imagingsystem for embryo viewing.Device use is limited tofive days (120 hr) coveringthe time from post-fertilization to day 5 ofdevelopment.

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 ofNonClinicalTests performedfor thedetermination ofSubstantialEquivalence	does not control anyhardware components inthe EmbryoScope (VersionD) device.Underwent and passedelectrical safetyelectromagneticcompatibility,environmental andoperating performancetesting. Classificationaccording to IEC 60601-1.The EmbryoViewersoftware is fulfilling therequirements of the EN62304 standard accordingto software testing.	Underwent and passedelectrical safetyelectromagneticcompatibility,environmental andoperating performancetesting. Classificationaccording to IEC 60601-1.
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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:

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

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.