K Number
K113075
Device Name
EMBRYO VIEWER SOFTWARE
Date Cleared
2011-12-21

(65 days)

Product Code
Regulation Number
884.6120
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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 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.
More Information

Not Found

No
The summary describes a time-lapse microscopy system for embryo incubation and an accessory software for viewing and annotating images. There is no mention of AI, ML, or any algorithms that perform automated analysis or interpretation of the images beyond simple display and user annotation. The performance studies focus on electrical safety, software validation, and data transfer, not on the performance of any analytical algorithms.

No.
The device is described as an embryo incubator that provides an environment for the development of embryos and performs timelapse microscopy for viewing. It does not state that it is used to diagnose, cure, mitigate, treat, or prevent disease, or affect the structure or function of the body.

No

The "EmbryoScope (Version D)" is an incubator with an integrated imaging system for observing embryo development. The "EmbryoViewer" software is an accessory that displays and stores images and user annotations; the text explicitly states, "The EmbryoViewer™ software does not perform any diagnostics." The device and software are for observation and data management, not for diagnosing a disease or condition.

No

The 510(k) summary describes the EmbryoScope (Version D) as an embryo incubator with integrated hardware (microscope and imaging system). While the EmbryoViewer software is an accessory, the submission covers the EmbryoScope device which is clearly not software-only.

Based on the provided information, the EmbryoScope (Version D) and the EmbryoViewer software are not described as IVDs (In Vitro Diagnostics).

Here's why:

  • Intended Use: The intended use focuses on providing a controlled environment for embryo development and imaging. It does not mention analyzing biological samples or providing diagnostic information about a patient's condition.
  • Device Description: The description emphasizes the incubator function, timelapse microscopy, and data logging. The EmbryoViewer software is explicitly stated as not performing any diagnostics.
  • Lack of Diagnostic Claims: There are no claims about diagnosing, monitoring, or predicting any disease or condition based on the data generated or displayed.
  • Performance Studies: The performance studies focus on electrical safety, electromagnetic compatibility, environmental performance, operating performance, and software validation (data transfer and annotation). There are no studies related to diagnostic accuracy (sensitivity, specificity, etc.).

While the device is used in the context of assisted reproductive technology, which involves biological samples (embryos), its described function is primarily related to maintaining and observing the embryos, not performing a diagnostic test on them.

Therefore, based solely on the provided text, the EmbryoScope (Version D) and EmbryoViewer software do not meet the typical definition of an In Vitro Diagnostic device.

N/A

Intended Use / 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.

Product codes (comma separated list FDA assigned to the subject device)

85 MQG

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 ViewerTM software does not perform any diagnostics, but only shows data from the EmbryoScopeTM (Version D) and data filled in by the user. The EmbryoViewerTM software assists the user by allowing for inspection of high resolution time-lapse images of embryo development, detailed annotation tools and inspection of EmbryoScopeTM (version D) running conditions.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Microscopy (time-lapse)

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

EmbryoViewer software is fulfilling the requirements of the EN 62304 standard according to software testing.
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.
Also, software testing has been conducted to verify correct annotation for a specific patient/embryo.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K092183, K111715

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 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.

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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/S
Tueager 1
DK-8200 Aarhus N
Denmark |
|---------------------------------------------|----------------------------------------------------------------------|
| Contact person: | Mette Munch, QA Consultant |
| Telephone Number:
Fax Number:
E-mail: | +45 89449500
+45 89449549
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 nameCommon nameClassCFR ReferenceProcode
EmbryoScope
(Version D) and
EmbryoViewerTM
softwareEmbryo
monitoring
systemII884.612085 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

1

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
EmbryoViewer software | EmbryoScope (Version D) |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 | 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. |

Phone: +45 89 44 95 00 Fax: +45 89 44 95 49 sales@fertilitech.com www.fertilitech.com

2

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
NonClinical
Tests performed
for the
determination of
Substantial
Equivalence | does not control any
hardware components in
the EmbryoScope (Version
D) device.
Underwent and passed
electrical safety
electromagnetic
compatibility,
environmental and
operating performance
testing. Classification
according to IEC 60601-1.
The EmbryoViewer
software is fulfilling the
requirements of the EN
62304 standard according
to software testing. | Underwent and passed
electrical safety
electromagnetic
compatibility,
environmental and
operating performance
testing. Classification
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

3

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

4

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 (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

5

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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