The EmbryoScope+ incubator provides an environment with controlled temperature and gas concentrations (CO2 and O2) for the development of embryos at or near body temperature. Use of the EmbryoScope+ incubator is limited to five days (120 hr) covering the time from post insemination to day five of development.

The EmbryoSlide+ culture dish is intended for preparing, storing, and transferring human embryos. The EmbryoSlide+ culture dish must be used together with the EmbryoScope+ incubator.

The Embryo Viewer software is intended for displaying, storing, and transferring images generated by the EmbryoScope+ incubator. This software includes a user annotation for capturing information on embryo development parameters as well as a user-defined modeling function, which allows the user to combine annotated information on embryo development parameters to aid in embryo Viewer software does not control any hardware components in the EmbryoScope+ incubator.

The ES Server software is intended to store, archive and transfer data. In addition, this software includes functions for managing models and performing calculations based on image data and embryo development parameters.

The EmbryoScope+ incubator, EmbryoViewer software, and ES Server software must be used together to export embryo images from the EmbryoScope+ incubator. The EmbryoViewer software must be used together to analyze the embryo images.

Device Description

EmbryoScope+ consists of the following devices: EmbryoScope+ incubator, EmbryoSlide+ culture dish, EmbryoViewer software, and ES Server software.

The EmbryoScope+ incubator is a bench top embryo incubator with a time-lapse imaging function. It provides temperature control, and time-lapse microscopy at multiple focal planes. This device can hold up to 15 culture dishes (EmbryoSlide+ culture dish) in the incubation chamber. The culture dishes are placed on the dish holder in the EmbryoScope+ incubator. The holder provides direct heat transfer to the EmbryoSlide+ culture dish. The built-in microscope consists of an LED illumination unit and an inverted microscope/camera unit. During image acquisition, each culture dish located on the culture dish holder is rotated to the microscopy system and individual image stacks are acquired from all individual embryos in each culture dish.

The EmbryoSlide+ culture dish is a radiation-sterilized polystyrene culture dish containing two separate reservoirs. Each reservoir has eight culture well is used to culture one embryo. Therefore, a total of 16 embryos can be cultured on one dish. Each dish includes four special wells that are only used for rinsing and handling the embryos either before or after incubation. An adhesive barcode label printed from the EmbryoViewer software is used to mark each dish. The barcode label contains two different 2D data matrices that provide information on the patient ID, treatment ID, and insemination time). The EmbryoSlide+ culture dish has a sterility assurance level of 10° and a shelf-life of four years. This device is subject to mouse embryo assay (MEA) and endotoxin testing before lot release.

The EmbryoViewer software is used for displaying, comparing, storing, and transferring images generated by the EmbryoScope+ incubator. The data that can be viewed using this software includes embryo images, incubation details, alarms, log files and other instrument parameters. This software also includes a user annotation for capturing information on embryo development parameters as well as a user-defined modeling function, which allows the user to combine annotated information on embryo development parameters to aid in embryo selection. The EmbryoViewer software neither controls any hardware components in the EmbryoScope+ incubator nor performs any diagnostics.

The ES Server software allows users to update and view common data. The server acts as the central unit, which stores data and controls the data flow to and from the connected devices. The server can be connected to multiple EmbryoScope+ incubators and computers with the EmbryoViewer software installed.

AI/ML Overview

The provided text does not contain information about a "study that proves the device meets the acceptance criteria" in the format of a clinical trial or a specific comparative effectiveness study with human readers and AI assistance. Instead, it describes non-clinical performance testing conducted to support the substantial equivalence of the EmbryoScope+ device to its predicate devices.

The acceptance criteria are generally implied by the design specifications and testing standards mentioned.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and the Reported Device Performance

The text doesn't explicitly present a direct "acceptance criteria" vs. "reported performance" table for all aspects. However, it lists performance specifications for the EmbryoScope+ incubator and the results of various non-clinical tests.

Characteristic / Test	Acceptance Criteria (Implied by design specification/standard)	Reported Device Performance
EmbryoScope+ Incubator
Culture dish capacity	N/A (Comparison to predicate)	15 dishes
Temperature range	N/A (Comparison to predicate)	36-39°C
Temperature accuracy	N/A (Comparison to predicate)	+/- 0.2°C
CO₂ accuracy	N/A (Comparison to predicate)	+/- 0.3 %
O₂ accuracy	N/A (Comparison to predicate)	+/- 0.5 %
Recirculation rate	N/A (Comparison to predicate)	>100 L/h (full purification of gas volume every 6 min)
CO₂ recovery (5% ± 0.3 %) after 30s load door open	<5 min	<5 min
O₂ recovery (5% ± 0.5 %) after 30s load door open	<3 min	<3 min
Illumination per image	N/A (Comparison to predicate)	<0.02 seconds
Total light exposure/embryo/day	N/A (Comparison to predicate)	<40 seconds
Total light dose during 5-day incubation (J/m²)	N/A (Comparison to predicate)	65.2
Time-lapse system	10 min cycle time for 11 focal planes for up to 5 days	10 min cycle time for 11 focal planes for up to 5 days
EmbryoSlide+ Culture Dish
Endotoxin testing	≤20 EU/device (per USP <85> and ANSI/AAMI ST72:2002)	Met the specification of ≤20 EU/device
Mouse embryo assay (MEA)	≥80% embryos developed to blastocyst in 96 hours (for 1-cell MEA)	"1-cell MEA ≥80% embryos developed to blastocyst in 96 hours."
General Non-Clinical Testing
Electrical safety	Compliance with IEC 60601-1:2005 + C1:2006 + C2:2007 + A1:2012	Testing conducted
Electromagnetic compatibility	Compliance with EN/IEC 60601-1-2:2007	Testing conducted
Software V&V	Met FDA Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (May 11, 2005)	Testing conducted
Radiation sterilization	Compliance with ISO 11137-2:2013	Testing conducted
Transportation simulation	Met ASTM D4169-16	Testing conducted
Package integrity (Bubble test)	Per ASTM F2096-11	Testing conducted
Package integrity (Peel strength)	Per ASTM F88/F88M-09	Testing conducted
Gas maintenance (levels, flow, recovery)	Met design specifications (described in Section 7)	Met design specifications
Temperature control	Within defined ranges and stable over time	Met design specifications
Time-lapse function (image acquisition, quality, resolution)	Met design specifications	Met design specifications
Light intensity	Lower than predicate device	Shown to be lower than the predicate device

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document describes non-clinical bench testing. For the Mouse Embryo Assay (MEA), the sample size is implicitly "one-cell mouse embryos" without a specific number. The data provenance is not mentioned (e.g., country of origin). The testing seems to be experimental/prospective in nature, rather than retrospective use of human patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The document describes non-clinical performance and engineering testing (electrical safety, EMC, software V&V, bench performance, sterilization, package integrity, endotoxin, mouse embryo assay). These do not involve human experts establishing ground truth for a diagnostic AI system.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as this is non-clinical performance testing, not a clinical study requiring adjudication of expert interpretations.

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

No MRMC comparative effectiveness study is mentioned. The device, EmbryoScope+, includes software (EmbryoViewer) with "user-defined modeling function, which allows the user to combine annotated information on embryo development parameters to aid in embryo selection." However, the text details non-clinical testing for substantial equivalence, not a clinical study on human reader performance with or without AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

While the EmbryoViewer software includes "user-defined modeling function" to "aid in embryo selection," the substantial equivalence argument relies on comparing the entire system (incubator, software, dish) to predicate devices through non-clinical performance metrics. There is no specific mention of a standalone algorithm performance study without human involvement, particularly relating to "embryo selection" capability. The software primarily displays, stores, transfers images, and allows for user annotation and user-defined modeling, implying human-in-the-loop use. It explicitly states, "The EmbryoViewer software neither controls any hardware components in the EmbryoScope+ incubator nor performs any diagnostics."

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the non-clinical tests described:

EmbryoSlide+ Culture Dish (MEA): The "ground truth" for the MEA test was defined by the biological outcome: "percent of embryos developed to the expanded blastocyst stage within 96 hours." This is an objective biological endpoint.
Other non-clinical tests (electrical safety, EMC, metrology, etc.): Ground truth is established by adherence to engineering specifications, recognized standards (e.g., IEC, EN, ASTM, ISO, USP, ANSI/AAMI), and design specifications.

8. The sample size for the training set

Not applicable. The document does not describe a machine learning model that requires a training set in the conventional sense. The "user-defined modeling function" in the EmbryoViewer software suggests that users define their own criteria based on embryo development parameters, rather than the device itself being trained on a large dataset.

9. How the ground truth for the training set was established

Not applicable, as no machine learning training set is described.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and reads "FDA U.S. FOOD & DRUG ADMINISTRATION".

May 11, 2018

Vitrolife A/S Belinda Dueholm Regulatory Affairs Specialist Jens Juuls Vej 20 DK-8260 Viby J Denmark

Re: K173264

Trade/Device Name: EmbryoScope+ Regulation Number: 21 CFR§ 884.6120 Regulation Name: Assisted Reproduction Accessories Regulatory Class: II Product Code: MOG, MOK, MTX Dated: April 6, 2018 Received: April 12, 2018

Dear Belinda Dueholm:

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.

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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 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.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Charles Viviano -S

For Benjamin R. Fisher, Ph.D. Director 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) K173264

Device Name EmbryoScope+

Indications for Use (Describe)

EmbryoScope+ consists of the following devices with the following indications for use:

The EmbryoSlide+ culture dish is intended for preparing, storing, and transferring human embryos. The EmbryoSlide+ culture dish must be used together with the EmbryoScope+ incubator.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary (K173264)

1. Submitter Information

Submitter	Vitrolife A/SJens Juuls Vej 20DK-8260 Viby JDenmark
Contact Person:Telephone:	Ms. Belinda Dueholm+45 7221 7900 (main)+45 2076 3707 (direct)
2. Date Prepared:	May 11, 2018
3. Device Information
Proprietary Name:Common Name:Regulation Number:	EmbryoScope+Embryo Incubator21 CFR 884.6120
Regulation Name:Product Code:	Assisted Reproduction AccessoriesMQG (Accessory, Assisted Reproduction), MQK (Labware, AssistedReproduction), MTX (Microscope and Microscope Accessories,Reproduction, Assisted)
Regulatory Class	II

4. Predicate devices

EmbryoScope time-lapse incubator (K133712) manufactured by Unisense FertiliTech A/S and EmbryoSlide culture dish (K150961) manufactured by Vitrolife A/S. These predicate devices have not been subject to any design related recalls.

5. Device Description

EmbryoScope+ consists of the following devices: EmbryoScope+ incubator, EmbryoSlide+ culture dish, EmbryoViewer software, and ES Server software.

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6. Indications for Use

EmbryoScope+ consists of the following devices with the following indications for use:

The EmbryoSlide+ culture dish is intended for preparing, and transferring human embryos. The EmbryoSlide+ culture dish must be used together with the EmbryoScope+ incubator.

The EmbryoViewer software is intended for displaying, storing, and transferring images generated by the EmbryoScope+ incubator. This software includes a user annotation function for capturing information on embryo development parameters as well as a user-defined modeling function, which allows the user to combine annotated information on embryo development parameters to aid in embryo selection. The EmbryoViewer software does not control any hardware components in the EmbryoScope+ incubator.

The EmbryoScope+ incubator, EmbryoViewer software, and ES Server software must be used together to export embryo images from the EmbryoScope+ incubator. The EmbryoViewer software and ES Server software must be used together to analyze the embryo images.

7. Comparison of Intended Use and Technological Characteristics of the Subject and Predicate Devices

Intended Use

Devices	Subject device (K173264)	Predicate device (K133712)	Predicate device (K150961)
Indicationsfor Use	EmbryoScope+ consists of the following deviceswith the following indications for use:The EmbryoScope+ incubator provides anenvironment with controlled temperature and gasconcentrations (CO2 and O2) for the developmentof embryos at or near body temperature. Use of theEmbryoScope+ incubator is limited to five days(120 hr) covering the time from post inseminationto day five of development.The EmbryoSlide+ culture dish is intended forpreparing, storing, and transferring human	The EmbryoScope (Version D)provides an environment withcontrolled temperature, CO2 (andother gases) for the developmentof embryos. This model has anintegrated inverted microscopeand imaging system for embryoviewing. Device use is limited tofive days (120 hr) covering thetime from post-fertilization to day5 of development.The EmbryoViewer software isan optional accessory software	The EmbryoSlideculture dish isintended forpreparing, storing,and transferringhuman embryos. Itis intended to beused only with theEmbryoScopedevice.

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embryos. The EmbryoSlide+ culture dish must beused together with the EmbryoScope+ incubator.The EmbryoViewer software is intended fordisplaying, comparing, storing, and transferringimages generated by the EmbryoScope+incubator. This software includes a user annotationfunction for capturing information on embryodevelopment parameters as well as a user-definedmodeling function, which allows the user tocombine annotated information on embryodevelopment parameters to aid in embryoselection. The EmbryoViewer software does notcontrol any hardware components in theEmbryoScope+ incubator.The ES Server software is intended to store,archive and transfer data. In addition, this softwareincludes functions for managing models andperforming calculations based on image data andembryo development parameters.The EmbryoScope+ incubator, EmbryoViewersoftware, and ES Server software must be usedtogether to export embryo images from theEmbryoScope+ incubator. The EmbryoViewersoftware and ES Server software must be usedtogether to analyze the embryo images.	package for use in displaying,comparing, storing, andtransferring images generated bythe EmbryoScope time-lapseincubator (Version D). Thesoftware includes a userannotation function for capturinginformation on embryodevelopment parameters as wellas a user-defined modelingfunction, which allows the user tocombine annotated informationon embryo developmentparameters to aid in embryoselection. The EmbryoViewersoftware does not control anyhardware components in theEmbryoScope time-lapseincubator (Version D).
Substantial equivalence discussion:

embryos. The EmbryoSlide+ culture dish must beused together with the EmbryoScope+ incubator.The EmbryoViewer software is intended fordisplaying, comparing, storing, and transferringimages generated by the EmbryoScope+incubator. This software includes a user annotationfunction for capturing information on embryodevelopment parameters as well as a user-definedmodeling function, which allows the user tocombine annotated information on embryodevelopment parameters to aid in embryoselection. The EmbryoViewer software does notcontrol any hardware components in theEmbryoScope+ incubator.The ES Server software is intended to store,archive and transfer data. In addition, this softwareincludes functions for managing models andperforming calculations based on image data andembryo development parameters.The EmbryoScope+ incubator, EmbryoViewersoftware, and ES Server software must be usedtogether to export embryo images from theEmbryoScope+ incubator. The EmbryoViewersoftware and ES Server software must be usedtogether to analyze the embryo images.

package for use in displaying,comparing, storing, andtransferring images generated bythe EmbryoScope time-lapseincubator (Version D). Thesoftware includes a userannotation function for capturinginformation on embryodevelopment parameters as wellas a user-defined modelingfunction, which allows the user tocombine annotated informationon embryo developmentparameters to aid in embryoselection. The EmbryoViewersoftware does not control anyhardware components in theEmbryoScope time-lapseincubator (Version D).

Substantial equivalence discussion:

Both subject and predicate devices are intended for culturing embryos, handling embryo data, annotating embryos, and analyzing embryo parameters to aid in embryo selection using user-defined modeling function. Therefore, the subject and predicate devices have the same intended uses.

Technological Characteristics

EmbryoScope+ incubator, EmbryoViewer software, and ES Server software
Devices	Subject device (K173264)	Predicate device (K133712)
EmbryoScope+ incubator
Culture dish capacity	15 dishes	6 dishes
Heating mechanism	Same as the predicate	Direct heat transfer
Temperature range	36-39°C	30-45°C
Temperature accuracy	+/- 0.2°C	+/- 0.1°C
CO2 accuracy	+/- 0.3 %	+/- 0.2 %
O2 accuracy	+/- 0.5 %	+/- 0.3 %
Recirculation rate	>100 L/h (full purification of gasvolume every 6 min)	>60 L/h (full purification of gas volume every 20min)
Recovery times when the loaddoor is closed after a 30-secondload door opening	CO2 (5% ± 0.3 %) <5 minO2 (5% ± 0.5 %) <3 min	CO2 (5% ± 0.3 %) <5 minO2 (5% ± 0.5 %) <15 min
Control of temperature and gas	Same as the predicate	Firmware
Computer	Same as the predicate	Integrated
Microscope	Same as the predicate	Inverted microscope
Type of camera	Monochrome CMOS	Monochrome CCD
Magnification	16x	20x
Focusing	Same as the predicate	Fully automated dish detection and embryofocusing
Numerical aperture	0.5	0.4
Number of pixels	2048 × 1088 pixels	1280 × 1024 pixels
Number of pixels in storedimages	800 × 800 pixels	500 × 500 pixels
Resolution	Same as the predicate	3 pixels per um

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Maximum number of images	7920	5040
Light source (for imaging)	Low-power red LED 627 nm	Low-power red LED 635 nm
Illumination per image	<0.02 seconds	< 0.1 seconds
Total light exposure/embryo/day	<40 seconds	<50 seconds
Total light dose during a 5-day(120 hours) incubation (J/m2)	65.2	67.2
Time-lapse system	Time-lapse imaging (HoffmanModulation Contrast Objective).10 Min cycle time for 11 focalplanes for up to 5 days	Time-lapse imaging (Hoffman Modulationcontrast objective). 10 min cycle time for amaximum of 7 focal planes. 2 min cycle time for amaximum of 1 focal plane for up to 5 days
EmbryoViewer software/ES Server software
Image display	Same as the predicate	High-resolution time-lapse images of singleembryos
Data handling	Same as the predicate	Export, storage and transfer of embryo data
Embryo annotation and dataanalysis	Same as the predicate	· Embryo annotation tools which assist the userin selecting embryos· Model designer· Model management· Data analysis using user-defined modelingfunction
Incubation condition monitoring	Same as the predicate	Inspection of incubation details, such astemperature and gas conditions

Substantial equivalence discussion:

EmbryoScope+ incubator

The subject incubator is an updated version of the predicate device. The new device has the same fundamental design and comparable design specifications. The subject device has a narrower temperature range, and slightly decreased temperature, CO2, and O2 control accuracies. Regarding gas flow rate and recovery rate, the subject device has the same or improved performance specifications. The subject device has increased embryo culture capacity.

The subject and predicate devices have similar microscopy systems; however, the subject device has improved image quality specifications. Also, they use comparable light sources and the subject device allows for reduced light exposure. Therefore, the image quality and photobiological safety of the subject and predicate devices are technologically comparable.

The differences between the subject and predicate devices do not raise different questions of safety and effectiveness.

EmbryoViewer software

The subject EmbryoViewer software represents an updated version of the predicate device and maintains most functions of the predicate device. The subject device is different from the predicate device in that it cannot export data from the incubator and perform data calculations. However, these functions are possessed by ES Server software that must work together with the EmbryoViewer software. Thus, the difference does not raise different questions of safety and effectiveness.

ES Server software

Unlike the predicate device, the subject device replaces some functions of the EmbryoViewer software, such as data handling and calculations. However, all functions of the predicate EmbryoViewer software remain when the subject EmbryoViewer software and ES Server software work together. The ES Server software also has new functions, including model management, remote access and wireless connection. However, these new functions do not raise different questions of safety and effectiveness and are seen in medical device software.

EmbryoSlide+ culture dish
Device	Subject device (K173264)	Predicate device (K150961)
General design	Same as the predicate	Optically clear culture dish with a lid
Culture wells on the dish	16 wells for individual embryoincubation	12 wells for individual embryo incubation
Rinsing wells in the dish	4 wells	2 wells
Material	Same as the predicate	Polystyrene PS K158
Substantial equivalence discussion:

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Both subject and predicate devices are customized embryo culture dishes. They have the same fundamental design and are manufactured with the same material. There is a difference in the number of culture wells; however, these differences do not raise different questions of safety and effectiveness.

8. Summary of Non-Clinical Performance Testing

The following studies have been conducted on the EmbryoScope+ incubator, EmbryoViewer software, and ES Server software to support substantial equivalence to the predicate device:

Electrical safety testing per IEC 60601-1:2005 (Third Edition) + C1:2006 + C2:2007 + A1:2012 ● (IEC 60601-1:2012 reprint)
Electromagnetic compatibility testing per EN/IEC 60601-1-2:2007 .
. Software verification and validation testing that met the requirements of the FDA Guidance Document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued on May 11, 2005
. Bench performance tests that met design specifications described in Section 7, as follows:
- - Gas maintenance testing to ensure that gas levels, flow rates, and gas recovery rates in chambers meet design specifications
- - Temperature control testing to ensure that culture chamber temperature conditions were within defined ranges and stable over time
- - Time-lapse testing to demonstrate that all design specifications of time-lapse function (image acquisition, quality, and resolution) are met
- - Light intensity testing to determine the maximum light dose embryos will be exposed to during device use, which was shown to be lower than the predicate device.

The following studies have been conducted on the EmbryoSlide+ culture dish to support substantial equivalence to the predicate device:

. Radiation sterilization validation testing per ISO 11137-2:2013
. Transportation simulation testing that met the requirements of ASTM D4169-16
. Package integrity testing after accelerated aging:
- - Bubble test per ASTM F2096-11
- - Peel strength testing ASTM F88/F88M-09
Endotoxin testing per USP <85> and ANSI/AAMI ST72:2002. The testing demonstrated that the . device met the specification of ≤20 EU/device.
. Mouse embryo assay (MEA) before and after accelerated aging:

One-cell mouse embryos were exposed to subject devices and cultured at 37°C in an atmosphere containing 5% CO2. The percent of embryos developed to the expanded blastocyst stage within 96 hours were assessed in comparison with the control group. The testing demonstrated that the device met acceptance criterion of "1-cell MEA ≥80% embryos developed to blastocyst in 96 hours."

In addition, the cleaning and disinfection information provided in cleared K133712 was leveraged in the current submission to support substantial equivalence to the predicate device.

9. Conclusion

The subject and predicate devices have the same intended use and fundamental technological characteristics. The differences in technological characteristics between subject and predicate devices do not raise different questions of safety and effectiveness. The performance data demonstrate that the subject devices are substantially equivalent to the predicate devices.

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.