The Eeva System is indicated to provide adjunctive information on events occurring during the first two days of development that may predict further development to the blastocyst stage on Day 5 of development. This adjunctive information aids in the selection of embryo(s) for transfer on Day 3 when, following morphological assessment on Day 3, there are multiple embryos deemed suitable for transfer or freezing. The device may also be used to collect additional time-lapse images until Day 5 of development for embryos not selected for transfer, to allow monitoring of continued embryo development.

Device Description

The Eeva™ System is an Assisted Reproduction Embryo Image Assessment System (21 CFR 884.6195), installed in an IVF lab and used by embryologists and other IVF professionals. None of the System components have an individual, prior 510(k) clearance. Eeva System, Model EVS210 requires the use of the 12-microwell configuration of the Eeva™ Dish (K141663, also referred to as the "dish"), which is placed on the Eeva Scope (an assisted reproductive microscope). The Eeva Scopes are placed in commercially-available standard-sized incubators. The microscope employs high resolution time-lapse imaging to record an embryo's development during its first two days of incubation. Automated measurements of cell division timing parameters and the Eeva Test results are provided to the user after approximately 42 hours predicting the likelihood of whether an embryo will develop to the blastocyst stage. In Eeva System, Model EVS2210, image recording may continue through Day 5 of embryo development.

AI/ML Overview

The Eeva™ System (EVS2210) provides adjunctive information on early embryo development (first two days) to predict progression to the blastocyst stage by Day 5. This information assists in selecting embryos for transfer on Day 3, especially when multiple suitable embryos are identified through morphological assessment.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly list acceptance criteria for specific performance metrics (like sensitivity, specificity, PPV, NPV) with predefined thresholds. However, it states that "simulated clinical testing (mechanical analysis) demonstrates that the Eeva System Model EVS2210 is informative, and the average specificity, sensitivity, positive predictive value, and negative predictive value performance are substantially equivalent in the adjunctive use of the subject and predicate devices." This implies that the performance of the Eeva System (EVS2210) closely matched that of its predicate device, Eeva System (EVS2000).

The "Algorithm Software Validation" and "Simulated Clinical Use" tests aimed to evaluate the ability of the Eeva System software to predict blastocyst formation and its clinical performance, including determination of sensitivity, specificity, positive predictive value, negative predictive value, and odds ratio.

Since the document asserts substantial equivalence, the implied acceptance criteria are that the EVS2210's performance metrics (sensitivity, specificity, PPV, NPV, odds ratio) should be comparable to or not worse than those of the predicate device (EVS2000).

Metric	Acceptance Criteria (Implied, relative to predicate)	Reported Device Performance (Implied)
Blastocyst Prediction	"informative" and "substantially equivalent" to predicate device EVS2000	Met, based on substantial equivalence claim
Sensitivity	"substantially equivalent" to predicate device EVS2000	Met, based on substantial equivalence claim
Specificity	"substantially equivalent" to predicate device EVS2000	Met, based on substantial equivalence claim
Positive Predictive Value	"substantially equivalent" to predicate device EVS2000	Met, based on substantial equivalence claim
Negative Predictive Value	"substantially equivalent" to predicate device EVS2000	Met, based on substantial equivalence claim
Odds Ratio	"substantially equivalent" to predicate device EVS2000	Met, based on substantial equivalence claim

2. Sample size used for the test set and the data provenance

The document mentions "Simulated Clinical Use" for evaluation but does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It refers to "clinical data submitted for the predicate device" as being "representative of expected safety and effectiveness of the Eeva System Model EVS2210," but this doesn't specify if new data was used for the EVS2210's simulated clinical use or if it entirely leveraged the predicate's data.

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

The document does not specify the number or qualifications of experts used to establish the ground truth for the "Simulated Clinical Use" test set.

4. Adjudication method for the test set

The document does not describe any adjudication method used for the test set.

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

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study, nor does it describe an effect size for human reader improvement with or without AI assistance. The device provides "adjunctive information" to aid embryologists, suggesting it's intended for human-in-the-loop use, but a formal MRMC study is not detailed.

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

The "Simulated Clinical Use" is described as evaluating "clinical performance of the Eeva System software including determination of sensitivity, specificity, positive predictive value, negative predictive value, and odds ratio." This suggests a standalone evaluation of the algorithm's performance in predicting blastocyst formation. The device provides "adjunctive information," implying its output is then used by an embryologist. Therefore, a standalone evaluation of the software's predictive capability appears to have been performed.

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

The ground truth used for the "Algorithm Software Validation" and "Simulated Clinical Use" tests was the "blastocyst formation." This is an objective biological outcome (whether an embryo develops to the blastocyst stage by Day 5).

8. The sample size for the training set

The document does not provide information regarding the sample size for the training set used for the Eeva System's algorithm.

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

The document does not provide information on how the ground truth for the training set was established. It only mentions that the device evaluates cell division timing parameters to predict blastocyst formation.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right, with flowing lines beneath them.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 24, 2014

Auxogyn, Inc. Julia Anastas Director, Regulatory Affairs 1490 O'Brien Drive, Suite A Menlo Park, CA 94025

Re: K142147 Trade/Device Name: Eeva™ System (EVS2210) Regulation Number: 21 CFR 884.6195 Regulation Name: Embryo Image Assessment System, Assisted Reproduction Regulatory Class: Class II Product Code: PBH Dated: October 31, 2014 Received: November 3, 2014

Dear Julia Anastas,

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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

{1}------------------------------------------------

the quality systems (OS) 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 contact the Division of Industry and Consumer Education 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. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education 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,

Benjamin R. Fisher -A

Benjamin Fisher Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K142147

Device Name EevaTM System, Model EVS2210

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510(k) Summary - K142147

Submitter:	Auxogyn, Inc.1490 O'Brien Drive, Suite AMenlo Park, CA 94025
Contact Person:	Julia S. AnastasDirector, Regulatory AffairsPhone: 650.763.3875Fax: 650.763.3875Email: janastas@auxogyn.com
Date Summary was Prepared:	November 20, 2014
Trade or Proprietary Name:	Eeva™ System
Model Number:	EVS2210
Common or Usual Name:	Assisted Reproduction Embryo Image Assessment System
Regulation Number:	21 CFR 884.6195
Product Code:	PBH
Device Class:	II
Predicate Device:	Eeva System, Model EVS2000; K120427, DEN120015This predicate has not been subject to a design-related recall

1.0 510(K) SUMMARY, K142147

No reference devices were used in this submission.

1.1 DESCRIPTION OF THE DEVICE

1.2 INDICATIONS FOR USE

The indications for use statement for the Eeva System is:

{4}------------------------------------------------

Image /page/4/Picture/1 description: The image shows the logo for Auxogyn. The logo features a stylized image of cells in shades of orange, pink, and purple, set against a gray circular background. Below the image, the word "auxogyn" is written in a lowercase, sans-serif font.

510(k) Summary — K142147

to collect additional time-lapse images until Day 5 of development for embryos not selected for transfer to allow monitoring of continued embryo development.

This statement is identical to that of the predicate device, with the addition of a new feature to collect additional time-lapse images to allow monitoring of continued embryo development up to Day 5 of development. This new device feature is a convenience for the user but does not alter or add to the intended use of the device.

The subject and predicate devices have intended use, which is to obtain and analyze light microscopy images, and provide information to aid in the selection of embryos(s) for transfer when there are multiple embryos deemed suitable for transfer or freezing.

SUMMARY OF TECHNOLOGICAL CHARACTERISTICS COMPARISON 1.3

The table below compares the subject and predicate device with respect to principles of operation, technological characteristics, and testing performed.

	Predicate DeviceEeva SystemModel EVS2000	Subject DeviceEeva SystemModel EVS2210
Principles of Operation /Conditions of Use	Assisted reproductive microscopeplaced in a standard (3rd party)incubator that captures time-lapseembryo images, and automaticallyevaluates cell division timingparameters to predict whether anembryo has a "High"/"Low"probability to reach the blastocyststageResults after ~42 hours (500images)Prescription use only device usedby embryologists and othertrained IVF professionals in an IVFlaboratory.	Same
Technological Characteristics
Design Features	Imaging system mounted in astandard (3rd party) incubatorallows recording of imageswithout opening incubator doorFully automated dish detectionand embryo focusing	Same
	Predicate DeviceEeva SystemModel EVS2000	Subject DeviceEeva SystemModel EVS2210
	Time-lapse dark field imaging insingle focal plane at 5 minuteintervals for up to 3 days	Same but with imaging availablefor up to 5 days
	Low-power red LED (625 nm)illumination provides observationof key morphology features	Same
Hardware Design andMaterials	Standard computer, touchscreenmonitors, electronics and optics;industry standard materials suchas metals and plastics	Same types of hardware andmaterials, with some specificcomponent changes
	Underwent and passed electricalsafety and electromagneticcompatibility performancetesting in compliance with BS EN60601-1: 2006 + A11:2011 andIEC 60601-1-2:2007	Underwent and passed electricalsafety and electromagneticcompatibility performancetesting in compliance with BS EN60601-1: 2006 + A11:2011 andIEC 60601-1-2:2007
Key SoftwareFunctionality	User Interface: Scopes, Patients,Administrative and Service Tabs,Dish and Microwell Screens	Same tabs and screens with minormodifications
	User Interface: Storage of up to200 sessions	Same storage with addition ofcapability to backup 2000 sessionsto external USB drive and torestore backed-up sessions to theEeva System
	Four reports: BlastocystPrediction Report, Image Report,Patient Report, UtilizationReport	Same reports, with formatting andnomenclature changes (e.g.,Blastocyst Predication Report nownamed Results Report) and imagetiming changes.
	System shut down required toreplace scopes	Service interface improvementsincluding ability to replacescopes without System shutdown
Embryo Image Analysis	Embryo isolation from 25-microwell configuration EevaDish	Embryo isolation from 12-microwell configuration Eeva Dish
Predicate DeviceEeva SystemModel EVS2000	Subject DeviceEeva SystemModel EVS2210
Feature extraction using celltracking and event inference	Two new processes have beencombined with cell tracking forevent inference
Blastocyst prediction model	Same

Table 1. Comparison of Technological Characteristics

{5}------------------------------------------------

Image /page/5/Picture/1 description: The image shows the logo for Auxogyn. The logo features a circular design with overlapping shapes in orange, pink, and red, surrounded by a gray ring. Below the logo, the word "auxogyn" is written in gray lowercase letters.

510(k) Summary – K142147

Table 1. Comparison of Technological Characteristics

{6}------------------------------------------------

Image /page/6/Picture/1 description: The image shows the logo for Auxogyn. The logo features a circular design with overlapping shapes in shades of orange, red, and purple. Below the logo, the word "auxogyn" is written in a simple, sans-serif font.

Table 1. Comparison of Technological Characteristics

Conclusions of Summary of Technological Comparison to Predicate Device 1.3.1

The key device technology changes that have been implemented in the Eeva System, Model EVS2210 do not raise new questions of safety or effectiveness because:

. The increase of the maximum imaging duration to 1440 embryo images (5 days) from 864 embryo images (3 days) raises the same questions of safety and as the predicate device, and has been appropriately evaluated using the same methods used previously,
Changes in specific hardware components do not introduce questions of safety and effectiveness beyond those already addressed through compliance to BS EN 60601-1: 2006 + A11:2011 and IEC 60601-1-2:2007.
. The addition of backup and restore capabilities, User Interface enhancements, and changes to Test Report formatting have no impact on the Eeva Test or the calculation of the results.
The changes to the Embryo Image Analysis software to process images from the 12-● microwell Eeva Dish and the addition of two new feature extraction processes raise the same questions of safety and effectiveness as the predicate device, and have been appropriately evaluated using the same methods used to evaluate the predicate. Further, The Eeva System, Model EVS2210 does not introduce any changes to the blastocyst prediction model or to the meaning of "High" and "Low" test results.

PERFORMANCE DATA 1.4

The following performance data were provided in support of the substantial equivalence determination, and include the same testing performed for the predicate device and required by the special controls for Assisted Reproduction Embryo Image Assessment Systems.

1.4.1 Biocompatibility/Materials

Eeva System materials do not come in direct or indirect contact with the patient during use. Therefore, biocompatibility testing of device materials was not necessary to assess device safety.

{7}------------------------------------------------

Image /page/7/Picture/1 description: The image shows the logo for Auxogyn. The logo features a circular design with three overlapping circles in different colors: orange, red, and purple. The circles are arranged in a way that creates a sense of depth and movement. The word "auxogyn" is written in lowercase letters below the circular design.

510(k) Summary — K142147

1.4.2 Shelf Life/Sterility

The Eeva System is a non-sterile device. Therefore, sterilization information was not necessary to assess device safety. The device does not have a stated shelf life, which, based upon the nature of the device components, is acceptable.

1.4.3 Software

Software verification and validation testing were conducted and documentation was provided as recommended for a moderate level of concern device, as outlined in FDA's Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005).

The testing conducted to validate device software is described in Section 1.4.4, Non-Clinical/Bench Studies.

1.4.4 Non-Clinical/Bench Studies

In addition to the testing described above, the sponsor conducted a series of non-clinical performance testing to demonstrate that the Eeva System would perform as anticipated, or in some instances leveraged testing performed on the predicate device as there had been no design or technological change. Testing is summarized in Table 2, below.

Test	Purpose and Reference (as applicable)
Embryotoxicity Assessment
Mouse EmbryoAssay (MEA)	To evaluate whether the Eeva System offers appropriate conditions within the incubator forembryo culture.
Cleaning and Disinfection
Cleaning	To evaluate the reprocessing procedures for the Eeva System (microscope, cable, stopper) toensure it can be properly cleaned by manual methods (reference AAMI TIR12: 2010 & AAMITIR30:2011).
Disinfection	To evaluate the reprocessing procedures to ensure they are adequate to properly disinfect theEeva System (microscope, cable, stopper) (reference AAMI TIR12: 2010 & AAMI TIR30:2011).
Media Spill	To evaluate the process for cleaning the Eeva Scope in case of a media spill and to ensure it issealed from any ingress of fluid that would impact functionality.
Package Integrity and Transit Testing
Eeva System	To evaluate if the Eeva System palletized shipping configuration can withstand simulatedtransit per ASTM D 4169-09.
EMC and Electrical Safety Testing
EMC Testing	To evaluate whether the Eeva System meets the EMC requirements of IEC 60601-1-2:2007.
Electrical SafetyTesting	To evaluate whether the Eeva System meets the product safety requirements of BS EN 60601-1: 2006 + A11:2011.
Simulated Use

	Table 2. Summary of Non-Clinical/Bench Studies
--	------------------------------------------------	--	--	--	--

{8}------------------------------------------------

Image /page/8/Picture/1 description: The image shows the logo for Auxogyn. The logo features a circular design with four overlapping shapes in different colors: orange, pink, and red. The word "auxogyn" is written in gray lowercase letters below the circular design. The logo is simple and modern, with a focus on the company's name.

510(k) Summary – K142147

InstallationVerification	To verify that the Eeva System can be installed and functionality verified in less than 8 hours.
System Usability	To verify that the Instructions for Use can be understood by the user and that the results ofeach action are stated in the IFU.
Simulated Use	To verify the Eeva System successfully operates in a real time simulated use procedures, and toverify that intermittent incubator door opening does not negatively impact imaging andembryo prediction.
Performance Testing - Bench
Hardware
Light Exposure andOutput	To document the amount of light exposure from the Eeva microscope compared to atraditional IVF microscope.The additive light exposure from the Eeva System to the overall light exposure expected duringstandard assisted reproductive microscopy should not result in excessive added illumination ofembryos during five days of imaging.
Hardware Controls	To verify that the hardware controls in the Eeva System properly limit the microscope lampLED, alignment LED and LCD, camera and motor, and turn them off if the limits are exceeded.
Microscope, ScopeScreen, ComputerHardware,UninterruptablePower Supply, andPrinter	To verify various microscope, incubator interface, scope screen, computer storage, accessoryparameters and interactions.
Software
Eeva SystemSoftwareVerification	To verify integrated system operation and various camera, workflow and Eeva Stationcomponent requirements.
Software Fail-SafeVerification	To verify safety related parameters for the LED, LCD, Camera and Motor, as well as variousworkflow and Eeva Station component requirements of the configuration, microscope userinterface, focus motor, LCD display and Eeva Station software components.
Algorithm SoftwareValidation	To validate the ability of the Eeva System software to predict blastocyst formation.
Algorithm SoftwareVerification	To verify the Eeva System image analysis
AlgorithmReproducibility	To evaluate the reproducibility of the Eeva System algorithm software.
Simulated ClinicalUse	To evaluate clinical performance of the Eeva System software including determination ofsensitivity, specificity, positive predictive value, negative predictive value, and odds ratio.

Table 2. Summary of Non-Clinical/Bench Studies

1.4.5 Performance Testing – Animal

In vivo animal studies were not conducted in support of the Eeva System, nor deemed necessary to support the safety and effectiveness of the Eeva System.

{9}------------------------------------------------

Image /page/9/Picture/1 description: The image features the logo for Auxogyn. The logo consists of a gray circle surrounding three overlapping circles in orange, red, and purple. Below the logo, the word "auxogyn" is written in a lowercase sans-serif font.

510(k) Summary - K142147

1.4.6 Clinical Studies

No new clinical testing was performed for the subject device. Clinical data submitted for the predicate device is representative of expected safety and effectiveness of the Eeva System Model EVS2210.

SUBSTANTIAL EQUIVALENCE CONCLUSION 1.5

Auxogyn's analyses show that the Intended Use, principles of operation, and conditions of use are identical for the subject and predicate devices, and that changes in technical characteristics do not raise different questions of safety and effectiveness. The Indications for Use statement has been updated to include a new feature allowing collection of additional time-lapse images until Day 5 of development for embryos not selected for transfer, to allow monitoring of continued embryo development. The scientific methods for evaluating the Eeva System's technological characteristics are the same as those used to evaluate the predicate, and completed testing meets the requisite special controls. The results of the testing performed provide evidence that the Eeva System Model EVS2210 meets device specifications and that the System performance is similar to the predicate device. Finally, simulated clinical testing (mechanical analysis) demonstrates that the Eeva System Model EVS2210 is informative, and the average specificity, sensitivity, positive predictive value, and negative predictive value performance are substantially equivalent in the adjunctive use of the subject and predicate devices. Based upon this analysis, Auxogyn asserts that the Eeva System Model EVS2000 and Eeva System Model EVS2210 are substantially equivalent.

Regulation Number and Section

§ 884.6195 Assisted Reproduction Embryo Image Assessment System.

(a)
Identification. An Assisted Reproduction Embryo Image Assessment System is a prescription device that is designed to obtain and analyze light microscopy images of developing embryos. This device provides information to aid in the selection of embryo(s) for transfer when there are multiple embryos deemed suitable for transfer or freezing.(b)
Classification. Class II (special controls). The special control(s) for this device are:(1) Clinical performance testing must demonstrate a reasonable assurance of safety and effectiveness of the device to predict embryo development. Classification performance (sensitivity and specificity) and predictive accuracy (Positive Predictive Value and Negative Predictive Value) must be assessed at the subject and embryo levels.
(2) Software validation, verification, and hazard analysis must be provided.
(3) Non-clinical performance testing data must demonstrate the performance characteristics of the device. Testing must include the following:
(i) Total light exposure and output testing;
(ii) A safety analysis must be performed based on maximum (worst-case) light exposure to embryos, which also includes the safety of the light wavelength(s) emitted by the device;
(iii) Simulated-use testing;
(iv) Mouse Embryo Assay testing to assess whether device operation impacts growth and development of mouse embryos to the blastocyst stage;
(v) Cleaning and disinfection validation of reusable components;
(vi) Package integrity and transit testing;
(vii) Hardware fail-safe validation;
(viii) Electrical equipment safety and electromagnetic compatibility testing; and
(ix) Prediction algorithm reproducibility.
(4) Labeling must include the following:
(i) A detailed summary of clinical performance testing, including any adverse events;
(ii) Specific instructions, warnings, precautions, and training needed for safe use of the device
(iii) Appropriate electromagnetic compatibility information;
(iv) Validated methods and instructions for cleaning and disinfection of reusable components; and
(v) Information identifying compatible cultureware and explain how they are used with the device.