The Welch Allyn RetinaVue Network is a web-based software system application intended for use in storing, managing, and displaying patient data, diagnostic data, and images from computerized diagnostic instruments. Original and enhanced images can be viewed by trained healthcare professionals.

Device Description

The RetinaVue Network software enables providers to transfer eye images.

Transfer images via the Client or Customer portal to the database for storage and/or to the Over-read (Physician) Portal for interpretation.
Allow for the enhancement and interpretation of images and report generation at the Over-read (Physician) Portal.
Transfer reports from the Over-read (Physician) Portal to the Customer Portal for download.

AI/ML Overview

The provided document is a 510(k) summary for the Welch Allyn RetinaVue Network. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving a device's performance against detailed acceptance criteria through a clinical study for a new intended use.

Specifically, the document states:

"PERFORMANCE DATA: RetinaVue Network is a software-only device and was designed and tested within the framework as defined by ISO 14971:2007 Medical devices - application of risk management to medical devices, FDA Guidance dated October 2, 2014 Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, FDA Guidance dated January 11, 2002 General Principles of Software Validation and IEC 62304:2006 Medical device software - software life cycle processes. Usability engineering/human factors testing and was performed in accordance with FDA Guidance dated February 3, 2016 Applying Human Factors and Usability Engineering to Medical Devices and IEC 62366-1:2015-02 incl. Corr. (2016) Application of Usability Engineering to Medical Devices. RetinaVue Network is DICOM compliant as stipulated in its DICOM Conformance Statement. Performance testing confirmed that RetinaVue Network performs as intended, supports the indications for use statement, demonstrates that the device is substantially equivalent to the predicate, and does not raise new questions regarding safety and effectiveness."
"CLINICAL PERFORMANCE DATA: None required nor submitted."

This explicitly states that no clinical performance data was required or submitted, and the performance testing conducted was focused on demonstrating substantial equivalence and compliance with relevant standards and guidance documents for a PACS medical image system, not on proving a specific clinical acceptance criteria (like diagnostic accuracy, sensitivity, specificity, etc.) with a test set involving human experts.

Therefore, most of the information requested in your prompt regarding clinical acceptance criteria and related study details (e.g., sample size for test set, expert ground truth, MRMC study, standalone performance, training set details) is not applicable to this 510(k) submission for the Welch Allyn RetinaVue Network.

Here's a breakdown of what can be answered based on the provided document:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: The document primarily focuses on demonstrating substantial equivalence to the predicate device (Zeiss FORUM® FORUM Archive, FORUM Viewer (K122938)) in terms of intended use, technological characteristics, and performance for a PACS medical image system. Specific quantitative clinical performance acceptance criteria (e.g., specific accuracy, sensitivity, or specificity thresholds for disease detection) are not stated or required for this type of device.
Reported Device Performance: The document states that "Performance testing confirmed that RetinaVue Network performs as intended, supports the indications for use statement, demonstrates that the device is substantially equivalent to the predicate, and does not raise new questions regarding safety and effectiveness." This implies the system functions correctly as a PACS for storing, managing, and displaying medical images, including image enhancement features. Specific metrics beyond functional conformity and compliance with standards are not provided.

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

Not applicable as no clinical test set for performance evaluation (e.g., diagnostic accuracy) was required or submitted. The testing referenced is software verification and validation, usability testing, and compliance with standards like DICOM, ISO, and IEC.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable; no clinical ground truth establishment was conducted for a clinical performance study. The "trained healthcare professionals" mentioned in the indications for use are expected to interpret the images.

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

Not applicable.

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, an MRMC study was not done. The device is described as a PACS system, not an AI-assisted diagnostic tool for humans, and explicitly states "CLINICAL PERFORMANCE DATA: None required nor submitted."

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

No, a standalone diagnostic performance analysis was not done. The device is a PACS, displaying images for human review. It is not an algorithm that outputs a diagnostic result on its own.

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

Not applicable for a clinical performance study. For software validation, the "ground truth" would be the expected functional behavior based on specifications and regulatory requirements.

8. The sample size for the training set

Not applicable; this is a PACS system, not a machine learning model that requires a training set for clinical diagnostic performance.

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

Not applicable.

Summary

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July 16, 2018

Welch Allyn, Inc. Megan Pellenz Lead Engineer, Regulatory Affairs 4341 State Street Rd. Skaneateles Falls, NY 13153

Re: K181016

Trade/Device Name: Welch Allyn RetinaVue™ Network REF 901108 PACS Medical Image System Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving and Communications System Regulatory Class: Class II Product Code: NFJ Dated: April 14, 2018 Received: April 17, 2018

Dear Megan Pellenz:

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.

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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 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.

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 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 yours,

Alexander Beylin -S 2018.07.16 15:46:15 -04'00' for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K181016

Device Name Welch Allyn RetinaVue™ Network REF 901108 PACS Medical Image System

Indications for Use (Describe)

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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Traditional 510(k) -Welch Allyn RetinaVue™ Network

510(k) SUMMARY [As required by 21 CFR 807.92]

SUBMITTED BY MANUFACTURER:	Welch Allyn, Inc. 4341 State Street Road Skaneateles Falls, NY 13153 USA
ESTABLISHMENT REGISTRATION NUMBER:	1316463
CONTACT PERSON:	Megan Pellenz Lead Engineer, Regulatory Affairs Phone: 1-315-685-4696 Fax: 1-315-685-2532
DATE PREPARED:	Updated July 3, 2018
DEVICE TRADE NAME:	Welch Allyn RetinaVue™ Network REF 901108 PACS Medical Image System
COMMON NAME:	System, Image Management, Ophthalmic
REGULATION NUMBER:	21 CFR 892.2050
DEVICE CLASS:	II
PRODUCT CODE:	NFJ
PREDICATE DEVICE:	Zeiss FORUM® FORUM Archive, FORUM Viewer (K122938)

DESCRIPTION OF THE DEVICE:

The RetinaVue Network software enables providers to transfer eye images.

1. Transfer images via the Client or Customer portal to the database for storage and/or to the Over-read (Physician) Portal for interpretation.
1. Allow for the enhancement and interpretation of images and report generation at the Over-read (Physician) Portal.

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Transfer reports from the Over-read (Physician) Portal to the Customer Portal for download.

INTENDED USE/INDICATIONS FOR USE:

Prescription only or "For Use by or on the order of a licensed medical professional".

CONTRAINDICATIONS:

There are no known contraindications.

TECHNOLOGICAL CHARACTERISTICS:

RetinaVue Network (RVN) is a web-based software application that works on standard network infrastructure provided by the user. RetinaVue Network consists of these main software items: RVN Client Application, RVN Web Service, RVN Database, Overread Physician Portal and Customer Portal.

RVN Client Application

The RVN Client Application provides the user interface for the Clinician. Its main functions are to obtain and present patient information along with an Eye Image from an Ophthalmic Camera to be submitted to the Overread Physician Portal.

RVN Web Service

The RVN Web Service provides the client application programming interface (API) for the RVN Client application to allow it to maintain its configuration and support taking and submitting images to the Overread Physician Portal.

RVN Database

The RVN Database is a database used to store data common to other RVN software items such as patient demographics, user account management, RVN Client application install inventory and configuration, wireless device inventory and configuration, customer account and clinic information, exam reports and billing information.

Overread Physician Portal

The Overread Physician Portal is an ASP.NET web application that allows physicians to over-read the exam images and to produce a diagnostic report. Functions the overread physician portal supports: ability to overread exams submitted from customers, ability to view enhanced versions of the ophthalmic images submitted to RVN, creation of PDF files of the over-read diagnostic report and ability to view statistical reports about the current user's use of the over-read portal.

Enhanced versions of ophthalmic images are the result of CLAHE - Contrast Limited Adaptive Histogram Equalization algorithms. Enhancement filters for Brightness/Contrast, Sharpen, Saturate and Chromium are available.

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Customer Portal

The Customer Portal is an ASP.NET web application that allows a customer to centrally maintain company and clinic data, user accounts, contacts, referring physicians, patient demographics, exam reports and wireless camera management.

COMPARISON TO THE PREDICATE DEVICE:

It is of the opinion of Welch Allyn, Inc. that RetinaVue Network is substantially equivalent to the predicate device, Zeiss FORUM® FORUM Archive, FORUM Viewer (K122938) as they share similar fundamental technical characteristics, intended use including indications for use, target population and use environment.

Characteristic	Predicate Device	Subject Device	Differences
Device Name	FORUM	RetinaVue Network	N/A
Manufacturer	Carl Zeiss Meditec AG	Welch Allyn, Inc.	N/A
510(k)Number	K122938	K181016	N/A
Product Code	NFJ	NFJ	Same
Device ClassCFR SectionCommon Name	Class II21 CFR 892.2050System, imagemanagement, ophthalmic	Class II21 CFR 892.2050System, imagemanagement, ophthalmic	Same
Indications for Use	FORUM is a softwaresystem intended for use instorage, management,processing, and display ofpatient, diagnostic, videoand image data andmeasurement fromcomputerized diagnosticinstruments ordocumentation systemsthrough networks. It isintended to work with otherFORUM applications.FORUM is intended for usein review of patient,diagnostic and image dataand measurement bytrained healthcareprofessionals.	The Welch AllynRetinaVue Network is aweb-based software systemapplication intended for usein storing, managing, anddisplaying patient data,diagnostic data, and imagesfrom computerizeddiagnostic instruments.Original and enhancedimages can be viewed bytrained healthcareprofessionals.	Similar – We havesimplified thestatement somewhat
Basic Description	FORUM is software formanaging, archiving, andviewing e.g. patient data,images, videos, and reportsprovided by computer-controlled diagnosticdevices or otherdocumentation systems	The Welch AllynRetinaVue Network is asystem for the transmissionof eye images, associatedpatient data, and diagnosticreports from one locationto another via the internet.	Equivalent-bothsoftware systems are fortransmission, storage andviewing of eye images andassociated data
Characteristic	Predicate Device	Subject Device	Differences
Target Population	Images / system is notpatient populationspecific.	Images / system is notpatient population specific	Same
Where Used	Throughout the patientcare process	Throughout the patientcare process	Same
Software Design Features
RVN Client Application
Entering and editingpatient and examinformation	Yes	Yes	Same
Managing applicationbehavior and cameraspecific settings	Will accept all images.	For additional security, oursystem will onlycommunicate with camerasknown to the system. Thisfeature is to register thecamera in the system.	Similar - Additionalcommunications security inour system
Entering and editing contactinformation	No	Yes	Similar - We allowpatient contactinformation to be includedin our patient database
RVN Web Service
Ability to query and reportthe status for submittedexams	Yes	Yes	Same
Maintain patientdemographic information	Yes	Yes	Same
Maintain Contact and Useraccount information	No	Yes	Similar - We allowpatient contactinformation to be includedin our patient database
Maintain last known set ofconfigurations	unknown	Yes	Minor - unable todetermine Zeiss's recoverycapability from thedocumentation available tous from Zeiss
Obtain encryption keys toencrypt data with	unknown	Yes	Minor - unable todetermine Zeiss's from thedocumentation available tous from Zeiss
RVN Database
Patient Demographics	Yes	Yes	Same
User Account Management(user roles)	Yes	Yes	Same
RVN Client applicationinstall inventory andconfiguration	Yes	Yes	K181016	Same
Wireless device inventoryand configuration	No	Yes		Minor – We allow wirelesscommunications
Customer Account andClinic information	No: CustomerAccount Yes:Clinic information	Yes – both		Minor - We store additionalpatient account/contactdata
Exam Reports	Yes	Yes		Same
Billing Information	No	Yes		Minor - We store additionalpatient account/contactdata
Overread Physician Portal
Ability to overread examssubmitted from customers	Yes	Yes		Same
Abilityto view enhancedversions of the ophthalmicimages	Yes	Yes		Same
Creation of PDF files of theover-read diagnostic report	Yes	Yes		Same
Abilityto view statisticalreports about the currentuser's use of the over-readportal	No	Yes		Minor – We providestatistical report to allowclinic to monitor theiractivities (not directed atpatientcare)
Customer Portal
Company and clinic data	Yes	Yes		Same
User accounts	Yes	Yes		Same
Contacts	Yes	Yes		Same
Referring Physicians	Yes	Yes		Same
Patient Demographics	Yes	Yes		Same
Exam Screening reports	Yes	Yes		Same
Wireless cameramanagement	No	Yes		Minor – We allow wirelesscommunications
Technology
EMR Interface	Yes	Yes		Same
HL7	Yes	Yes		Same
Image Enhancement and Measurement
Brightness/Contrast	Yes	Yes		Same
Sharpen	No	Yes		Minor – Filter only appliedduring review. Nativeimage maintained
			K181016
Saturate	No	Yes	Minor - Filter only appliedduring review. Nativeimage maintained
Chromium (greyscale)	No	Yes	Minor - Filter only appliedduring review. Nativeimage maintained
Pan/Zoom	Yes	Yes	Same
Image Measurements	Yes	No	Minor - Predicate offersoption of performingmeasurements of calibratedophthalmic images
Image formats
PDF	Yes	Reports only	Minor - We supply reportimages in .pdf
JPEG	Yes	Yes	Same
TIFF	Yes	Reports only	Minor - We supply reportimages in .tif
DICOM	Yes	Yes	Same

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PERFORMANCE DATA:

RetinaVue Network is a software-only device and was designed and tested within the framework as defined by ISO 14971:2007 Medical devices - application of risk management to medical devices, FDA Guidance dated October 2, 2014 Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, FDA Guidance dated January 11, 2002 General Principles of Software Validation and IEC 62304:2006 Medical device software - software life cycle processes. Usability engineering/human factors testing and was performed in accordance with FDA Guidance dated February 3, 2016 Applying Human Factors and Usability Engineering to Medical Devices and IEC 62366-1:2015-02 incl. Corr. (2016) Application of Usability Engineering to Medical Devices.

RetinaVue Network is DICOM compliant as stipulated in its DICOM Conformance Statement.

Performance testing confirmed that RetinaVue Network performs as intended, supports the indications for use statement, demonstrates that the device is substantially equivalent to the predicate, and does not raise new questions regarding safety and effectiveness.

CLINICAL PERFORMANCE DATA:

None required nor submitted.

CONCLUSIONS:

The Welch Allyn RetinaVue Network is substantially equivalent in operation and performance to the Carl Zeiss Meditec AG FORUM (K122938). The introduction of the Welch Allyn RetinaVue Network to the medical market raises no new questions of safety and effective and we therefore request clearance to proceed to market.

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).