Welch Allyn RetinaVue Network REF 901108 PACS Medical Image System

K181016 · Welch Allyn, Inc. · NFJ · Jul 16, 2018 · Radiology

Device Facts

• Record ID: K181016
• Device Name: Welch Allyn RetinaVue Network REF 901108 PACS Medical Image System
• Applicant: Welch Allyn, Inc.
• Product Code: NFJ · Radiology
• Decision Date: Jul 16, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

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 Story

Web-based software system for transmission, storage, management, and display of eye images and associated patient data. Clinicians use the Client Application to submit images from ophthalmic cameras to the Overread Physician Portal. Physicians use the portal to view original or enhanced images, interpret findings, and generate diagnostic reports. Enhancement features include CLAHE (Contrast Limited Adaptive Histogram Equalization) and filters for brightness/contrast, sharpen, saturate, and chromium. System includes a database for patient demographics, exam reports, and billing info. Used in clinical settings to facilitate remote interpretation of ophthalmic exams; supports clinical decision-making by providing enhanced visualization of diagnostic images.

Clinical Evidence

No clinical data required or submitted. Device validation relied on bench testing, software life cycle processes (IEC 62304), risk management (ISO 14971), and usability engineering (IEC 62366-1).

Technological Characteristics

Web-based software application; ASP.NET architecture. Components: Client Application, Web Service, Database, Overread Physician Portal, Customer Portal. Connectivity: Networked, DICOM compliant, HL7 support. Image processing: CLAHE algorithm, brightness/contrast, sharpen, saturate, and chromium filters. Software life cycle: IEC 62304 compliant.

Indications for Use

Indicated for use by or on the order of a licensed medical professional for storing, managing, and displaying patient data, diagnostic data, and images from computerized diagnostic instruments.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• Zeiss FORUM® FORUM Archive, FORUM Viewer (K122938)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.

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 ([e-mail]) or phone [phone] 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)

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.

| 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: [phone] Fax: [phone] |
| 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.
- 2. Allow for the enhancement and interpretation of images and report generation at the Over-read (Physician) Portal.

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

## INTENDED USE/INDICATIONS FOR USE:

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.

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 Class<br>CFR Section<br>Common Name | Class II<br>21 CFR 892.2050<br>System, image<br>management, ophthalmic | Class II<br>21 CFR 892.2050<br>System, image<br>management, ophthalmic | Same | |
| Indications for Use | FORUM is a software<br>system intended for use in<br>storage, management,<br>processing, and display of<br>patient, diagnostic, video<br>and image data and<br>measurement from<br>computerized diagnostic<br>instruments or<br>documentation systems<br>through networks. It is<br>intended to work with other<br>FORUM applications.<br><br>FORUM is intended for use<br>in review of patient,<br>diagnostic and image data<br>and measurement by<br>trained healthcare<br>professionals. | The Welch Allyn<br>RetinaVue Network is a<br>web-based software system<br>application intended for use<br>in storing, managing, and<br>displaying patient data,<br>diagnostic data, and images<br>from computerized<br>diagnostic instruments.<br>Original and enhanced<br>images can be viewed by<br>trained healthcare<br>professionals. | Similar – We have<br>simplified the<br>statement somewhat | |
| Basic Description | FORUM is software for<br>managing, archiving, and<br>viewing e.g. patient data,<br>images, videos, and reports<br>provided by computer-<br>controlled diagnostic<br>devices or other<br>documentation systems | The Welch Allyn<br>RetinaVue Network is a<br>system for the transmission<br>of eye images, associated<br>patient data, and diagnostic<br>reports from one location<br>to another via the internet. | Equivalent-both<br>software systems are for<br>transmission, storage and<br>viewing of eye images and<br>associated data | |
| Characteristic | Predicate Device | Subject Device | Differences | |
| Target Population | Images / system is not<br>patient population<br>specific. | Images / system is not<br>patient population specific | Same | |
| Where Used | Throughout the patient<br>care process | Throughout the patient<br>care process | Same | |
| Software Design Features | | | | |
| RVN Client Application | | | | |
| Entering and editing<br>patient and exam<br>information | Yes | Yes | Same | |
| Managing application<br>behavior and camera<br>specific settings | Will accept all images. | For additional security, our<br>system will only<br>communicate with cameras<br>known to the system. This<br>feature is to register the<br>camera in the system. | Similar - Additional<br>communications security in<br>our system | |
| Entering and editing contact<br>information | No | Yes | Similar - We allow<br>patient contact<br>information to be included<br>in our patient database | |
| RVN Web Service | | | | |
| Ability to query and report<br>the status for submitted<br>exams | Yes | Yes | Same | |
| Maintain patient<br>demographic information | Yes | Yes | Same | |
| Maintain Contact and User<br>account information | No | Yes | Similar - We allow<br>patient contact<br>information to be included<br>in our patient database | |
| Maintain last known set of<br>configurations | unknown | Yes | Minor - unable to<br>determine Zeiss's recovery<br>capability from the<br>documentation available to<br>us from Zeiss | |
| Obtain encryption keys to<br>encrypt data with | unknown | Yes | Minor - unable to<br>determine Zeiss's from the<br>documentation available to<br>us from Zeiss | |
| RVN Database | | | | |
| Patient Demographics | Yes | Yes | Same | |
| User Account Management<br>(user roles) | Yes | Yes | Same | |
| RVN Client application<br>install inventory and<br>configuration | Yes | Yes | K181016 | Same |
| Wireless device inventory<br>and configuration | No | Yes | | Minor – We allow wireless<br>communications |
| Customer Account and<br>Clinic information | No: Customer<br>Account Yes:<br>Clinic information | Yes – both | | Minor - We store additional<br>patient account/contact<br>data |
| Exam Reports | Yes | Yes | | Same |
| Billing Information | No | Yes | | Minor - We store additional<br>patient account/contact<br>data |
| Overread Physician Portal | | | | |
| Ability to overread exams<br>submitted from customers | Yes | Yes | | Same |
| Abilityto view enhanced<br>versions of the ophthalmic<br>images | Yes | Yes | | Same |
| Creation of PDF files of the<br>over-read diagnostic report | Yes | Yes | | Same |
| Abilityto view statistical<br>reports about the current<br>user's use of the over-read<br>portal | No | Yes | | Minor – We provide<br>statistical report to allow<br>clinic to monitor their<br>activities (not directed at<br>patientcare) |
| 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 camera<br>management | No | Yes | | Minor – We allow wireless<br>communications |
| 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 applied<br>during review. Native<br>image maintained |
| | | | K181016 | |
| Saturate | No | Yes | Minor - Filter only applied<br>during review. Native<br>image maintained | |
| Chromium (greyscale) | No | Yes | Minor - Filter only applied<br>during review. Native<br>image maintained | |
| Pan/Zoom | Yes | Yes | Same | |
| Image Measurements | Yes | No | Minor - Predicate offers<br>option of performing<br>measurements of calibrated<br>ophthalmic images | |
| Image formats | | | | |
| PDF | Yes | Reports only | Minor - We supply report<br>images in .pdf | |
| JPEG | Yes | Yes | Same | |
| TIFF | Yes | Reports only | Minor - We supply report<br>images in .tif | |
| DICOM | Yes…