K Number
K181016
Device Name
Welch Allyn RetinaVue Network REF 901108 PACS Medical Image System
Manufacturer
Date Cleared
2018-07-16

(90 days)

Product Code
Regulation Number
892.2050
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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 Description
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. 3. Transfer reports from the Over-read (Physician) Portal to the Customer Portal for download.
More Information

Not Found

No
The document describes a software system for storing, managing, and displaying medical images and data, with features for image transfer, enhancement, interpretation, and report generation. It does not mention any AI or ML capabilities, training sets, test sets, or performance metrics typically associated with AI/ML algorithms. The focus is on data management and viewing, not automated analysis or diagnosis using AI/ML.

No
The device is described as a web-based software system for storing, managing, and displaying patient data and images; it does not directly treat or prevent any medical condition.

No

The device is a web-based software system for storing, managing, and displaying patient data, diagnostic data, and images from computerized diagnostic instruments. It is not listed as performing diagnostic functions itself, but rather facilitating the viewing and interpretation of data and images from other diagnostic instruments.

Yes

The device description explicitly states it is a "web-based software system application" and describes software functionalities like storing, managing, displaying, transferring, enhancing, and interpreting data and images. While it interacts with images from computerized diagnostic instruments (hardware), the device itself is presented as the software system.

Based on the provided information, the Welch Allyn RetinaVue Network is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
  • RetinaVue Network's Function: The RetinaVue Network is a software system that stores, manages, and displays images from computerized diagnostic instruments (specifically ophthalmic cameras). It facilitates the transfer, enhancement, and interpretation of these images by healthcare professionals.
  • No Sample Analysis: The system does not analyze biological samples taken from the patient. It works with images generated by a separate diagnostic instrument.

Therefore, while it's a medical device used in the diagnostic process, it does not fit the definition of an In Vitro Diagnostic.

N/A

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.

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

NFJ

Device Description

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

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ophthalmic Camera

Anatomical Site

Eye

Indicated Patient Age Range

Not Found (Images / system is not patient population specific)

Intended User / Care Setting

Trained healthcare professionals.
Throughout the patient care process.

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

Not Found

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

Not Found

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

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.

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

Not Found

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

Zeiss FORUM® FORUM Archive, FORUM Viewer (K122938)

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

Not Found

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

Not Found

§ 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).

0

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.

1

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

2

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)

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

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.

4

  1. 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.

5

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.

CharacteristicPredicate DeviceSubject DeviceDifferences
Device NameFORUMRetinaVue NetworkN/A
ManufacturerCarl Zeiss Meditec AGWelch Allyn, Inc.N/A
510(k)NumberK122938K181016N/A
Product CodeNFJNFJSame
Device Class
CFR Section
Common NameClass II
21 CFR 892.2050
System, image
management, ophthalmicClass II
21 CFR 892.2050
System, image
management, ophthalmicSame
Indications for UseFORUM is a software
system intended for use in
storage, management,
processing, and display of
patient, diagnostic, video
and image data and
measurement from
computerized diagnostic
instruments or
documentation systems
through networks. It is
intended to work with other
FORUM applications.

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

6

7

8

9

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.