Who is the manufacturer of Harmony Referral System?

Topcon Healthcare Solutions EMEA Oy filed the 510(k) submission for Harmony Referral System (K210396).

What is the FDA product code for Harmony Referral System?

NFJ. It is classified under 21 CFR 892.2050 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for Harmony Referral System?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like Harmony Referral System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Harmony Referral System

K210396 · Topcon Healthcare Solutions EMEA Oy · NFJ · Sep 13, 2021 · Radiology

Device Facts

Record ID	K210396
Device Name	Harmony Referral System
Applicant	Topcon Healthcare Solutions EMEA Oy
Product Code	NFJ · Radiology
Decision Date	Sep 13, 2021
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.2050
Device Class	Class 2
Attributes	Software as a Medical Device

Intended Use

Harmony Referral System (Harmony RS) is a comprehensive software platform intended for use in importing, processing, viewing, measurement and storage of clinical images and videos as well as in management and communication of patient data, diagnostic and clinical information and reports from ophthalmic diagnostic instruments through either direct connection with the instruments or through computerized networks. The system neither performs any interpretations nor provides treatment recommendations.

Device Story

Harmony Referral System (Harmony RS) is a web-based software platform for ophthalmic image and data management. It imports clinical images, videos, and reports from ophthalmic diagnostic instruments via direct connection or computerized networks. The system stores, processes, and displays this data at a PC workstation for review by trained professionals. It provides standard viewing tools (zoom, rotate, flip), image enhancement (contrast adjustment), and manual measurement tools (line, area, cup-disc ratio) based on user-marked pixels. It does not perform automated image analysis, clinical interpretation, or provide treatment recommendations. The system facilitates communication with other PACS and EMR systems. Security is maintained via SSL encryption, firewalls, VPN, and IP-based access restrictions. By centralizing diagnostic information, it assists clinicians in reviewing patient data to support clinical decision-making.

Clinical Evidence

No clinical data provided. Bench testing and software verification/validation demonstrate the device performs as intended and meets specifications.

Technological Characteristics

Web-based software platform; operates on Debian Linux (archive/application/integration servers) and Windows Server (integration server). Client-side requires browser support (Edge Chromium, Firefox). Supports DICOM communication, SSL encryption, VPN, and IP-based access control. Image formats: JPEG, JPEG 2000, RAW, encapsulated in DICOM. Manual measurement tools based on pixel spacing.

Indications for Use

Indicated for use by trained professionals for the management, viewing, and measurement of ophthalmic clinical images, videos, and patient data imported from 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

Topcon Harmony (K182376)

Related Devices

K182376 — Harmony · Topcon Medical Systems, Inc. · Sep 28, 2018
K151952 — Synergy ODM · Topcon Medical Systems, Inc. · Oct 1, 2015
K110006 — OIS SYMPHONY IMAGE MANAGMENT SYSTEM · Ophthalmic Imaging Systems · May 18, 2011
K113696 — OPTOS ADVANCE · Optos Plc. · May 25, 2012
K093313 — SYNERGY · Topcon Medical Systems, Inc. · Dec 2, 2009

Submission Summary (Full Text)

{0}------------------------------------------------ September 13, 2021 Image /page/0/Picture/1 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. Topcon Healthcare Solutions EMEA Oy % Maureen O'Connell President O'Connell Regulatory Consultants, Inc. 44 Oak Street Stoneham, Massachusetts 02180 Re: K210396 Trade/Device Name: Harmony Referral System Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management and Processing System Regulatory Class: Class II Product Code: NFJ Dated: August 18, 2021 Received: August 19, 2021 Dear Maureen O'Connell: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrl/cfdocs/cfpmn/pmn.cfm identifies.combination product submissions. 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 {1}------------------------------------------------ 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Elvin Ng Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K210396 Device Name Harmony Referral System (Harmony RS) #### Indications for Use (Describe) Harmony Referral System (Harmony RS) is a comprehensive software platform intended for use in importing, processing, viewing, measurement and storage of clinical images and videos as well as in management and communication of patient data, diagnostic and clinical information and reports from ophthalmic diagnostic instruments through either direct connection with the instruments or through computerized networks. The system neither performs any interpretations nor provides treatment recommendations. | Type of Use ( Select one or both, as applicable ) | | |---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--| | <div> <svg class="bi bi-check-square-fill" fill="currentColor" height="1em" viewbox="0 0 16 16" width="1em" xmlns="http://www.w3.org/2000/svg"> <path d="M2 0a2 2 0 0 0-2 2v12a2 2 0 0 0 2 2h12a2 2 0 0 0 2-2V2a2 2 0 0 0-2-2H2zm10.03 4.97a.75.75 0 0 0-1.08.022L7.477 9.417 5.384 7.323a.75.75 0 0 0-1.06 1.06L6.97 11.03a.75.75 0 0 0 1.079-.02l3.992-4.99a.75.75 0 0 0-.01-1.05z" fill-rule="evenodd"></path> </svg> Prescription Use (Part 21 CFR 801 Subpart D) </div> | | | <div> <svg class="bi bi-square" fill="currentColor" height="1em" viewbox="0 0 16 16" width="1em" xmlns="http://www.w3.org/2000/svg"> <path d="M14 1H2a1 1 0 0 0-1 1v12a1 1 0 0 0 1 1h12a1 1 0 0 0 1-1V2a1 1 0 0 0-1-1zM2 0a2 2 0 0 0-2 2v12a2 2 0 0 0 2 2h12a2 2 0 0 0 2-2V2a2 2 0 0 0-2-2H2z" fill-rule="evenodd"></path> </svg> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | | #### 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 Topcon Healthcare Solutions Harmony Referral System (Harmony RS) ### 510(k) Owner Topcon Healthcare Solutions EMEA Oy Makelininkatu 43 90100 Oulu, Finland Phone: (201) 599-5208 Contact Person: Ramya Sundaram ### Submission Correspondent Maureen O'Connell O'Connell Regulatory Consultants, Inc. 44 Oak Street Stoneham. MA 02180 Phone: (978) 207-1245 Email: Maureen@oconnellregulatory.com Date Prepared: August 16, 2021 ### Trade Name of Device Harmony Referral System (Harmony RS) #### Common or Usual Name System, image management, ophthalmic #### Classification Name 21 C.F.R. 892.2050 Medical Image Management and Processing System #### Predicate Device Topcon Harmony cleared in K182376 #### Indications for Use Harmony Referral System (Harmony RS) is a comprehensive software platform intended for use in importing, processing, viewing, measurement and storage of clinical images and videos as well as in management and communication of patient data, diagnostic and clinical information and reports from ophthalmic diagnostic instruments through either direct connection with the instruments or through computerized networks. The system neither performs any interpretations nor provides treatment recommendations. #### Device Description Harmony Referral System is an internet-browser-based software platform that allows users to access examination data of a patient from different sources. Harmony Referral System may be used together with a number of computerized digital imaging devices and third party software. In {4}------------------------------------------------ addition. Harmony Referral System software collects and manages patient demographics, image data, and clinical reports from a range of approved medical devices. Harmony Referral System enables a real-time review of diagnostic patient information at a PC workstation. The software uses SSL encryption in network communication and secure network infrastructure with firewalls and additionally also VPN and IP-based access restrictions to ensure secure networking environment. The Harmony Referral System does not perform automated image analysis but provides measurements based on pixels of an image, which were marked by the user manually on the screen including cup-disk ratio and line and area measurements. #### Performance Data No performance data was required or provided. Software validation and verification demonstrate that Harmony RS performs as intended and meets its' specifications. ### Substantial Equivalence The Harmony RS is substantially equivalent to Topcon Healthcare Solutions' Harmony cleared in K182376. The Harmony RS has the same intended use and similar indications for use, technological characteristics, and principles of operation as the previously cleared predicate. Both devices are software only image management systems which manage, display and analyze ophthalmic images. Regarding acquisition, Harmony RS and Harmony (K182376) do not offer capture components. Both devices import digital images, patient data, diagnostic data and clinical information from other software capture systems and directly from ophthalmic devices. The Harmony RS has an absolute measurement tool which is derived from pixel spacing information provided by the source device and does not perform any automated image analysis. It provides line and area measurements as well as cup-disc ratio based on the user manually marking the images on the screen which are the same measurements performed by the Harmony. The Harmony also performs MPS which is not performed by Harmony RS. Harmony RS and Harmony both allow standard viewing operations such as zoom in/out, flip/rotate, etc. and standard image enhancements such as contrast adjustment, and drawing tools. Harmony RS provides DICOM communication with other PACS as does Topcon Healthcare Solutions' Harmony (K182376). Harmony RS and Harmony both provide similar customizable print templates and archive and backup functionality. The minor differences including the operating system, hardware requirements, system access, and measurement and analysis. The predicate device is operated on a MS Windows Server and supports the Chrome browser while the Harmony RS uses additional servers and browsers. The predicate software is used on a Windows XP/2000 PC while the Harmony RS operates on a Desktop PC operating Windows. The predicate device is available both on a desktop and webbased while the Harmony RS is only web-based. The different technological characteristics of the devices do not raise new questions of safety and effectiveness. The differences in hardware requirements and system access are all system features that can be evaluated during software validation and verification and were primarily revised to allow the system to operate with newer hardware, browsers and operating systems. {5}------------------------------------------------ The Harmony RS shares similar technological characteristics with the predicate device, both in terms of the manner in which images are captured, and stored, as well as the operation of the device by the intended user. The software validation and verification shows that the Harmony RS performs as intended and supports substantial equivalence. The following table compares the Harmony RS to the Harmony cleared in K182376. | | Proposed Device | Predicate Device | |-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Trade name | Harmony Referral System | Harmony | | 510(k) number | K210396 | K182376 | | Manufacturer | Topcon Healthcare Solutions EMEA Oy | Topcon Healthcare Solutions, Inc. | | Device Type | System, Image Management, Ophthalmic | System, Image Management, Ophthalmic | | Regulation Description | Picture archiving and communications system | Picture archiving and communications system | | Regulation Medical Specialty | Radiology | Radiology | | Review Panel | Ophthalmic | Ophthalmic | | Product Code | NFJ | NFJ | | Regulation Number | 892.2050 | 892.2050 | | Device Class | 2 | 2 | | Indications for Use | Harmony Referral System (Harmony RS) is a comprehensive software platform intended for use in importing, processing, viewing, measurement and storage of clinical images and videos as well as in management and communication of patient data, diagnostic and clinical information and reports from ophthalmic diagnostic instruments through either direct connection with the instruments or through computerized networks. The | Harmony is a comprehensive software platform intended for use in acquisition or importing, processing, measurement, analysis and storage of clinical images and videos of the eye as well as in management of patient data, diagnostic data, clinical information, reports from ophthalmic diagnostic instruments through either a direct connection with the | | | | | | | system neither performs any interpretations nor provides treatment recommendations. | instruments or through computerized networks. | | Device Type | Software only | Software only | | User Population | Trained professionals | Trained professionals | | Platform / Operating System | Archive & application server: Debian Linux Integration server: Debian Linux, Windows Server Client: operating system supporting the following browsers: Microsoft Edge Chromium, Mozilla Firefox (two latest verssons) | Server: MS Windows Server 2012 R2 Client: operating system supporting the following browsers: Chrome | | Hardware requirements | Processor performance level: i3 7th gen dual core, i5 4th gen quad core Ram: 4GB Full HD 1920x1080 resolution monitor Any operating system capable of running supported browser Network connection: 100 Mbps (recommended), 5 Mbps (minimum upload/download) | Window XP/2000 PC Monitor Keyboard Mouse | | Web based access | Harmony Referral System is web- based system | Desktop and web-based access | | Image Data compression | JPEG (lossy), JPEG 2000 (lossy, lossless), RAW (uncompressed) All files encapsulated inside DICOM format. | TIFF - uncompressed, PNG - lossless compress, JPEG - lossy compress, DICOM - lossy & lossless | | Virtualization | Yes | Yes | | User administration | centralized | centralized | | HIS/EMR integration | Yes | Yes | | DICOM | Yes | Yes | | communication with other PACS | Image processing | | | Image processing | Standard image viewing operation such as zoom in/out, flip/rotate, etc. Standard image enhancement adjustment such as contrast adjustment, etc. Text annotation Line/circle/freehand drawing | Standard image viewing operation such as zoom in/out, flip/rotate, etc. Standard image enhancement adjustment such as contrast adjustment, etc. Text annotation Line/circle/freehand drawing | | Measurement and analysis | Scale to display pixel dimensions of the image Line and area measurements Cup-disc ratio | Perform line/area measurement with retinal images, Cup-Disc ratio, MPS | | Reporting | available | available | TABLE 1 HARMONY REFERRAL SYSTEM SUBSTANTIAL EQUIVALENCE CHART {6}------------------------------------------------ {7}------------------------------------------------