Who is the manufacturer of FORUM?

Carl Zeiss Meditec, AG filed the 510(k) submission for FORUM (K213527).

What is the FDA product code for FORUM?

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

What is the regulatory pathway for FORUM?

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

What are the predicate devices for FORUM?

FORUM Archive and Viewer (K122938).

Who can help prepare an FDA 510(k) submission like FORUM?

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.

FORUM

K213527 · Carl Zeiss Meditec, AG · NFJ · Aug 15, 2022 · Radiology

Device Facts

Record ID	K213527
Device Name	FORUM
Applicant	Carl Zeiss Meditec, AG
Product Code	NFJ · Radiology
Decision Date	Aug 15, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.2050
Device Class	Class 2
Attributes	Software as a Medical Device

Intended Use

FORUM is a software system intended for use in management, processing 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 (including but not limited to Retina Workplace, Glaucoma Workplace). FORUM is intended for use in review of patient, diagnostic and image data and measurement by trained healthcare professionals.

Device Story

FORUM is an ophthalmic data management software system; receives patient diagnostic, video, and image data via DICOM protocol from various ophthalmic instruments (e.g., CIRRUS, CLARUS, 3rd party systems). Operates as a central repository; allows remote access and bidirectional data exchange between FORUM Workplaces. Used by trained healthcare professionals in clinical settings to review, annotate, and manage patient data. Provides tools for fundus image/movie review, OCT image stack display, and measurement. Facilitates clinical workflow through EMR integration and patient chart management. Cloud connectivity is supported via non-medical device accessories. Output consists of processed diagnostic data and images for clinical review, supporting healthcare providers in diagnostic decision-making and patient management.

Clinical Evidence

Bench testing only. No clinical data provided. Software verification and validation testing were conducted in accordance with FDA guidance for software in medical devices. The device was classified as a 'Moderate' level of concern. Testing confirmed that all requirements for proposed changes were met and that the device performs as intended.

Technological Characteristics

Software-based ophthalmic image management system. Operates on Windows Server and Windows/macOS client platforms. Connectivity via LAN and DICOM interface. Supports bidirectional data exchange and cloud integration via non-medical accessories. Software version 4.3. Moderate level of concern.

Indications for Use

Indicated for trained healthcare professionals to manage, process, and review patient diagnostic, video, and image data and measurements from computerized ophthalmic diagnostic instruments or documentation systems via networks.

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

FORUM Archive and Viewer (K122938)

Related Devices

K090439 — FORUM · Carl Zeiss Meditec, Inc. · Mar 25, 2009
K122938 — FORUM FORUM ARCHIVE FORUM ARCHIVE & VIEWER FORUM ASSIST MATCH · Carl Zeiss Meditec, AG · Nov 2, 2012
K132667 — SYNERGY ODM · Topcon Medical Systems, Inc. · Oct 9, 2013
K093313 — SYNERGY · Topcon Medical Systems, Inc. · Dec 2, 2009
K151952 — Synergy ODM · Topcon Medical Systems, Inc. · Oct 1, 2015

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the U.S. Food & 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 is a blue square with the letters "FDA" in white, followed by the words "U.S. Food & Drug Administration" in blue. Carl Zeiss Meditec AG % Maria Golovina Head of Regulatory - USA Carl Zeiss Meditec USA Inc 5300 Central Parkway Dublin, California 94548 ### Re: K213527 Trade/Device Name: Forum Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: NFJ Dated: June 30, 2022 Received: July 6, 2022 #### Dear Maria Golovina: 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/cdrh/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 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 {1}------------------------------------------------ 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 medical devices and radiation-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, for 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) K213527 Device Name FORUM Indications for Use (Describe) FORUM is a software system intended for use in management, processing 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 (including but not limited to Retina Workplace). FORUM is intended for use in review of patient, diagnostic and image data and measurement by trained healthcare professionals. Type of Use (Select one or both, as applicable) | <div> X Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> □ 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}------------------------------------------------ Image /page/3/Picture/0 description: The image contains the word "ZEISS" in a bold, sans-serif font. The text is white and is set against a solid dark blue background. The logo is simple and recognizable, representing the Zeiss brand. # FORUM: 510(k) Summary In accordance with 21 CFR 807.92, the following summary of information is provided in the 510(k) submission. # 1. Identification of the Submitter | Applicant | Carl Zeiss Meditec AG Goeschwitzer Strasse 51-52 D-07745 Jena, Germany | |-------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Primary Contact | Maria Golovina Head of Regulatory Affairs - USA Carl Zeiss Meditec, Inc. 5300 Central Parkway Dublin, CA 94568 (925) 216-1078 Phone (925) 557-4259 Fax E-mail: maria.golovina@zeiss.com (preferred) | | Secondary Contact | Tanesha Bland Senior Regulatory Affairs Specialist- USA Carl Zeiss Meditec, Inc. 5300 Central Parkway Dublin, CA 94568 (925) 216-7963 Phone E-mail: tanesha.bland@zeiss.com (preferred) | | Date Prepared | August 11, 2022 | ## 2. Identification of the Product | Trade Name | FORUM | |----------------------------|--------------------------------------| | Software Version | Software Version 4.3 | | Classification/Common Name | System, Image Management, Ophthalmic | | Device Class | II | | Product Code | NFJ | # 3. Predicate Device to which Equivalence is Claimed ## Primary Predicate: | Device Name | FORUM Archive and Viewer | |----------------|--------------------------------------------------| | Manufacturer | Carl Zeiss Meditec AG | | | Goeschwitzer Strasse 51-52 D-07745 Jena, Germany | | 510(k) Number | K122938 | | Product Code | NFJ | | Classification | System, Image Management, Ophthalmic | {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the word "ZEISS" in a bold, sans-serif font. The letters are white and are set against a solid blue background. The logo is simple and modern, with a focus on the company name. #### 4. Summary of Device Description FORUM and its accessories are a computer software system designed for 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 receives data via DICOM protocol from a variety of ophthalmic diagnostic instruments (such as CIRRUS, CLARUS, and 3rd Party systems), allows central data storage and remote access to patient data. This version of FORUM allows the user to access their data in the cloud via ZEISS developed non-medical device accessories. FORUM is an ophthalmic data management solution. FORUM provides basic viewing functionalities and is able to connect all DICOM compliant instruments. This version of FORUM provides additional device functions such as review and annotation functionality of fundus images/movies, display of OCT image stacks, bidirectional data exchange between FORUM Workplaces, customization of document viewing abilities, user interface improvements, and user management updates. This version of FORUM has additional non-medical device functions that are performed by non-medical device accessories, such as documentation storage, export of data in various formats, export to the cloud, improved IT integration capability into the existing IT network, image sorting, EMR log in improvements, numerous backend improvements with the purpose of streamlining clinical workflow. ### 5. Intended Use and Indications for Use The Indications for Use (IFU) statement for the subject device is as follows: FORUM is a software system intended for use in management, processing 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 (including but not limited to Retina Workplace, Glaucoma Workplace). FORUM is intended for use in review of patient, diagnostic and image data and measurement by trained healthcare professionals. Prescription Use (Rx) ### 6. Substantial Equivalence Comparison to the Predicate Device The substantial equivalence was drawn solely on the medical device features as they were related to the predicate. {5}------------------------------------------------ | Table 1. Subject Device to Reference Device Comparison (Technical Characteristics) | |------------------------------------------------------------------------------------| |------------------------------------------------------------------------------------| | Attribute/Function | Subject Device (K213527) | Primary Predicate Device (K122938) | Equivalency Analysis | |-----------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Trade Name | FORUM | FORUM Archive and Viewer | Updated | | Software version | Software version 4.3 | Software version 3.0 | Updated | | Manufacturer | Carl Zeiss Meditec AG | Carl Zeiss Meditec AG | Identical | | Device Classification Name | System, Image Management, Ophthalmic | System, Image Management, Ophthalmic | Identical | | Regulation Description | Medical image management and processing system | Picture archiving and communications system | Equivalent. Regulation change. | | Regulation medical specialty | Ophthalmic | Ophthalmic | Identical | | Review panel | Ophthalmic | Ophthalmic | Identical | | Product code, subsequent product codes | NFJ – Class II | NFJ — Class II | Identical | | Regulation number | 21CFR892.2050 | 21CFR892.2050 | Identical | | Device class | II | II | Identical | | Indications for use | FORUM is a software system intended for use in management, processing 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 (including but not limited to Retina Workplace, Glaucoma Workplace). | FORUM is a software system intended for use in management, processing 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. | Equivalent. A removal of the word 'storage' and display from the indications for use due to an updated definition of MIMS does not constitute a substantial change, thus is deemed equivalent. | | Attribute/Function | Subject Device (K213527) | Primary Predicate Device (K122938) | Equivalency Analysis | | FORUM is intended for use in review of patient, diagnostic and image data and measurement by trained healthcare professionals. | FORUM is intended for use in review of patient, diagnostic and image data and measurement by trained healthcare professionals. | | | | Application | Ophthalmology | Ophthalmology | Identical | | Platform/Operating System | Server: • Windows Server 2012 R2, • Windows Server 2016, • Windows Server 2019, • Windows 8.1, • Windows 10 | Server: • Windows XP (32 bit) with Service Pack 3 • Windows Server 2003 (32 bit) with Service Pack 2 • Windows 7 (64 bit) with Service Pack 1 Windows Server 2008 R2 (64 bit) with Service Pack 1 | Equivalent; backend improvements do not impact the indications for use, device risk profile, and technical specifications of the subject device as demonstrated in risk documentation and testing results. | | | Client: • Windows Server 2012 R2, • Windows Server 2016, • Windows Server 2019, • Windows 8.1, • Windows 10 • Apple OS X 11.x (BigSur) | Client: • Windows XP (32 bit) with Service Pack 3 • Windows 7 (64 bit) with Service Pack 1 Windows Server 2008 R2 (64 bit, English Edition) • Apple OS 10.7 “Lion” | Equivalent; backend improvements do not impact the indications for use, device risk profile, and technical specifications of the subject device as demonstrated in risk documentation and testing results. | | Database Features* | Central database: Yes | Central database: Yes | Identical | | | Administer patient data: Yes | Administer patient data: Yes | Identical | | | Patient chart/ patient management: Yes | Patient chart/ patient management: Yes | Identical | | | Search & sort patients/documents: Yes | Search & sort patients/documents: Yes | Identical | | Attribute/Function | Subject Device (K213527) | Primary Predicate Device (K122938) | Equivalency Analysis | | | Administer exam data: Yes | Store & administer exam data: Yes | Identical | | | Search Exams: Yes | Search Exams: Yes | Identical | | | Scheduling exams: Yes - Modality Worklist Scheduler (Patient to Device) | Scheduling exams: Yes - Modality Worklist Scheduler (Patient to Device) | Identical | | Image Processing | Image Processing Function (Review of medical documents) - Fundus: Yes - Stereo view for fundus images, red green blue (RGB) split for fundus images, display of fundus angiography movies, rotation of fundus images, measurements on wide-field fundus images | Image Processing Function (Review of medical documents) - Fundus: - Yes, to general functionality - No, to specific functions as compared to the subject device | Different; however, the addition of this functionality does not impact the indications for use, device risk profile, and technical specifications of the subject device as demonstrated in risk documentation and testing results. | | | Image Processing Function (Review of medical documents) Image Annotations: Yes, Addition of free hand and circle measurement ability, text annotations on images, rotation | Image Processing Function (Review of medical documents) Image Annotations: - Yes, to general functionality - No, to specific functions as compared to the subject device | Different; however, the addition of this functionality does not impact the indications for use, device risk profile, and technical specifications of the subject device as demonstrated in risk documentation and testing results. | | Access/Connectivity* | Connection to LAN: Yes | Connection to LAN: Yes | Identical | | | DICOM Interface: Yes | DICOM Interface: Yes | Identical | | | Remote data access via Internet: No, only via Virtual Private Network | Remote data access via Internet: No, only via Virtual Private Network | Identical | | | Import exam data from various ophthalmic diagnostic devices: Yes | Import exam data from various ophthalmic diagnostic devices: Yes | Identical | | Attribute/Function | Subject Device (K213527) | Primary Predicate Device (K122938) | Equivalency Analysis | | | Interface to Electronic Medical Records (EMRs) or Practice Management Systems: Yes | Interface to Electronic Medical Records (EMRs) or Practice Management Systems: Yes | Identical | | | Cloud Connection: Yes via ZEISS developed non-medical device accessories | Cloud Connection: No | Equivalent. The addition of the non- medical accessories that support cloud connectivity does not impact the indications for use and do not impact the functionality of the medical device. | | | Data Exchange: Yes, bidirectional data exchange between FORUM Workplaces | Data Exchange: Yes, unidirectional data exchange between FORUM Workplaces | Different; however, the addition of this functionality does not impact the indications for use, device risk profile, and technical specifications of the subject device as demonstrated in risk documentation and testing results. | | Image/Data Transfer via DICOM | Yes | Yes | Identical | {6}------------------------------------------------ Image /page/6/Picture/4 description: The image shows the word "ZEISS" in white text on a blue background. The text is bold and sans-serif. The background is a solid, dark blue color. The logo is simple and modern. {7}------------------------------------------------ {8}------------------------------------------------ *The addition of new and/or modified medical device functions does not impact safety and equivalence of the subject device because risks associated with these functions were mitigated. Appropriate risk analysis and testing documentation was provided to demonstrate that these modifications do not impact the substantial equivalence as compared to the predicate device. ** The addition of new and/or modical functions and accessories does not impact safety and equivalence of the subject device because the functionality they provide does not have an impact to the FORUM medical device. This was demonstrated by providing appropriate risk assessments and testing information. {9}------------------------------------------------ #### 7. Summary of the Studies FORUM (version 4.3) has successfully undergone extensive software verification and validation testing to ensure that all requirements for proposed changes have been met. Software Verification and Validation testing were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "Moderate" level of concern, since a failure or latent flaw in the software could indirectly result in minor injury to the patient or operator through incorrect or delayed information or through the action of a care provider. All testing followed internally approved procedures and processes. These procedures and processes are in compliance with referenced standards and FDA guidance documents. #### 8. Conclusion The indications for use are equivalent to the indications for use of the predicate device; are deemed to be equivalent in their relationship to safety and effectiveness. The technological characteristics and risk profile of the subject device are equivalent to the predicate device and reference device; and therefore, are deemed to be equivalent in their relationship to safety and effectiveness. Testing methods are equivalent to those of the predicate device and reference device; and therefore, are deemed to be equivalent in their relationship to safety and effectiveness. Therefore, the subject device meets the requirements for substantial equivalence.