K090439 · Carl Zeiss Meditec, Inc. · NFJ · Mar 25, 2009 · Radiology
Device Facts
Record ID
K090439
Device Name
FORUM
Applicant
Carl Zeiss Meditec, Inc.
Product Code
NFJ · Radiology
Decision Date
Mar 25, 2009
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 892.2050
Device Class
Class 2
Attributes
Software as a Medical Device, 3rd-Party Reviewed
Indications for Use
FORUM is a software system application intended for use in storing, managing, and displaying patient data, diagnostic data, videos and images from computerized diagnostic instruments or video documentation systems through networks.
Device Story
FORUM is a client-server software system for ophthalmic data management. It ingests DICOM images, videos, and reports from connected diagnostic instruments and surgical microscopes via network. The system comprises two main components: the FORUM Archive (server/client) for storage and administration, and the FORUM Viewer (client module) for retrieval, display, and review. The viewer includes a modality worklist scheduling function. Used by clinicians in ophthalmic settings to manage the workflow from patient scheduling to examination result archiving and review. The system allows side-by-side comparison of multiple documents. It facilitates clinical decision-making by providing centralized access to longitudinal patient diagnostic data, potentially improving diagnostic efficiency and patient care coordination.
Clinical Evidence
Bench testing only. No clinical data provided. Performance testing confirmed the system functions as intended and is DICOM compliant.
Technological Characteristics
Client-server software architecture; central database for storage of DICOM-compliant ophthalmic diagnostic data (images, videos, reports). Network-based connectivity for data import from diagnostic instruments and remote web-based access. Supports DICOM standards.
Indications for Use
Indicated for use in clinical settings to store, manage, and display patient diagnostic data, images, and videos from ophthalmic instruments and surgical microscopy systems.
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
Nidek Advanced Vision Information System (NAVIS) (K013694)
Submission Summary (Full Text)
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5110(k) 4: k09b439
510(K) SUMMARY
# SECTION 5.
#### 5. 510(K) SUMMARY
# Mar 2.5 2009
#### 510(k) SUMMARY (per 21 CFR §807.92)
#### FORUM
### GENERAL INFORMATION
.
| Manufacturer: | Carl Zeiss Surgical GmbH<br>Carl Zeiss Strasse 22<br>D-73446 Oberkochen, Germany<br>49 7364-20-2555 (phone)<br>49 7364-20-2035 (fax)<br>Est. Reg. No. 2431026 |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Kent W. Jones<br>Vice President, RA/CA/QA/Compliance<br>Carl Zeiss Meditec, Inc.<br>5160 Hacienda Drive<br>Dublin, California 94568<br>925 557-4353 (phone)<br>925 557-4259 (fax) |
| Device | System, Image Management, Ophthalmic |
| Classification: | 21 CFR 892.2050 |
| Device Class: | II |
| Product Code: | NFJ |
| Common Name: | Picture Archiving and Communications System |
| Trade/Proprietary Name: | FORUM™ |
### PREDICATE DEVICE
| Company: | Nidek, Inc. |
|----------|--------------------------------------------------|
| Device: | Nidek Advanced Vision Information System (NAVIS) |
| | (K013694) |
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# SECTION 5.
# 510(K) SUMMARY
#### INDICATIONS FOR USE
FORUM is a software system application intended for use in storing, managing, and displaying patient data, diagnostic data, videos and images from computerized diagnostic instruments or video documentation systems through networks.
#### DEVICE DESCRIPTION
FORUM is a personal computer software system designed for storage, retrieval, and review of DICOM images, videos and reports originating from ophthalmic instruments and surgical microscopy. FORUM consists of two components: the FORUM Archive and the FORUM Viewer. The FORUM Archive, which contains both a server and client application, provides an archive for storage and administration of medical documents and patient data. The FORUM Viewer is an additional module to the client application which allows images, reports and videos stored in the archive to be reviewed. The FORUM Viewer also includes a modality worklist scheduling function.
When utilized together, the FORUM Archive and Viewer provide a complete workflow cycle from administering patient information via scheduling patients for examinations on connected instruments, through archiving the results of the examinations to retrieval and review of examination data.
#### SUBSTANTIAL EQUIVALENCE
It is the opinion of Carl Zeiss Surgical GmbH that FORUM is substantially equivalent to the Nidek Advanced Vision Information System (NAVIS). The indications for use statement for FORUM is similar to the indications for the predicate device cited in this application. A technological comparison demonstrates that FORUM is functionally equivalent to the predicate device.
Evaluation performed on FORUM supports the indications for use statement, demonstrates that the device is substantially equivalent to the predicate device and does not raise new questions regarding safety and effectiveness.
#### TECHNOLOGICAL CHARACTERISTICS
The fundamental technological characteristics of FORUM are similar to those of the predicate device. Both systems comprise a central database to store diagnostic documents (i.e. retinal images and reports of other ophthalmic diagnostic devices).
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# SECTION 5.
These documents are imported from the diagnostic devices via a network connection.
Both systems are client - server systems which provide a software application (client) to view the data stored in the database (server). The viewer software allows the user to search for patients and their respective documents and to display multiple documents for comparison purposes. In both cases, the client software can be used to access the database from a remote location via web based access.
FORUM and the predicate device serve the same principal purpose of clinical usage and provide a wide range of comparable functionality for their users.
### PERFORMANCE DATA
Performance testing was conducted on FORUM and was found to perform as intended. FORUM is DICOM compliant according to its DICOM conformance statement.
#### SUMMARY
As described in this 510(k) Summary, all testing deemed necessary was conducted on FORUM to ensure that the device is safe and effective for its intended use when used in accordance with its Instructions for Use.
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#### DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes extending from its wing. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the left side of the logo.
#### Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
## MAR 2 5 2009
Carl Zeiss Meditec, Inc. c/o Mr. Mark Job Regulatory Technology Services LLC 1394 25th Street, NW Buffalo, MN 55313
Re: K090439
Trade/Device Name: FORUM™ Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: NFJ Dated: March 12, 2009 Received: March 13, 2009
Dear Mr. Job:
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. Ilisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
M. B. Everitt, m.s.
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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## SECTION 4.
## INDICATIONS FOR USE STATEMENT
#### 4. INDICATIONS FOR USE STATEMENT
510(k) Number (if known): _ | 096 439
FORUM™ Device Name:
Indications for Use:
FORUM is a software system application intended for use in storing, managing, and displaying patient data, diagnostic data, videos and images from computerized diagnostic instruments or video documentation systems through networks.
Prescription Use x (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page of of
(Division Sign-Off) Division of Ophthalmic and Ear, Nose and Throat Devices
510(k) Number k090439
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
