K013694 · Nidek, Inc. · NFJ · Nov 19, 2002 · Radiology
Device Facts
Record ID
K013694
Device Name
NIDEK ADVANCED VISION INFORMATION SYSTEM (NAVIS)
Applicant
Nidek, Inc.
Product Code
NFJ · Radiology
Decision Date
Nov 19, 2002
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 892.2050
Device Class
Class 2
Attributes
Software as a Medical Device
Indications for Use
The Nidek Advanced Vision Information System (NAVIS) is a software program intended for use in the collection, storage and clinical information management of patient data, diagnostic data and the images from computerized diagnostic instruments through direct connection with the instruments, or through networks.
Device Story
NAVIS is a software-based ophthalmic information management system. It collects, stores, and manages patient data, examination records, and diagnostic images from various computerized ophthalmic instruments via direct connection or network. The system provides real-time review of diagnostic information at PC workstations and integrates office scheduling and billing. Optional modules support specific applications, including Cell Analysis Eyebank, Fundus Measurement, and networking/internet connectivity. The software includes an image manipulation module for retinal and slit lamp imaging. Used by eye care professionals in clinical environments to centralize patient records, the system facilitates clinical decision-making by providing organized access to diagnostic data and images, potentially improving workflow efficiency and patient record management.
Clinical Evidence
Bench testing only. Performance testing was conducted based on product specifications and hazard analysis. The system performed as intended and was found equivalent to the predicate device.
Technological Characteristics
Software-based ophthalmic database and image processing system. Operates on PC workstations. Features include data collection/storage, image manipulation (retinal/slit lamp), and optional modules for cell analysis and fundus measurement. Connectivity via direct instrument connection or network. No specific hardware materials or energy sources defined as it is a software system.
Indications for Use
Indicated for use in ophthalmic clinical settings for the collection, storage, and management of patient data, diagnostic information, and images acquired from computerized ophthalmic 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).
{0}------------------------------------------------
Nidek Advanced Vision Information System (NAVIS) Original Premarket 510(k) Notification
K013694
#### SUMMARY OF SAFETY AND EFFECTIVENESS SECTION 16:
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and CFR 807.92.
#### SUBMITTER INFORMATION 16.1
| a. | Company Name: | Nidek, Inc. |
|----|--------------------------------------|-----------------------------------------------|
| b. | Company Address: | 47651 Westinghouse Drive<br>Fremont, CA 94539 |
| c. | Company Phone:<br>Company Facsimile: | (510) 226-5700<br>(510) 226-5750 |
| d. | Contact Person: | Hiro Matsuzaki<br>Quality Assurance Manager |
| e. | Date Summary Prepared: | November 18, 2002 |
#### DEVICE IDENTIFICATION 16.2.
| a. Trade/Proprietary Name: | Nidek Advanced Vision Information System<br>(NAVIS) |
|----------------------------|----------------------------------------------------------------|
| b. Classification Name: | Radiological Image Processing System<br>21 CFR 892.2050 86 NFJ |
#### IDENTIFICATION OF PREDICATE DEVICES 16.3
| Company | Device | 510(k) No. | Date Cleared |
|----------------|-------------------------------------|------------|--------------|
| AETmed, S.P.A. | AETmed Image Processing<br>Software | K012093 | 09/21/2001 |
#### DEVICE DESCRIPTION 16.4
The Nidek Advanced Vision Information System (NAVIS) is a computer technology software that collects, stores and maintains patient data information.
{1}------------------------------------------------
Nidek Advanced Vision Information System (NAVIS) Original Premarket 510(k) Notification
> NAVIS provides real-time review of diagnostic patient information from a number of ophthalmic medical instruments at any PC workstation. NAVIS incorporates patient data, examination data, office scheduling and billing into one system.
The Nidek Advanced Vision Information System (NAVIS) contains a main core software program and a number of optional software modules that can be installed. The additional software modules support the number of application instruments that can be used with NAVIS in order to directly transfer and enhance the patient examination data. Additional software modules include the Cell Analysis Eyebank module, the Fundus Measurement module and a software module to allow for networking of several PC workstations and internet access.
#### SUBSTANTIAL EQUIVALENCE 16.5
The Nidek Advanced Vision Information System is substantially equivalent to the AETmed Image Processing Software is terms of image processing, patient data collection and data management. NAVIS is also comparable to IFA Systems ifa System device and the Topcon Instruments Corporation IMAGEnet device in terms of their use in ophthalmic practice to collect and store clinical data. These devices transfer patient data from computerized diagnostic ophthalmic instruments via direct connections or through networks.
#### 16.6 INDICATIONS FOR USE
The Nidek Advanced Vision Information System (NAVIS) is a software program intended for use in collection, storage and clinical information management of patient data, diagnostic data and the images from computerized diagnostic instruments through direct connection with the instruments, or through networks.
{2}------------------------------------------------
#### TECHNOLOGICAL CHARACTERISTICS 16.7
The fundamental technical characteristics of NAVIS are similar to those of the predicate devices. The functionality and the indications for use for NAVIS are similar to the predicates. NAVIS and the predicate devices are patient databases that collect and store data from connected medical ophthalmic instruments. NA VIS differs from the predicate devices in that it contains an image manipulation module, which contains functions for retinal imaging and slit lamp imaging. The Imaging module can also contain the Cell Analysis and Fundus Measurement software for advanced data analysis.
#### PERFORMANCE DATA 16.8
Performance testing was conducted on the Nidek Advanced Vision Information System. System and supported instrument testing was completed based on product specifications and hazard effects determined from the risk analysis. The Nidek Advanced Vision Information System performed as intended and has thus is deemed substantially equivalent to the predicate device and comparable to other ophthalmic patient database devices.
### 16.9 CONCLUSIONS
This notification contains all information required by 21 CFR 807.87. A completed copy of the Premarket Notification 510(k) Reviewer's Checklist is provided in this submission. The Nidek Advanced Vision Information System (NAVIS) has been tested and found to perform as intended. NAVIS has been compared to a legally cleared predicate device and found to be substantially equivalent. Comparisons to other ophthalmic patient database software have also been performed and NAVIS was found to have equivalent functions.
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the circle is a stylized image of three human profiles facing to the right, with wavy lines below them.
## NOV 1 9 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NIDEK, Inc. c/o Ms. Carol White Patterson Consulting Group, Inc. · 21911 Erie Lane Lake Forest, CA 92630
Re: K013694 Trade/Device Name: Nidek Advanced Vision Information System (NAVIS) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: NFJ Dated: November 5, 2002 Received: November 7, 2002
Dear Ms. White:
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. Iisting 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.
{4}------------------------------------------------
## Page 2 - Ms. Carol White
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrlv/dsma/dsmamain.html
Sincerely yours,
A. Ralph Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
{5}------------------------------------------------
Nidek Advanced Vision Information System (NAVIS) Original Premarket 510(k) Notification
# INDICATION FOR USE
510(k) Number:
To Be Assigned By FDA
K013694
Device Name:
Nidek Advanced Vision Information System (NAVIS)
The Nidek Advanced Vision Information System (NAVIS) is a Indications for Use: software program intended for use in the collection, storage and clinical information management of patient data, diagnostic data and the images from computerized diagnostic instruments through direct connection with the instruments, or through networks.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | | |
|-------------------------------------------------------------------------------|----|----------------------|
| | | |
| (Division Sign-Off)<br>Division of Ophthalmic Ear,<br>Nose and Throat Devises | | |
| 510(k) Number_ | | |
| Prescription Use | OR | Over-The-Counter Use |
| (Per 21 CFR 801 109) | | |
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.
