K991284 · Nidek, Inc. · MXK · Aug 6, 1999 · Ophthalmic
Device Facts
Record ID
K991284
Device Name
ANTERIOR EYE-SEGMENT ANALYSIS SYSTEM
Applicant
Nidek, Inc.
Product Code
MXK · Ophthalmic
Decision Date
Aug 6, 1999
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 886.1850
Device Class
Class 2
Indications for Use
The EAS-1000 "Anterior Eye-Segment Analysis System" is intended to take photographs of the eye and surrounding area, for non-invasive illumination, magnification, observation, analysis and photography of the anterior segments of the eye, which include the cornea, aqueous, lens, vitreous and retina of the eye. To evaluate and analyze conditions of lens (opaque crystalline lens), lens position (pre and post Intraocular Lens Transplant), anterior or posterior cortical opacity, cataracts (nuclear, subcapsular and or cortical) using cross slit imaging or retro-illumination, or both with densitometry and biometry analyses where applicable.
Device Story
EAS-1000 is a table-mounted, AC-powered ophthalmic diagnostic system. It captures images of the eye and surrounding area using the Scheimpflug principle for slit-image photography. Inputs include optical data from the eye via a Xenon flash lamp for flash photography and an infrared LED (800 nm) for retro-illumination. The system features a CCD camera, viewing optics, and a CPU for digital image processing. Operated by clinicians in a clinical setting, the device provides digital images and data displayed on a CRT monitor. The system performs densitometry and biometry analyses to assist in evaluating corneal shape, lens opacity, cataract progression, and anterior chamber angles. These outputs support clinical decision-making regarding ocular health and surgical planning (e.g., IOL transplants). The device benefits patients by providing non-invasive, objective documentation and quantitative analysis of anterior segment structures.
Clinical Evidence
Evidence provided via published journal articles supporting use, accuracy, safety, and effectiveness. No internal non-clinical performance data provided in the submission. Clinical studies were used to validate the device for its intended diagnostic applications.
Technological Characteristics
Table-mounted, AC-powered (100 Vac, 50/60 Hz). Features: Xenon flash lamp (200Wsec), 800 nm Infrared LED for retro-illumination, CCD camera, 5.5" B&W CRT display. Resolution: 640 x 400 pixels. Scheimpflug principle-based slit imaging. Non-invasive, patient-contact limited to chin/forehead rest. Weight: 25 kg.
Indications for Use
Indicated for patients requiring non-invasive imaging and analysis of the anterior eye segment, including cornea, aqueous, lens, vitreous, and retina. Used to evaluate corneal shape, lens conditions (including pre/post-transplant), anterior chamber angles, cortical opacities, and cataract degree/location.
Regulatory Classification
Identification
An AC-powered slitlamp biomicroscope is an AC-powered device that is a microscope intended for use in eye examination that projects into a patient's eye through a control diaphragm a thin, intense beam of light.
Special Controls
*Classification.* Class II (special controls). The device, when it is intended only for the visual examination of the anterior segment of the eye, is classified as Group 1 per FDA-recognized consensus standard ANSI Z80.36, does not provide any quantitative output, and is not intended for screening or automated diagnostic indications, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.
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K991284
# 510(k) SUMMARY [As required by 21 CFR 807.93]
#### GENERAL INFORMATION I
Applicant's Name & Address: Nidek Incorporated 47651 Westinghouse Drive Fremont, California 94539-7474 Mr. Jerry Tsutsumi Contact: Regulatory/Quality Manager Date Summary Prepared: 12 April 1999
#### DEVICE NAME II
Trade or Proprietary Name: Model Number: Common/Classification Name: Class: Classification Panel: Product Code: Regulation Number:
Anterior Eye-Segment Analysis System EAS-1000 Ophthalmic Camera Class II 86 MXK 886.1850
#### III PREDICATE DEVICES
The Nidek EAS-1000 Anterior Eye-Segment Analysis System is claimed to be substantially equivalent to the following currently Marketed Devices:
- Nidek, 3-DXF Stereo Fundus Camera K973533 received 11/4/ 97 .
- KOWA Optimed Inc., SC-1200 Slit Lamp -- K955442 received 1/3/96 .
### IV PRODUCT DESCRIPTION
This DEVICE is a non-invasive, table mounted, AC powered diagnostic sytem intended to take photographs of the eye and surrounding area. The system contains a illumination device, viewing optics, a computer (CPU), image capturing devices, and is based on the Scheimpflug Principle for Slit Image photography. The system uses a Xenon flash lamp for Flash Photography, and an Infrared LED for Retro-Illumination.
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| | EW DEVICE. | PREDICATE DEVICE | PREDICATION WORLDE |
|----------|----------------------------|-----------------------------|----------------------------|
| | Nidek Inc. | Nidek Inc. | Kowa Optimed |
| | EAS-1000 | 3DXF Stereo Fundus Camera | KOWA SC-1200 |
| | Single Aperature | Stereo Aperature | Single or Stereo |
| | | | Aperature |
| | 5.5" Black & White CRT | Eyepiece, Stereo Viewing | Eyepiece, Stereo/Mono |
| | | Optics | Viewing Optics |
| | Infrared LED for Retro- | Halogen Lamp | Halogen Lamp |
| | Illumination 800 nm | 50W | 30W |
| | Xenon Lamp | Xenon Lamp | Xenon Lamp |
| | 200Wsec | 200Wsec | 300W |
| | 4 Step - Selectable | 5 Step – Manual | 5 Step - Manual |
| | (50, 100, 150, 200 WS) | (25, 50, 100, 200, 400 WS) | (25, 50, 100, 200, 300 WS) |
| | CCD Camera | 35 mm Film Plane | 35 mm Film Plane |
| | | or Polaroid Media | or Polaroid Media |
| | Data digital and can be | Image is a film hard copy | Image is a film hard copy |
| | displayed on a CPU | only | only |
| | 640 x 400 pixels | N/A | N/A |
| | | | |
| GAMAN | 8 mm X 6.6 mm | 20 mm X 16 mm (stereo) | 24 mm X 17 mm (stereo) |
| | | | 24 mm X 24 mm (mono) |
| | | | 24 mm X 36 mm (right) |
| otograph | Offers Photographic angles | Offers a swing angle of 15° | Offers a Slit Projection |
| | from 0 to 180° | right or left | angle of 90° from vertical |
| | 0.5 X | 2.6X | 0.7, 1.1, 1.7, 2.8, 4.3X |
| | | | Stereo |
| | 2 ~ 14 mm, adjustable | N/A | 0 ~ 11 mm, adjustable |
| | 150 V A | 600 VA | 1300 VA |
| | | | |
| | 100 Vac | AC 100, 120, 220, 240V | AC 100, 117 , 220, 240V |
| | 50/60 Hz | 50/60 Hz | 50/60 Hz |
| | 25 Kg | 30 kg | N/A |
#### INDICATIONS FOR USE V
Intended Use: The EAS-1000 is intended to take photographs of the eye and surrounding area, which includes the cornea, aqueous, lens, vitreous and retina of the eye. To evaluate:
- corneal shape,
- and analyze conditions of lens (opaque crystalline lens), ●
- the state of lens (pre and post Intraocular Lens Transplant), .
- and analyze anterior chamber angles, .
- and analyze anterior or posterior cortical opacity, .
- the degree and location of cataracts (nuclear, subcapsular and or cortical) . using cross slit imaging or retro-illumination, or both with densitometry and biometry analyses where applicable.
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## VI CLINICAL PERFORMANCE DATA
Published Journal Articles were supplied to support the claims for use, accuracy, safety and effectiveness of the EAS-1000 for the prescribed intended uses defined in this submission.
## VII NON-CLINICAL PERFORMANCE DATA
None provided at this time.
## VIII RATIONAL FOR SUBSTANTIAL EQUIVALENCE
The GENERAL INTENDED USES of all three of these devices is "to take photographs of the eye and surrounding area".
Our claim of Substantial Equivalence, and is also based on the following;
- The devices compared, utilize the same or similar OPERATING PRINCIPLES, in . that they all contain an optical system, a source of illumination for observation, a source of illumination for photography, and photographic mediums.
- All three devices utilize the same DEVICE FEATURES, a Head Stabilizing device, . an External Fixation Target, a Joy Stick or Control Mechanism, and a Exposure Control.
- All three devices utilize a ILLUMINATION SOURCE, and a FLASH OUTPUT ● SOURCE, and safety concerns regarding "Photo Toxicity" is not an issue with these devices.
- All three devices are considered "Non Invasive" devices as defined in 21 CFR . §812.3(k) and are considered NOT to be a "Significant Risk Device" as defined in 21 CFR §812.3(m).
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#### IX SAFETY AND EFFECTIVENESS
The EAS-1000 is a non-invasive diagnostic system and only contacts the patient on his/her chin and forehead, and DOES NOT present or pose any new or additional significant effects or risks on the safety, performance, use or effectiveness for its prescribed intended uses. Light safety concerns or "Photo Toxicity" is not an issue with this device as light output is of an eyesafe intensity and wavelength. Electrical Safety requirements for medical device are met. The device is proven effective for its intended uses through internal company and independent international clinical studies. The information provided in this submission reasonably assures this product to be Safe and Effective for it intended uses.
#### CONCLUSION ×
We believe that the data submitted in this document, demonstrates that the EAS-1000 is substantially equivalent with respect to the indications for use, operating principles, and the device features to other legally market predicate devices. The safety and effectiveness of this product can be reasonably assured, as the EAS-1000 DOES NOT pose any new or additional significant effects on the safety, performance, use or effectiveness of this device for its prescribed intended uses. We believe that this device clearly meets the requirement for substantial equivalence according to the 510(k) guidelines. Therefore, justifying 510(k) PreMarket Notification Clearance for commercial sale and distribution of this product within the United States.
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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with three lines representing its body and wings. The eagle is facing to the right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG -6 1999
Mr. Jerry Tsutsumi Regulatory/Quality Manager Nidek Incorporated 47651 Westinghouse Drive Fremont, California 94539-7474
Re: K991284 Trade Name: Anterior Eye-Segment Analysis System Regulatory Class: II Product Code: 86 MXK Dated: July 13, 1999 Received: July 14, 1999
Dear Mr. Tsutsumi:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations .
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Page 2 - Mr. Jerry Tsutsumi
This letter will allow you to begin marketing your device as described in your 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 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
A. Ralph Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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### Concurrence of CDRH ODE Form
510(k) Number (if known): K991284
Device Name: Nidek Inc. EAS-1000 Anterior Eye Segment Analysis System
## INDICATIONS FOR USE:
The EAS-1000 "Anterior Eye-Segment Analysis System" is intended to take photographs of the eye and surrounding area, for non-invasive illumination, magnification, observation, analysis and photography of the anterior segments of the eye, which include the cornea, aqueous, lens, vitreous and retina of the eye. To evaluate and analyze conditions of lens (opaque crystalline lens), lens position (pre and post Intraocular Lens Transplant), anterior or posterior cortical opacity, cataracts (nuclear, subcapsular and or cortical) using cross slit imaging or retro-illumination, or both with densitometry and biometry analyses where applicable.
# Concurrence of CDRH, Office of Device Evaluation (ODE)
Everett Beam
(Division Sign-Off)
Prescription Use
(Per 21 CFR 801.109)
OR
Over the Counter Use
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.
