ANTERIOR EYE-SEGMENT ANALYSIS SYSTEM

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

Intended 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.

Predicate Devices

• Nidek, 3-DXF Stereo Fundus Camera (K973533)
• KOWA Optimed Inc., SC-1200 Slit Lamp (K955442)

Submission Summary (Full Text)

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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 [phone]. Additionally, for questions on.the.promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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