NON-MYDRIATIC FUNDUS CAMERA, MODEL NM-1000

K014274 · Nidek, Inc. · HKI · Apr 17, 2002 · Ophthalmic

Device Facts

• Record ID: K014274
• Device Name: NON-MYDRIATIC FUNDUS CAMERA, MODEL NM-1000
• Applicant: Nidek, Inc.
• Product Code: HKI · Ophthalmic
• Decision Date: Apr 17, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.1120
• Device Class: Class 2

Intended Use

The Nidek Non-Mydriatic Fundus Camera Model NM-1000 is intended for use in capturing images of the retina and the anterior segment of the eye. This fundus camera can transfer images to a personal computer.

Device Story

Stationary, table-top non-mydriatic fundus camera; captures digital images of retina and anterior eye segment. Uses infrared light for patient alignment/monitoring; xenon flash for image capture. Integrated 6.4-inch LCD monitor displays patient ID, focusing indicators, and real-time color still images. Operator uses joystick for shutter release and manual motor-driven focus. Captured images saved to internal memory; transferable to PC via USB, RGB analog, or NTSC composite video. Eliminates need for 35mm/instant film. Used in clinical settings by eye care professionals to facilitate immediate image quality assessment and documentation.

Clinical Evidence

Bench testing only. Device evaluated for electrical safety (EN 60601-1), electromagnetic compatibility (EN 60601-1-2), programmable electrical medical systems (EN 60601-1-4), and ophthalmic instrument performance (ISO 15004). No clinical data presented.

Technological Characteristics

Table-top unit with integrated power supply. Light sources: Halogen (12V 50W) with infrared filter for observation; Xenon flash (max 25WS) for imaging. 6.4-inch LCD monitor. 1/3-inch CCD (observation) and 1/2-inch digital progressive scan CCD (imaging). Dioptric compensation: -32D to +40D. Connectivity: USB, RGB analog, NTSC composite. Manual motor-driven focus. Sterilization: N/A (non-invasive).

Indications for Use

Indicated for use in capturing images of the retina and anterior segment of the human eye.

Regulatory Classification

Identification

An ophthalmic camera is an AC-powered device intended to take photographs of the eye and the surrounding area.

Special Controls

*Classification.* Class II (special controls). The device, when it is a photorefractor or a general-use ophthalmic camera, 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

• Canon CR6-45NM Non-Mydriatic Retinal Camera (K980246)

Submission Summary (Full Text)

{0}------------------------------------------------

APR 1 7 2002

KO14274

# SECTION 17

# 510(k) SUMMARY

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

Confidential

{1}------------------------------------------------

2.

## 510(k) SUMMARY Nidek Non-Mydriatic Fundus Camera Model NM-1000

#### SUBMITTER INFORMATION 1.

| A. | Company Name: | Nidek Incorporated |
|----|--------------------------------|-----------------------------------------------------------------------|
| B. | Company Address: | 47651 Westinghouse Drive.<br>Fremont, CA 94539-7474 |
| C. | Company Phone:<br>Company Fax: | [phone]<br>[phone] |
| D. | Contact Person: | Mr. Hiro Matsuzaki<br>Quality Assurance Manager<br>Nidek Incorporated |
| E. | Date Summary Prepared: | December 21, 2001 |
| | DEVICE IDENTIFICATION | |
| A. | Classification Name: | Ophthalmic Camera (AC-Powered) |
| B. | Trade/Proprietary Name: | Nidek Non-Mydriatic Fundus Camera Model |

- Class II (per 21 CFR 886.1120) C. Device Classification:
- HKI Product Code: D.

#### SUBSTANTIAL EQUIVALENCE 3.

The Nidek Incorporated NM-1000 device is of comparable type and is substantially equivalent to the following predicate device:

NM-1000

| Predicate Device | Manufacturer | 510(k) No. | Date Cleared |
|-------------------------------------------------|----------------|------------|--------------|
| Canon CR6-45NM Non-<br>Mydriatic Retinal Camera | Canon USA, Inc | K980246 | May 6, 1998 |

、 …

{2}------------------------------------------------

#### DEVICE DESCRIPTION 4.

Nidek Co., Ltd. has developed the Model NM-1000, which is a stationary-type ophthalmic non-mydriatic fundus camera. Without using 35mm or instant films, this fundus camera incorporates a full digital video capturing system with memory functions, and can transfer captured images to a personal computer. The NM-1000 is designed to deliver its full performance as a fundus camera specializing in digital video capturing as a stand-alone unit or in combination with an image filing system.

In the same manner as other conventional fundus cameras, the Model NM-1000 fundus camera projects the fundus using invisible infrared beams of light during alignment and monitors patient's eye using an infrared video system which does not burden the patient's eye. As a high-sensitivity CCD chip captures an image during use, only a very small amount of flash is used as compared to the flash intensity used with instant film, therefore only giving a mild shock to the patient. The Model NM-1000 fundus camera can capture images with a very low amount of light as compared to a conventional fundus camera that uses an instant film.

The Model NM-1000 fundus camera design incorporates the camera unit and power unit into a single integrated table-top unit. During alignment, the camera displays (on the video monitor) patient ID number, as well as focusing functions such as a working distance detection spot and the focusing indicator.

The captured image is temporarily saved in the camera unit just after being captured, and is displayed as a color still image on the video monitor in real time. This allows the operator to immediately judge if the captured image is satisfactory or not. Furthermore, a large-scale 6.4-inch LCD display is used to enhance ease of operation.

Various terminals are provided to allow the operator to output and use the temporarily saved images for various purposes. The Model NM-1000 fundus camera can

{3}------------------------------------------------

interface with other devices through the use of a USB port, RGB analog output and composite video output (NTSC) connections.

#### INTENDED USE 5.

The Nidek Non-Mydriatic Fundus Camera Model NM-1000 is intended for use in capturing images of the retina and the anterior segment of the eye. This fundus camera can transfer images to a personal computer.

#### TECHNOLOGICAL CHARACTERISTICS 6.

A comparison of the technological characteristics of the Nidek Non-Mydriatic Fundus Camera Model NM-1000 and the predicate device has been performed, and the results are summarized in the table below. The results of this comparison demonstrate that the Nidek Non-Mydriatic Fundus Camera Model NM-1000 has the same basic technological characteristics as the predicate device and is equivalent to the marketed predicate device. The differences between the Nidek Non-Mydriatic Fundus Camera Model NM-1000 and the predicate device are insignificant and do not affect the safety or effectiveness of the device.

{4}------------------------------------------------

| PREDICATE DEVICE COMPARISON CHART | | |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|
| | Nidek Non-mydriatic Fundus<br>Camera Model NM-100 | Canon CR6-45NM<br>K980246 |
| Indications For Use | The Nidek NM-1000 is an ophthalmic camera that is indicated for use in capturing images of the retina and the anterior segment of the eye. | The CR6-45NM is indicated for use in taking pictures of the retina of the human eye. |
| <b>CAMERA:</b> | | |
| Saved Image Format | Nidek format (extension NFC) or Tiff format (extension TIF) | JPEG, TIF, DICOM |
| Picture angle | 45° | 45° |
| Working distance | 43.3 mm (from camera body to cornea) | 45 mm (from objective to cornea) |
| Working distance detection method | Anterior (Observation)<br>Fundus (Focusing on blight spots) | Anterior (Split Focus)<br>Fundus (Focusing on blight spots) |
| Minimum diameter of pupil | 4 mm | 4 mm |
| CCD Camera for observation | 1/3 inch CCD Camera Analog<br>Interlace Scan | 1/3 inch CCD Camera Analog<br>Interlace Scan |
| CCD Camera for<br>Photographing | ½ inch CCD Camera Digital<br>Progressive Scan (built-in) | TV Adapter & ½ inch 3 CCD Camera, Analog Non-Interlace Scan (Outer<br>Attachment) |
| Observation Display (B/W) | 6.4 inch LCD Monitor | 5 inch CRT Monitor |
| Photographing Display<br>(Color | 6.4 inch LCD Monitor | Outer Monitor (Option) Use |
| Dioptric compensation | Total -32 D to +40 D | Total -33D to +35D |
| Focusing | Manual (motor driven)<br>Split line focus on the retina (-10 to<br>+14 D) | Manual<br>Split line focus on the retina (-12 to<br>+15) |
| Observation Light Source | Halogen lamp (Max. 12V 50W) with<br>infrared filter | Halogen lamp (Max. 12V 75W) with<br>infrared filter |
| Photographing Light Source | Xenon flash (Max. 25WS) | Xenon flash (Max. 300WS) |

、「。

{5}------------------------------------------------

T

| | PREDICATE DEVICE COMPARISON CHART | |
|-----------------------------------------------------------|------------------------------------------------------|-------------------------------------------------------------------------|
| | Nidek Non-mydriatic Fundus<br>Camera Model NM-100 | Canon CR6-45NM<br>K980246 |
| Internal Fixation Navigation | Manual lever moving | LCD Display |
| Switching light path of<br>observation &<br>photographing | Beam Splitter | Mobile Mirror |
| Image File Function | Compact Flash Memory with PC Card<br>adapter | Connection to external device |
| Data Input | 15 characters, by the use of a numeric<br>keypad | Manual writing data (write on the card<br>and slide it in) |
| Observation Light<br>Adjustment | Volume adjustment style | Volume adjustment style |
| Photographing Light<br>Adjustment | Step adjustment style (8 steps) | Step adjustment style (5 steps) |
| CAMERA STAND (BASE): | | |
| Type | Table top; power source built-in | Table top; power source built-in |
| Horizontal Movement | 65 mm forward and backward, 106<br>mm left and right | 40 mm forward and backward<br>100 mm left and right |
| Vertical Movement | 30 mm | 40 mm |
| Shutter Release | Joystick upper button | Joystick upper button |
| Signal Outlet | USB, RGB Analog, NTSC Composite<br>Video | RGB Analog, NTSC or PAL<br>Composite Video (depending on CCD<br>camera) |
| CHINREST: | | |
| Vertical movement of | 65 mm | 70 mm |

#### PERFORMANCE DATA 7.

The following testing was performed on the Nidek Non-Mydriatic Fundus Camera Model NM-1000 to demonstrate that it meets all specified requirements and is equivalent to the predicate device:

Electrical Safety Testing & Electromagnetic Compatibility A..

{6}------------------------------------------------

The Nidek Non-Mydriatic Fundus Camera Model NM-1000 was tested in accordance with EN 60601-1 and EN 60601-1-2, and was found to meet all requirements of both standards.

Programmable Electrical Medical Systems B.

> The Nidek Non-Mydriatic Fundus Camera Model NM-1000 was tested in accordance with EN 60601-1-4 and was found to meet all requirements of the standard.

Test Requirements and Test Methods for Ophthalmic Instruments C.

> The Nidek Non-Mydriatic Fundus Camera Model NM-1000 was tested in accordance with ISO 15004 and was found to meet all requirements of the standard.

#### CONCLUSIONS 8.

Nidek Incorporated has demonstrated through its evaluation of the Nidek Non-Mydriatic Fundus Camera Model NM-1000 that the device is equivalent to the predicate device with respect to intended use, technological characteristics, and safety and effectiveness.

{7}------------------------------------------------

Image /page/7/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around an abstract symbol. The symbol consists of three stylized human profiles facing to the right, stacked on top of each other. The profiles are represented by thick, curved lines, giving the logo a modern and minimalist appearance.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Nidek Inc. C/O Mr. Carol Patterson President Patterson Consulting Group, Inc. 21911 Erie Lane Lake Forest, CA 92630

APR 17 2002

Re: K014274

Trade/Device Name: Non-Mydriatic Fundus Camera, Model NM -1000 Regulation Number: 21 CFR 886.1120 Regulation Name: AC-powered ophthalmic camera Regulatory Class: Class II Product Code: HKI Dated: April 9, 2002 Received: April 11, 2002

Dear Ms. Patterson:

We have reviewed your Section 510(k) premarket notification of intent to market the device wfo neve 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 for worked of 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, 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 (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 I loas of the 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 or uny 1 watt 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 orth 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.

{8}------------------------------------------------

### Page 2 - Mr. Carol Patterson

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 [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" (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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/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

{9}------------------------------------------------

# INDICATIONS FOR USE

(To Be Assigned By FDA) 510(k) Number:

Nidek Non-Mydriatic Fundus Camera Model NM-1000

Indications For Use:

Device Trade Name:

The Nidek Non-Mydriatic Fundus Camera Model NM-1000 is an ophthalmic camera that is indicated for use in capturing images of the retina and the anterior segment of the eye.

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

2-26-02

(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises

| 510(k) Number | K014274 |
|---------------|---------|
|---------------|---------|

| Prescription Use | OR | Over-The-Counter Use |
|------------------|----|----------------------|
|------------------|----|----------------------|

(Per 21 CFR 801.109)(Per 21 CFR 801.109)