NIDEK STEREO DISC CAMERA(3-DX)/NIDEK STEREO FUNDUS CAMERA(3-DXF)

K973533 · Nidek, Inc. · HKI · Nov 4, 1997 · Ophthalmic

Device Facts

• Record ID: K973533
• Device Name: NIDEK STEREO DISC CAMERA(3-DX)/NIDEK STEREO FUNDUS CAMERA(3-DXF)
• Applicant: Nidek, Inc.
• Product Code: HKI · Ophthalmic
• Decision Date: Nov 4, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.1120
• Device Class: Class 2

Intended Use

Model 3-DX captures simultaneous stereo photographs of disc/ fundus area on a single frame - suitable picture angle for stereoscopic optic disc glaucoma diagnosis. Model 3-DXF has an additional fluorescence angiography capability to 3-DX.

Device Story

Nidek 3-DX/3-DXF are ophthalmic cameras for capturing stereo photographs of the ocular fundus and optic disc. Model 3-DX captures simultaneous stereo images on a single frame for glaucoma diagnosis. Model 3-DXF includes additional fluorescence angiography capability. Devices are used by eye care professionals in clinical settings to document retinal and optic disc pathology. Output consists of photographic images used by clinicians to assess ocular health and support diagnostic decision-making.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Ophthalmic fundus camera system. Model 3-DX provides stereoscopic imaging; Model 3-DXF adds fluorescence angiography. Optical imaging system.

Indications for Use

Indicated for patients requiring stereoscopic optic disc glaucoma diagnosis via fundus photography (Model 3-DX) or fluorescence angiography (Model 3-DXF).

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.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 4 1997

Mr. Ken Kato Vice President Nidek, Inc. 47651 Westinghouse Drive Fremont, CA 94539

Re: K973533

Trade Name: Nidek 3- DX/3DXF Stereo Disc/Fundus Cameras Regulatory Class: II Product Code: 86 HKI Dated: September 17, 1997 Received: September18, 1997

Dear Mr. Kato:

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. Kato

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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| THE CHANGE THE PERSONAL PROPERTY | |

## 510(k) Number (if known): K9735333

Nidek 3-DX/3-DXF Stereo Disc/Fundus Cameras Device Name:

## Indications For Use:

Model 3-DX captures simultaneous stereo photographs of disc/ fundus area on a single frame - suitable picture angle for stereoscopic optic disc glaucoma diagnosis.

Model 3-DXF has an additional fluorescence angiography capability to 3-DX.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Am Williams

(Division Sign-Off)
Division of Ophthalmic Devices
510(k) Number K973533

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)

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