ORION

K070231 · Nidek Technologies Srl · HKI · Apr 24, 2007 · Ophthalmic

Device Facts

• Record ID: K070231
• Device Name: ORION
• Applicant: Nidek Technologies Srl
• Product Code: HKI · Ophthalmic
• Decision Date: Apr 24, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.1120
• Device Class: Class 2

Intended Use

ORION is intended for use as Fundus Camera. The color image of the fundus obtained in nonmydriatic conditions, using an IR sensible camera as a visible flash for illuminating the retina at picture taking.

Device Story

ORION is an AC-powered ophthalmic fundus camera used for diagnosing retinal diseases. It captures color images of the patient retina using CCD cameras, Xenon light, and IR LEDs for illumination in nonmydriatic conditions. The system integrates with dedicated NAVIS software running on Windows OS. Operated by eye care professionals in clinical settings, the device provides digital fundus images to assist clinicians in visualizing retinal structures. These images support clinical decision-making by enabling the documentation and assessment of retinal pathology, potentially benefiting patients through improved diagnostic monitoring.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

AC-powered ophthalmic camera; CCD sensor; Xenon light and IR LED illumination sources; nonmydriatic operation; software-based image capture and management (NAVIS software); Windows-based platform.

Indications for Use

Indicated for use in capturing images of the retina in patients requiring ophthalmic examination.

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

• MP-1 MICRO PERIMETER (K023719, K061768)
• NON-MYDRIATIC FUNDUS CAMERA, MODEL NM-1000 (K014274)

Submission Summary (Full Text)

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# K0702

ORION

## SUBMITTER INFORMATION

# APR 2 4 2007

| A. | Company Name: | Nidek Technologies Srl |
|----|--------------------------------|--------------------------------------------------------------------|
| B. | Company Address: | Via Dell'Artigianato, 6/A<br>Albignasego (Padova), Italy 35020 |
| C. | Company Phone:<br>Company Fax: | [phone]<br>[phone] |
| D. | Contact Person: | Mr. Aldo Cocchiglia<br>Managing Director<br>Nidek Technologies Srl |
| E. | Date Summary Prepared: | January 18, 2007 |

.

#### DEVICE IDENTIFICATION

| A. | Generic Device Name: | Ophthalmic camera, AC-powered |
|----|-------------------------|-------------------------------|
| B. | Trade/Proprietary Name: | ORION |
| C. | Classification: | Class II |
| D. | Product Code: | HKI |

.

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#### ORION

#### DEVICE DESCRIPTION

The Nidek Technologies Srl ORION is an instrument for the diagnosis of retinal diseases. It is able to capture color images of the patient retina through CCD cameras.

The fundus camera ORION is supplied with Xenon light and IR LEDs sources suitable for performing the above described examinations.

The system includes also the dedicated NAVIS software (running with Windows XP e 2000 operative system).

#### INTENDED USE

ORION is intended for use as Fundus Camera. The color image of the fundus obtained in nonmydriatic conditions, using an IR sensible camera as a visible flash for illuminating the retina at picture taking.

#### SUBSTANTIAL EQUIVALENCE

The Nidek Technologies Srl ORION device is of comparable type and is substantially equivalent to the following predicate devices:

| Predicate Device | 510(K) Holder | 510(k) No. | Date<br>Cleared |
|-----------------------------------------------|------------------------|--------------------|---------------------------------|
| MP-1 MICRO PERIMETER | NIDEK TECHNOLOGIES SRL | K023719<br>K061768 | 12 / 23 / 2002<br>09 / 28 /2006 |
| NON-MYDRIATIC FUNDUS<br>CAMERA, MODEL NM-1000 | NIDEK, INC | K014274 | 04/17/2002 |

In further support of a substantial equivalence determination, Section 5 provides a comparison chart of the fundus camera ORION and the predicate devices.

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#### 510(k) NOTIFICATION

# TECHNOLOGICAL CHARACTERISTICS

A comparison of the technological characteristics of ORION and the predicate devices has been performed. The results of this comparison demonstrate that the fundus camera ORION is equivalent to the marketed predicate devices.

### PERFORMANCE DATA

The performance data indicate that the fundus camera ORION device meets all specified requirements, and is substantially equivalent to the predicate device.

ORION

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circle around the eagle. The eagle is depicted in black, and the text is also in black. The logo is simple and recognizable, representing the department's mission to protect the health of all Americans.

ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Nidek Technologies, srl c/o Aldo Cocchiglia Via dell'Artigianato, 6/A 35020 Albignasego (Padova) Italy

Re: K070231

APR 2 4 2007

Trade/Device Name: ORION™ Regulation Number: 21 CFR 886.1120 Regulation Name: AC-Powered Ophthalmic Camera Regulatory Class: II Product Code: HKI Dated: April 2, 2007 Received: April 5, 2007

Dear Mr. Cocchiglia:

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, listing of devices, good manufacturing practice, labeling, and prohibitions against misbrandi, no 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.

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#### Page 2 – Aldo Cocchiglia

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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.

Sincerely yours,

MB Egelman, M.D.

Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# INDICATIONS FOR USE

510(k) Number (if known):

KO70231

Device Name:

.

ORION

.

Indications for Use:

ORION is an ophthalmic camera that is indicated for use in capturing images of the retina.

Prescription Use
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
ORION 510(k)

| | <div><img alt="Signature" src="signature.png"/></div> <div>(Division Sign-Off)</div> <div>Division of Ophthalmic Ear,</div> <div>Nose and Throat Devises</div> |
|---------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K070231 |