MP-1 MICROPERIMETER

K061768 · Nidek Technologies Srl · HKI · Sep 28, 2006 · Ophthalmic

Device Facts

• Record ID: K061768
• Device Name: MP-1 MICROPERIMETER
• Applicant: Nidek Technologies Srl
• Product Code: HKI · Ophthalmic
• Decision Date: Sep 28, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.1120
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MP-1 MICRO PERIMETER is intended for use as: 1) Color retinography Color image of the fundus obtained in non-mydriatic conditions, using an IR sensible camera as a viewfinder and a visible flash for illuminating the retina at picture taking. 2) Fixation exam This examination consists in: - locating, in the patient's fundus, his/her fixation site (anatomical information); recording the positions, during a certain interval, of the point at which the patient is fixating, as a measure of fixation stability (functional information). 3) Fundus-related microperimetry Consists in: - projecting light stimuli on patient retina at given positions; - recording the patient's subjective answer to each stimulus (seen/ not seen); - associating precisely the subjective answers (functional information) with the retinal location of the stimuli (anatomical information), compensating wroperly for eye fundus movements during the examination; - generating a sensitivity map of the inspected retinal region. 4) Visual rehabilitation The biofeedback tool consists of a software module which implements a new exam mode, called the "feedback exam". The feedback exam represents a visual rehabilitation tool, which helps the doctor training patients with unstable fixation to develop a new preferred retinal locus (PLR) being led by an audible bio-feedback signal

Device Story

MP-1 Micro Perimeter captures infrared live sequences and color fundus images via CCD cameras; projects light stimuli onto specific retinal locations; records patient subjective responses (seen/not seen) to stimuli; compensates for eye movements during examination. Used in clinical settings by physicians to generate retinal sensitivity maps, assess fixation stability, and perform visual rehabilitation. Biofeedback module provides audible signals to train patients with unstable fixation to develop a new preferred retinal locus (PLR). System includes Xenon/Halogen light sources, insulation transformer, LCD monitor, and IBM PC running NAVIS software. Output allows clinicians to diagnose retinal diseases and monitor functional/anatomical changes.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological comparison and bench testing.

Technological Characteristics

Ophthalmic camera/microperimeter; CCD camera; Xenon and Halogen light sources; LCD S-VGA monitor; IBM PC-based architecture; Windows 2000 OS; NAVIS software; AC-powered; includes insulation transformer.

Indications for Use

Indicated for color retinography, fixation examination, fundus-related microperimetry, and visual rehabilitation in patients requiring retinal disease diagnosis or fixation training.

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)
• AR-1 PHYSIOLOGICAL PRODESSOR (K810880)

Submission Summary (Full Text)

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K 06/768

# SUMMARY OF SAFETY AND EFFECTIVENESS MP-1 MICRO PERIMETER

SEP 2 8 2006

## SUBMITTER INFORMATION

| 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: | August 08, 2006 |

## DEVICE IDENTIFICATION

:

| A. | Generic Device Name: | Ophthalmic camera, AC-powered<br>Automated Micro Perimeter, AC-powered |
|----|-------------------------|------------------------------------------------------------------------|
| B. | Trade/Proprietary Name: | MP-1 MICRO PERIMETER |
| C. | Classification: | Class II |
| D. | Product Code: | HKI , HPT |

510(k)

Page 149

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K06 1768

### DEVICE DESCRIPTION

The Nidek Technologies Srl MP-1 MICRO PERIMETER is an instrument for the diagnosis of retinal diseases. It is able to capture infrared live sequences and color images of the patient retina through CCD cameras and at the same time to project light stimuli on the retina in those retinal positions chosen by the operator.

The MP-1 MICRO PERIMETER is supplied with Xenon light and Halogen light sources suitable for performing the above described examinations.

The system includes also a suitable Insulation transformer, a LCD S-VGA Monitor and

an IBM Personal Computer, which incorporates the dedicated NAVIS software (with

Windows 2000 operative system).

### INTENDED USE

The MP-1 MICRO PERIMETER is intended for use as:

#### 1) Color retinography

Color image of the fundus obtained in non-mydriatic conditions, using an IR sensible camera as a viewfinder and a visible flash for illuminating the retina at picture taking.

#### 2) Fixation exam

This examination consists in:

- locating, in the patient's fundus, his/her fixation site (anatomical information);
recording the positions, during a certain interval, of the point at which the patient is fixating, as a measure of fixation stability (functional information).

#### 3) Fundus-related microperimetry

Consists in:

-

. . .

- projecting light stimuli on patient retina at given positions; -
- recording the patient's subjective answer to each stimulus (seen/ not seen); -
- associating precisely the subjective answers (functional information) with the retinal location of the stimuli (anatomical information), compensating wroperly for eye fundus movements during the examination;
- generating a sensitivity map of the inspected retinal region. -

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K061768

#### 4) Visual rehabilitation

The biofeedback tool consists of a software module which implements a new exam mode, called the "feedback exam".

The feedback exam represents a visual rehabilitation tool, which helps the doctor training patients with unstable fixation to develop a new preferred retinal locus (PLR) being led by an audible bio-feedback signal

### SUBSTANTIAL EQUIVALENCE

The Nidek Technologies Srl MP-1 MICRO PERIMETER device is of comparable type and is substantially equivalent to the following predicate device:

| Predicate Device | 510(K) Holder | 510(k) No. | Date Cleared |
|---------------------------------|---------------------------|------------|----------------|
| MP-1 MICRO PERIMETER | NIDEK TECHNOLOGIES<br>SRL | K023719 | 12 / 23 /2002 |
| AR-1 PHYSIOLOGICAL<br>PRODESSOR | ATAL RESEARCHES LTD. | K810880 | 05 / 27 / 1981 |

In further support of a substantial equivalence determination, Section 5 provides a comparison chart of the modified MP-1 MICRO PERIMETER and the predicate devices.

## TECHNOLOGICAL CHARACTERISTICS

A comparison of the technological characteristics of the modified MP-1 MICRO PERIMETER and the predicate devices has been performed. The results of this comparison demonstrate that the modified MP-1 MICRO PERIMETER device is equivalent to the marketed predicate devices.

### PERFORMANCE DATA

:

The performance data indicate that the modified MP-1 MICRO PERIMETER device meets all specified requirements, and is substantially equivalent to the predicate device.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 8 2006

Nidek Technologies SRL c/o Mr. Aldo Cocchiglia Via Dell' Artigianato, 6/A Albignasego (Padova), Italy 35020

Re: K061768

Trade/Device Name: MP-1 Micro Perimeter Regulation Number: 21 CFR 886.1120 Regulation Name: Ophthalmic camera Regulatory Class: II Product Code: HKI, HPT Dated: August 11, 2006 Received: August 23, 2006

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 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 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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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,

M B Egelman SiWD

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): K061768

Device Name:

### MP-1 MICRO PERIMETER

Indications for Use:

The MP-1 MICRO PERIMETER is indicated for use as :

- Color retinography .
- Fixation examiner ●
- Fundus-related microperimetry .
- Visual rehabilitation. .

Prescription Use V (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)

Denis L. McCarthy

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

510(k) Number K061768

MP-1 510(k)

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