ALLEGRO OCULYZER

K071183 · Wavelight AG · MXK · Jul 20, 2007 · Ophthalmic

Device Facts

• Record ID: K071183
• Device Name: ALLEGRO OCULYZER
• Applicant: Wavelight AG
• Product Code: MXK · Ophthalmic
• Decision Date: Jul 20, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.1850
• Device Class: Class 2

Intended Use

The ALLEGRO Oculyzer is designed to take photos of the anterior segment of the eye, which includes the cornea, pupil, anterior chamber and the lens of the eye. To evaluate: - Corneal shape - Analyze condition of the lens (opaque crystalline lens) - Analyze the anterior chamber angle - Analyze the anterior chamber depth - Analyze the volume of the anterior chamber - Analyze the anterior and posterior cortical opacity - Analyze the location of the cataracts (nuclear, subcapsular and or cortical), using cross-lit images with densitometry - Corneal thickness.

Device Story

ALLEGRO Oculyzer is a table-mounted Scheimpflug camera system for anterior eye segment imaging. Input: slit lamp images captured via 475nm UV-free LED illumination and CCD camera. Operation: device rotates around eye, capturing up to 50 images; system digitizes images and transfers data to external PC. Processing: PC constructs 3D mathematical model from 25,000 elevation points. Output: 3D model and densitometry data used by clinicians to evaluate corneal shape, thickness, chamber dimensions, and cataract location/opacity. Used in clinical settings by eye care professionals to assist in diagnostic decision-making regarding corneal and lens conditions.

Clinical Evidence

No clinical data presented; bench testing only.

Technological Characteristics

Table-mounted Scheimpflug camera; 475nm UV-free LED illumination; CCD camera; electric motor for rotation; memory board and CPU for image storage/analysis; communication board for PC connectivity. Software performs 3D mathematical modeling and densitometry analysis.

Indications for Use

Indicated for patients requiring evaluation of the anterior segment of the eye, including corneal shape, corneal thickness, anterior chamber parameters (angle, depth, volume), and lens conditions such as cataracts and cortical opacities.

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

• Oculus Pentacam Scheimpflug Camera system (K030719)

Reference Devices

• Orbscan II Keratometer

Submission Summary (Full Text)

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KO71183

JUL 20 2007

Image /page/0/Picture/2 description: The image shows the word "WaveLight" with a stylized wave symbol to the left of the word. The word "WaveLight" is written in a sans-serif font. The wave symbol consists of three horizontal, curved lines stacked on top of each other.

### 510(k) Summary of Safety and Effectiveness

This 510(k) Summary of Safety and Effectiveness is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92

## 1. General Information

| Submitter: | WaveLight AG<br>Am Wolfsmantel 5<br>91058 Erlangen<br>Germany |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Alexander Popp<br>Am Wolfsmantel 5<br>91058 Erlangen<br>Germany<br>Telephone: [phone]<br>Fax: [phone] |
| Summary Preparation Date: | April 17, 2007 |

Names

| Device Name: | ALLEGRO Oculyzer |
|----------------------|----------------------------------------------------------------|
| Classification Name: | Ophthalmic Camera<br>Product Code: MXK<br>Panel: Ophthalmology |

### 3. Predicate Devices

2.

The ALLEGRO Oculyzer system is substantially equivalent to the Oculus Pentacam Scheimpflug Camera system (K030719)

# 4. Device Description

The ALLEGRO Oculyzer Scheimpflug Camera is based on the Scheimpflug principle for slit lamp photography. The system is table mounted onloing powered by an external power supply. The system contains

(a) measuring devices including:

- illumination unit with LED's, 475nm wavelength UV-free to illuminate the . anterior segment of the eye,
- a CCD-Camera unit to take the Scheimpflug Images, .

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K071183

Image /page/1/Picture/1 description: The image shows the logo for WaveLight. The logo consists of a symbol resembling three stacked sine waves on the left, followed by the word "WaveLight" in a simple, sans-serif font. A small trademark symbol appears to the upper right of the word "WaveLight".

## 510(k) Summary of Safety and Effectiveness

- a CCD-Camera unit in the center for the fixation monitoring and internal . correction,
- a optical lens system to project the slit, .
- two infrared LED's to illuminate the pupil for fixation monitoring. .

(b) electrical devices, including:

- a memory board and a CPU and which stores and analyses the taken . images.
- a power supply board which prepares and controls the electrical conditions of . the ALLEGRO Oculyzer Scheimpflug system
- an electric motor for rotating .
- a communication board for transferring the images to external standard high . speed PC's (part of the device)

All the mentioned parts are mounted internal the system and the housing around separates this parts from any external illegal operation.

The measurement can be done in two different ways, depending of what you like to evaluate:

- (c) Taking photos from one Camera position:
The Camera takes pictures from one fixed position as it is already well known from the common Scheimpflug Cameras. The intended use is to get information of the condition of the lens.

- (d) Taking photos from several positions:
The Camera rotates around the eye and takes up to 50 Scheimpflug Images from several positions. Every single picture has 500 measured true elevation points. So in the summary we get 25.000 measured true elevation points. The Scheimpflug Images taken during the examination are digitalized in the system. All Image Data are transferred to the external PC. When the examination is finished, the PC calculates a three dimensional mathematical model from which all additional information is derived.

-2-

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K071183

Image /page/2/Picture/1 description: The image shows the logo for WaveLight. The logo consists of three horizontal wavy lines on the left, followed by the word "WaveLight" in a sans-serif font. There is a trademark symbol in the upper right corner of the word "WaveLight".

## 510(k) Summary of Safety and Effectiveness

The intention is to get information about

- anterior and posterior surface of the cornea, .
- . thickness of the cornea.
- chamber angle, volume and depth. .

Other systems which are already on the market and has an FDA admission like the Orbscan IITM Keratometer, measured at the beginning about 9.000 true elevation points and now about 18.000 measurement points at all. This instrument calculates the pachymetry and the posterior surface using the measured points, too.

There is also a device called Pentacam Scheimpflug Camera. As the WaveLight Device consists of the Measuring device from Oculus the WaveLight device fulfills the same technical specifications. Also the software includes the same basic functions but is customized to the WaveLight Corporate Design.

### 5. Indications for Use

The ALLEGRO Oculyzer is designed to take photos of the anterior segment of the eye which includes the cornea, pupil, anterior chamber and lens of the eye. To evaluate:

- corneal shape .
- analyse conditions of the lens (opaque crystalline lens) .
- . analyse the anterior chamber angle
- analyse anterior chamber depth .
- analyse the volume of the anterior chamber .
- analyse anterior and posterior cortical opacity .
- analyse the location of cataracts (nuclear, subcapsular and or cortical), using . cross lit images with densitometry
- . corneal thickness.
- 6. Performance Data

None presented.

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Public Health Service

Image /page/3/Picture/2 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

WaveLight AG c/o Ralph Saettele Am Wolfsmantel 5 91058 Erlangen Germany

JUL 2 U 2007

Re: K071183

> Trade/Device Name: ALLEGRO Oculyzer Regulation Number: 21 CFR 886.1850 Regulation Name: AC-powered slitlamp biomicroscope Regulatory Class: Class II Product Code: MXK Dated: July 09, 2007 Received: July 11, 2007

Dear Mr. Saettele:

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) I mis lotter notification. The FDA finding of substantial equivalence of your device to a legally promated 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 rr you a the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to (210) 110 01161cation" (21CFR Part 807.97). For questions regarding postmarket surveillance, promation hotellance in Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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. Egolkins, mD

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: K071183 Device Name: ALLEGRO Oculyzer

Indications For Use:

The ALLEGRO Oculyzer is designed to take photos of the anterior segment of the eye, which includes the cornea, pupil, anterior chamber and the lens of the eye.

To evaluate:

- . Corneal shape
- . Analyze condition of the lens (opaque crystalline lens)
- Analyze the anterior chamber angle ●
- Analyze the anterior chamber depth
- Analyze he volume of the anterior chamber ●
- Analyze the anterior and posterior cortical opacity .
- Analyze the location of the cataracts (nuclear, subcapsular and or cortical), using cross-lit . images with densitometry
- Corneal thickness .

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Tean.

510(k) Number K071183