ALCON LADARWAVE CUSTOMCORNEA WAVEFRONT SYSTEM

K023249 · Alcon Laboratories, Inc. · NCF · Oct 18, 2002 · Ophthalmic

Device Facts

• Record ID: K023249
• Device Name: ALCON LADARWAVE CUSTOMCORNEA WAVEFRONT SYSTEM
• Applicant: Alcon Laboratories, Inc.
• Product Code: NCF · Ophthalmic
• Decision Date: Oct 18, 2002
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 886.1760
• Device Class: Class 1

Intended Use

The LADARWave" CustomCornea® Wavefront System is used for measuring, recording, and analyzing visual aberrations (such as myopia, hyperopia, astigmatism, coma and spherical aberration) and for displaying refractive error maps of the eye to assist in prescribing refractive corrections. This device is enabled to export wavefront data and associated anatomical registration information to a compatible treatment laser with an indication for wavefront-guided refractive surgery.

Device Story

Aberrometer using Hartmann-Shack wavefront sensing; measures ocular aberrations. Four subsystems: fixation (adjusts for spherocylindrical error), video (operator eye positioning/registration), probe beam (infrared radiation into eye), wavefront detection (images re-emitted wavefront onto sensor). Operated by clinicians in clinical settings. Software controls subsystems; processes wavefront data; generates refractive error maps. Exports data/anatomical registration to compatible treatment lasers for wavefront-guided refractive surgery. Benefits patient by providing precise diagnostic data for customized refractive correction.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use.

Technological Characteristics

Hartmann-Shack wavefront sensor; infrared probe beam; four optical subsystems (fixation, video, probe beam, wavefront detection). Software-controlled. Class I ophthalmic refractometer.

Indications for Use

Indicated for patients requiring measurement and analysis of visual aberrations, including myopia, hyperopia, astigmatism, coma, and spherical aberration, to assist in prescribing refractive corrections and planning wavefront-guided refractive surgery.

Regulatory Classification

Identification

An ophthalmic refractometer is an automatic AC-powered device that consists of a fixation system, a measurement and recording system, and an alignment system intended to measure the refractive power of the eye by measuring light reflexes from the retina.

Predicate Devices

• K000637

Submission Summary (Full Text)

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

<023249

# Abbreviated 510(k) Summary Alcon LADARWave" CustomCornea" Wavefront System

# General Information I.

| a. Applicant: | Alcon<br>2501 Discovery Drive, Suite 500<br>Orlando FL 32826 |
|------------------------------|--------------------------------------------------------------|
| b. Contact Person: | Christy Stevens, OD |
| c. Telephone:<br>Fax: | [phone]<br>[phone] |
| d. Summary Preparation Date: | September 27, 2002 |

### II. Names

Alcon LADARWave™ CustomCornea® Wavefront System Device Name: Primary Classification Name: Ophthalmic Diagnostic Device Refractometer Class I 886.1760

### III. Predicate Devices

Predicate Devices: As defined in the 21 CFR Sections 886.1350, 1760, 1770, and 1780, there are several diagnostic devices employed to measure the refractive power and any refractive errors of the eye. Some measure the corneal curvature (MMQ, HJA, 886.1350), some measure the refractive power of the eye by measuring light reflexes from the retina (HKO, 886.1760), some use lenses and subjective responses from the subject being measured (HKN, 886.1770) and some illuminate the retina and note the direction of movement of the light on the retinal surface to determine the refraction by the eye of the emergent rays (HKL, 886.1780). Each of these diagnostic devices provides some valuable information in assessing the refractive errors of the ocular system. However, no one product is available to date which is able to provide a comprehensive assessment of refractive errors.

The LADARWave" CustomCornea" Wavefront System has the following characteristics in common with other refractive diagnostic device products:

- . Each of the diagnostic devices, which serve as predicates to this device, measure refractive characteristics of the eye.
- Each of the diagnostic approaches operates on a similar principle of using some form of light energy reflected off an ocular structure (cornea, retina), which is then documented to communicate the degree from which the eve deviates from normal.
- Each of the diagnostic devices used to assess refractive errors of the eye pose no significant risk to the patient.

The LADARWave" CustomCornea" Wavefront System is substantially equivalent to prior aberrometers and the predicate model approved under K000637.

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

# Product Description IV.

The LADARWave" CustomCornea® Wavefront System is an aberrometer, utilizing Hartmann-Shack wavefront sensing to measure the aberrations in the human eye. The device contains four major optical subsystems used in the clinical wavefront examination.

- A fixation subsystem provides the patient with an unambiguous point of fixation. . Optics in this path adjust automatically to correct for the patient's spherocylindrical error so that the target is clearly observed.
- A video subsystem provides the device operator with a view of the eye at the . measurement plane. The operator uses the video imagery to position the eye for the measurement and to record the geometry of the wavefront relative to anatomical features.
- A probe beam subsystem directs a narrow beam of eye-safe infrared radiation into the . eye to generate the re-emitted wavefront.
- A wavefront detection subsystem images the re-emitted wavefront onto the entrance ● face of the Hartmann-Shack wavefront sensor.

These subsystems are all under control of the device software.

### V. Indications for Use

The LADARWave" CustomCornea" Wavefront System is used for measuring, recording, and analyzing visual aberrations (such as myopia, astigmatism, coma and spherical aberration) and for displaying refractive error maps of the eye to assist in prescribing refractive corrections. This device is enabled to export wavefront data and associated anatomical registration information to a compatible treatment laser with an indication for wavefront-guided refractive surgery.

### VI. Rationale for Substantial Equivalence

The LADARWave" CustomCorneas Wavefront System shares the same indication for use and similar design features as the predicate devices.

### VII. Conclusion

The LADARWave" CustomCornea" Wavefront System is substantially equivalent to currently marketed aberrometers. The LADARWave" CustomCornea" Wavefront System shares the same intended use and indication for use and other basic system characteristics as the predicate systems. This device is enabled to export wavefront data and associated anatomical registration information to a compatible treatment laser with an indication for wavefront-guided refractive surgery.

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

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, resembling a bird-like shape.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Alcon Laboratories, Inc. c/o Christy Stevens, OD Director Clinical Affairs 2501 Discovery Drive, Suite 500 Orlando, FL 32826

OCT 1 8 2002

Re: K023249

Trade/Device Name: Alcon LADAR Wave™ CustomCornea® Wavefront System Regulation Number: 21 CFR 886.1760 Regulation Name: Ophthalmic Refractometer Regulatory Class: Class I Product Code: NCF Dated: September 27, 2002 Received: September 30, 2002

Dear Dr. Stevens:

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.

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

Page 2 - Christy Stevens, OD

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

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

# Indications for Use Statement

510(k) Number (if known): K023249

Alcon LADARWave™ CustomCornea® Wavefront System Device Name:

The LADARWave" CustomCornea® Wavefront System is used for Indications for Use: measuring, recording, and analyzing visual aberrations (such as myopia, hyperopia, astigmatism, coma and spherical aberration) and for displaying refractive error maps of the eye to assist in prescribing refractive corrections.

> This device is enabled to export wavefront data and associated anatomical registration information to a compatible treatment laser with an indication for wavefront-guided refractive surgery.

# (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use: X (Per 21 CFR 801.109)

Over the Counter Use:

Enether Beem

Or

wision Sian-Off Division of Ophthalmic Ear, Nose and Throat Devises

Optional Format 1-2-96

510(k) Number Y023249