LADARWAVE CUSTOMCORNEA WAVEFRONT SYSTEM

K062930 · Alcon Research, Ltd. · NCF · Nov 8, 2006 · Ophthalmic

Device Facts

• Record ID: K062930
• Device Name: LADARWAVE CUSTOMCORNEA WAVEFRONT SYSTEM
• Applicant: Alcon Research, Ltd.
• Product Code: NCF · Ophthalmic
• Decision Date: Nov 8, 2006
• 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 where a wavefront-guided treatment is indicated. This device can also export centration data and associated registration information for conventional phoropter-based refractive surgery with the LADAR6000™ System.

Device Story

LADARWave® CustomCornea® Wavefront System is an ophthalmic aberrometer using Hartmann-Shack wavefront sensing. Input: infrared probe beam reflected from the eye. Subsystems: fixation (adjusts for spherocylindrical error), video (operator eye positioning/registration), probe beam (infrared), and wavefront detection (imaging re-emitted wavefront). Operation: operator uses video imagery to align eye and record wavefront geometry relative to anatomical features. Output: refractive error maps and electronic files containing wavefront data, patient ID, and registration information. Used in clinical settings by eye care professionals. Data exported to compatible lasers (LADARVision®4000 or LADAR6000™) for customized ablative surgery. Assisted registration (overlay method) automates alignment, improving translational and cyclotorsional registration accuracy compared to manual methods. Benefits: enables precise wavefront-guided or conventional refractive surgery planning.

Clinical Evidence

Bench testing only. Equivalence study compared automated 'overlay' registration method against manual 'Sputnik' method. Sample: eye images collected for sessions with and without eye marks. Primary endpoints: accuracy of translational (x,y) and cyclotorsional registration. Results: 'overlay' method demonstrated accuracy as good as or better than 'Sputnik' method across all registration error values. Software verification and validation performed per FDA guidance.

Technological Characteristics

Hartmann-Shack wavefront sensing aberrometer. Infrared probe beam. Four optical subsystems: fixation, video, probe beam, wavefront detection. Proprietary software for data analysis and registration. Connectivity: export to removable media for compatible laser systems. Encrypted proprietary file format. Class I device.

Indications for Use

Indicated for patients requiring measurement and analysis of visual aberrations (myopia, hyperopia, astigmatism, coma, spherical aberration) to assist in prescribing refractive corrections and planning 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

• LADARWave® CustomCornea® Wavefront System (K023249)

Reference Devices

• LADARVision®4000
• LADAR6000™ System

Submission Summary (Full Text)

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K062930

# 510(k) Summary LADARWave® CustomCornea® Wavefront System

Alcon Research Ltd., on behalf of Alcon RefractiveHorizons 2501 Discovery Drive, Suite 500 Orlando, FL 32826

## A. Contact Person:

NOV - 8 2006

Janet G. Johnson Senior Manager Regulatory Affairs Telephone [phone] Fax [phone] Date Summary was Prepared: September 27, 2006

## B. Device Information:

| Proprietary Name: | LADARWave® CustomCornea® Wavefront System |
|-----------------------|-------------------------------------------|
| Common Name: | Abberrometer, Ophthalmic |
| Classification Name | Ophthalmic Refractometer |
| and Regulatory Class: | 21 CFR 886.7160 Class I |
| Product Code: | NCF |

## C. Substantial Equivalence Device (Predicate):

LADARWave® CustomCornea® Wavefront System (K023249)

### D. Indications for Use:

The LADARWave® CustomCornead 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 where a wavefront-guided treatment is indicated.

This device can also export centration data and associated registration information for conventional phoropter-based refractive surgery with the LADAR6000" System.

## E. Device Description:

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 automatically adjusts to correct for the patient's spherocylindrical error so that the target is clearly observed.

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- 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.

Once the wavefront examination is complete, the operator may export the exam data to removable media. The exported electronic file contains all information necessary to perform customized ablative surgery using either the LADARVision®4000 or LADAR6000" System. The information includes the wavefront measurement, essential patient identification information, and geometric registration data. The electronic file is in a proprietary format and is encrypted so that wavefront data cannot be exported for use by an incompatible treatment device.

#### F. Substantial Equivalence Comparison:

The LADARWave® CustomCornea® Wavefront System with Assisted Registration has the same indications for use, intended use, and same technological characteristics (i.e., design, material, chemical composition, energy source) as the current LADARWave® CustomCornea® Wavefront System.

The LADARWave® CustomCornea® Wavefront System with Assisted Registration software has automated the registration process, allows the option for LADARWave wavefront measurements (pre-op) to be performed on an alternate day than the surgery, and allows centration data and associated registration data, for conventional surgery, to be performed on the LADARWave and exported to the LADAR6000™ System.

## G. Testing:

Eye images were collected to perform equivalence testing of the new automated registration process. For each eye, one LADARWave wavefront session (centration photo and five wavefront measurements with associated photos) with eye marks and a session without eye marks were taken for the testing. These images were compared using the current manual "Sputnik" method and the "Overlay" assisted registration method. The primary test was to establish equivalence of the two methods of registration by testing that the accuracy in translational (x,y) and cyclotorsional registration for the "overlay" method are at least as good as with the current "sputnik" method.

The results demonstrate that the "overlay" method is as good or better than the "sputnik" method in offset registration and rotational registration at all values of registration error (i.e. at all x-axis values).

Additionally, system level software verification and validation were successfully completed in accordance with General Principles of Software Validation; Final Guidance for Industry and FDA Staff dated January 11, 2002.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Alcon Research, Ltd. c/o Ms. Janet G Johnson Senior Manager, Regulatory Affairs 2501 Discovery Drive, Suite 500 Orlando. FL 32826

NOV - 8 2006

Re: K062930

Trade/Device Name: LADARWave® CustomCornea® Wavefront System Regulation Number: 21 CFR 886.1760 Regulation Name: Ophthalmic Refractometer Regulatory Class: I Product Code: NCF Dated: September 27, 2006 Received: September 28, 2006

Dear Ms. Johnson:

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 misbrandijng 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 devire 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 - Janet G. Johnson

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. Egelmisi MD

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

Enclosure

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#### KO62930 510(k) Number (if known): Alcon LADARWave® CustomCornea® Wavefront System Device Name:

## Indications for Use Statement

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 where a wavefront-guided treatment is indicated.

This device can also export centration data and associated registration information for conventional phoropter-based refractive surgery with the LADAR6000™ System.

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

Arnl L. Kouchi

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

510(k) Number k062930

Prescription Use: X (Per 21 CFR 801.109)

Over the Counter Use:

Or