WAVESCAN WAVEFRONT SYSTEM MODEL HS 1

{0}------------------------------------------------ MAY - 2 2000 Image /page/0/Picture/1 description: The image shows the logo for Visx. Above the name is a curved line with a circle in the middle. Below the name is the tagline "WE MAKE THINGS CLEAR." K000327 ## Summary Statement SUBMITTER: Submitted by: Company Name: VISX, Inc. 3400 Central Expressway Santa Clara, California 95051 (408) 773-7327 (408) 773-7324 CONTACT PERSON: David M. Patino Vice President, Regulatory and Clinical Affairs DATE SUMMARY PREPARED: Address: Phone: Fax: WaveScan™ Wavefront System Model HS 1 TRADE NAME: COMMON NAME: Autorefractor January 31, 2000 # SUBSTANTIALLY EQUIVALENT TO: The WaveScan™ Wavefront System Model HS 1 is substantially equivalent to the predicate device, the Canon R-50m. Both devices have the same indication for use, in that they are devices which are diagnostic tools for obtaining objective output measurements of refractive error of the eye. These devices obtain this information by means of light ray deflection principles to measure the refractive elements of the eye and provide automated read-outs of refractive error. The principle of light waves incorporates the known elements of light energy moving in successive flat sheets, or wavefronts. The measurement principles of both instruments utilize the element of wavefront measurements from the refractive elements of the eye, the lens and cornea as light interference changes the wavefront as affected by these elements. Each instrument utilize condensing lenses within the body of the instrument, and a fogging technique which blurs a fixation target for the patient who is being measured. The output measures for each instrument consist of the spherical, cylindrical and axis of the subject's refractive error which are provided in a printed read-out format. {1}------------------------------------------------ ## DESCRIPTION of the DEVICE: The WaveScan™ Wavefront System Model HS 1 autorefractor device is a diagnostic instrument designed to measure refractive error of the eye automatically by use of wavefront technology. Light travels in a procession of flat sheets known as wavefronts. As these wavefronts pass through an imperfect refractive medium including the cornea and the lens, the aberrations which are created by the irregular surfaces "wrinkle" the light rays and create wavefront errors or distortions. The instrument contains tiny sensors which measure the gradient, or slope, of the wavefront which emanate from the eye. After light travels through the eye's optical system and out again, the sensors accurately detect slight variations of wavefront irregularities as they exit the eye. The sensors then provide additional information within the confines of the instrument through a series of lenses and apertures which are subject to mathematical algorithms and software. Once analyzed by the computer, a refractive error read-out is provided to the user. This analysis is made from multiple points of light which precisely pinpoint variations in refractive status across the entrance pupil of the eye. This allows for the high level of accuracy of the instrument thus providing the user with very precise readings of refractive error. ## INDICATIONS FOR USE: The VISX WaveScanted System Model HS 1 is a diagnostic instrument indicated for the automated measurement and analysis of refractive errors of the eye including hyperopia and myopia from +6.00 to -8.00 diopters spherical, and astigmatism from 0.00 to -6.00 diopters. I | | VISX WaveScan | |-----------------------|-------------------------------------------------------------------------------------------------| | Accuracy | No Specification | | Reproducibility | No Specification | | Power<br>Requirements | 110/120V, 50/60Hz | | Measurable<br>Range | Sphere -8 to +6 in 0.1D increments<br>Cylinder 0 to -6 in 0.1D increments<br>Axis 0-180 degrees | | Data Output | Print or Electronic | | Approvals | ETL | | Measurement<br>Points | Up to 100 points | #### SPECIFICATIONS OF THE DEVICE: {2}------------------------------------------------ ## TESTING OF THE DEVICE: Comparison testing was conducted under a protocol designed to demonstrate the equivalence of the WaveScan™ Wavefront Model HS 1 to the Canon Model R-50m autorefractor. These devices which are basically equivalent, measure refractive error of the eye automatically by use of scanning light deflection through the optics of the eye. The near infrared light acts as a secondary light source reflected off the back of the eye at the retina. The emerging light passes through the optics of the lens and cornea and is affected by a series of apertures and lenses which are then systematically analyzed through mathematical models and reveal the measurement of refractive error. The tests were conducted using a model test eve developed by VISX. Inc. and modeled after the Gullstrand Standard Test Eye Model established for bench testing in the ophthalmic community. Tests were conducted across a range of refractive errors including myopia, hyperopia, and astigmatic errors of refraction at various and orientations. Combinations of myopic and hyperopic astigmatism were employed. Each of these test conditions was repeated five times in each instrument, and subject to statistical analysis. The results indicated that the WaveScan™, Wavefront System performed within statistical 95% level of confidence in all parameters measured and was equivalent or superior to the control instrument in accuracy and repeatability. Overall, the WaveScan device provided estimates of refractive error with less variability than the control device as seen in the data, from standard deviation estimates. ## LABELING The WaveScan™ Wavefront System Model HS 1 is provided to the user with a User Manual of Operator's Instructions. The device is a diagnostic tool used by professionals and ancillary personnel in the determination of preliminary diagnostic refractive error information. > VISX. Inc. 3400 Central Expressway Santa Clara, CA 9505 1 (408) 733-2020 > > GOODS B {3}------------------------------------------------ Public Health Service Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of a bird-like figure, possibly representing an eagle or other national symbol. The image is in black and white. MAY - 2 2000 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Mr. David M. Patino Vice President, Regulatory and Clinical Affairs VISX, Inc. 3400 Central Expressway Santa Clara, CA 95051-0703 Re: K000327 Trade Name: WaveScan™ Wavefront System Regulatory Class: I Product Code: HKO Dated: January 31, 2000 Received: February 2, 2000 Dear Mr. Patino: We have reviewed your Section 510(k) notification of intent to market the device we have leviewed your bowe 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 in interstace commerce prior to thay been reclassified in accordance with the provisions of Amendinents, of to devices that have ester (Act). You may, therefore, market the device, the rederal 1 000, Drug, and Cosmisions of the Act and the limitations described below. subject to the general controls pool the Act include requirements for annual registration, I no golf devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. The Office of Device Evaluation has determined that there is a reasonable likelihood that This device will be used for an intended use not identified in the proposed labeling and that this device will be ased for an inteliare, in accordance with Section 513(i)(1)(E) of the Act, such use coura cause na must appear in the Warnings section of the device's labeling: The safety and effectiveness of the WaveScan™ Wavefront System have not been I the Jacesy and encess release as an accessory interfaced to a refractive laser for the established for ase of the aberrations of the eye by photorefractive keratectomy (PRK), ercatinent of might or orectory (PTK) or laser-assisted in situ keratomileusis (LASIK). If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major ( remaines affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the {4}------------------------------------------------ ## Page 2 - David M. Patino Current Good Manufacturing Practice requirements, as set forth in the Quality System Current Good Manufacturing Fress: General regulation (21 CFR Part 820) and that, Regulation (Q) for Mechear Devices. Sood and Drug Administration (FDA) will verify through periodic Q5 inspections, the GMP regulation may result in regulation may result in regulatory such assumptions. Tandre to comply while announcements concerning your device in action. In addition, I DA may publish response to your premarket notification submission in the Federal Register. Thease noter thight have under sections 531 through 542 of the Act does not allect any obligation you might nation Control provisions, or other Federal laws or regulations. The FDA finding of substantial equivalence of your device to a legally marketed predicate I he FDA inding of substantial equit device and permits your device to proceed to the device results in a Classification for you to begin marketing your device as described in your market. This letter will anow you to bight marketing , 510(k) premarket notification if the limitation statement above is added to your labeling, as described. Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Prease note that the above labeling inned before these limitations are modified in any way or removed from the device's labeling. If you desire specific information about the application of other labeling requirements to If your desire specific information abditionally 809.10 for in vitro diagnostic devices). your device (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices your device (21 CFR Part of Compliance at (301) 594-4613. Additionally, for questions on please contact the Office of Compliance av ise, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to (201) 594-607. Thise, picase note 97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers responsibilities under the Net may De 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html". Sincerely yours, Robert R. Satting/ రా David W. Feigal, Jr., M.D., M.P.H. Acting Director Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ Page / of 510(k) Number (if known): K000327 Device Name: _ WaveScan™ Wavefront System Indications For Use: The VISX WaveScan™ Wavefront System is a diagnostic instrument indicated for the automated measurement and analysis of refractive errors of the eye including hyperopia and myopia from +6.00 to -8.00 diopters spherical, and astigmatism from 0.00 to -6.00 diopters. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Eurenett Bellum 510(k) Number (Optional Format 3-10-98)