VARILUX VISIONPRINT SYSTEM (VPS)

{0}------------------------------------------------ ## TAB D ## 510(k) SUMMARY Varilux® VisionPrint™ System Essilor International, Inc. This 510(k) summary of safety and effectiveness for the Varilux® VisionPrint™ System is submitted in accordance with the requirements of SMDA and follows Office of Device Evaluation guidance concerning the organization and content of a 510(k) summary. | Applicant: | Essilor International, Inc. | |----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Address: | c/o Essilor of America, Inc.<br>2400 118" Avenue North<br>St Petersburg, FL 33176<br>(727) 572-0844<br>(727) 592-0358 (FAX)<br>gwalsh@essilorusa.com | | Contact Person: | Marc J. Scheineson, Esq.<br>Regulatory Counsel | | Telephone: | (202) 414-9243 (telephone)<br>(202) 414-9299 (fax) | | Preparation Date: | December 19, 2003 | | Device Trade Name: | Varilux® VisionPrint™ System or VPS | | Common Name: | Eye Movement Monitor | | Classification Name: | Eye Movement Monitor (see 21 C.F.R. § 886.1510) | | Product Code: | HLL | | Predicate Device: | OBER2 Eye Movement Monitor, 510(k) # K902954 | | Device Description: | The VPS is a non-invasive ultrasonic device intended to<br>measure the pattern of eye and head movement when<br>viewing lateral LED fixation lamps. It consists of a headset<br>and a main body with an ultrasonic transmitter. Two<br>ultrasonic receivers are imbedded in the center nosepiece of<br>the headset. The patient wears the headset and looks at<br>three orange LED fixation lamps in the main body as they<br>light up in succession. As the patient follows the lights from | {1}------------------------------------------------ | | side to side, the device measures the degree of head<br>movement from the center light against a target angle of 40°<br>and a standard deviation. Eye movement is extrapolated to<br>fill the remaining vision angle. The calculated ratio of<br>head/eye movement is used to determine the shape of the<br>peripheral and central fields of the progressive spectacle<br>lenses. | |-------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Specifications: | The VPS emits ultrasound at sound pressure levels of 115<br>dB at 40 kHz, to which the patient is exposed for<br>approximately 2 minutes during testing. | | Intended Use: | The VPS is a non-invasive ultrasonic device intended to<br>measure the pattern of eye and head movement when<br>viewing lateral visual stimulus, to use as a guide for<br>prescribing progressive power eyeglass lenses. | | Performance Data: | In a clinical study, 175 presbyopic patients were measured<br>for head and eye movement by two devices: an<br>electromagnetic sensor -- the Polhemus Fastrak -- and an<br>ultrasound transmitter and receivers. The measurement by<br>the ultrasound device was reproducible. Subjects were<br>measured on two separate days. For 90% of those subjects<br>the differences between the measurements were lower than<br>0.20. Moreover, the standard deviation - <i>i.e.</i> , the dispersion<br>among the 20 measurements for each subject taken in one<br>session - was similarly reliable, with 98% of the<br>measurement differences lower than 0.11. The<br>measurements taken by the ultrasound device showed a<br>close correlation with those taken by the electromagnetic<br>Polhemus Fastrak. | | CONCLUSIONS: | Based on the foregoing and other information contained in<br>this application, Essilor believes that the Varilux® VPS is<br>substantially equivalent to its claimed predicates under<br>conditions of intended use. | · " ・ {2}------------------------------------------------ Image /page/2/Picture/1 description: The image is a circular seal or logo. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top and bottom of the circle. Inside the circle is a stylized image of an eagle or bird with three curved lines representing its wings or feathers. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JUL - 2 2004 Essilor International, Inc. c/o Marc J. Scheineson, Esq. Alston & Bird, L.L.P. 601 Pennsylvania Avenue, N.W. Washington, DC 20004-2601 Re: K033949 K059947 Trade/Device Name: Varilux® VisionPrint™ System Regulation Number: 21 CFR 886.1510 Regulation Name: Eye Movement Monitor Regulatory Class: Class II Product Code: HLL Dated: June 25, 2004 Received: June 25, 2004 Dear Mr. Scheineson: We have reviewed your Section 510(k) premarket notification of intent to market the device in we nave reviewed your becaon 910(x) premained 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 commerce prof to May 20, 1976, the encordance with the provisions of the Federal Food, Drug, devices that have been reculise in assess approval of a premarket approval application (PMA). and Costience Act (Act) that do not require to the general controls provisions of the Act. The 1 ou may, merceive, market the Act include requirements for annual registration, listing of general controls provisions of the tice, 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 If your device is classified (600 abor of ols. Existing major regulations affecting your device can may be subject to succeral Regulations, Title 21, Parts 800 to 898. In addition, FDA may ou found in the Overning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean I loast be advised that I Dri- brosan that your device complies with other requirements of the Act that I DA has made a acterimations administered by other Federal agencies. You must or any I cacial statutes and equirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI K Far 607); adoling (21 CFR Part 820); and if applicable, the electronic 101111 m the quality of bections (Sections 531-542 of the Act); 21 CFR 1000-1050. {3}------------------------------------------------ Page 2- Marc J. Scheineson 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 (301) 594-4613. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours, A Kalpi 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 Enclosure {4}------------------------------------------------ ## Indications for Use 510(k) Number (if known): KO33949_ Device Name: Varilux® VisionPrint™ System (VPS) Indications For Use: The VPS is a non-invasive ultrasonic device intended to measure the pattern of eye and head movement when viewing lateral visual stimulus, to use as a guide for prescribing progressive power eyeglass lenses. Prescription Use_ X (Part 21 CFR 801 Subpart D) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ AND/OR のお店舗の賃貸マンション (賃貸マンション) (賃貸マンション) (賃貸マンション) (賃貸マンション) (賃貸マンション) (賃貸マンション) (賃貸マンション) (賃貸マンション) (賃貸マンション) (賃貸マンション) (賃貸マンション) (賃貸マンション) (賃貸マンション) (賃貸マンション) (賃貸マン 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) | (Division Sign-Off) | | |-----------------------------|---------| | Division of Ophthalmic Ear, | | | Nose and Throat Devises | | | 510(k) Number | K033949 |