OPD-STATION SOFTWARE

{0}------------------------------------------------ ## SUMMARY OF SAFETY AND EFFECTIVENESS NIDEK INCORPORATED OPD-STATION SOFTWARE # SUBMITTER INFORMATION | A. | Company Name: | Nidek Incorporated | |----|--------------------------------|-----------------------------------------------------------------------| | B. | Company Address: | 47651 Westinghouse Drive.<br>Fremont, CA 94539-7474 | | C. | Company Phone:<br>Company Fax: | (510) 353-7719<br>(510) 226-5750 | | D. | Contact Person: | Mr. Hiro Matsuzaki<br>Regulatory and QA Manager<br>Nidek Incorporated | | E. | Date Summary Prepared: | August 22, 2005 | #### DEVICE IDENTIFICATION | A. | Generic Device Name: | Ophthalmic, aberrometer<br>Topographer, corneal, ac-powered | |----|-------------------------|-------------------------------------------------------------| | B. | Trade/Proprietary Name: | OPD-Station software | | C. | Classification: | Class I 886.1760 | | D. | Product Code: | NCF, MMQ | # SUBSTANTIAL EQUIVALENCE The Nidek Incorporated OPD-Station software is of comparable type and is substantially equivalent to the following predicate devices: | Predicate Device | Manufacturer | 510(k) No. | Date Cleared | |--------------------------------|------------------|------------|---------------| | Topographic<br>Modeling System | Computed Anatomy | K944207 | Dec. 7, 1994 | | Nidek OPD-Scan | Nidek Co. Ltd. | K003299 | March 9, 2001 | {1}------------------------------------------------ #### DEVICE DESCRIPTION Nidek has developed a stand-alone software option for users of the OPD-Scan™ device called OPD-Station, which will run on an independent PC (i.e., separate from the OPD-Scan™ device). The OPD-Station software is able to access data measured by the OPD-Scan™ device via a separate Nidek data management software package called NAVIS. The OPD-Station uses the same software as that used for the OPD-Scan device so that a physician can view OPD-Scan data on their PC of choice. However, the OPD-Station software has the following new functions: - Maps of Point Spread Function (PSF), Modulation Transfer Function (MTF), MTF . graphing, and Visual Acuity mapping - Improved color mapping . #### INTENDED USE The OPD-Station software is indicated for use in analyzing the corneal shape and refractive powers measured by the OPD-Scan Models ARK-9000 or ARK-10000, and to display the data in the form of maps, and manage the data. ### TECHNOLOGICAL CHARACTERISTICS A comparison of the technological characteristics of the OPD-Station software and the predicate devices has been performed, and the results of this comparison demonstrate that the OPD-Station software is equivalent to the marketed predicate devices #### PERFORMANCE DATA The performance data indicate that the OPD-Station software meets all specified requirements, and is substantially equivalent to the predicate devices. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized graphic of three human profiles facing right, arranged in a way that resembles a bird in flight. The graphic is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. Public Health Service AUG 2 4 2005 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Nidek Co., Ltd. % Ms. Carol L. Patterson, President Patterson Consulting Group, Inc. 21911 Erie Lane Lake Forest, CA 92630 Re: K050336 Trade/Device Name: OPD-Station Software Regulation Number: 21 CFR 886.1760 Regulation Name: Ophthalmic Refractometer Regulatory Class: Class I Product Code: NCF, MMQ Dated: July 15, 2005 Received: July 18, 2005 Dear Ms. Patterson: 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 may or do Jeer 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 r rease of action and 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 or any I outhal 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 roluct radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {3}------------------------------------------------ This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to oegh manteling your antial equivalence of your device to a legally premarket notification: The PDF mailing of bassification 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 If you desire specific davies in 1984 at 1991) 827-8910. Also, please note the regulation entitled, Contact the Office of Collifed of Collines of CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general information on your responsive Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, David M. Whipple David M. Whipple Acting 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 K 050336 510(k) Number: Device Trade Name: Indications For Use: OPD-Station Software The OPD-Station software is indicated for use in analyzing the corneal shape and refractive powers measured by the OPD-Scan Models ARK-9000 or ARK-10000, and to display the data in the form of maps, and manage the data. Prescription Use _____________________________________________________________________________________________________________________________________________________________ (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) | (Division Sign-Off) | |-----------------------------| | Division of Ophthalmic Ear, | | Nose and Throat Devises | 510(k) Number_________________________________________________________________________________________________________________________________________________________________ Concurrence of CDRH, Office of Device Evaluation (ODE) 27 ン・し Page 1 of 1