NIDEK GREEN LASER PHOTOCOAGULTOR MODEL GYC-1000 CONNECTED WITH THE ENDOPHOTOCOAGULATION DELIVERY UNIT

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for NIDEK. The logo features a stylized eye above the word "NIDEK" in bold, block letters. The eye is composed of curved lines forming the upper and lower lids, with a large, circular pupil in the center. The overall design is simple and modern. **NIDEK CO., LTD.** 4-14, Machoma, Uraishi-cho, Gamagori, Aichi 443-0038, Japan richt schip ## 7.510(K) SUMMARY This summary of the 510(k) premarket notification for the Nidek Green Laser Photocoagulator Model GYC-1000 connected with the Endophotocoagulation Delivery Unit (for sterilized endophoto probe) is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92. OCT 3 1 2013 510(k) Notification K _131894 GENERAL INFORMATION Applicant: NIDEK CO., LTD. 34-14 Maehama, Hiroishi Gamagori, Aichi, 443-0038 Japan Contact Person: Yoneji Mizuno Contact Title: Senior Manager, Regulatory Affairs Department Contact Phone Number: +81-533-67-8901 Contact Fax Number: +81-533-67-6628 E-mail: Yoneji_Mizuno@nidek.co.jp. Date Prepared: June 20, 2013 Classification: 21 CFR § 878.4810, Class II NIDEK CO., LTD. Special 510(k) GYC-1000 connected with Endophotocoagulation Delivery Unit (for sterilized endophoto probe) Proprietary and Confidential Information 1 of 4 {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows the Nidek logo. The logo consists of an eye symbol above the word "NIDEK" in bold, block letters. The eye symbol is stylized, featuring a large, circular pupil within an outlined eye shape. 34-14, Mastama, reishicho, Seragen, Aichi 443-0038, Japar. Maps & Impex ars of Ophthaka's Instuments and Ope Flatronics Irstumer n 1 - 2 - 2 - 2 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 / were ricks . . C.in 0 / / www.licugcom #### Classification name: Laser surgical instrument for use in general and plastic surgery and in dermatology # Product Code: GEX #### Trade Name: GREEN LASER PHOTOCOAGULATOR MODEL GYC-1000 connected with the Endophotocoagulation Delivery Unit (for sterilized endophoto probe) #### Generic/Common Name: Powered laser surgical instrument #### Predicate Device Nidek Green Laser Photocoagulator Model GYC-1000 (K032085) #### Indications for use The Nidek Green Laser Photocoagulator Model GYC-1000 is indicated for use in ophthalmic surgical procedures, including retinal and macular photocoagulation, iridotomy and trabeculoplasty. #### Product Description Nidek Green Laser Photocoagulator Model GYC-1000 connected with the Endophotocoagulation Delivery Unit (for sterilized endophoto probe) is an ophthalmological photocoagulation system using a solid state laser (green laser beam) with a wavelength of 532nm. Like conventional laser photocoagulation systems, this system is used in ophthalmic surgical procedures, including retinal and macular photocoagulation, iridotomy and trabeculoplasty when a delivery unit such as the Endophotocoagulation Delivery Unit is connected. {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the Nidek logo. The logo consists of a stylized eye above the word "NIDEK" in bold, sans-serif font. The eye is formed by a curved line representing the upper eyelid and a filled circle representing the pupil. The logo is black and white. **IDEK CO., LTD.** tochners = spentes 3 lincorres el Octobralor's and Orger manones basioners a: / immoides co.in 1pr.//www.nidok.com #### Substantial Equivalence The GYC-1000 connected with the proposed Endophotocoagulation Delivery Unit (for sterilized endophoto probe) is substantially equivalent to the predicate device with regard to design, function, technological characteristics, intended use and performance characteristics. The differences between the proposed and old Endophotocoagulation Delivery Units and justifications as to why these differences do not raise safety or efficacy concerns are as follows: - 23G and 25G sterilized endopho probes were added to the proposed device and available as options. They have been FDA cleared (k 021696). - The fiber core diameter at the end of the probe tip was reduced to 300 um for 20G or 23G probe and 200 um for 25G probe from 400 um. The smaller fiber core diameter will result in increase in the power per unit size. As the probe is moved closer to the retina, the beam diameter becomes smaller. On the other hand, as the probe is moved away from the retina, the beam diameter becomes larger. In practice, the surgeon adjusts the beam diameter by moving the probe before emission of the laser. Therefore, the change in fiber core diameter raises no new issues of safety or efficacy. - Cone angle, the degree the laser beam that disperses from the aperture of the probe, was changed from 11º or less to 12.5º or less. The cone angle is dependent on the used fiber, rather than on the gauge of the endophoto probe. As the probe is moved away from the retina, the beam diameter becomes larger. On the other hand, as the probe is moved closer to the retina, the beam diameter becomes smaller. In practice, the surgeon adjusts the beam diameter by moving the probe before emission of the laser. Therefore, the change in cone angle because of the change of the probes raises no new issues of safety or efficacy. #### NIDEK CO., LTD. Special 510(k) GYC-1000 connected with Endophotocoagulation Delivery Unit (for sterilized endophoto probe) Proprietary and Confidential Information 3 of 4 {3}------------------------------------------------ Image /page/3/Picture/12 description: The image shows the logo for NIDEK. The logo consists of an eye symbol above the word "NIDEK". The eye symbol is a stylized representation of an eye, with a large pupil and a curved upper eyelid. The word "NIDEK" is written in a bold, sans-serif font. **IDEK CO., LTD.** скончых поставля в призоръ в Сервания в своенность словенского компин 1 / Nanus Kith Co.it. 11 / 1 - 1 - 10 0 11 - 11 - 11 - 11 - 11 - - Fixed protective filter was added to the proposed device and available as an option. The major specifications such as guard wavelength, and optical density for the added fixed protective filter are the same as those for the electrically-powered and manual protective filters except for operation principle, dimensions, mass and its cable length. The design modifications outlined in this Special 510(k) premarket notification do not (1) affect the intended use or the indication for use or (2) alter the fundamental scientific technology of the device. The proposed Endophotocoagulation Delivery Unit shares the same indications for use, the same technological characteristics and the same principle of operation as the old Endophotocoagulation Delivery Unit of the predicate device. Therefore, based on the similarities between the two devices, the proposed Endophotocoagulation Delivery Unit is substantially equivalent to the old Endophotocoagulation Delivery Unit covered by the cleared GYC-1000 (K032085) as the predicate device. ### Testing in Support of Substantial Equivalence Determination We have verified and validated that the GYC-1000 connected with the proposed Endophotocoagulation Delivery Unit (for sterilized endophoto probe) meets its functional specifications and performance requirements, and complies with applicable international standards (IEC 60601-1, 60601-1-2, 60601-2-22, 60825-1, ISO10993-1}. As mentioned, all necessary bench testing was conducted on the modifications, the addition of the proposed Endophotocoagulation Delivery Unit (for sterilized endophoto probe) to support a determination of substantial equivalence to the predicate device. #### Summary The Nidek Green Laser Photocoagulator Model GYC-1000 connected with the proposed Endophotocoagulation Delivery Unit (for sterilized endophoto probe) is substantially equivalent to the predicate device. NIDEK CO., LTD. Special 510(k) GYC-1000 connected with Endophotocoagulation Delivery Unit (for sterilized endophoto probe) Proprietary and Confidential Information 4 of 4 {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular fashion around the caduceus symbol. The logo is black and white. October 31, 2013 Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 NIDEK Corporation, LTD. Yoneji Mizuno Senior Manager, Regulatory Affairs 34-14 Maehama Hiroishi-cho Gamagori, Aichi China Re: K131894 Trade/Device Name: GREEN LASER PHOTOCOAGULATOR MODEL GYC-1000 Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: GEX Dated: September 6, 2013 Received: October 13. 2013 Dear Mizuno: ್ಗಾ 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 mav 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 {5}------------------------------------------------ Page 2 - Yoneji Mizuno CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. 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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, Long H Chen -A for MXM Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ ## Indications for Use #### 510(k) Number:_ K131894 Device Name: Nidek Green Laser Photocoagulator Model GYC-1000 connected with the Endophotocoagulation Delivery Unit (for sterilized endophoto probe) Indications For Use: The Nidek Green Laser Photocoagulator Model GYC-1000 is indicated for use in ophthalmic surgical procedures, including retinal and macular photocoagulation, iridotomy and trabeculoplasty. 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) Concurrence of Center for Devices and Radiological Health (CDRH) Neil R Ogden= 2013.10.31 110:40:28 -04'00' (Division Sign-Off) for MXM Division of Surgical Devices 510(k) Number K131894 Page 1 of 1