Regulatory Affairs Manager Olympus Surgical Technologies America 3500 .

)HEUXDU\ Olympus Medical Systems Corp. Sheri MusgnungRegulatory Affairs ManagerOlympus Surgical Technologies America3500 Corporate Parkway PO Box 610Center Valley, PA 18034-0610Re: K182102Trade/Device Name: Rhino-laryngo Videoscope Olympus ENF-VH2, Rhino-laryngoVideoscope Olympus ENF-V4Regulation Number: 21 CFR 874.4760Regulation Name: Nasopharyngoscope (Flexible or Rigid) And AccessoriesRegulatory Class: Class IIProduct Code: EOB, NWBDated: January 4, 2019Received: January 7, 2019Dear Sheri Musgnung:We have reviewed your Section 510(k) premarket notification of intent to market the devicereferenced above and have determined the device is substantially equivalent (for the indicationsfor use stated in the enclosure) to legally marketed predicate devices marketed in interstatecommerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or todevices 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.Although this letter refers to your product as a device, please be aware that some clearedproducts may instead be combination products. The 510(k) Premarket Notification Databaselocated at /cfpmn/pmn.cfm identifiescombination product submissions. The general controls provisions of the Act includerequirements for annual registration, listing of devices, good manufacturing practice, labeling,and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluateinformation related to contract liability warranties. We remind you, however, that devicelabeling 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 befound in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA maypublish further announcements concerning your device in the Federal Register.U.S. Food & Drug Administration10903 New Hampshire AvenueSilver Spring, MD 20993www.fda.govDo4017.03.05

K182102 - Sheri MusgnungPage2Please be advised that FDA's issuance of a substantial equivalence determination does not meanthat FDA has made a determination that your device complies with other requirements of the Actor any Federal statutes and regulations administered by other Federal agencies. You mustcomply with all the Act's requirements, including, but not limited to: registration and listing(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medicaldevice-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting(21 CFR 4, Subpart B) for combination products ceRegulatoryInformation/ucm597488.htm);good manufacturing practice requirements as set forth in the quality systems (QS) regulation(21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A)for combination products; and, if applicable, the electronic product radiation control provisions(Sections 531-542 of the Act); 21 CFR 1000-1050.Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDRregulation (21 CFR Part 803), please go Problem/default.htm.For comprehensive regulatory information about medical devices and radiation-emittingproducts, including information about labeling regulations, please see Device gulationandGuidance/) and CDRH Learn(http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division ofIndustry and Consumer Education (DICE) to ask a question about a specific regulatory topic.See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE byemail (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).Sincerely,Srinivas Nandkumar -Sfor Malvina B. Eydelman, M.D.DirectorDivision of Ophthalmic and Ear, Nose,and Throat DevicesOffice of Device EvaluationCenter for Devices and Radiological HealthEnclosure

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug AdministrationForm Approved: OMB No. 0910-0120Expiration Date: 06/30/2020Indications for UseSee PRA Statement below.510(k) Number (if known)K182102Device NameRHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF-VH2RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF-V4Indications for Use (Describe)This instrument is intended to be used with an Olympus video system center, light source, documentation equipment,display monitor, and other ancillary equipment for endoscopic diagnosis. This instrument is indicated for use within thenasal lumens and airway anatomy (including nasopharynx and trachea).Type of Use (Select one or both, as applicable)Prescription Use (Part 21 CFR 801 Subpart D)Over-The-Counter Use (21 CFR 801 Subpart C)CONTINUE ON A SEPARATE PAGE IF NEEDED.This section applies only to requirements of the Paperwork Reduction Act of 1995.*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*The burden time for this collection of information is estimated to average 79 hours per response, including thetime to review instructions, search existing data sources, gather and maintain the data needed and completeand review the collection of information. Send comments regarding this burden estimate or any other aspectof this information collection, including suggestions for reducing this burden, to:Department of Health and Human ServicesFood and Drug AdministrationOffice of Chief Information OfficerPaperwork Reduction Act (PRA) StaffPRAStaff@fda.hhs.gov“An agency may not conduct or sponsor, and a person is not required to respond to, a collection ofinformation unless it displays a currently valid OMB number.”FORM FDA 3881 (7/17)Page 1 of 1PSC Publishing Services (301) 443-6740EF

K182102Traditional 510(k) NotificationRHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF-VH2, ENF-V4February 4, 2019510(k) Summary1 GENERAL INFORMATION 510(k) Submitter:OLYMPUS MEDICAL SYSTEMS CORP.2951 Ishikawa-cho, Hachioji-shi, Tokyo, Japan192-8507 Contact Person:Sheri L. MusgnungOlympus Surgical Technologies America3500 Corporate Parkway PO Box 610Center Valley, PA 18034-0610, USAPhone: 484-896-3147Fax: 484-896-7128Email: sheri.musgnung@olympus.com2 DEVICE IDENTIFICATION Device NameRHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF-VH2RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF-V4 Common NameRHINO-LARYNGO VIDEOSCOPE Regulation Number Regulation Name8874.4760, 876.1500 Regulatory ClassNasopharyngoscope (flexible or rigid) and accessories,Endoscope and accessories.II Product CodeEOB, NWB Classification PanelEar Nose & Throat510(k) SummaryPage 1 of 9

K182102Traditional 510(k) NotificationRHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF-VH2, ENF-V43 PREDICATE DEVICE Predicate deviceDevice nameVISERA RHINO-LARYNGOVIDEOSCOPE PLYMPUS ENFTYPE V2(EVIS EXERA II CV-180 SYSTEM)510(k) SubmitterOLYMPUS MEDICALSYSTEMS CORP.510(k) No.K0613134 DEVICE DESCRIPTION General Description of the subject deviceThis instrument is intended to be used with an Olympus video systemcenter, light source, documentation equipment, display monitor, and otherancillary equipment for endoscopic diagnosis. This instrument is indicatedfor use within the nasal lumens and airway anatomy (includingnasopharynx and trachea).It mainly consists of four functional parts:- video connection section including a video connector and video cablethat connects the endoscope to the video system center for displayingimages on compatible video monitors.- light guide connector section that links the endoscope with light sourceand transmits light to the distal end of the endoscope.- control section that operates endoscope such as controlling angulationto guide insertion and observation.- insertion section that goes through and contacts with the nasallumens and airway anatomy (including nasopharynx and trachea)under light guide. Principle of Operationa. Basic principle510(k) SummaryPage 2 of 9

K182102Traditional 510(k) NotificationRHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF-VH2, ENF-V4- Illumination light supplyThe endoscope receives the illumination light from the light source by light guideconnector connected to the light source device. The illumination light is transferred tothe distal end through the optical fiber bundle inside of the endoscope and illuminatesthe inside of the patient body through the illumination lens at the distal end.- Image constructionThe endoscope receives the reflected light from the inner lumen of a patient byobjective lens at the distal end. The built-in CCD at the distal end converts the light tothe electrical signal, and the signal is sent to the video system center via the electricalcable and the video connector of the endoscope. The endoscope transfers the imagesignal and displays the observation image on the screen.- Bending operationThe UP/DOWN angulation control lever and bending section are connected witheach other by 2 independent wires. It is possible to bend the bending section to theUP/DOWN direction by operating the UP/DOWN angulation control lever.b. Technological characteristics- New control sectionThe new control section of ENF-VH2 and ENF-V4 consists of a pistol grip shape.The new control section reduces the angle of the wrist and enables the insertion sectionto be directed to the nasal cavity of sitting patient even when the wrist and arm of thephysician is in a relaxed situation.- New layout of switchesBy arranging the 3 switches of new ENT control section, physicians can easily pushthe 3 switches with only an index finger- Reduced total weightNewly developed configuration of control section and thinner and lighter universalcord leads to a reduction in the handling mass of the endoscope control section.510(k) SummaryPage 3 of 9

K182102Traditional 510(k) NotificationRHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF-VH2, ENF-V4-List of compatible equipmentTable 1 Compatible equipmentModel name510(k) numberENF-V4K182102 (this submission)ENF-VH2K182102 (this submission)VISERA ELITE video system centerOTV-S190K111425Video system centerCV-170K122831VISERA ELITE xenon light sourceCLV-S190K111425Strobe LED Light sourceCLL-S1EXEMPT from Premarket NotificationVideo Endoscopes510(k) SummaryPage 4 of 9

K182102Traditional 510(k) NotificationRHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF-VH2, ENF-V45 INDICATIONS FOR USEThis instrument is intended to be used with an Olympus video system center, light source,documentation equipment, display monitor, and other ancillary equipment for endoscopicdiagnosis. This instrument is indicated for use within the nasal lumens and airwayanatomy (including nasopharynx and trachea).6 COMPARISON OF TECHNOLOGY CHARACTERISTICS WITH THEPREDICATE DEIVCEThe ENF-VH2 and ENF-V4 have the same technological characteristics and design as thepredicate device except for the following new features:-Changes on optical system parameters (total number of pixels, resolution, etc.)Configuration modification of control section to improve operabilityDimensional and material changes on the insertion sectionExtension of reprocessing methodsSoftware implementation to correct the pixel defectAll other technological characteristics of both the subject and predicate devices areidentical.Validation from non-clinical testing demonstrated that these technological features do notraise any new issues of safety or effectiveness of the subject device.510(k) SummaryPage 5 of 9