IVUE 500

{0}------------------------------------------------ ## 510(k) Summary Optovue iVue 500 K133892 MAR 1 9 2014 This 510(k) summary for the iVue 500 is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92 | Category | Comments | |---------------------------------|---------------------------------------------------------------------------------------------------------| | Sponsor: | Optovue, Inc.<br>2800 Bayview Pkwy<br>Fremont, CA 94538 | | Correspondents: | Michael Sarrasin, Esq.,<br>VP, Regulatory Affairs and Quality Assurance<br>michael_sarrasin@optovue.com | | Manufacturer: | Optovue, Inc.<br>2800 Bayview Parkway<br>Fremont, CA 94538 | | Device Common Name: | Optical Coherence Tomography (OCT) System | | Device Proprietary Name: | iVue 500 | | Device Classification | CI II, HLI, 21 CFR §886.1570 | | Predicate Device | IVue with NDB, K121739 | | Predicate Device Manufacturer | Optovue, Inc. | | Predicate Device Classification | CI II, HLI, 21 CFR §886.1570 | Date Summary was Prepared: January 7, 2014 Device Description: The iVue 500 is a modification of its predicate device iVue with Normative Database (NDB) (K121739). The intended use, system performance, sub-assemblies, and key components of the iVue with NDB are all the same as the iVue with NDB. The intent of this redesign was to make the iVue a more compact desktop device, so it is more convenient to use and set-up in a lypical office. Additionally operation via touchscreen or mouse driven technology, makes it simpler for a technician to use. - Intended Use: The iVue 500 with normative database is an optical coherence tomography system intended for in vivo imaging, axial crosssectional, three-dimensional imaging and measurement of anterior and posterior ocular structures. - Indications for Use: The iVue 500 with normative database is a non-contact, high resolution tomographic imaging device. It is intended for in vivo imaging, axial cross-sectional and three-dimensional imaging and measurement of anterior and posterior ocular structures, {1}------------------------------------------------ including retina, retinal nerve fiber layer, ganglion cell complex (GCC), optic disc, cornea, and anterior chamber of the eye. The iVuc 500 with normative database is a quantitative tool for the comparison of retinal nerve fiber layer, ganglion cell complex, and optic disc measurements to a database of known normal subjects. The iVuc 500 with normative database is indicated for use as a device to aid in the diagnosis, documentation, and management of ocular health and diseases in the adult population. (identical to predicate device) - Technological Characteristics: The iVue 500 is a non-invasive device for imaging the cornea, anterior chamber, and retinal tissue structure with micrometer range resolution. - Comparison to Predicate Device: The iVue 500 is a modification of its predicate device iVue with Normative Database (NDB) (K121739). The intended use, system performance, sub-assemblies, and key components of the iVue 500 with NDB are all the same as the iVue with NDB. | Device | Predicate | Current | |------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------| | 510(k) Reference: | K121739 | K133892 | | Intended Use: | The iVue with Normative<br>Database is an optical<br>coherence tomography<br>system intended for in vivo<br>imaging, axial cross-<br>sectional, three-<br>dimensional imaging and<br>measurement of anterior<br>and posterior ocular<br>structures. | Same | | Device Description: | Optical Coherence<br>Tomography (OCT)<br>System | Same | | Device Common Name: | Optical Coherence<br>Tomography (OCT)<br>System | Same | | Device Classification: | Class II HLI<br>(21 CFR 886.1570) | Same | | Manufacturer: | Optovue, Inc. | Same | Summary of Testing: Testing was performed to verify design, and showed there were no new questions of safety or effectiveness with the subject device, This testing included electrical safety testing, electrical emissions testing, as well as bench. Bench testing demonstrated that the {2}------------------------------------------------ iVue 500 is able to align to appropriate working distance on both left and right eyes within the predefined acceptance criteria. The bench test of iVue 500 utilizing 2 model eyes provides evidence that the software assisted motorized iVue 500 is able to complete the initial alignment of moving the scanner head to working position and to align the scanner head with the pupil within ±1mm tolerance. These are the general requirements to align a scanner to be able to capture an OCT image. Also the iVue 500 is able to move scanner head between right and left eyes. | Retina<br>Mode | Range | Average | Criteria | Results | |---------------------|-----------------|---------|----------|---------| | Working<br>distance | 20.3-22mm | 21.3 | +/- 1mm | Pass | | centering | 0-.2mm | n/a | +/- 1mm | Pass | | Pupil<br>distance | 66.1-<br>66.6mm | n/a | +/- 1mm | Pass | | Cornea<br>Mode | Range | Average | Criteria | Results | |---------------------|-----------------|---------|----------|---------| | Working<br>distance | 16.4-<br>17.3mm | 16.7 | +/- 1mm | Pass | | centering | 0-.1mm | n/a | +/- 1mm | Pass | | Pupil<br>distance | 65.7-<br>66.8mm | n/a | +/- 1mm | Pass | Conclusion: As described in this 510(k) Summary, all necessary testing and analyses were completed on the iVue 500 to ensure that the device is substantially equivalent to the identified predicate device. {3}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 2093-0002 March 19, 2014 Optovuc, Inc. % Mr. Michael Sarrasin, Esq. Vice President, Regulatory Affairs & Quality Assurance 2800 Bayview Drive Fremont, CA 94538 Rc: K133892 Trade/Device Name: iVue 500 Regulation Number: 21 CFR 886.1570 Regulation Name: Ophthalmoscope Regulatory Class: Class II Product Code: HILI Dated: February 19, 2014 Received: February 20, 2014 Dear Mr. Sarrasin: 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, F12A may publish further announcements concerning your device in the Eederal 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. {4}------------------------------------------------ Page 2 - Mr. Michael Sarrasin, Esg. You must comply 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 medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the clectronic product radiation control provisions (Scctions 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.lda.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/ReportalProblem/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. ## Deborah L. Falls -S for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear. Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ #### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ### Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page. #### 510(k) Number (if known) K133892 Device Name iVue 500 Indications for Use (Describe) The iVue 500 with normative database is a non-contact, high resolution tomographic imaging device. It is intended for in vivo imaging, axial cross-sectional and three-diment of anterior and posterior and posterior ocular structures, including reinal nerve fiber layer, ganglion cell complex (GCC), optic disc, cornea, and anterior chamber of the eye. The iVue 500 with normalive database is a quantitative tool for the comparison of retinal nerve fiber layer, ganglion cell complex, and optic disc measurements to a database of known normal subjects. The iVue 500 with normative database is indicated for use as a device to aid in the diagnosis, documentation, and management of ocular health and diseases in the adult population. Type of Use (Select one or both, as applicable) [x] Prescription Use (Part 21 CFR 801 Subpart D) ] Over-The-Counter Use (21 CFR 801 Subpart C) #### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) # Rahul K. Ram -S (Affiliate) 2014.03.13 15:02:55 -04'00' FORM FDA 3881 (9/13)