PDF《July 28, 2016 Topcon Corporation》

8588668 v1 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: January 31,

2017 See PRA Statement on last page 510(k) Number (if known) K161509 Device Name 3D OCT-1 Maestro Indications for Use (Describe) The Topcon 3D OCT-1 Maestro is a non-contact, high resolution tomographic and biomicroscopic imaging device that incorporates a digital camera for photographing, displaying and storing the data of the retina and surrounding parts of the eye to be examined under Mydriatic and non-Mydriatic conditions. The 3D OCT-1 Maestro is indicated for in vivo viewing, axial cross sectional, and three-dimensional imaging and measurement of posterior ocular structures, including retina, retinal nerve fiber layer, macula and optic disc as well as imaging of anterior ocular structures. It also includes a Reference Database for posterior ocular measurements which provide for the quantitative comparison of retinal nerve fiber layer, optic nerve head, and the macula in the human retina to a database of known normal subjects. The 3D OCT-1 Maestro is indicated for use as a diagnostic 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) 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 the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [email protected] An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number \\DC - 026811/000013 -

8588672 v1 510(k) SUMMARY C K161509 Topcon Corporation'

s 3D OCT-1 Maestro Submitter Information: Applicant: Topcon Corporation 75-1 Hasunuma-cho, Itabashi-ku Tokyo, Japan 174-8580 Phone: (201) 599-5533 Fax: (201) 599-5248 Contact Person: Charles Reisman Senior Manager, Global R&

D Topcon Medical Systems, Inc.

111 Bauer Drive Oakland, NJ

07436 1 (201) 599-5283 Date Prepared: July 25,

2016 Subject Device: Device Name: 3D OCT-1 Maestro Common Name: Optical Coherence Tomography Classification Name: Ophthalmoscope Regulation: Class II,

21 C.F.R. § 886.1570 Product Code(s): OBO, HKI Predicate Device(s): Primary Predicate: Optovue'

s iVue with Normative Database (K121739) Secondary Predicate: Topcon'

s TRC-NW300 Non-Mydriatic Retinal Camera (K123460) \\DC - 026811/000013 -

8588672 v1 Indications for Use: The Topcon 3D OCT-1 Maestro is a non-contact, high resolution tomographic and biomicroscopic imaging device that incorporates a digital camera for photographing, displaying and storing the data of the retina and surrounding parts of the eye to be examined under Mydriatic and non-Mydriatic conditions. The 3D OCT-1 Maestro is indicated for in vivo viewing, axial cross sectional, and three-dimensional imaging and measurement of posterior ocular structures, including retina, retinal nerve fiber layer, macula and optic disc as well as imaging of anterior ocular structures. It also includes a Reference Database for posterior ocular measurements which provide for the quantitative comparison of retinal nerve fiber layer, optic nerve head, and the macula in the human retina to a database of known normal subjects. The 3D OCT-1 Maestro is indicated for use as a diagnostic device to aid in the diagnosis, documentation and management of ocular health and diseases in the adult population. Device Description: The Maestro is a non-contact, high-resolution, tomographic and bio-microscopic imaging system that merges OCT and fundus cameras into a single device. The technological characteristics of the OCT employed are similar to those of already 510(k)-cleared OCT products, such as Topcon'