3D OCT-1000 MARK II OPTICAL COHERENCE TOMOGRAPHY SYSTEM

K083316 · Topcon Medical Systems, Inc. · OBO · Mar 13, 2009 · Ophthalmic

Device Facts

• Record ID: K083316
• Device Name: 3D OCT-1000 MARK II OPTICAL COHERENCE TOMOGRAPHY SYSTEM
• Applicant: Topcon Medical Systems, Inc.
• Product Code: OBO · Ophthalmic
• Decision Date: Mar 13, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.1570
• Device Class: Class 2

Intended Use

The Topcon 3D OCT-1000 MARK II is a non-contact ophthalmic imaging system for the viewing and axial cross sectional imaging of posterior ocular structures. It is used for in vivo imaging of the retina, retinal nerve fiber layer and optic disc. It is intended for use as a diagnostic device to aid in the detection and management of ocular diseases, including but not limited to macular edema and central serous retinopathy.

Device Story

Non-contact ophthalmic imaging system; captures axial cross-sectional images of posterior ocular structures (retina, retinal nerve fiber layer, optic disc). Operates via optical coherence tomography (OCT); utilizes pulsed light source for scan delivery. Used in clinical settings by eye care professionals to aid diagnosis and management of ocular diseases (e.g., macular edema, central serous retinopathy). Output consists of visual images for clinician review; supports clinical decision-making regarding ocular pathology. Benefits include non-invasive visualization of retinal structures.

Clinical Evidence

No clinical data. Evidence consists of bench testing, including software validation and image capture testing comparing the 3D OCT-1000 MARK II to the predicate 3D OCT-1000. Results demonstrated sufficient agreement between captured images from both devices.

Technological Characteristics

Non-contact ophthalmic imaging system; utilizes optical coherence tomography. Key technological difference from predicate is the use of a pulsed light source for scan delivery instead of a continuous wave (CW) source. Device is a Class II ophthalmoscope (21 CFR 886.1570).

Indications for Use

Indicated for patients requiring in vivo imaging of posterior ocular structures, including the retina, retinal nerve fiber layer, and optic disc, to aid in the detection and management of ocular diseases such as macular edema and central serous retinopathy.

Regulatory Classification

Identification

An ophthalmoscope is an AC-powered or battery-powered device containing illumination and viewing optics intended to examine the media (cornea, aqueous, lens, and vitreous) and the retina of the eye.

Special Controls

*Classification.* Class II (special controls). The device, when it is an AC-powered opthalmoscope, a battery-powered opthalmoscope, or a hand-held ophthalmoscope replacement battery, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.

Predicate Devices

• 3D OCT-1000 Optical Coherence Tomography System (K063388)

Submission Summary (Full Text)

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510(k): k093316

# MAR 1 3 2009

## 5. 510(k) Summary as required by 21 CFR 807.92(c)

- 510(k) Owner: Topcon Corporation. 75-1 I-lasunuma-cho, Itabashi-ku Tokyo, Japan 174
U.S. Facility: Topcon Medical Systems, Inc. 37 West Century Road Paramus, New Jersey 07652 [phone] Telephone: Facsimile: [phone]

Barbara S. Fant, Pharm.D. Contact person: Clinical Research Consultants, Inc. 310 Terrace Avenue Suite 201 Cincinnati, OH 45220 Phone: [phone] Facsimile: [phone]

October 12, 2008 Date:

3D OCT-1000 MARK II Trade Name:

Optical Coherence Tomography System Common names: OCT Mark II

- Classification Name: Tomography, Optical Coherence 21 CFR§886.1570 Ophthalmoscope
Product Code: OBO (Tomography, Optical Coherence)

#### Identification of a Legally Marketed Predicate Device

The 3D OCT-1000 MARK II is substantially equivalent to the 3D OCT-1000 Optical Coherence Tomography System marketed by Topcon, 510(k) Premarket Notification Number K063388, FDA Product Code OBO.

General Description

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510 (k): k-083316

The Topcon 3D OCT-1000 is a non-contact ophthalmic imaging system for the viewing and axial cross sectional imaging of posterior ocular structures. It is used for in vivo imaging of the retinal nerve fiber layer and optic disc. It is intended for use as a diagnostic device to aid in the detection and management of ocular diseases, including but not limited to macular edema and central serous retinopathy.

The 3D OCT-1000 Mark II has the same intended uses and indications for use as the 3D OCT-1000. The technological characteristics are the identical for the two devices, with the exception that during OCT imaging, the scan pattern for the 3D OCT-1000 is delivered as continuous wave (CW) light source; whereas, it is delivered as pulsed lighting in the 3D OCT-1000 Mark II.

#### Intended Use

The Topcon 3D OCT-1000 MARK II is a non-contact ophthalmic imaging system for the viewing and axial cross sectional imaging of posterior ocular structures. It is used for in vivo imaging of the retina, retinal nerve fiber layer and optic disc. It is intended for use as a diagnostic device to aid in the detection and management of ocular diseases, including but not limited to macular edema and central serous retinopathy.

#### Performance Data

Software validation testing and image capture testing were performed on the 3D OCT-1000 MARK II. Test results for the 3D OCT-1000 MARK II demonstrated sufficient agreement with captured images from the 3D OCT-1000. The results of performance testing and software validation testing did not raise any issues on the safety or effectiveness of the device.

### Basis of Substantial Equivalence

The 3D OCT-1000 MARK II is substantially equivalent to the 3D OCT-1000 Optical Coherence Tomography System marketed by Topcon, 510(k) Premarket Notification Number K-63388, FDA Product Code OBO, and regulation 21CFR8886.1570 (Ophthalmoscope) in technological characteristics, engineering design and specifications, software design and specifications, laser classification and intended use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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MAR 1 3 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Topcon Medical Systems, Inc c/o Barbara S. Fant, Pharm.D. Clinical Research Consultants, Inc.

310 Terrace Avenue, Suite 201 Cincinnati, OH 45220

Re: K083316

Trade Name: 3D OCT-1000 Optical Coherence Tomography System Regulation Number: 21 CFR 886.1570 Regulation Name: Ophthalmoscope Regulatory Class: Class II Product Code: OBO Dated: October 12, 2008 Received: November 12, 2008

Dear Dr. Fant:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced aboye 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 be found in the 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 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 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 product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

M. B. Egbertms, mD

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

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Indications for Use Statement র .

510(k) Number (if known): __ k 083316

Device Name: 3D OCT-1000 MARK II --

Indications for Use:

The Topcon 3D OCT-1000 MARK II is a non-contact ophthalmic imaging system for the viewing and axial cross sectional imaging of posterior ocular structures. It is used for in vivo imaging of the retinal nerve fiber layer and optic disc. It is intended for use as a diagnostic device to aid in the detection and management of ocular discases, including but not limited to macular edema and central serous retinopathy.

Prescription Use_

OR

Over-The-Counter Use

PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Ophthalmic and Ear, Nose and Throat Devices

510(k) Number k093316