CIRRUS HD-OCT, MODEL 4000

K063378 · Carl Zeiss Meditec, Inc. · HLI · Jan 26, 2007 · Ophthalmic

Device Facts

• Record ID: K063378
• Device Name: CIRRUS HD-OCT, MODEL 4000
• Applicant: Carl Zeiss Meditec, Inc.
• Product Code: HLI · Ophthalmic
• Decision Date: Jan 26, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.1570
• Device Class: Class 2

Intended Use

The Cirrus™ HD-OCT is a non-contact, high resolution tomographic and biomicroscopic imaging device. It is indicated for in vivo viewing, axial cross-sectional, and threedimensional imaging and measurement of posterior ocular structures, including retina, retinal nerve fiber layer, macula, 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 holes, cystoid macular edema, diabetic retinopathy, age- related macular degeneration and glaucoma.

Device Story

Computerized, non-contact, high-resolution tomographic and biomicroscopic imaging instrument; uses low-coherence interferometry to acquire cross-sectional tomograms of posterior ocular structures. Operates as diagnostic aid for clinicians to view, measure, and manage ocular diseases. Produces high-resolution 2D and 3D images of retina, retinal nerve fiber layer, macula, and optic disc. Used in clinical settings; provides objective data to assist healthcare providers in clinical decision-making and disease monitoring; benefits patients through non-invasive, high-resolution visualization of ocular pathology.

Clinical Evidence

Clinical data collected and evaluated to support indications for use and demonstrate substantial equivalence to the Stratus OCT predicate.

Technological Characteristics

Non-contact, low-coherence interferometry imaging system. Computerized instrument for tomographic and biomicroscopic imaging. Class II ophthalmoscope (21 CFR 886.1570).

Indications for Use

Indicated for in vivo viewing, axial cross-sectional, and 3D imaging/measurement of posterior ocular structures (retina, retinal nerve fiber layer, macula, optic disc) in patients to aid in detection and management of ocular diseases including macular holes, cystoid macular edema, diabetic retinopathy, age-related macular degeneration, and glaucoma.

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

• Stratus OCT™ with Retinal Nerve Fiber Layer Normative and Macula Database
• Visante™ OCT

Submission Summary (Full Text)

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# 510(K) SUMMARY

## 5. 510 (K) SUMMARY

| | 510(k) SUMMARY | | |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|-------------|
| | (per 21 CFR §807.92) | | JAN 26 2007 |
| | CIRRUS™ HD-OCT | | |
| GENERAL INFORMATION | | | |
| Manufacturer: | Carl Zeiss Meditec Inc.<br>5160 Hacienda Drive<br>Dublin, California 94568<br>[phone] (phone)<br>[phone] (fax)<br>Est. Reg. No. 2918630 | | |
| Contact Person: | Judith A. Brimacombe, MA<br>Director, Regulatory/Clinical Affairs<br>Carl Zeiss Meditec, Inc.<br>5160 Hacienda Drive<br>Dublin, California 94568<br>[phone] (phone)<br>[phone] (fax) | | |
| Classification Name: | Ophthalmoscope | | |
| Classification: | Class II (acc. 21 CFR 886.1570) | | |
| Product Code: | 86 HLI | | |
| Trade/Proprietary Name: | Cirrus™ HD-OCT | | |
| PREDICATE DEVICE | | | |
| Company:<br>Device: | Carl Zeiss Meditec, Inc.<br>Stratus OCT™ with Retinal Nerve Fiber Layer Normative<br>and Macula Database | | |
| Company:<br>Device: | Carl Zeiss Meditec, Inc.<br>Visante™ OCT | | |
| INTENDED USE | | | |

The Cirrus™ HD-OCT is intended for use in the viewing and axial cross sectional imaging of posterior ocular structures.

:

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### INDICATIONS FOR USE

The Cirrus™ HD-OCT is a non-contact, high resolution tomographic and biomicroscopic imaging device. It is indicated for in vivo viewing, axial cross-sectional, and threedimensional imaging and measurement of posterior ocular structures, including retina, retinal nerve fiber layer, macula, 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 holes, cystoid macular edema, diabetic retinopathy, age- related macular degeneration and glaucoma.

#### DEVICE DESCRIPTION

The Cirrus™ HD-OCT is a computerized instrument that acquires and analyzes crosssectional tomograms of posterior ocular structures (including retina, retinal nerve fiber layer, macula, and optic disc.). It employs non-invasive, non-contact, low-coherence interferometry to obtain these high-resolution images. Using this non-invasive optical technique, Cirrus HD-OCT produces high-resolution cross-sectional tomograms of the eye without contacting the eye.

### SUBSTANTIAL EQUIVALENCE

The Cirrus™ HD-OCT is substantially equivalent to the predicate devices identified previously. The Cirrus™ HD-OCT is substantially equivalent to the predicate devices with regard to intended use, operating principle, function, and materials.

Evaluation performed on the Cirrus™ HD-OCT supports the indications for use statement and demonstrates the device is substantially equivalent to the predicate devices and does not raise new questions regarding safety and effectiveness with respect to ophthalmoscopes.

### CLINICAL EVALUATION

Clinical data was collected and evaluated to support the indications for use statement for the Cirrus™ HD-OCT and to demonstrate substantial equivalence to the Stratus OCT.

#### CONCLUSION

As described in this 510(k) Summary, all testing deemed necessary was conducted on the Cirrus™ HD-OCT to ensure that the device is safe and effective for its intended use when used in accordance with its Instructions for Use.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Carl Zeiss Meditec, Inc. c/o Judy Brimacombe Director, Regulatory/Clinical Affairs 5160 Hacienda Drive Dublin, CA 94568

JAN 26 2007

Re: K063378

Trade/Device Name: Cirrus HD-OCT Regulation Number: 21 CFR 886.1570 Regulation Name: Ophthalmoscope, AC-Powered Regulatory Class: Class II Product Code: HLI Dated: November 6, 2006 Received: November 8, 2006

Dear Ms. Brimacombe:

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.

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, RDA 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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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. Eichelman Simd

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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#### 4. INDICATIONS FOR USE STATEMENT

Device Name: Cirrus™ HD-OCT

Indications for Use:

The Cirrus™ HD-OCT is a non-contact, high resolution tomographic and biomicroscopic imaging device. It is indicated for in vivo viewing, axial cross-sectional, and threedimensional imaging and measurement of posterior ocular structures, including retina, retinal nerve fiber layer, macula, 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 holes, cystoid macular edema, diabetic retinopathy, age- related macular degeneration and glaucoma.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Clay R. Buttereau

510(k) Number K063378

000012