STRATUSOCT WITH RNFL & MACULA NORMATIVE DATABASE

K033123 · Carl Zeiss Meditec, Inc. · HLI · Apr 20, 2004 · Ophthalmic

Device Facts

• Record ID: K033123
• Device Name: STRATUSOCT WITH RNFL & MACULA NORMATIVE DATABASE
• Applicant: Carl Zeiss Meditec, Inc.
• Product Code: HLI · Ophthalmic
• Decision Date: Apr 20, 2004
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 886.1570
• Device Class: Class 2

Intended Use

The STRATUSOCT™ is a high resolution tomographic device for the viewing and axial cross sectional imaging of posterior ocular structures. It is used for in vivo imaging and measurement of the retina, retinal nerve fiber layer, macula, and optic disk. The STRATUSOCT™ with Retinal Nerve Fiber Layer ("RNFL") & Macula Normative Database is a quantitative tool for the comparison of retinal nerve fiber layer and the macula in the human retina to a database of known normal subjects. 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, central serous retinopathy, and glaucoma.

Device Story

Microprocessor-based low-coherence interferometry instrument; uses scanning optical beam to measure reflections/backscatter from internal ocular tissue. Generates high-resolution tomographic images of posterior ocular structures. Includes normative database for quantitative comparison of RNFL and macula measurements against normal human subjects. Used in clinical settings by eye care professionals. Output provides clinicians with quantitative data and cross-sectional images to assist in diagnosis and management of ocular pathologies like glaucoma and macular edema.

Clinical Evidence

Clinical data collected on a statistically significant number of normal human patients to validate the Macula Normative Database. No comparative clinical trial results or specific performance metrics (sensitivity/specificity) provided in the summary.

Technological Characteristics

Microprocessor-based low-coherence interferometry system. Employs scanning optical beam for tissue imaging. Standalone digital instrument. Software-based normative database comparison.

Indications for Use

Indicated for in vivo imaging and measurement of posterior ocular structures (retina, RNFL, macula, optic disk) in humans to aid in detection and management of ocular diseases including macular edema, central serous retinopathy, 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

• STRATUSOCT™ with Retinal Nerve Fiber Layer Normative Database (1)

Submission Summary (Full Text)

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# APR 2 0 2004

## 510(k) Summary Carl Zeiss Meditec Incorporated STRATUSOCT™ with RNFL & Macula Normative Database

This 510(k) summary for the STRATUSocr™ with RNFL & Macula Normative Database is submitted in accordance with the requirements of SMDA 1990 and 21 C.F.R § 807.92.

#### 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: | R. Michael Crompton<br>Vice President, Regulatory / Clinical Affairs<br>and Quality Assurance |
| DEVICE DESCRIPTION | |
| Classification: | Class II |
| Trade Name: | STRATUSOCTTM with Retinal Nerve Fiber Layer and Macula<br>Normative Database |
| Generic/Common Name: | Ophthalmoscope (21 CFR § 886.1570)<br>Ultrasonic pulsed echo imaging system (21 CFR § 892.1560) |

#### PREDICATE DEVICE

STRATUSOCT™ with Retinal Nerve Fiber Layer Normative Database (1)

### INTENDED USE

The STRATUSOCT™ is a high resolution tomographic device for the viewing and axial cross sectional imaging of posterior ocular structures. It is used for in vivo imaging and measurement of the retinal nerve fiber layer, macula, and optic disk. The STRATUSOCT™ with Retinal Nerve Fiber Layer ("RNFL") & Macula Normative Database is a quantitative tool for the comparison of retinal nerve fiber layer and the macula in the human retina to a database of known normal subjects. 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, central serous retinopathy, and glaucoma.

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## DEVICE DESCRIPTION

The STRATUSOCT™ with RNFL & Macula Normative Database is a microprocessor-based low-coherence digital instrument employing low coherence interferometry to generate inages of internal ocular tissue microstructures. The device measures optical reflections or backscatter from tissue using a scanning optical beam. Results obtained for the Retinal Nerve Fiber Layer and the Macula can be compared to a database of known normal human patients.

## SUBSTANTIAL EQUIVALENCE

The STRATUSOCT™ with RNFL & Macula Normative Database is substantially equivalent to the predicate device identified previously. The STRATUSOCT™ with RNFL & Macula Normative Database is substantially equivalent to the predicate device with regard to intended use, operating principle, function, and materials.

Clinical evaluation performed on the STRATUS with RNFL & Macula Normative Database supports the expanded indications for use statement and demonstrates the device is substantially equivalent to the predicate device and does not raise new questions regarding safety and effectiveness with respect to ophthalmoscopes and ultrasonic pulsed echo imaging systems.

## CLINICAL EVALUATION

Clinical data was collected on a statistically significant number of normal human patients and analyzed to support the inclusion of the Macula Normative Database in the STRATUSOCT™.

### CONCLUSION

As described in this 510(k) Summary, all testing deemed necessary was conducted on the STRATUSOCT™ with RNFL & Macula Normative Database 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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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are connected by a flowing line that forms the shape of a bird. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the image.

MAY 2 9 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Carl Zeiss Meditec, Inc. c/o Ms. Judith A. Brimacombe 5160 Hacienda Drive Dublin, CA 94568

Re:

K030433 and K033123 Trade/Device Name: STRATUSOCT™ with Retinal Nerve Fiber Layer (RNFL) & Macula Normative Database Regulation Number: 21 CFR 886.1570 Regulation Name: Ophthalmoscope Regulatory Class: II Product Code: OBO Dated: February 7, 2003 and September 26, 2003 Received: February 10, 2003 and September 30, 2003

Dear Ms. Brimacombe:

This letter updates our substantially equivalent letters of May 1, 2003 and April 20, 2004, respectively.

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 (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 additional controls. Existing major regulations affecting your

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#### Page 2 - Ms. Judith A. Brimacombe

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.

This letter will allow you to continue 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/dsma/dsmamain.html

Sincerely vours.

Evenette W. Beers PhD

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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# Statement of Indications for Use

510(k) Number (if known): K033123_____________________________________________________________________________________________________________________________________________

Device Name: STRATUSOCT™ with RNFL & Macula Normative Database

Indications for Use: TThe STRATUSocT™ is a high resolution tomographic device for the viewing and axial cross sectional imaging of posterior ocular structures. It is used for in vivo imaging and measurement of the retina, retinal nerve fiber layer, macula, and optic disk. The STRATUSOCT™ with Retinal Nerve Fiber Layer ("RNFL") & Macula Normative Database is a quantitative tool for the comparison of retinal nerve fiber layer and the macula in the human retina to a database of known normal subjects. 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, central serous retinopathy, and glaucoma.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | <img alt="signature" src="signature.png"/> |
|-----------------------------------------------------|---------------------------------------------------------------------------|
| Division of Ophthalmic Ear, Nose and Throat Devises | |
| 510(k) Number | K033123 |
| Prescription Use | <div style="display:inline-block;">✓</div> OR Over-the-Counter Use ______ |
| (Per 21 C.F.R. § 801.109) | |