VISANTE OCT

K051789 · Carl Zeiss Meditec, Inc. · HLI · Sep 30, 2005 · Ophthalmic

Device Facts

• Record ID: K051789
• Device Name: VISANTE OCT
• Applicant: Carl Zeiss Meditec, Inc.
• Product Code: HLI · Ophthalmic
• Decision Date: Sep 30, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.1570
• Device Class: Class 2

Intended Use

The Visante OCT is intended for use in the viewing and imaging of anterior segment ocular structures.

Device Story

Visante OCT is a computerized, non-contact, high-resolution tomographic and biomicroscopic imaging system. It utilizes low-coherence interferometry to capture cross-sectional images of the anterior eye segment, including the cornea, anterior chamber, iris, and central lens. Operated by eye care professionals in a clinical setting, the device processes optical signals to generate high-resolution tomograms. These images allow clinicians to visualize ocular structures and perform measurements, such as corneal and LASIK flap thickness, to assist in clinical assessment and surgical planning. The non-invasive nature of the device benefits patients by providing diagnostic information without physical contact with the eye.

Clinical Evidence

Clinical data collected on a statistically significant number of normal human patients to support the indications for use. No specific performance metrics (sensitivity/specificity) provided in the summary. Testing confirmed the device is safe and effective for its intended use.

Technological Characteristics

Non-contact, high-resolution tomographic and biomicroscopic device. Employs low-coherence interferometry for imaging. Computerized instrument. Class II device. Product code OBO (Ophthalmoscope).

Indications for Use

Indicated for in vivo imaging and measurement of anterior segment ocular structures, including corneal and LASIK flap thickness, in patients requiring anterior segment evaluation.

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 and Macula Database
• Orbscan™ II

Submission Summary (Full Text)

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# SEP 3 0 2005

# 510(k) Summary KOS/789 Carl Zeiss Meditec Incorporated

This 510(k) summary for the Visante OCT 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: | Judith A. Brimacombe, MA<br>Director, Regulatory / Clinical Affairs |

#### DEVICE DESCRIPTION

| Classification: | Class II |
|-----------------|----------|
|-----------------|----------|

Visante™ OCT Trade Name:

Device, Analysis, Anterior Segment; Ophthalmoscope Generic/Common Name:

# PREDICATE DEVICES

- (1) STRATUSOCT™ with Retinal Nerve Fiber Layer Normative and Macula Database
- (2) Orbscan™ II

#### INTENDED USE

The Visante OCT is intended for use in the viewing and imaging of anterior segment ocular structures.

#### INDICATIONS FOR USE

The Visante™ OCT is a non-contact, high resolution tomographic and biomicroscopic device indicated for the in vivo imaging and measurement of ocular structures in the anterior segment, such as corneal and LASIK flap thickness.

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# DEVICE DESCRIPTION

The Visante OCT is computerized instrument that acquires and analyzes cross-sectional tomograms of the anterior eye segment (cornea, anterior chamber, iris and the central portion of the lens). It employs non-invasive, non-contact, low-coherence interferometry to obtain these high-resolution images. Using this non-invasive optical technique, Visante OCT produces high-resolution cross-sectional tomograms of the eye without contacting the eye.

## SUBSTANTIAL EQUIVALENCE

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

Clinical evaluation performed on the Visante 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 anterior segment analysis devices and ophthalmoscopes.

# CLINICAL EVALUATION

Clinical data was collected on a statistically significant number of normal human patients and analyzed to support the indications for use statement for the Visante OCT.

#### CONCLUSION

As described in this 510(k) Summary, all testing deemed necessary was conducted on the Visante 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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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 an eagle with three heads in profile, facing to the right. The eagle is enclosed in a circle of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 9 2007

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

Re: K051789

> Trade/Device Name: Visante™ OCT Regulation Number: 21 CFR 886.1570 Regulation Name: Ophthalmoscope Regulatory Class: II Product Code: OBO Dated: July 1, 2005 Received: July 7, 2005

Dear Ms. Brimacombe:

This letter updates our substantially equivalent letter of September 30, 2005.

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 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.

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Page 2 - Ms. Judith A. Brimacombe

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 yours,

Evenette N. Beers PhD

for

N
L
I

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): K051789

Device Name: Visante™ OCT

Indications for Use: The Visante™ OCT is a non-contact, high resolution Indications for OSCF The Nearly device indicated for the in vivo imaging and tomographic und blomierosoph a in the anterior segment, such as corneal and LASIK flap thickness.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Clay R. Butterman, DOED

Prescription Use
(Per 21 C.F.R. § 801.109)

OR

Over-the-Counter Use__________________________________________________________________________________________________________________________________________________________