VISUCAM PRO NM

K052268 · Carl Zeiss Meditec, AG · HKI · Nov 2, 2005 · Ophthalmic

Device Facts

• Record ID: K052268
• Device Name: VISUCAM PRO NM
• Applicant: Carl Zeiss Meditec, AG
• Product Code: HKI · Ophthalmic
• Decision Date: Nov 2, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 886.1120
• Device Class: Class 2

Intended Use

The VISUCAM™ PRO NM Digital Camera is suitable 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. These photographs support the diagnosis and subsequent observation of eye diseases which can be visually monitored and photographically documented.

Device Story

VISUCAM PRO NM is an ophthalmic digital camera for capturing, displaying, and storing retinal and ocular images. Device utilizes flash illumination and optical sensors to acquire images under both mydriatic and non-mydriatic conditions. Operated by eye care professionals in clinical settings to document and monitor eye diseases. Output consists of digital photographs viewed by clinicians to aid in diagnosis and longitudinal observation of ocular pathology. Benefits include non-invasive visualization of retinal structures to support clinical decision-making.

Clinical Evidence

Bench testing only.

Technological Characteristics

Ophthalmic camera; utilizes flash illumination and optical sensors for image capture; supports mydriatic and non-mydriatic imaging modes; AC-powered; Class II device.

Indications for Use

Indicated for patients requiring retinal and ocular imaging for diagnosis and monitoring of eye diseases under mydriatic and non-mydriatic conditions.

Regulatory Classification

Identification

An ophthalmic camera is an AC-powered device intended to take photographs of the eye and the surrounding area.

Special Controls

*Classification.* Class II (special controls). The device, when it is a photorefractor or a general-use ophthalmic camera, 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

• VISUCAM™ C Digital Camera (K043222)

Submission Summary (Full Text)

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Carl Zeiss Meditec Visucam PRO NM Special 510(k) Notification

K052268

#### NOV - 2 2005

## 510(k) SUMMARY

# VISUCAM™ PRO NM Digital Camera

This 510(k) summary for the VISCUCAM™ PRO NM Digital Camera is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92 .

# GENERAL INFORMATION

| Manufacturer: | Carl Zeiss Meditec AG<br>Göschwitzer Strasse 51 - 52<br>07740 Jena<br>Germany<br>Est. Reg. No. 9615030 |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Michael Giebe<br>RA-Manager |
| U.S. Designated Agent: | Kent W. Jones<br>Vice President, RA/CA/Compliance<br>Carl Zeiss Meditec Inc.<br>5160 Hacienda Drive<br>Dublin, California 94568<br>[phone] (phone)<br>[phone] (fax) |

## DEVICE DESCRIPTION

| Classification: | Class II |
|----------------------|-----------------------------------------------------|
| Trade Name: | VISUCAM™ PRO NM Digital Camera |
| Regulation Name/No.: | Camera, Ophthalmic, AC-powered; (21 CFR § 886.1120) |
| Product Code: | HKI |

PREDICATE DEVICE VISUCAM™ C Digital Camera (K043222)

# 000158

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Carl Zeiss Meditec Visucam PRO Special 510(k) Notification

K052268

#### INTENDED USE

The VISUCAM™ PRO NM Digital Camera is suitable 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. These photographs support the diagnosis and subsequent observation of eye diseases which can be visually monitored and photographically documented.

#### DEVICE DESCRIPTION

The VISUCAM™ PRO NM Digital Camera is intended to capture, display and store images of the eye, especially the retinal area, as well as surrounding areas, to aid in diagnosing or monitoring diseases of the eye that may be observed and photographed. The VISUCAM™ PRO NM Digital Camera is indicated for use in non-mydriatic mode. As such, it incorporates appropriate light sources so that retinal areas of interest may be observed under non-mydriatic conditions and images may be captured with a flash illumination.

### SUBSTANTIAL EQUIVALENCE

The VISUCAM™ PRO NM Digital Camera is substantially equivalent to the VISUCAM™ C Digital Camera (K043222) because it is a modification of this ophthalmic camera. Both devices are intended for examination and capturing images of the eye and incorporate features, such as light sources, sensors, and filters, in order to function in accordance with their respective intended uses.

#### CONCLUSION

As described in this 510(k) Summary, all testing deemed necessary was conducted on the VISUCAM™ PRO NM Digital Camera 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 shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a caduceus, a symbol often associated with healthcare, featuring a staff with a serpent entwined around it.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 2 2005

Carl Zeiss Meditec AG c/o Kent W. Jones Vice President, RA/CA/Compliance 5160 Hacienda Drive Dublin, GA 94568

Re: K052268

Trade/Device Name: VISUCAM™ PRO NM Digital Camera Regulation Number: 21 CFR 886.1120 Regulation Name: Ophthalmic Camera Regulatory Class: Class II Product Code: HKI Dated: October 20, 2005 Received: October 21, 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 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. Iisting 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 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.

David M. Whipple

David M. Whipple Acting 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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Carl Zeiss Meditec Visucam™ PRO NM Special 510(k) Notification

### STATEMENT OF INDICATIONS FOR USE

510(k) Number (if known): K 05 ≥ 2 6 8 VISUCAM™ PRO NM Digital Camera Device Name:

Indications for Use:

The VISUCAM PRO NM Digital Camera is suitable 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. These photographs support the diagnosis and subsequent observation of eye diseases which can be visually monitored and photographically documented.

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

# Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

Dozul

10/30/200

ision Sion-Off vision of Onhthalmic Nose and Throat Dr

510(k) Number K052268