VISUCAM

K021787 · Carl Zeiss Ophthalmic Systems, Inc. · NFF · Jun 21, 2002 · Radiology

Device Facts

• Record ID: K021787
• Device Name: VISUCAM
• Applicant: Carl Zeiss Ophthalmic Systems, Inc.
• Product Code: NFF · Radiology
• Decision Date: Jun 21, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.2010
• Device Class: Class 1

Intended Use

The VISUCAM™ Fundus Camera is intended to capture, display and store images of eye, especially the retina area, as well as surrounding areas, to aid in diagnosing or monitoring diseases of the eye that may be observed and photographed.

Device Story

VISUCAMlite is a compact fundus camera for general ophthalmology practices. It captures, displays, and stores images of the retina and surrounding eye areas. Compared to the predicate VISUPAC system, it features reduced light intensity, lower image resolution, and fewer viewing angles; it eliminates external power supplies, external computers, and dedicated external cameras/photographic equipment. Operated by eye care professionals in clinical settings, the device assists in diagnosing and monitoring ocular diseases by providing visual documentation of the fundus. The healthcare provider reviews the captured images to inform clinical decision-making regarding patient eye health.

Clinical Evidence

No clinical data provided; substantial equivalence is based on side-by-side technical comparisons and design modifications to the predicate device.

Technological Characteristics

AC-powered ophthalmic camera. Compact form factor. Integrated image processing software. Reduced viewing angles and image resolution compared to predicate. Reduced light intensity. Standalone operation (external computer/archiving modules removed).

Indications for Use

Indicated for patients requiring ophthalmic imaging of the retina and surrounding eye structures to aid in the diagnosis or monitoring of eye diseases. For prescription use only.

Regulatory Classification

Identification

A medical image storage device is a hardware device that provides electronic storage and retrieval functions for medical images. Examples include electronic hardware devices employing magnetic and optical discs, magnetic tapes, and digital memory.

Predicate Devices

• FF450plus Fundus Camera and VISUPAC Digital Image Archiving System (K011877)

Submission Summary (Full Text)

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K02/787

## Carl Zeiss Jena GmbH, Ophthalmic Instruments Division

## VISUCAMlite Fundus Camera Special 510(k) - Device Modification Summary

| Name of Unmodified Device: | FF450plus Fundus Camera and VISUPAC<br>Digital Image Archiving System |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name of Modified Device: | VISUCAMlite Fundus Camera |
| Common or Usual Name: | Fundus Imaging Device<br>(Camera) and<br>Accessories |
| Classification Name: | Camera, Ophthalmic, AC-powered;<br>Device, Storage, Images, Ophthalmic;<br>Device, Communication, Images, Ophthalmic |
| Product Code: | HKI, NFF, NF |
| Submitter: | Carl Zeiss Ophthalmic Systems Inc.<br>Hacienda Drive<br>Dublin, CA 94568, USA<br>Tel.: [phone]<br>Fax: [phone] |
| Contact Person: | Nancy E. Funston |
| Consultant: | Jonathan S. Kahan<br>Partner<br>Hogan & Hartson L.L.P.<br>555 Thirteenth Street, N.W.<br>Washington, DC 20004-1109<br>Tel.: [phone]<br>Fax: [phone] |
| Date Prepared: | May 24, 2002 |

Intended Use:

The VISUCAM™ Fundus Camera is intended to capture, display and store images of eye, especially the retina area, as well as surrounding areas, to aid in diagnosing or monitoring diseases of the eye that may be observed and photographed.

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## Device Modification:

Zeiss' VISUCAMite model is designed for a more general ophthalmology practice than the VISUPAC Fundus Camera. Therefore the VISUCAM™ is a more compact model of the VISUPAC Fundus Camera and designed for less specialized ophthalmic practices. Certain technical specifications for the VISUCAMite have been modified because the VISUCAM™ model is not designed for indocyanine angiography and imaging that requires very high image resolution, different field angles, and corresponding viewing fields. Specifically, Zeiss has modified the cleared device to: {1} reduce the light intensity; (2) eliminate specific device equipment like an external power supply unit, an external computer with storage and archiving module, and different external dedicated electronic cameras as well as dedicated photographic equipment; (3) reduce the available viewing angles and image resolution; and (4) revise the device software to accommodate less demanding image processing requirements.

## Conclusion

Side-by-side comparisons of the VISUCAMite Fundus Camera versus the predicate FF450plus Fundus Camera and VISUPAC Digital Image Archiving System as approved with the notification K011877 demonstrate that both devices are virtually identical with exception of minor variations that are detailed introduced. Finally, we conclude based on our review and assessment of the similarities and the differences the new VISUCAMite Fundus Camera does not affect any question for safety and efficacy.

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Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the seal is a stylized image of three human profiles facing to the right, with flowing lines extending from the bottom of the profiles.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Carl Zeiss Ophthalmic System Inc. c/o Johnathan S. Kahan Partner Hogan & Hartson L.L.P. 555 Thirteenth Street, N.W. Washington, DC 20004 -1109

JUN 2 1 2002

| Re: | K021787 |
|--------------------|----------------------------------------------------------------------------------------------------------------------|
| Trade/Device Name: | VISUCAMlite Fundus Camera |
| Regulation Number: | 21 CFR 886.1120; 21 CFR 892.2010; 21 CFR 892.2020 |
| Regulation Name: | Camera, Ophthalmic, AC-powered;<br>Device, Storage, Images, Ophthalmic;<br>Device, Communication, Images, Ophthalmic |
| Regulatory Class: | Class II; Class I; Class I |
| Product Code: | HKI; NFF; NFG |
| Dated: | May 24, 2002 |
| Received: | May 30, 2002 |

Dear Mr. Kahan

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

A. Ralph Rosenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

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Page 1 of 1 510(k) Number (if known): Device Name: VISIICAMIit

The VISUCAMlite Fundus Camera is intended to Indication for Use: capture, display and store images of eye, especially the retina area, as well as surrounding areas, to aid in diagnosing or monitoring diseases of the eye that may be observed and photographed.

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

Concurence of CDRH, Office of Device Evaluation (ODE) (Optional Format 3-10-98)

DeXiu Shu 6-14-2002

510(k) Number K021787

Prescription Use
(Per 21 CFR 801.109)