FF450 PLUS FUNDUS CAMERA AND VISUPAC DIGITAL IMAGE ARCHIVING SYSTEM, OR FF450 PLUS VISUPAC SYSTEM

K011877 · Carl Zeiss Jena GmbH · HKI · Sep 26, 2001 · Ophthalmic

Device Facts

• Record ID: K011877
• Device Name: FF450 PLUS FUNDUS CAMERA AND VISUPAC DIGITAL IMAGE ARCHIVING SYSTEM, OR FF450 PLUS VISUPAC SYSTEM
• Applicant: Carl Zeiss Jena GmbH
• Product Code: HKI · Ophthalmic
• Decision Date: Sep 26, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.1120
• Device Class: Class 2

Intended Use

The FF450 plus VISUPAC system is intended to capture, display, store, and manipulate 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

FF450 plus VISUPAC system is an ophthalmic camera and image management system. It uses a monocular fundus camera to capture images of the eye and retina using an external light source. Images are displayed on a monitor, stored on electronic media, and manipulated by the user via system software. Used in clinical settings by eye care professionals to aid in the diagnosis and monitoring of ocular diseases. The system facilitates image acquisition, storage, and retrieval, allowing clinicians to review and analyze retinal images to inform clinical decision-making and patient management.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use compared to legally marketed predicate devices.

Technological Characteristics

Monocular ophthalmic fundus camera; AC-powered; digital image management system; includes monitor for display and computer system for storage/manipulation; software-based image processing.

Indications for Use

Indicated for patients requiring diagnostic imaging or monitoring of eye diseases, specifically the retina and surrounding ocular structures, via fundus photography.

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

• IMAGEnet Digital Ophthalmic Imaging System
• ImageScape Digital Retinal Imaging System

Submission Summary (Full Text)

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SEP 2 6 2001

K611877

# Carl Zeiss Jena's FF450 plus VISUPAC System 510(k) Summary

| Name of Device | FF450 plus VISUPAC System |
|-----------------------------------------------------------|-----------------------------------------------------------------------------|
| Common or Usual Name | Fundus Imaging Device (Camera) |
| Classification Names | Ophthalmic Camera, AC-Powered and Accessories<br>(21 C.F.R. § 886.1120) |
| Product Codes | HKI |
| Submitter | Carl Zeiss Jena GmbH<br>Ophthalmic Instrument Division<br>Germany |
| Phone:<br>Facsimile:<br>Contact Person:<br>Date Prepared: | 011 49 3641 64 2474<br>011 49 3641 64 2451<br>Michael Giebe<br>May 18, 2001 |

### Predicate Devices

Trade Name IMAGEnet Digital Ophthalmic Imaging System ImageScape Digital Retinal Imaging System

Manufacturer Topcon Inc Tomey Corporation

### Intended Use

The FF450 plus VISUPAC system is intended to capture, display, store, and manipulate 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.

### Substantial Equivalence

The FF450 plus VISUPAC system and the predicate devices have the same intended use and indications. All of these devices are ophthalmic camera and image management systems intended to capture, display, store, and manipulate 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.

To acquire these images the FF450 plus VISUPAC system and the predicate devices use monocular ophthalmic cameras that function according to the same principles of operation and technological characteristics. Light from an

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external light source is used to generate images of the eye which are captured using the fundus camera, displayed on a monitor, stored on electronic media by a computer system, and manipulated by the user via the system software. The question of safety and effectiveness, namely - does each system permit the accursition, manipulation, storage, and retrieval of images, is the same for the FF450 plus VISUPAC system and the predicate devices despite minor differences in the way in which each device manipulates or stores the image.

#### Conclusion

Carl Zeiss Jena's FF450 plus VISUPAC system has the same intended use and indications for use, and similar principles of operation and technological characteristics as the Topcon, Inc. IMAGEnet Digital Ophthalmic Imaging System and Tomey Corporation ImageScape Digital Retinal Imaging System. The minor technological differences between the FF450 plus VISUPAC system and the class II predicate devices, including the degree of user support and storage media, do not raise new questions of safety or effectiveness. Thus, the FF450 plus VISUPAC system is substantially equivalent to legally marketed devices intended to capture, display, store, and manipulate 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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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" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines suggesting movement or connection.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 6 2001

Johnathan S. Kahan Regulatory Counsel Hogan & Hartson L.L.P. 555 Thirteenth Street, N.W. Washington, DC 20004 -1109

> Re: K011877 Trade/Device Name: FF450 Plus Funds Camera and VISUPAC Digital Image Archiving System Regulation Number: 21 CFR 886.1120; 21 CFR 892.2010; 21 CFR 892.2020 Regulation Name: Camera, Ophthalmic, AC-powered; Device, Storage, Images, Ophthalmic; Device, Communication, Images, Ophthalmic Regulatory Class: Class II; Class I; Class I Product Code: HKI: NFF; NFF; NFG Dated: June 15, 2001 Received: June 15, 2001

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, 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, 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

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Page 2 - Johnathan S. Kahan

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 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,

David M. Whipple

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

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## KO1187 510(k) Number (if known):

FF450 plus Fundus Camera and VISUPAC System Device Name:

Indications for Use:

The FF450 plus VISUPAC system is intended to capture, display, store, and manipulate 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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dexing Lin 9-28-2001

Division Sign-Off) Division of Ophthalmic Dev 510(k) Number.

Prescription Use
(Per 21 CFR 801.109) ✓

OR

Over-The-Counter Use _ (Optional Format 1-2-96)

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