VISCUCAM C DIGITAL CAMERA

K043222 · Carl Zeiss Meditec, AG · HKI · Feb 14, 2005 · Ophthalmic

Device Facts

• Record ID: K043222
• Device Name: VISCUCAM C DIGITAL CAMERA
• Applicant: Carl Zeiss Meditec, AG
• Product Code: HKI · Ophthalmic
• Decision Date: Feb 14, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.1120
• Device Class: Class 2

Intended Use

The VISUCAM C Digital Camera is intended 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 C Digital Camera captures, displays, and stores digital images of retina and surrounding ocular structures; operates in both mydriatic and non-mydriatic modes using integrated light sources and filters. Used by eye care professionals in clinical settings to document and monitor ocular pathology. Output consists of digital retinal photographs viewed by clinicians to aid in diagnosis and longitudinal observation of eye disease. Device facilitates clinical decision-making by providing visual evidence of disease progression or status.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Ophthalmic camera; AC-powered; incorporates light sources and filters for mydriatic and non-mydriatic imaging; digital image capture, display, and storage capabilities.

Indications for Use

Indicated for patients requiring retinal and ocular imaging for diagnosis and monitoring of eye diseases; usable under both 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

• VISUCAMLITE™ Fundus Camera (K021787)
• Canon Non-Mydriatic Retinal Camera, Model CR6-45NM (K980246)

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 3 2005

Carl Zeiss Meditec AG c/o Mr. R. Michael Crompton Vice President, Regulatory/Clinical Affairs and Quality Assurance Carl Zeiss Meditec Incorporated 5160 Hacienda Drive Dublin, CA 94568

Re: K043222

Trade/Device Name: Carl Zeiss Meditec AG VISUCAM™ C Digital Camera Regulation Number: 21 CFR 886.1120 Regulation Name: Ophthalmic Camera Regulatory Class: Class II Product Code: HKI Dated: January 19,2005 Received: January 21,2005

Dear Mr. Crompton:

This letter corrects our substantially equivalent letter dated February 14,2005 regarding the Product Code that was stated incorrectly in the reference block as MKI. The correct Product Code should read HKI.

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.

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### Page 2 - Mr. R. Michael Crompton

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.

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,

David M. Whipple

Acting Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

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## Statement of Indications for Use

510(k) Number (if known): Kod 3222

Device Name: VISUCAM™ C Digital Camera

Indications for Use: The VISUCAM C Digital Camera is intended 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.

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Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off
Division of Ophthalmic Ear,
Nose and Throat Devises)

| 510(k) Number | K043222 |
|---------------------------|---------|
| Prescription Use | |
| (Per 21 C.F.R. § 801.109) | |
| OR | |
| Over-the-Counter Use | |

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K043222

FEB 1 4 2005

### 510(k) Summary Carl Zeiss Meditec AG

# VISUCAM C™ Digital Camera

This 510(k) summary for the VISCUCAM C™ Digital Camera is submitted in accordance with the This 916(it) 800 SMDA 1990 and 21 CFR 807.92.

### GENERAL INFORMATION

| Manufacturer: | Carl Zeiss Meditec AG<br>Carl Zeiss Promenade 10<br>07740 Jena<br>Germany<br>Est. Reg. No. 9615030 |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Michael Giebe<br>RA-Manager |
| U.S. Designated Agent: | R. Michael Crompton<br>Vice President, RA/CA/QA<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: | VISCUCAM C™ Digital Camera |
| Generic/Common Name: | Ophthalmic Camera, AC-powered (21 CFR § 886.1120) |

#### PREDICATE DEVICE

- VISUCAMLITETM Fundus Camera (K021787) (1)
- Canon Non-Mydriatic Retinal Camera, Model CR6-45NM (K980246) (2)

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#### INTENDED USE

The VISUCAM C Digital Camera is intended for photographing, displaying and storing the data of the retina and surrounding parts of the eye to be camined 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 VISCUCAM CM Digital Camerais 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 VISCUCAM C™ Digital Camera is indicated for use in both mydriatic and non-mydriatic modes. As such, it acorporates appropriate light sources and filters so that images can be captured under both mydriatic and non-mydriatic conditions.

#### SUBSTANTIAL EQUIVALENCE

The VISCUCAM C™ Digital Camera is substantially equivalent to the VISUCAM비ਾדm Fundus Camera (K021787) and the Canon Non-Mydriatic Retinal Camera, Model CR6-45NM (K980246). All three devices are intended to capture images of the eye and incorporate features, such as light sources 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 VISCUCAM C™ Digital Camera to ensure that the device is safe and effective for its intended use when used in accordance with its Instructions for Use.