K Number
K021787
Device Name
VISUCAM
Date Cleared
2002-06-21

(22 days)

Product Code
Regulation Number
892.2010
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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 Description
The 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.
More Information

Not Found

No
The summary describes a fundus camera with image processing capabilities, but there is no mention of AI, ML, or related concepts like deep learning, training sets, or performance metrics typically associated with AI/ML algorithms. The focus is on hardware modifications and basic image processing adjustments.

No
The device is intended to capture, display, and store images for diagnosing or monitoring diseases, not to treat them.

Yes
The intended use statement explicitly states that the device is "to aid in diagnosing or monitoring diseases of the eye", which directly indicates a diagnostic purpose.

No

The device description explicitly mentions modifying hardware components like reducing light intensity and eliminating external power supply units, computers, and cameras, indicating it is not solely software.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is to "capture, display and store images of eye... to aid in diagnosing or monitoring diseases of the eye". This describes an imaging device used for visual examination and documentation, not a test performed on biological samples in vitro (outside the body).
  • Device Description: The description details a camera designed to take pictures of the eye. It doesn't mention any components or processes related to analyzing biological specimens.
  • Anatomical Site: The device interacts directly with the eye, which is an in vivo (within the body) application.
  • Lack of IVD Characteristics: There is no mention of reagents, assays, analysis of biological fluids or tissues, or any other typical characteristics of an IVD device.

IVD devices are specifically designed to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device is an imaging tool used for direct observation of the eye.

N/A

Intended Use / Indications for 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.

Product codes (comma separated list FDA assigned to the subject device)

HKI, NFF, NFG

Device Description

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.

Mentions image processing

revise the device software to accommodate less demanding image processing requirements.

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

eye, especially the retina area, as well as surrounding areas

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K011877

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 892.2010 Medical image storage device.

(a)
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.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.

0

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
Digital Image Archiving System |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name of Modified Device: | VISUCAMlite Fundus Camera |
| Common or Usual Name: | Fundus Imaging Device
(Camera) and
Accessories |
| Classification Name: | Camera, Ophthalmic, AC-powered;
Device, Storage, Images, Ophthalmic;
Device, Communication, Images, Ophthalmic |
| Product Code: | HKI, NFF, NF |
| Submitter: | Carl Zeiss Ophthalmic Systems Inc.
Hacienda Drive
Dublin, CA 94568, USA
Tel.: (925) 557 4193
Fax: (925) 557 4504 |
| Contact Person: | Nancy E. Funston |
| Consultant: | Jonathan S. Kahan
Partner
Hogan & Hartson L.L.P.
555 Thirteenth Street, N.W.
Washington, DC 20004-1109
Tel.: (202) 637-5794
Fax: (202) 637-5910 |
| 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.

1

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.

2

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;
Device, Storage, Images, Ophthalmic;
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.

3

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 (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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)