(22 days)
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.
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.
The provided text describes a 510(k) premarket notification for a device modification, not a study designed to meet specific acceptance criteria with performance metrics. The document asserts "substantial equivalence" to a predicate device rather than demonstrating performance against a predefined set of criteria through a dedicated study.
Therefore, many of the requested details about acceptance criteria, specific study design, sample sizes, expert involvement, and ground truth establishment are not present in this type of regulatory submission. The submission focuses on explaining the modifications and arguing that these modifications do not affect safety or efficacy when compared to the previously cleared predicate device.
Here's an attempt to answer the questions based only on the provided text, highlighting where information is absent:
Acceptance Criteria and Device Performance
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria or specific reported device performance metrics against such criteria. The core assertion is that the modified device is "virtually identical" to the predicate with "minor variations that are detailed introduced," meaning it is expected to perform equivalently.
The modifications are:
- Reduced light intensity.
- Elimination of specific device equipment (external power supply, external computer with storage/archiving, external dedicated electronic cameras, dedicated photographic equipment).
- Reduced available viewing angles and image resolution.
- Revised device software for less demanding image processing.
The conclusion drawn is that these modifications "do not affect any question for safety and efficacy," implying the device's performance, post-modification, is still considered safe and effective at a level comparable to the predicate for its intended use, despite the reduced capabilities.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is a 510(k) submission for a device modification asserting substantial equivalence. There is no mention of a formal "test set" or a study involving patient data to evaluate performance for these specific modifications. The comparison appears to be on the technical specifications and components of the modified device versus the predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. No "experts" are described as being used to establish ground truth for a test set in this regulatory submission. The comparison is feature-based against the predicate device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set requiring adjudication is mentioned.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This document pertains to a fundus camera modification, not an AI-based diagnostic tool. No MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This document pertains to a fundus camera, not an algorithm, and no standalone performance study is mentioned.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No ground truth is established or discussed in the context of a performance study for these modifications. The "ground truth" for the submission is the performance and safety profile of the legally marketed predicate device (FF450plus Fundus Camera and VISUPAC Digital Image Archiving System).
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device; thus, no training set size is relevant or mentioned.
9. How the ground truth for the training set was established
Not applicable. See point 8.
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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 VISUPACDigital Image Archiving System |
|---|---|
| Name of Modified Device: | VISUCAMlite Fundus Camera |
| Common or Usual Name: | Fundus Imaging Device(Camera) andAccessories |
| 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 DriveDublin, CA 94568, USATel.: (925) 557 4193Fax: (925) 557 4504 |
| Contact Person: | Nancy E. Funston |
| Consultant: | Jonathan S. KahanPartnerHogan & Hartson L.L.P.555 Thirteenth Street, N.W.Washington, DC 20004-1109Tel.: (202) 637-5794Fax: (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.
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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;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.
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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 (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)
§ 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.