(103 days)
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.
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 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.
This 510(k) summary (K011877) for the Carl Zeiss Jena's FF450 plus VISUPAC System does not contain detailed acceptance criteria or a study demonstrating that the device meets such criteria.
The document primarily focuses on establishing "substantial equivalence" of the FF450 plus VISUPAC System to predicate devices (Topcon, Inc. IMAGEnet Digital Ophthalmic Imaging System and Tomey Corporation ImageScape Digital Retinal Imaging System). Substantial equivalence means that the new device has the same intended use and similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness.
Therefore, many of the requested details about acceptance criteria, specific performance studies, sample sizes, ground truth establishment, expert qualifications, and MRMC studies are not present in this 510(k) submission.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as pass/fail metrics. The "acceptance criteria" here are implicitly related to demonstrating "substantial equivalence" to predicate devices for its intended use (capturing, displaying, storing, and manipulating images to aid in diagnosing/monitoring eye diseases).
- Reported Device Performance: No specific performance metrics (e.g., accuracy, sensitivity, specificity, resolution) are provided in the document. The document states that the device functions according to the "same principles of operation and technological characteristics" as the predicate devices, and that it permits the acquisition, manipulation, storage, and retrieval of images.
2. Sample sized used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not mentioned. This document does not describe a clinical performance study with a test set.
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 mentioned. No test set or ground truth establishment process is described.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not mentioned. No test set or adjudication method is described.
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
- No MRMC study was mentioned.
- This device is described as an "ophthalmic camera and image management system," not an AI-assisted diagnostic tool, so "human readers improve with AI" is not applicable in this context.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- This device is an imaging and image management system, not an algorithm, so "standalone algorithm performance" is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not mentioned. No ground truth is described.
8. The sample size for the training set
- Not mentioned. No training set is described as this is not an AI/ML device that undergoes a training process.
9. How the ground truth for the training set was established
- Not mentioned. Not applicable as no training set is described.
Summary based on the provided document:
The 510(k) submission for the FF450 plus VISUPAC System establishes substantial equivalence to existing predicate devices (Topcon IMAGEnet and Tomey ImageScape). The implicit "acceptance criteria" for this submission appear to be:
- Intended Use Equivalence: The device shares the same intended use as the predicate devices (capture, display, store, manipulate eye images to aid in diagnosing/monitoring diseases). (Met)
- Technological Characteristics Equivalence: The device operates on the same principles (monocular ophthalmic camera, light source for image generation) and has similar technological characteristics. Minor differences (e.g., user support, storage media) do not raise new safety or effectiveness concerns. (Met)
The document does not provide data from specific performance studies, clinical trials, or expert reviews for its own performance, but rather leverages the regulatory pathway of substantial equivalence to already marketed devices.
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SEP 2 6 2001
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(21 C.F.R. § 886.1120) |
| Product Codes | HKI |
| Submitter | Carl Zeiss Jena GmbHOphthalmic Instrument DivisionGermany |
| Phone:Facsimile:Contact Person:Date Prepared: | 011 49 3641 64 2474011 49 3641 64 2451Michael GiebeMay 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 (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,
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)
§ 886.1120 Ophthalmic camera.
(a)
Identification. An ophthalmic camera is an AC-powered device intended to take photographs of the eye and the surrounding area.(b)
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.