(84 days)
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.
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.
This document is a 510(k) summary for the Carl Zeiss Meditec AG VISUCAM™ C Digital Camera. It states that the device is substantially equivalent to previously marketed predicate devices. However, it does not contain the specific information required to answer the questions about acceptance criteria and a study proving the device meets those criteria. The provided text primarily focuses on regulatory approval based on substantial equivalence, rather than detailed performance study results against predefined acceptance criteria.
Therefore, the following information cannot be extracted from the provided text:
- A table of acceptance criteria and the reported device performance
- Sample size used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and their qualifications
- Adjudication method for the test set
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size
- If a standalone (algorithm only) performance study was done
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The sample size for the training set
- How the ground truth for the training set was established
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird figure.
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 (240) 276-8910. 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 (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
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.
(Please DO NOT WRITE BELOW THIS UNE-CONTINUE ON ANOTHER PAGE I F NEEDED)
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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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 AGCarl Zeiss Promenade 1007740 JenaGermanyEst. Reg. No. 9615030 |
|---|---|
| Contact Person: | Michael GiebeRA-Manager |
| U.S. Designated Agent: | R. Michael CromptonVice President, RA/CA/QACarl Zeiss Meditec Inc.5160 Hacienda DriveDublin, California 94568(925) 557-4353 (phone)(925) 557-4481 (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.
§ 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.