(90 days)
The EyeCap Imaging System is used by Health Professionals to capture, store and manage output images from Retinal Cameras, Fundus Cameras and Video Slit Lamps.
EyeCap Imaging System
I am sorry, but the provided text does not contain any information about acceptance criteria or a study proving the device meets them. The document is an FDA 510(k) clearance letter for the EyeCap Imaging System, which primarily states that the device is substantially equivalent to a legally marketed predicate device.
Therefore, I cannot provide the requested table or answer the specific questions about the study, sample sizes, ground truth, or expert qualifications.
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Public Health Service
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY - 4 2000
Clement Clarke International, LTD c/o Mr. M. J. Wilkinson Edinburgh Way Harlow, Essex CM20 2TT United Kingdom
K000368 Re:
Trade Name: EyeCap Imaging System Regulatory Class: Class II Product Code: HKI Regulation: 886.1120 (Accessory to Ophthalmic Camera) Dated: January 25, 2000 Received: February 4, 2000
Dear Mr. Wilkinson:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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This letter will allow you to begin marketing your device as described in your 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 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
sincerely yours,
A. Joseph Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic, Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Clement Clar
A HAAG-STREIT COMPANY
APPENDIX 3
| 510(K) Number (if known) | : | Not yet allocated K000368 |
|---|---|---|
| -------------------------- | --- | --------------------------- |
:
Indications for Use :
Device Name
The EyeCap Imaging System is used by Health Professionals to capture, store and manage output images from Retinal Cameras, Fundus Cameras and Video Slit Lamps.
EyeCap Imaging System
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Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Ophthalmic Devices
510(k) Number K000368
Prescription Use -------------------------------------------------------------------------------------------------------------------------------------------------------------(Per 21 CFR 801.109)
(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.