(83 days)
Device is intended for viewing the retinal and/or choroidal circulation patterns that are illuminated using fluorescein or indocyanine green dye, and for aiding in the:
- management of age-related macula degeneration (AMD)
- detection of choroidal neovascularization (CNV)
- assessment of diabetic retinopathy
and the comments of - assessment of diabetic maculopathy
- treatment control of diabetic maculopathy, AMD, CNV
- detection of retinal vascular disturbances
- assessment of choroidal circulation
- diagnosis of chorioditis or choroidal diseases
Not Found
The provided text is a 510(k) clearance letter from the FDA for a medical device called the "Heidelberg Retina Angiograph FA/ICGA (HRA/C)". This document confirms that the device has been found substantially equivalent to a predicate device and can be marketed.
However, the provided text does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies. The letter is a regulatory approval document and does not include the technical study details that would typically be part of a submission to demonstrate performance.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input. The document explicitly states:
- "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 to devices marketed in interstate commerce prior to May 28, 1976..."
- "A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements..."
This indicates a regulatory clearance based on substantial equivalence, rather than a detailed performance study evaluation described within the provided text.
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Image /page/0/Picture/10 description: The image is a black and white circular logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol resembles a stylized caduceus, with a staff and a serpent winding around it, representing health and medicine.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 9 1997
Gerhard Zinser, Ph.D. ... Managing Director Heidelberg Engineering GmbH Tiergartenstrasse 17 D-69121 Heidelberg Germany
Re: K971671. . . . . Trade Name: Heidelberg Retina Angiograph FA/ICGA (HRA/C) Regulatory Class: II Product Code: 86 HLI Dated: May 5, 1997 Received: May 7, 1997
Dear Dr. Zinser:
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 to 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 (QS)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 noufication 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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Page 2 - Gerhard Zinser, Ph.D.
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" (21 CFR 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/dsmamain.html".
Sincerely yours,
A Ralph Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510(k) Number (if known):__K971671
Device Name:_Heidelberg Retina Angiograph FA/ICGA (HRA/C)
Indications For Use:
Device is intended for viewing the retinal and/or choroidal circulation patterns that are illuminated using fluorescein or indocyanine green dye, and for aiding in the:
- . management of age-related macula degeneration (AMD)
- detection of choroidal neovascularization (CNV) .
- . assessment of diabetic retinopathy
and the comments of
- . assessment of diabetic maculopathy
- treatment control of diabetic maculopathy, AMD, CNV
- . detection of retinal vascular disturbances
- assessment of choroidal circulation
- diagnosis of chorioditis or choroidal diseases .
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Quynh Hoang Scientific Reviewer
(Division Sign-Off)
Division of Ophthalmic Devices
510(k) Number K971671
Prescription Use Y (Per 21 CFR 801.109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
§ 886.1570 Ophthalmoscope.
(a)
Identification. An ophthalmoscope is an AC-powered or battery-powered device containing illumination and viewing optics intended to examine the media (cornea, aqueous, lens, and vitreous) and the retina of the eye.(b)
Classification. Class II (special controls). The device, when it is an AC-powered opthalmoscope, a battery-powered opthalmoscope, or a hand-held ophthalmoscope replacement battery, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.