HEIDELBERG RETINA ANGIOGRAPH FA/ICGA (HRA/C)

K971671 · Heidelberg Engineering · HLI · Jul 29, 1997 · Ophthalmic

Device Facts

• Record ID: K971671
• Device Name: HEIDELBERG RETINA ANGIOGRAPH FA/ICGA (HRA/C)
• Applicant: Heidelberg Engineering
• Product Code: HLI · Ophthalmic
• Decision Date: Jul 29, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.1570
• Device Class: Class 2

Intended 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 .

Device Story

Heidelberg Retina Angiograph (HRA/C) is an ophthalmic imaging system; utilizes fluorescein or indocyanine green dye to illuminate retinal and choroidal circulation patterns. Device captures images of ocular vasculature; enables clinicians to visualize blood flow dynamics. Used in clinical settings by ophthalmologists or trained technicians. Output consists of high-resolution angiographic images; allows assessment of vascular pathologies including AMD, CNV, and diabetic retinopathy. Facilitates diagnosis, treatment planning, and monitoring of retinal/choroidal diseases. Benefits patient through improved visualization of vascular abnormalities, supporting targeted clinical interventions.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on 510(k) regulatory review.

Technological Characteristics

Ophthalmic imaging system; utilizes laser-based illumination for fluorescein and indocyanine green angiography. System designed for retinal and choroidal visualization. Connectivity and specific material standards not detailed in provided documentation.

Indications for Use

Indicated for patients requiring visualization of retinal and choroidal circulation patterns to assist in the diagnosis and management of age-related macular degeneration (AMD), choroidal neovascularization (CNV), diabetic retinopathy, diabetic maculopathy, retinal vascular disturbances, and choroiditis.

Regulatory Classification

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.

Special Controls

*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.

Submission Summary (Full Text)

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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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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 .

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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)