RETINADX

K003236 · Regulatory Associates, Inc. · HKI · Nov 2, 2000 · Ophthalmic

Device Facts

• Record ID: K003236
• Device Name: RETINADX
• Applicant: Regulatory Associates, Inc.
• Product Code: HKI · Ophthalmic
• Decision Date: Nov 2, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.1120
• Device Class: Class 2

Intended Use

The RetinaDx Angiography System is intended for use by trained medical professionals (physicians, ophthalmic technicians, ophthalmic photographers or others with similar training) in a medical office, hospital or other medical setting. It is indicated when a medical professional suspects a patient could have damage or disease of the retina. It is used to take photographs of the patient's retina, which are then studied by the medical professional to get additional information about the retina to consider in his or her efforts to decide on a diagnosis and treatment plan. The RetinaDx system can be used with any patient of any age or condition who is able to sit still enough to have the photographs taken.

Device Story

RetinaDx Digital Angiography System captures digital photographs of the retina; used by trained medical professionals (physicians, technicians, photographers) in clinical or hospital settings. Device facilitates visualization of retinal structures; images are reviewed by clinicians to assist in diagnosis and treatment planning. System requires patient cooperation to remain still during image acquisition. Output consists of retinal images for professional interpretation.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Digital ophthalmic camera system; intended for retinal imaging. Technical specifications and materials not detailed in provided documentation.

Indications for Use

Indicated for patients of any age or condition requiring retinal imaging to assess suspected retinal damage or disease, provided the patient can remain still for photography.

Regulatory Classification

Identification

An ophthalmic camera is an AC-powered device intended to take photographs of the eye and the surrounding area.

Special Controls

*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.

Submission Summary (Full Text)

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Public Health Service

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 2 2000

Mr. Kevin Walls, RAC President Regulatory Associates, Incorporated 777 S. Wadsworth Blvd. Bldg. 2, Ste. 102 Lakewood, Colorado 80226

Re: K003236 Trade Name: RetinaDx Digital Angiography System (Camera Ophthalmic) Regulatory Class: II Product Code: 86 HKI Regulation: 886.1120 Dated: October 16, 2000 Received: October 17, 2000

Dear Mr. Walls:

We have reviewed your Section 510(k) notification of intent to market the device referenced we nave tevice your occares be device is substantially equivalent (for the indications for use stated in the enclosure) 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 the chacinem date of the 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 (Free). The general controls provisions of the Act include requirements for annual registration, Isting 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 ( remairies iffecting 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 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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## Page 2 - Mr. Kevin Walls, RAC

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 nouncation. The I DA miding of essow.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 If you desire specific ativice for your assications), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please 574-0415. Industrially, for quese at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information INISOFanonis of responsibilities under the Act may be obtained from the Division of Small Manufacturers On your responsionates and on [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,
A. Ralph Rosenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

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**510(k) Number (if known):** K003236

Device Name:

RetinaDx Digital Angiography System

Indications for Use: The RetinaDx Angiography System is intended for use by trained medical professionals (physicians, ophthalmic technicians, ophthalmic photographers or others with similar training) in a medical office, hospital or other medical setting. It is indicated when a medical professional suspects a patient could have damage or disease of the retina. It is used to take photographs of the patient's retina, which are then studied by the medical professional to get additional information about the retina to consider in his or her efforts to decide on a diagnosis and treatment plan. The RetinaDx system can be used with any patient of any age or condition who is able to sit still enough to have the photographs taken.

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Denis L. McCarthy
(Division Sign-Off)

Division of Ophthalmic Devices

510(k) Number

Prescription Use × (Per 21 CFR 801.109)

OR

Over-The-Counter Use (Optional Format 1-2-96)