(16 days)
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.
RetinaDx Digital Angiography System (Camera Ophthalmic)
This FDA document is a 510(k) clearance letter for the RetinaDx Digital Angiography System and does not contain the detailed study information required to answer your questions about acceptance criteria and device performance.
The letter explicitly states: "We have reviewed your Section 510(k) 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 devices marketed in interstate commerce prior to May 28, 1976..."
This means the device was cleared based on substantial equivalence to a predicate device, not necessarily on a new clinical study demonstrating specific performance against predefined acceptance criteria for a novel technology. Therefore, most of the information you requested would not be present in this type of FDA document.
To answer your questions, one would typically need access to the actual 510(k) submission, which is not publicly available in this detail, or a peer-reviewed publication of a clinical study for the device, which is not provided here.
{0}------------------------------------------------
Public Health Service
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
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 .
{1}------------------------------------------------
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 (301) 594-6413. Additionally, for questions on the promotion and advertising of your device, please 574-0415. Industrially, for quese at (301) 594-4639. 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 (300) 638-2041 or (301) 443-6597 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
{2}------------------------------------------------
Page 1 of 1
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)
§ 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.