(62 days)
The 3-Mirror Lens is an ophthalmic device used for the examination of the ocular fundus.
The 3-Mirror Lens is an optical device, which by the intermidiary of the mirrors, allows the ophthalmologist to observe different parts of the posterior chamber of the eye, in particular, the retina. The ophthalmologist holds the 3-Mirror Lens with his hand on the eye of the patient and he observes the images from the mirrors with a slit-lamp.
The provided text is a 510(k) premarket notification letter from the FDA to Luneau S.A. regarding their Luneau 3-Mirror Lens. This document does not contain any information about acceptance criteria, device performance, study design, sample sizes, expert qualifications, adjudication methods, or ground truth establishment for a study proving the device meets acceptance criteria.
The letter is an FDA determination of substantial equivalence to a legally marketed predicate device, allowing Luneau S.A. to market the device. It outlines the regulatory classification, general controls, and other applicable regulations. It describes the device and its indications for use but does not present any efficacy or performance study data.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study as the necessary information is not present in the provided text.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 4 2002
Luneau S.A., c/o Jean Noel Young B.P. 252 28005 Chartres Cedex France
Re: K022413
Trade/Device Name: Luneau 3-Mirror Lens Regulation Number: 21 CFR 886.1385 Regulation Name: Polymethylmethacrylate (PMMA) diagnostic contact lens Regulatory Class: Class II Product Code: HJK Dated: July 11, 2002 Received: July 24, 2002
Dear Mr. Young:
We have reviewed your Section 510(k) premarket 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 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Jean Noel Young
This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 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 Part 807.97), Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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,
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): K022413
Device Name: LUNEAU 3-MIRROR LENS
Indications For Use:
The 3-Mirror Lens is an ophthalmic device used for the examination of the ocular fundus.
Description of the device:
The 3-Mirror Lens is an optical device, which by the intermidiary of the mirrors, allows the ophthalmologist to observe different parts of the posterior chamber of the eye, in particular, the retina. The ophthalmologist holds the 3-Mirror Lens with his hand on the eye of the patient and he observes the images from the mirrors with a slit-lamp.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X
Daniel W.R. Brown, Ph.D.
(Division Sign Off)
(Division Sign-Off) Division of Ophthalmic Ear, Nose and Throat Devises
(Optional Format 3-10-98)
510(k) Number ________________________________________________________________________________________________________________________________________________________________
§ 886.1385 Polymethylmethacrylate (PMMA) diagnostic contact lens.
(a)
Identification. A polymethylmethacrylate (PMMA) diagnostic contact lens is a device that is a curved shell of PMMA intended to be applied for a short period of time directly on the globe or cornea of the eye for diagnosis or therapy of intraocular abnormalities.(b)
Classification. Class II.