(94 days)
Indications for use :
The tonometer separation prisms is an accessory to the tonometer which is a manual device used to measure the intraocular pressure of the eye.
The Luneau tonometer separation prisms is an optical plastic monobloc piece which is transparent made of 1 plane surface in contact with the eye and of 2 small prisms allowing the ophthalmologists to observe 2 half circles.
The provided document is a 510(k) premarket notification letter from the FDA for a device called "Luneau tonometer separation prisms." This letter confirms that the device is substantially equivalent to legally marketed predicate devices.
However, the document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or any of the other specific details requested in your prompt.
The 510(k) clearance process primarily focuses on demonstrating substantial equivalence to a predicate device, meaning it has the same intended use and technological characteristics as a legally marketed device, or different technological characteristics but is as safe and effective as a legally marketed device and does not raise different questions of safety and effectiveness. It does not typically require the detailed performance studies or AI-specific information you've requested.
Therefore, I cannot fill in the table or answer the specific questions based solely on the provided text. The document is an FDA clearance letter, not a study report.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 0 2003
LUNEAU S.A c/o Jean Noel Young B.P. 252 28005 Chartres Cedex France
Re: K023838
Trade/Device Name: Luneau tonometer separation prisms Regulation Number: 886.1930 Regulation Name: Manual tonometer Regulatory Class: II Product Code: HKY Dated: February 6, 2003 Received: February 10, 2003
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. Iisting 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 - Mr. 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), please contact the Office of Compliance at (301) 594-4613. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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 vours.
A halpi korenthal
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
Enclosure
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Page Of 1
510 (k) NUMBER (IF KNOWN) : Not yet allocated.
Luneau tonometer separation prisms. DEVICE NAME:
INDICATIONS FOR USE:
Indications for use :
The tonometer separation prisms is an accessory to the tonometer which is a manual device used to measure the intraocular pressure of the eye.
Description of the device : .
The Luneau tonometer separation prisms is an optical plastic monobloc piece which is transparent made of 1 plane surface in contact with the eye and of 2 small prisms allowing the ophthalmologists to observe 2 half circles.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED: )
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use "Per 21 CFR 801.109)
OR
Over-The-Counter-Use (Optional Format 1-
Dennis L. McCarthy
(Division Sign Off)
(Division Sign-Off) Division of Ophthalmic Ear, Nose and Throat Devises
510(k) Number K023838
§ 886.1930 Tonometer and accessories.
(a)
Identification. A tonometer and accessories is a manual device intended to measure intraocular pressure by applying a known force on the globe of the eye and measuring the amount of indentation produced (Schiotz type) or to measure intraocular tension by applanation (applying a small flat disk to the cornea). Accessories for the device may include a tonometer calibrator or a tonograph recording system. The device is intended for use in the diagnosis of glaucoma.(b)
Classification. Class II.