(420 days)
The Tono-Film Tonometer Tip Cover is intended to be used in conjunction with the Tono-Pen Tonometer, which is intended to be used to measure intraocular pressure and used in the diagnosis of glaucoma.
Tonometer Tip Covers
The provided text is a 510(k) clearance letter from the FDA for a device called "Tono-Pen Tonometer Tip Cover." This document confirms the device's substantial equivalence to a predicate device and allows it to be marketed.
However, the letter does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement. It is a regulatory clearance document, not a detailed study report.
Therefore, I cannot provide the requested information based on the given text.
To answer your request, I would need a different document, such as a study report, clinical trial results, or a more detailed section of the 510(k) submission that describes the testing and validation of the device.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 3 2004
TRA & ACCESSORIES c/o Mr. Richard Mastroleo 449 West Allen Ave. Suite 107 San Dimas, CA 91773
Re: K033146
Trade/Device Name: Tono-Pen Tonometer Tip Cover Regulation Number: 21 CFR 886.1930 Regulation Name: Tonometer and Accessories Regulatory Class: Class II Product Code: HKY Dated: October 12, 2004 Received: November 18, 2004
Dear Mr. Mastroleo:
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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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 yours,
Afalgi 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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510(k) Submission TRA & ACCESSORIES Tonometer Tip Covers - Tonometer, Manual
Statement of Indications for Use
The Tono-Film Tonometer Tip Cover is intended to be used in conjunction with the Tono-Pen Tonometer, which is intended to be used to measure intraocular pressure and used in the diagnosis of glaucoma.
Prescription Use
(Per 21 CFR 801.109)
Everette K. Bean
(Division Sign-Off)
on of Ophthalmic Ear and Throat D
510(k) Number K033146
§ 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.