(142 days)
The PT100 is a hand held non contact tonometer intended to measure the intraocular pressure of the eye.
Not Found
This document is a 510(k) clearance letter for the Reichert PT100 Portable Tonometer. It does not contain information about the acceptance criteria or a study proving that the device meets those criteria. The letter primarily confirms that the device is substantially equivalent to legally marketed predicate devices and outlines regulatory responsibilities.
Therefore, I cannot provide the requested information based on the provided text.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 0 2002
Mr. Frank J. Drexelius Regulatory Affairs Manager Leica Microsystems, Inc. 3374 Walden Ave. Dephew, NY 14043
Re: K013259
Trade/Device Name: Reichert PT100 Portable (Tonometer) Regulation Number: 21 CFR 886.1930 Regulation Name: Non-Contact Tonometer Regulatory Class: II Product Code: HKX Dated: January 15, 2002 Received: January 17, 2002
Dear Mr. Drexelius:
We have reviewed your Section 510(k) premarket notification of intent to market the device wt have reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreaty to togally to the enactment date of the Medical Device Amendments, or to commerce proc to May 20, 1978, are cassordance with the provisions of the Federal Food, Drug, devices that have been require approval of a premarket approval application (PMA). and Cosmetion (110. (110.) that be nevice, subject to the general controls provisions of the Act. The I ou may, diereleve, mains of the Act include requirements for annual registration, listing of general controls provision 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 If your device is exassince (too as controls. Existing major regulations affecting your device can may be subject to back access as 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 I loase of devices that I bromination that your device complies with other requirements of the Act that I Dr Horal statutes and regulations administered by other Federal agencies. You must or any is 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 Of It Fat 0077; accems (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. Frank J. Drexelius
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 premaince nedicate 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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Section D
510(k) Number (if known):_K(0)3 259
Device Name:_PT100
Indications for use:
The PT100 is a hand held non contact tonometer intended to measure the intraocular pressure of the eye.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Iluska L. Biuke nicholas
ivision Sign-Off) Division of Ophthalmic Devices
510(k) Number_K0/3259
Prescription Use_ Y (Per 21 CFR 801.109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
§ 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.