(57 days)
Measurement of the Intraocular Pressure
Not Found
The provided text is an FDA 510(k) clearance letter for the Keeler Pulsair 3000 Non Contact Tonometer. It generally confirms that the device is substantially equivalent to legally marketed predicate devices and states its intended use (measurement of Intraocular Pressure).
However, the document does not contain the specific information requested about acceptance criteria, detailed study results, sample sizes, ground truth establishment, or expert qualifications for the device's performance. These details are typically found in the 510(k) submission itself or in separate scientific publications, not in the clearance letter.
Therefore, I cannot provide the requested table and study details based solely on the given text.
To answer your request, I would need access to the actual 510(k) submission for the Keeler Pulsair 3000 or a summary of its performance studies.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 5 1999
Mr. Eugene R. Van Arsdale Marketing Manager Keeler Instruments, Inc. 456 Parkway Broomall, PA 19008
Re: K990257
Trade Name: Keeler Pulsair 3000 Non Contact Tonometer Regulatory Class: II Product Code: 86 HKX Dated: January 25, 1999 Received: January 27, 1999
Dear Mr. Van Arsdale:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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, 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). 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 (Premarket Approval), 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 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 .
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Page 2 - Mr. Eugene R. Van Arsdale
· 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 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 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
A. Roerl. Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health ..............
Enclosure
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510(k) Number (if Known) 《鳥羽のここ「フ
Page 1 of 1
Device Name: Keeler Pulsair 3000 Non Contact Tonometer
Indications For Use: Measurement of the Intraocular Pressure
(PLEASE DO NOT WRITE BELOW THE LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use ×
OR
Over-The-Counter USE
(Optional Format 1-2-96)
Denis L. McCarthy
§ 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.