(330 days)
FOR THE MEASUREMENTS OF INTRAOCULAR PRESSURE TO AID IN THE DIAGNOSIS OF GLAUCOMA.
Not Found
The provided text is a set of FDA correspondence regarding the 510(k) premarket notification for the Kowa Automated Tonometer KT-500. This document primarily focuses on regulatory approval based on substantial equivalence to a legally marketed predicate device.
Crucially, this document does NOT contain information about specific acceptance criteria for device performance, a study proving those criteria were met, sample sizes for test or training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.
The document states that the FDA reviewed the premarket notification and determined the device is "substantially equivalent" to legally marketed predicate devices. This determination is based on the device meeting the same indications for use and having similar technological characteristics to a device already on the market. It does not provide details of a clinical study or performance data from the manufacturer's submission to demonstrate specific performance metrics against pre-defined acceptance criteria.
Therefore, I cannot fulfill your request for the detailed information you've outlined, as it is not present in the provided text.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized representation of three human figures, depicted as flowing, interconnected lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 2002
Kowa Optimed. Inc. c/o Frances K. Wu Hyman, Phelps & McNamara, P.C. . 700 Thirteenth Street, N.W. Suite 1200 Washington, D.C. 20005
Re: K013805/S001
Trade/Device Name: Kowa Automated Tonometer KT-500 Regulation Number: 21 CFR 886.1930 Regulation Name: Tonometer Regulatory Class: Class II Product Code: HKX Dated: September 27, 2002 Received: September 30, 2002
Dear Ms. Wu:
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 mav 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 mav 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
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Page 2 - Frances K. Wu
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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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.qov/cdrh/dsma/dsmamain.html
Sincerely yours,
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 1 of 1
510(k) Number (if known): KOl 3 805
Device Name: Kowa Automated Tonometer KT-500
Indications For Use:
FOR THE MEASUREMENTS OF INTRAOCULAR PRESSURE TO AID IN THE DIAGNOSIS OF GLAUCOMA.
Division Sign-Off
Division of Ophthalmic Ea Nose and Throat Dev
510(k) Number
( 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
§ 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.