KOWA AUTOMATED TONOMETER KT-500

K013805 · Kowa Optimed, Inc. · HKX · Oct 11, 2002 · Ophthalmic

Device Facts

• Record ID: K013805
• Device Name: KOWA AUTOMATED TONOMETER KT-500
• Applicant: Kowa Optimed, Inc.
• Product Code: HKX · Ophthalmic
• Decision Date: Oct 11, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.1930
• Device Class: Class 2

Intended Use

FOR THE MEASUREMENTS OF INTRAOCULAR PRESSURE TO AID IN THE DIAGNOSIS OF GLAUCOMA.

Device Story

Kowa Automated Tonometer KT-500 measures intraocular pressure (IOP) to assist in glaucoma diagnosis. Device operates as an automated tonometer; utilizes non-contact air-puff or similar mechanism to measure ocular resistance; provides digital IOP readings to clinician. Used in clinical settings by eye care professionals. Output facilitates clinical decision-making regarding glaucoma screening and management. Benefits patient through non-invasive, objective IOP assessment.

Clinical Evidence

No clinical data provided in the document; substantial equivalence determination based on 510(k) regulatory review.

Technological Characteristics

Automated tonometer; Class II device (21 CFR 886.1930); product code HKX. Device utilizes automated sensing for intraocular pressure measurement. Specific materials, energy sources, and software architecture details are not disclosed in the provided documentation.

Indications for Use

Indicated for the measurement of intraocular pressure to aid in the diagnosis of glaucoma in patients requiring such assessment.

Regulatory Classification

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.

Submission Summary (Full 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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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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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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