KOWA KT-800

K053444 · Kowa Co. , Ltd. · HKX · Jun 9, 2006 · Ophthalmic

Device Facts

• Record ID: K053444
• Device Name: KOWA KT-800
• Applicant: Kowa Co. , Ltd.
• Product Code: HKX · Ophthalmic
• Decision Date: Jun 9, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.1930
• Device Class: Class 2

Intended Use

The KOWA KT-800 is indicated for measuring intraocular pressure without contacting the eye to aid in the screening and diagnosis of glaucoma.

Device Story

KOWA KT-800 is a non-contact tonometer used by clinicians to measure intraocular pressure (IOP) for glaucoma screening/diagnosis. Device uses air-puff technology to measure IOP; features 3D automated alignment (horizontal, vertical, forward/backward) to position measurement head relative to patient eye. Input: optical alignment data and air-puff response; Output: IOP measurement displayed on 5.6-inch color TFT monitor and printed via thermal printer. Device operates in clinical settings; provides automated measurement to assist physician decision-making regarding glaucoma management. Benefits include non-invasive IOP assessment and improved alignment efficiency compared to 2D-only predicate.

Clinical Evidence

Bench testing only. Device evaluated for electrical safety (IEC60601-1), electromagnetic compatibility (IEC60601-1-2), risk management (ISO14971), ophthalmic instrument requirements (ISO15004), optical hazard (IEC60825-1, Class 1), and tonometer performance (ISO8612). No clinical data presented.

Technological Characteristics

Non-contact tonometer; air-puff measurement principle. 3D auto-alignment (horizontal, vertical, forward/backward). 5.6-inch color TFT display. Thermal line printer. Power: AC 100-230V, 50/60Hz. Dimensions: 274mm(W) x 457mm(L) x 458mm(H). Weight: 18kg. Internal green LED fixation light. Complies with IEC60601-1, IEC60601-1-2, ISO14971, ISO15004, IEC60825-1, and ISO8612.

Indications for Use

Indicated for measuring intraocular pressure in patients to aid in the screening and diagnosis of glaucoma. Non-contact method.

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.

Predicate Devices

• Kowa Automated Tonometer KT-500 (K013805)

Submission Summary (Full Text)

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K053444

JUN = 9 2006

# 10. Certification 10.1 Summary for public disclosure

# Submitter information:

| Applicant: | Kowa Company, Ltd.<br>4-14, Nihonbashi-honcho 3-Chome<br>Chuo-ku, Tokyo, 103-8433 Japan<br>Phone: [phone]<br>Fax: [phone] |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Shigeru Takimoto<br>Research and development section<br>Phone: [phone]<br>FAX: [phone] |
| Date summary prepared: | December 5, 2005 |

# Device identification:

| Device trade name: | KOWA KT-800 |
|----------------------|-----------------------|
| Classification name: | TONOMETER, AC-POWERED |
| Product code: | HKX |

#### Intended use:

The KOWA KT-800 is indicated for measuring intraocular pressure without contacting the eye to aid in the screening and diagnosis of glaucoma.

# Comparison:

As a substantial equivalent device, Kowa Automated Tonometer KT-500 is chosen. In Table 10.1, regulation information of Kowa Automated Tonometer KT-500 is shown and in Table 10.2, detail information of the device is shown. KOWA KT-800 and Kowa automated Tonometer KT-500 have the same intended used and the similar to technological characteristics.

Kowa Automated Tonometer KT-500 is a non-contact tonometer with two direction automated alignment ability, up and down duration and left and right direction alignment. In addition, Kowa Automated Tonometer KT-500 can measure the intraocular pressure automatically by blowing the air to the subject eye.

KOWA KT-800 has an auto alignment ability of back and forth direction in addition to the same ability as the predicate device.

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KOWA KT-800 delivers safety equivalent to that of the predicate device. The comparison of the devices are provided in Table 10.2.

#### Performance data:

KOWA KT-800 was tested the following terms and conformed to all specific requirements based on standards. KOWA KT-800 is equivalent to the predicted device.

### Electrical safety

KOWA KT-800 was tested in accordance with IEC60601-1: 1988, Amendment 1:1991 and Amendment 2: 1995, and met to all requirements of standard and amendments.

# Electromagnetic compatibility

KOWA KT-800 was tested in accordance with IEC60601-1-2: 2001, and met to all requirements of standard.

#### Risk management

KOWA KT-800 was evaluated in accordance with ISO14971: 2000, and met to all requirements of standard. The risk management of the device were deemed satisfactory. Remaining risks will be noted in the user manual, so users will be able to avoid them.

Test requirements and test procedure for ophthalmic instruments

KOWA KT-800 was tested in accordance with ISO15004: 1997 and was found to meet all requirements of the standard. For optical hazard, KOWA KT-800 was evaluated in accordance with IEC60825-1: 1993 and amendments, A1: 1997 and A2: 2001.The results were Class 1.

Test requirements and test procedure for tonometer

KOWA KT-800 was evaluated in accordance with ISO8612: 2001 and was found to meet all requirements of the standard.

#### Conclusion:

KOWA KT-800 is equipped with the fundamental technology features equivalent to the predicate device, and also delivers the equivalent level of safety.

Thus it is concluded that there is no difference in the basic functions and safety between KOWA KT-800 and the predicate device.

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| Table 10.1: Predicate device | | | |
|------------------------------------|--------------------|------------|--------------|
| Predicate Device | Manufacturer | 510(k) No. | Date Cleared |
| Kowa Automated Tonometer<br>KT-500 | Kowa Company, Ltd. | K013805 | 10/11/2002 |

Table 10 1· Predic -.. は

Table 10.2: Predicate device comparison

| Table 10.2: Predicate device comparison | | |
|-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|
| | Submitted device | Predicate device |
| Device name | KOWA KT-800 | Kowa Automated Tonometer KT-500 |
| Intended use | For measuring intraocular pressure without contacting the eye to aid in the screening and diagnosis of glaucoma. | For the measurements of intraocular pressure to aid in the diagnosis of glaucoma. |
| Measuring function | | |
| Measuring range | same | 0 to 60mmHg |
| Measuring accuracy | same | +/-1mmHg for 0 to 30mmHg less<br>+/- 2mmHg for 30mmHg to 60mmHg |
| Measurement time | same | within 100milisecond |
| Working distance | same | 11mm |
| Automatic alignment function | 2D auto alignment:<br>Horizontal & vertical direction<br>3D auto alignment:<br>Horizontal & vertical direction, and forward & backward<br>Manual alignment:<br>Manual alignment | 2D auto alignment:<br>Horizontal & vertical direction<br>Manual alignment:<br>Manual alignment |
| Automatic measurement function | same | Automatic air blow<br>manual air blow |
| Moving range for measurement head | Up/Down: +/- 3mm<br>Right/Left: +/- 3mm<br>Forward/Backward +/- 3mm | Up/Down: +/- 3mm<br>Right/Left: +/- 3mm |
| Fixation light | same | Internal green LED |
| Display and Printer | | |
| Display | 5.6 inch color TFT monitor | 5 inch B&W CRT monitor |
| Printer | same | 58mm wide thermal line printer |
| Power specification and dimension | | |
| Dimension | 274mm(W) x 457mm(L) x 458mm(H) | 260mm(W) x 450mm(L) x 450mm(H) |
| Weight | 18kg | 17kg |
| Power supply | AC 100V to 230V, 50/60Hz | AC 100 to 240V, 50/60Hz |
| Power consumption | 60VA | 65VA |

Кома Страну - Чи. КОИ ССР 800

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles three abstract shapes, possibly representing human figures or elements of health and well-being.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Kowa Co. Ltd. c/o Shinichi Yamanaka, Cosmos Corporation 319 Akeno Obata-Cho, Watarai-Gun Mie-Ken,

Japan 519-05

Re: K053444

Trade/Device Name: Kowa KT-800 Regulation Number: 21 CFR 886.1930 Regulation Name: Tonometer Regulatory Class: Class II Product Code: HKX Dated: May 25, 2006 Received: May 30, 2006

Dear Mr. Yamanaka:

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 indictions 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 Fedral 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, Inting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

JUN - 9 2006

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 100-100.

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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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

M.B. Eichelman SimWD

Malvina B. Eydelman, 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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# Indications for Use

-K053444_ 510(k) Number (if know):

Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications for Use:

The KOWA KT-800 is indicated for measuring intraocular pressure without contacting the eye to aid in the screening and diagnosis of glaucoma.

> Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use_ (21 CFR 801 Subpart C)

(PLEASE DO WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device

Clay R. Buttemer

510(k) Number K053444

Kowa Cemograv, Ltd., KOWA KT SOF

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