CANON FULL AUTO TONOMETER TX-F

K023816 · Canon, Inc.-Utsunomiya Optical Products Operation · HKX · Nov 26, 2002 · Ophthalmic

Device Facts

• Record ID: K023816
• Device Name: CANON FULL AUTO TONOMETER TX-F
• Applicant: Canon, Inc.-Utsunomiya Optical Products Operation
• Product Code: HKX · Ophthalmic
• Decision Date: Nov 26, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.1930
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The Canon FULL AUTO TONOMETER TX-F is intended to be used for the measurement of intraocular pressure of the human eye.

Device Story

Non-contact tonometer; uses air puff to measure intraocular pressure. Features full auto-alignment system; automatically detects and aligns to eye; automatically changes between right/left eye positions. Operated by clinician in clinical setting. Provides intraocular pressure measurements in mmHg. Includes power-assisted chin rest and software-controlled safety stopper. Output displayed on 5-inch B/W CRT; printout format includes R/L, date, time, average, and ID. Assists clinicians in monitoring intraocular pressure for ocular health assessment.

Clinical Evidence

No clinical data provided; substantial equivalence based on bench testing and comparison of technological characteristics.

Technological Characteristics

Non-contact air puff measurement system. Measuring range: 0-30/0-60 mmHg. Increment: 1 mmHg. Measuring time: 3ms. Fixation target: green LED. Power-assisted chin rest. Software-controlled safety stopper. Display: 5-inch B/W CRT. Dimensions: 280x540x480mm. Weight: 20.5kg. AC powered.

Indications for Use

Indicated for the measurement of intraocular pressure of the human eye in clinical settings.

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

• Canon TX-10 Tonometer (K963079)

Submission Summary (Full Text)

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K023816

## 510(k) Summary

## NOV 2 6 2002

#### Prepared: August 22, 2002

#### Submitter:

| Company Name: | Canon USA, Inc. (U.S. agent/official correspondent for Canon Inc.) |
|------------------|--------------------------------------------------------------------|
| Company Address: | One Canon Plaza<br>Lake Success, NY 11042 U.S.A. |
| Contact Person: | Sheila Driscoll, Senior Product Safety Engineer |
| Phone Number: | [phone] |
| Fax Number: | [phone] |

#### Proposed Device:

| Reason For 510(k): | New Model |
|----------------------|------------------------------|
| Manufacturer: | Canon Inc. |
| Trade Name: | Canon |
| Model Name: | FULL AUTO TONOMETER TX-F |
| Classification Name: | 86HKX, Tonometer, AC powered |
| Classification #: | 886.1930 |
| FDA 510(k) #: | To be assigned |

### Predicate Device:

| Manufacturer: | Canon Inc. |
|----------------------|------------------------------|
| Trade Name: | Canon |
| Model Name: | TX-10 Tonometer |
| Classification Name: | 86HKX, Tonometer, AC powered |
| Classification #: | 886.1930 |
| FDA 510(k) #: | K963079 |

#### Description Of Device:

The Canon FULL AUTO TONOMETER TX-F is a tonometer designed using a non-contact measurement system.

Air puff gently measures the intraocular pressure with the help of a full auto-alignment system.

### Intended Use:

The Canon FULL AUTO TONOMETER TX-F is intended to be used for the measurement of intraocular pressure of the human eye.

### Technical Characteristics:

Please refer to the attached COMPARISON CHART.

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| | Model | CANON TONOMETER TX-10 | CANON TONOMETER TX-F |
|-------------------------------------|----------------------------|--------------------------------------------------------|--------------------------------------------------------------------------------------|
| Specification | Measuring Range<br>Setting | 0-30/0-60mmHg<br>(Automatic) | Same as TX-10 |
| | Alignment Method | Auto Mode<br>Monitor and auto alignment | Full Auto Mode<br>Monitor and auto alignment<br>and Change R/L position<br>Auto Mode |
| | | | Same as TX-10 |
| | Manual Mode | Manual Mode<br>Monitor with two dots | Same as TX-10 |
| | Increment | 1mmHg | Same as TX-10 |
| | Measuring Time | 3 millisecond<br>(0.003 second) | Same as TX-10 |
| | Fixation Target | LED(green) | Same as TX-10 |
| | Chin Rest | Power assisted<br>(driving at controller) | Same as TX-10 |
| | Safety Mechanism | Software Controlled Stopper | Same as TX-10 |
| Printout Format | | R/L,Date,time,avarage,ID,<br>3 or 10 data for each eye | Same as TX-10 |
| | Display | 4"(inch)Color LCD | 5"(inch)B/W CRT |
| Dimentions<br>(with×depth×height)mm | | Body<br>299×340×177<br>Controller<br>170×183×177 | 280×540×480±15 |
| Weight(kg) | | Body<br>16.0<br>Controller<br>1.5 | 20.5 |

# CANON TONOMETER COMPARISON CAHRT

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administratio 9200 Corporate Boulevard Rockville MD 20850

Canon USA. Inc. Underwriters Laboratories Inc. B c/o Mr. Kent Donhue 1285 Walt Whitman Road Melville, NY 11747

Re: K023816

Trade Name: Canon "Full Auto Tonometer TX-F" Classification Regulation Number: 886.1930 Regulatory Class: II Product Code: HKX Dated: November 1, 2002 Received: November 15, 2002

Dear Mr. Donhue:

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 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 1000-1050.

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Page 2. - Mr. Kent Donhu

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.gov/cdrlv/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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K023816

## Indications Statement

of l

510(K)Number(if known):

Device Name: FULL AUTO TONOMETER TX-F

Indications for Use:

The Canon FULL AUTO TONOMETER TX-F is intended to be used for the measurement of intraocular pressure of the human eye.

# LEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHERT PAGE

Concurrence of CDRH, Office of Device Evaluation(ODE)

| Prescription Use | <div style="display:inline-block;">✓</div> OR <div style="display:inline-block;"></div> Over-The-Counter Use |
|----------------------|--------------------------------------------------------------------------------------------------------------|
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) |

(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises

| 510(k) Number | K023816 |
|---------------|---------|
|---------------|---------|