CANON TX-10 TONOMETER

K963079 · Canon USA, Inc. · HKX · Mar 3, 1997 · Ophthalmic

Device Facts

• Record ID: K963079
• Device Name: CANON TX-10 TONOMETER
• Applicant: Canon USA, Inc.
• Product Code: HKX · Ophthalmic
• Decision Date: Mar 3, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.1930
• Device Class: Class 2

Indications for Use

The TX-10 tonometer is intended to be used for the measurement of intraocular pressure of the human eye.

Device Story

TX-10 is a non-contact tonometer using air-puff technology to measure intraocular pressure. Device features auto-alignment system for measurement; includes auto and manual alignment modes. Operated by clinician in clinical setting. System includes power-assisted chin rest and 4-inch color LCD display. Output consists of intraocular pressure measurements, date, time, and patient ID. Device provides automated measurement, reducing need for special operator skills. Safety mechanism includes software-controlled stopper.

Clinical Evidence

Bench testing comparing TX-10 and T-2 performance. TX-10 demonstrated regression slope of 0.996, Y-intercept of 0.462 mmHg, and standard deviation of difference (Sd) of 1.56 mmHg. Results meet proposed ISO specifications (slope 0.95-1.05; intercept -1.0 to +1.0; Sd < 2.5 mmHg).

Technological Characteristics

Non-contact air-puff tonometer. Features auto-alignment system, power-assisted chin rest, and 4-inch color LCD. Software-controlled safety stopper. Measuring range 0-60 mmHg; 1 mmHg increment. Measuring time 3 milliseconds. LED fixation target.

Indications for Use

Indicated for measurement of intraocular pressure in human eyes.

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 T-2 Tonometer (K943939)

Submission Summary (Full Text)

{0}

03/03/97 16:58 FAX [phone]
104 10000000
Canon
K963079
MAR - 3 1997
CANON U.S.A., INC.
ONE CANON PLAZA
LAKE SUCCESS, NY 11042-1198
TELEPHONE: [phone]
GENERAL FAX TELEPHONE
[phone]

# 510(k) Summary

1. Date Prepared: July 23, 1996

2. Applicant's Name: Canon USA, Inc.
One Canon Plaza
Lake Success, NY 11042
U.S.A.

Mr. Glenn Impal / Mr. Ken Shadoff
Phone: [phone]
Fax: [phone]

3. Model Name: Canon TX-10 Tonometer
86HKX, Tonometer, AC Powered
Document Control Number: ?

4. Predicate Model: Canon T-2 Tonometer
86HKX, Tonometer, AC Powered
Document Control Number: K943939

5. Device Description: The TX-10 is a tonometer designed using a non-contact measurement system. Air puff gently measures the intraocular pressure with the help of an auto-alignment system. Features quick and easy measurement that does not require any special skills.

6. Intended Use: The TX-10 tonometer is intended to be used for the measurement of intraocular pressure of the human eye.

7. Summary of Technological Characteristics: See the attached comparison chart.

8. Assessment of Performance Data: See Attachment 1

{1}

Comparison in the measurement accuracy among Canon TX-10 and Canon T-2

| | TX-10 | T-2 | ISO Specifications (proposed) |
| --- | --- | --- | --- |
| Regression Slope | 0.996 | 0.907 | 0.95 to 1.05 |
| Regression Y intercept | 0.462mmHg | 1.08mmHg | -1.0 to +1.0 |
| Standard Deviation of Difference, Sd | 1.56mmHg | 2.12mmHg | 2.5mmHg |
| Coefficient of Correlation | 0.926 | 0.858 | Unspecified |

{2}

K963079

# CANON TONOMETERS COMPARISON CHART

| MODEL | | CANON NON CONTACT TONOMETER T-2 | CANON TONOMETER TX-10 |
| --- | --- | --- | --- |
| Specification | Measuring Range Setting | 0~30/0~60mmHg
(Automatic) | Same as T-2 |
| | Alignment Method | One bright dot with alignment level display | **Auto Mode**
Monitor and auto fine alignment |
| | | | **Manual Mode**
Monitor with two dots |
| | Increment | 1 mmHg | Same as T-2 |
| | Measuring Time | 3 millisecond
(0.003 second) | Same as T-2 |
| | Fixation Target | LED (green) | Same as T-2 |
| | Chin Rest | Manual | Power assisted
(driving at controller) |
| Safety Mechanism | | Mechanical Stopper | Software Controlled Stopper |
| Printout Format | | R/L, date, time, avarage, ID, 3 or 10 data for each eye | Same as T-2 |
| Display | | 5" (inch) B/W CRT | 4" (inch) Color LCD |
| Dimentions
(width x depth x height) mm | 286 x 445 x 472 | **Body**
299 x 340 x 177 | |
| | | **Controller**
170 x 183 x 177 | |
| Weight (kg) | 22.0 | **Body**
16.0 | |
| | | **Controller**
1.5 | |