Canon TX-10 Tonometro

510(k) Summary
Prepared: August 22,2002
Submitter:
Company Name: Canon USA, Inc. (U.S. agent/official correspondent for Canon Inc.)
Company Address: One Canon Plaza
Lake Success, NY 1 1042 U.S.A.
Contact Person: Sheila Driscoll, Senior Product Safety Engineer
Phone Number: ( 5 16) 328-5602
Fax Number: (5 16) 328-5 I69
Proposed Device:
Reason For 5 lO(k): New Model
Manufacturer : Canon Inc.
Trade Name: Canon
Model Name: FULL AUTO TONOMETER TX-F
Classification Name: 86HKX,Tononieter, AC powered
Classification #: 886.1930
FDA 5 1O(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 5 1O(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.
-GI-
CANON TONOMETER COMPARISON C@!JRT
Model CANON TONOMETER TX- 10 CANON TONOMETER TX-F

Specification Measuring Range 0-30/0-60mmHg Same as TX-10
Setting (Automatic)
Alignment Method Auto Mode Full Auto Mode
Monitor and auto alignment Monitor and auto alignment
and Change R L position
Auto Mode
Same as TX-10
Manual Mode Manual Mode
Monitor with two dots Same as TX-10
Increment 1mmHg Same as TX-10
Measuring Time 3 millisecond Same as TX-10
(0.003 second)
Fixation Target LED(green) Same as TX-10
Chin Rest Power assisted Same as TX-10
(driving at controller)
Software Controlled Stopper Same as TX-10
Printout Format R L ,Date,time ,avarage,ID, Same as TX- 10
3 or 10 data for each eye
Display 4”(inch)Color LCD 5”(inch)B/W CRT
Dimentions Body 280 X 540 X 480 k 15
(with X depth X height)mm 299 X 340 X 177
Controller
170 X 183X 177
Weight (kg) Body 20.5
16.0
Controller
1.5
DEPARTMENT OF HEALTH &HUMAN SERVICES Publtc tie‘ilttl b,cflvIL<:
Food and Drug Administration

9200 Corporate Boulevard
Rockville MD 20850
NOW 2 6 2002
Canon USA, Inc.
Underwriters Laboratories 1nc.Q
c/o Mr. Kent Donhue
1285 Walt Whitman Road
Melville, NY 1 1747
Re: KO23816
Trade Name: Canon “Full Auto Tonometer TX-F”
Classification Regulation Number: 886.1930
Regulatory Class: I1
Product Code: HKX
Dated: November 1,2002
Received: November 15,2002
Dear Mr. Donhue:
We have reviewed your Section 5 1O(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 I1 (Special Controls) or class 111 (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 (2 1 CFR Part 80 1); 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 53 1-542 of the Act); 2 1 CFR 1000-1050.
Page 2.- Mr. Kent Donhue
This letter will allow you to begin marketing your device as described in your Section 5 lO(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 (2 1 CFR Part 80 1 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" (2 lCFR 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
h t tp ://MWY. fda .gov/cd r lddsma/ds mamai n .ht n i 1
Sincerely yours,
A. Ralph Ro-senthal, M.D.

Director
Division of Ophthalmic and Ear,
Nose and Throat Devices
Office of Device Evaluation
Center for Devices and
Rad iological Health
Indications Statement
51O(K)Number(if known):
Device Name. FULL AUTO TONOMETER TX-F
Indicat ions for Use:
The Canon FULL AUTO TONOMETER TX-F is intended to be used for the
measurement of intraocular pressure of the human eye.
1FPLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHERT PAGE

NEEDED)
Concurrence of CDRH, Office of Device Evaluation(0DE)

' A
Prescription Use I/OR Over-The-Counter Use

(Per 21 CFR 801.109)
- -.w K I L k
i.
q / L
(Optional Format 1-2-96)
.(Di&ibn Sign-off)
Division of Ophthalmic Ear,
Nose and Throat Devises
filB(k) Number 6

Canon TX-10 Tonometro

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510(k) Summary

Prepared: August 22,2002

Model CANON TONOMETER TX- 10 CANON TONOMETER TX-F

Food and Drug Administration

Dear Mr. Donhue:

A. Ralph Ro-senthal, M.D.

Device Name. FULL AUTO TONOMETER TX-F

Indicat ions for Use:

1FPLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHERT PAGE

Concurrence of CDRH, Office of Device Evaluation(0DE)

Prescription Use I/OR Over-The-Counter Use

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