FULL AUTO TONOMETER MODEL TX-20

K111710 · Canon Inc. -Medical Equipment Group · HKX · Sep 20, 2011 · Ophthalmic

Device Facts

• Record ID: K111710
• Device Name: FULL AUTO TONOMETER MODEL TX-20
• Applicant: Canon Inc. -Medical Equipment Group
• Product Code: HKX · Ophthalmic
• Decision Date: Sep 20, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 886.1930
• Device Class: Class 2

Intended Use

The Canon Full Auto Tonometer TX-20 is intended to be used for the measurement of intraocular pressure of the human eye.

Device Story

Canon TX-20 is a non-contact tonometer; utilizes air puff mechanism to measure intraocular pressure. Features full auto-alignment system for positioning. Operated by clinical staff in eye care settings. Device transforms air puff interaction into pressure measurement output. Provides objective data for intraocular pressure assessment; assists clinicians in monitoring ocular health.

Clinical Evidence

Bench testing only. Electrical safety, electromagnetic compatibility, and performance testing were conducted to demonstrate compliance with applicable standards and guidance. No clinical data provided.

Technological Characteristics

Non-contact tonometer; air puff measurement system; full auto-alignment system. Class II device (21 CFR 886.1930).

Indications for Use

Indicated for the measurement of intraocular pressure of the human eye.

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 Full Auto Tonometer TX-F (K023816)

Submission Summary (Full Text)

{0}------------------------------------------------

K/// 7/0

Section 5: 510(k) Summary 510(k) Summary

SEP 2 0 2011

# Prepared:

June 17, 2011

New Model

#### Submitter/Holder:

Company Name: Company Address: Contact Person: Phone Number: Fax Number:

CANON INC. 30-2 Shimomaruko 3-chome, Ohta-ku, Tokyo 146-8501, Japan Naoyasu Asaka (81)3-3758-2111 (81)3-5482-3960

#### Proposed Device:

Reason For 510(k): Trade Name: Model Name: Classification Name: FDA 510(k) #:

## Predicate Device:

Trade Name: Model Name: Classification Name: FDA 510(k) #:

CANON INC. Full Auto Tonometer TX-20P HKX, Tonometer and accessories. To be assigned

CANON INC. Canon Full Auto Tonometer TX-F HKX, Tonometer and accessories. K023816

#### Description of Device:

The Canon Full Auto Tonometer TX-20 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-20 is intended to be used for the measurement of intraocular pressure of the human eye.

#### Comparison to Predicate:

The TX-20 is substantially equivalent to the predicate device identified previously with regard to intended use, safety and effectiveness.

#### Performance testing:

The Electrical safety, Electromagnetic compatibility and other performance testings were performed on the TX-20 and the TX-20 complies with applicable standards and guidances. Evaluation performed on the TX-20 demonstrated that it's safe and effective.

### Conclusion:

The Performance Data demonstrate that TX-20 is as safe and effective as predicate device, Canon Full Auto Based on the information in this submission, similarity to predicate device, and the results Tonometer TX-F. of our design control activities and non-clinical testing, it is the opinion of CANON INC. that the Full Auto Tonometer TX-20 described in this submission is substantially equivalent to predicate device.

{1}------------------------------------------------

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows a logo with a stylized bird-like symbol on the right and text arranged in a circular pattern on the left. The bird-like symbol is composed of three curved lines that resemble wings or feathers. The text on the left appears to be part of a circular seal or emblem, but the specific words are not clear due to the image quality.

Food and Drug Administration 10905 New Hampshire Avenue Document Control Room WO66-G609 Silver Spring, MI) 20993-0002

Canon, Inc. - Medical Equipment Group c/o Mr. Koji Kubo Manager Cosmos Corporation 6-5-3 Beaune Honkomagome 2F, Honkomagome, Bunkyo-ku Tokyo. 113-0021 Japan

SEP 2 0 2011

Re: K111710

Trade/Device Name: Canon TX-20 Full Auto Tonometer Regulation Number: 21 CFR 886.1930 Regulation Name: Tonometer and accessories Regulatory Class: Class II Product Code: HKX Dated: August 30. 2011 Received: August 31, 2011

Dear Mr. Kubo:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

ff your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

{2}------------------------------------------------

Page 2 -- Mr. Koji Kubo

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); medical device reporting of medical device-related adverse events) (21 CFR 803); 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,

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm11.5809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Fesia Alexander

Image /page/2/Picture/8 description: The image shows a handwritten script, possibly a signature or a stylized word. The script is in black ink on a white background. The writing appears cursive and flowing, with a combination of sharp angles and rounded curves.

Malvina B. Eydelman. M.D. Director Division of Ophthalmic. Neurological. and Ear. Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

# Indications for Use

510(K) Number (if known): Kl(17170 Full Auto Tonometer TX-20 Device Name: Indications for Use: The Canon Full Auto Tonometer TX-20 is intended to be used for the measurement of intraccular pressure of the human eye. Prescription Use OR × Over-The-Counter Use (Part 21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHERT PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation(ODE)

1 Page of 1

(Division Sign-Off)

Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number k111710