(92 days)
Not Found
No
The summary does not mention AI, ML, or any related terms, and the device description focuses on a non-contact measurement system with auto-alignment, which is a common feature in many medical devices and does not inherently imply AI/ML.
No
The device is solely intended for measurement (diagnosis) and does not provide any treatment or therapy.
Yes
The device measures intraocular pressure, which is a diagnostic measurement used to detect conditions like glaucoma.
No
The device description explicitly states it is a "non-contact measurement system" that uses an "air puff" and a "full auto-alignment system," which are hardware components. The performance studies also mention "Electrical safety, Electromagnetic compatibility and other performance testings" performed on the physical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body ("in vitro").
- Device Function: The Canon Full Auto Tonometer TX-20 measures intraocular pressure directly on the human eye using an air puff. This is a non-invasive measurement performed on the body, not on a specimen taken from the body.
Therefore, based on the provided information, the Canon Full Auto Tonometer TX-20 is a medical device, but it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Canon Full Auto Tonometer TX-20 is intended to be used for the measurement of intraocular pressure of the human eye.
Product codes
HKX
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human eye
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 886.1930 Tonometer and accessories.
(a)
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.(b)
Classification. Class II.
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.
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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 (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Fesia Alexander
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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
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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