← Product Code [HKX](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKX) · K963079 # CANON TX-10 TONOMETER (K963079) _Canon USA, Inc. · HKX · Mar 3, 1997 · Ophthalmic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKX/K963079 ## Device Facts - **Applicant:** Canon USA, Inc. - **Product Code:** [HKX](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKX.md) - **Decision Date:** Mar 3, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 886.1930 - **Device Class:** Class 2 - **Review Panel:** Ophthalmic ## 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. ## Regulatory 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](/device/K943939.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} 03/03/97 16:58 FAX 316 328 5.52 104 10000000 Canon K963079 MAR - 3 1997 CANON U.S.A., INC. ONE CANON PLAZA LAKE SUCCESS, NY 11042-1198 TELEPHONE: (516) 328-5000 GENERAL FAX TELEPHONE (516) 328-5069 # 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: (516) 328-5600 Fax: (516) 328-5169 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 | | --- **Source:** [https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKX/K963079](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKX/K963079) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com