NON-CONTACT TONOMETER, MODEL FT-1000

K073087 · Tomey Corporation · HKX · Nov 18, 2008 · Ophthalmic

Device Facts

• Record ID: K073087
• Device Name: NON-CONTACT TONOMETER, MODEL FT-1000
• Applicant: Tomey Corporation
• Product Code: HKX · Ophthalmic
• Decision Date: Nov 18, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.1930
• Device Class: Class 2

Intended Use

The NON-CONTACT TONOMETER FT-1000 is indicated for the measurement of intraocular pressure without contacting the eye to aid in the screening and diagnosis of glaucoma.

Device Story

Non-contact tonometer; uses air-puff mechanism to measure intraocular pressure (IOP) without eye contact. Device features auto-alignment, auto-shot, and touch-alignment capabilities. Operated by clinicians in clinical settings. Input: air-puff pressure response from human eye. Output: IOP measurement in mmHg or hPa displayed on 5.7-inch color LCD. Includes software-controlled safety stopper and touch sensor to prevent contact. Data output via RS232C; includes thermal printer. Assists clinicians in glaucoma screening/diagnosis by providing non-invasive pressure readings.

Clinical Evidence

No clinical data provided; substantial equivalence based on bench testing and comparison of technical characteristics.

Technological Characteristics

Non-contact air-puff tonometer. Measurement range 0-60 mmHg. Features: 5.7-inch color LCD, RS232C data output, thermal printer, power-assisted chin rest. Safety: software-controlled stopper and touch sensor. Power: AC100-240V, 50/60Hz. Dimensions: 306(W)x493(D)x463(H)mm. Weight: ~18kg.

Indications for Use

Indicated for measurement of intraocular pressure in humans to aid in screening and diagnosis of glaucoma.

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

• FULL AUTO TONOMETER TX-F (K023816)

Submission Summary (Full Text)

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K073087

# 1. Company Identification

TOMEY CORP. 2-11-33 Noritakeshinmachi, Nishi-ku, Nagoya, Aichi, JAPAN 451-0051 Tel: [phone] Fax: [phone]

# 2. Official Correspondent

Tomoko Watanabe (Ms.) International Dept.

NOV 1 8 2008

- 3. Date of Submission October 31, 2007
### 4. Device Trade name NON-CONTACT TONOMETER FT-1000

# 5. Common/Usual Name

Tonometer and accessories

#### 6. Classification Number

Class II, 86HKX, 21 CFR 886.1930 - Tonometer AC-Powered

#### 7. Predicate Device

Manufacturer : Canon Inc. : FULL AUTO TONOMETER TX-F Trade Name 510(k) No. : K023816

#### 8. Description of Device

The NON-CONTACT TONOMETER FT-1000 is a tonometer designed using a non-contact measurement system. Air puff gently measures the intraocular pressure of the human eye.

# 9. Indication for use

The NON-CONTACT TONOMETER FT-1000 is indicated for the measurement of intraccular pressure without contacting the eye to aid in the screening and diagnosis of glaucoma.

#### 10. Technical Characteristics

Comparison table of the principal characteristics of 2 devices in Attachment 1 shows that new and predicate devices are equivalent in the areas of fechnical characteristics, general functions.

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# Appendix 1: Comparison Table with Predicate Device

| Manufacturer/ Model | CANON TONOMETER TX-F<br>(K023816) | TOMEY<br>NON-CONTACT TONOMETER<br>FT-1000 |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Type | Non-contact (air-puff) type | Same as TX-F |
| Indication for Use | The Canon FULL AUTO<br>TONOMETER TX-F is intended to<br>be used for the measurement of<br>intraocular pressure of the human<br>eye. | The NON-CONTACT<br>TONOMETER FT-1000 is<br>indicated for the measurement of<br>intraocular pressure without<br>contacting the eye to aid in the<br>screening and diagnosis of<br>glaucoma. |
| Measurable range | 0 to 60 mmHg<br>Includes automatic shifting<br>between 30/60 mmHg | 0 to 60 mmHg<br>(manually changing between 30/60<br>mmHg) |
| Measuring increment | 1 mmHg | Same as TX-F |
| Measuring unit | mmHg | mmHg / hPa |
| Fixation Target | LED(green) | LED(orange) |
| Operation distance | 11.3mm | 11.0mm |
| Observation range | Approx. 15 x 12 mm | Approx. 15 x 9 mm |
| Alignment | Full Auto/Auto/Manual<br>Full auto R/L, Alignment, Shot<br>Auto Alignment, Shot | Auto alignment<br>Auto shot<br>(These are set independently)<br>Touch alignment |
| Safety Mechanism | Software Controlled Stopper | Software Controlled Stopper(Same<br>as TX-F)<br>Touch Sensor |
| Memory | Max. 10 measurements for each<br>eye | Same as TX-F |
| Data output | RS232C | Same as TX-F |
| Power-saving system | Available | Same as TX-F |
| Display | 5-inch monochrome CRT monitor | 5.7-inch color LCD monitor |
| Printer | Thermal line printer | Same as TX-F |
| Chin Rest | Power assisted | Same as TX-F |
| Power Supply | AC100-240V,<br>50/60Hz,<br>0.4-0.8A,<br>Approx.80VA | AC100-240V,<br>50/60Hz,<br>85-110VA |
| Operating range<br>(Movable range) | Front/back: 40mm<br>Left/right: 90mm<br>Up/Down: 30mm | Front/back: 40mm<br>Left/right: 88mm<br>Up/Down: 45mm |
| Dimensions | 280(W)x520(D)x495(H)mm | 306(W)x493(D)x463(H)mm |
| Wight | 20.5kg(45.2lbs.) | Approx. 18kg |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Tomey Corporation c/o Kojo Kubo Comos Corporation 3F, 2-17 Akebono-cho. Tachikawa Tokyo 190-0012 Japan

NOV 1 8 2008

Re: K073087

Trade Device Name: Non-Contact Tonometer FT-1000 Regulation Number: 21 CFR 886.1930 Regulation Name: Ophthalmoscope Regulatory Class: II Product Code: HKX Dated: November 7, 2008 Received: November 10, 2008

Dear Mr. Kubo:

This letter corrects our substantially equivalent letter of November 18, 2008.

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 (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 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.

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); 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.

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This letter will allow you to begin marketing your device as described in your Section 510(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 (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrh/industry/support/index.html.

Sincerely yours.

Malina Berglund

Malvina B. Eydelman, M.D Director Division of Ophthalmic 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): K073087

Device Name : NON-CONTACT TONOMETER, FT-1000

Indications For Use:

The NON-CONTACT TONOMETER FT-1000 is indicated for the measurement of intraocular pressure without contacting the eye to aid in the screening and diagnosis of glaucoma.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Am I right

Division Sign-Off)
Division of Ophthalmic and Ear,
Nose and Throat Devices

510(k) Number K073087