TGDC-01 PRA

K021937 · Truevision Instruments · HKX · Oct 11, 2002 · Ophthalmic

Device Facts

• Record ID: K021937
• Device Name: TGDC-01 PRA
• Applicant: Truevision Instruments
• Product Code: HKX · Ophthalmic
• Decision Date: Oct 11, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.1930
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The TGDC - 01 PRA Tonometer is isseel to ineasur ocular pressure ( 10P) in the diagnosis for use The tended clevictis 0, 1101

Device Story

TGDc-01 "PRA" is a portable, handheld tonometer for measuring intraocular pressure (IOP) through the eyelid at the sclera. Device enables painless, non-contact measurement without anesthetics or antiseptics; eliminates infection risk. Operated by clinicians or patients (home use) in sitting or supine positions. Measurement takes approximately 3 seconds. IOP results are displayed on an integrated LCD screen. Device facilitates glaucoma screening and treatment monitoring; provides results independent of corneal curvature. Includes a pressure control device for verifying operational integrity. Benefits include portability, safety, and ability for repeated daily measurements without ocular trauma.

Clinical Evidence

Comparison medical tests performed against Goldmann and Canon T-2 tonometers. Results demonstrated high coincidence degree across the measurement range. No specific statistical metrics (sensitivity/specificity) provided. Bench testing included measurement range (5-60 mm Hg) and operational longevity (1500 measurements per battery set).

Technological Characteristics

Handheld tonometer; weight ≤79g; dimensions 173.5 x 25.5 x 19.5 mm. Measurement range 5-60 mm Hg. Power: 2x CR2032 batteries (3V). Measurement principle: trans-palpebral scleral tonometry. Digital LCD output. No sterilization required. Service life: 8 years.

Indications for Use

Indicated for measurement of intraocular pressure (IOP) in patients for glaucoma diagnosis and monitoring. Suitable for use in children, patients post-corneal surgery, and general population mass screening. No specific age or gender contraindications noted.

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

• GOLDMAN MANUAL TONOMETER (K981432)
• CANON NON-CONTACT TONOMETER T-2 (K943939)

Reference Devices

• Shiotz Tonometer
• Tono Pen

Submission Summary (Full Text)

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KO21937

# 10. 510 (k) Summary

10.1. Common

OCT 11 2002

### 10.1.1. Requlatory Code

Code of Federal Regulations Title 21, Volume 8: Revised as of April 1, 2001 21CFR886.1930

### 10.1.2. Company Name/Contact

Distributor in USA: Ralf Thomaier Truevision Instruments 4220 Cesar Chavez #536 San Francisco, CA94131 Tel: [phone] Fax: [phone]

Manufacturer: Ryazan State Instrument-Making Enterprise 32 Kalvaev St. Ryazan, 390 000 Russia

### 10.1.3. Medical Specialty

Ophthalmic

10.1.4. Name of Device

Trade name: Common Name: Tonometer TGDc-01"PRA" Tonometer and accessories subpart B - Diagnostic devices

10.1.5. Product Code

HKX

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10.1.6. Device Class

Class II

# 10.1.7. Regulation Number

886.1930

# 10.1.8. Predicate Devices

The TGDc-01 "PRA" is substantially equivalent to the following legally marketed devices:

| GOLDMAN MANUAL<br>TONOMETER<br>produced by<br>GOLDEN VISION, INC.<br>7436 S.W. 117TH<br>AVE.,SUITE 103<br>MIAMI, FL 33183 3816 | 510(k) Number:<br>K981432 |
|----------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|
| CANON<br>NON-CONTACT<br>TONOMETER T-2<br>produced by<br>CANON, INC.<br>30-2<br>SHIMOMARUKO<br>3-CHOME<br>OHTA-KU,<br>TOKYO, JAPAN,<br>JA 146 | 510(k) Number:<br>K943939 |

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## 10.2. Intended Use

Quick and accurate measurement of IOP in various situations independent of place and time is the dream of every ophthalmologist. Today the portable tonometer TGDc-01 "PRA" gives you that capability. This new IOP measuring method through the eyelid in the sclera area, unique to our device, eliminates completely any effect on the mucous eye membrane.

- Painless diagnostics without anesthetics and antiseptics .
- Elimination of infection risk .
- Measuring results independent of cornea's crookedness .
- Evaluation of IOP in patients after any operations on cornea .
- IOP measurement in children .
- Monitoring of Glaucoma treatment .

## 10.3. Technological Characteristics

| Measurement range | 5-60 mm Hg |
|---------------------------------------------------------------------------------------|------------------------|
| The time of a single measurement, not more | 3 sec. |
| Autonomous power supply: 2 feed elements CR2032<br>"VARTA" or similar. Supply voltage | 3 V |
| Number of measurements using one set of feed elements, 1500<br>not less | |
| Serviceability, not less | 8 years |
| Weight, not more | 79 g |
| Dimensions, not more | 173,5 õ 25,5 õ 19,5 mm |

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| FEATURES | TGDc-01 | Goldmann<br>Tonometer | Shiotz<br>Tonometer | Air-jet | Tono Pen |
|-----------------------------------------------------|---------|-----------------------|---------------------|---------|----------|
| No direct effect on the cornea | + | | | | |
| Portability | + | | + | | + |
| Displays independence from<br>cornea's crookedness. | + | | + | + | |
| Digital IOP indication | + | + | | + | + |
| Measurement in sitting position | + | + | | + | + |
| Measurement in supine position | + | | + | + | + |
| Short-time measurement | + | | | + | + |
| Sterilization is not required | + | | | + | + |
| Anesthesia is not required | + | | | + | |

## 10.4. Conclusion

The results of the comparison medical tests of Tonometer TGDc-01 "PRA" and Goldmann tonometer as well as Canon Tonometer T-2 demonstrated their high coincidence degree in the whole range with the compared devices. We achieved the same results from all devices.

Taking into account the comparison medical tests findings as well as tonometer TGDc-01 "PRA" advantages (anesthetics and antiseptics are not necessary; elimination of infection risk; short-time measurement; results independent of cornea's crookedness) its wide application in ophthalmology is recommended alongside with Goldmann tonometer and Canon tonometer, especially while carrying out mass examination of population. Also, it is recommended for use at home to control ophthalmotonus condition under drugs and medical treatment.

Tonometer TGDc-01 "PRA" represents new technology to ophthalmology. It is compact, handy, and can be easily placed in a smock pocket or in a handbag.

Portability, safety and simplicity make tonometer TGDc-01 "PRA" ideal for a wide range of application:

- · for mass examination of the population
- · at the patient's bedside

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- in geriatrics homes .
- · in children hospitals
- · at the army
- at home. .

Tonometer TGDc-01 "PRA" is not only good for determining the potential for glaucoma onset. It can also be used for monitoring treatement effectiveness throughout the day. Unlike other Tonometers, TGDc-01 "PRA" can be used repeatedly during the day with no effect on the eye.

Tonometer TGDc-01 "PRA" is easy to use. A simple operating manual will be provided with each device. It takes only some seconds to measure the IOP, with the patient in a sitting or supine position. The IOP measurement is displayed on an LCD screen of the device. To test the tonometer's operational integrity there is a pressure control device provided.

Tonometer TGDc-01 "PRA" uses the latest technologies which provide it high reliability, quality and longevity.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

OCT 1 1 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Truevision Instruments c/o Mr. Ralf Thomaier 4220 Cesar Chavez #536 San Francisco, CA 94131

Re: K021937

Trade Name: Tonometer TGDc-01 "PRA" Classification Regulation Number: 886.1930 Regulatory Class: II Product Code: HKX Dated: September 19, 2002 Received: September 23, 2002

Dear Mr. Thomaier:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (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 (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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#### Page 2 - Mr. Ralf Thomaier

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 proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 [phone] or [phone] or at its Internet address littp://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

A. Ralph Rosenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

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#### INDICATION FOR USE FORM

#### FDA/CDRH/510K PROGRAM

510(k) Number (if known): K 02i 937 TONO METE -01 PRA Device Name: 760c Indications For Use:

The TGDC - 01 PRA Tonometer is isseel to ineasur ocular pressure ( 10P) in the diagnosis for use The tended clevictis 0, 1101

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

*James L Mc Carthy*
(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises

510(k) Number K021937