(121 days)
Not Found
No
The summary does not mention AI, ML, or any related technologies, and the device description is purely hardware-focused.
No
This device is a diagnostic tool used to measure ocular pressure, not to treat a condition. While it aids in the diagnosis of conditions that may require therapy, it does not provide therapy itself.
Yes
The device is used to measure ocular pressure (IOP) "in the diagnosis for use," indicating its role in identifying or characterizing a medical condition.
No
The device description clearly outlines physical hardware components including batteries, an LCD screen, and specific dimensions and weight, indicating it is a physical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device function: The TGDC - 01 PRA Tonometer measures ocular pressure (IOP) directly on the eye (specifically through the eyelid in the sclera area). It does not analyze samples taken from the body.
Therefore, this device falls under the category of a medical device used for diagnosis, but not an in vitro diagnostic device.
N/A
Intended Use / 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
Product codes
HKX
Device Description
Trade name: Common Name: Tonometer TGDc-01"PRA" Tonometer and accessories subpart B - Diagnostic devices
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mucous eye membrane, cornea, eye
Indicated Patient Age Range
children
Intended User / Care Setting
ophthalmologist, mass examination of population, at home, at the patient's bedside, in geriatrics homes, in children hospitals, at the army, at home
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 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.
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
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: (415)-643 98 38 Fax: (415)-643 98 39
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
1
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
TONOMETER
produced by
GOLDEN VISION, INC.
7436 S.W. 117TH
AVE.,SUITE 103
MIAMI, FL 33183 3816 | 510(k) Number:
K981432 |
|----------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|
| CANON
NON-CONTACT
TONOMETER T-2
produced by
CANON, INC.
30-2
SHIMOMARUKO
3-CHOME
OHTA-KU,
TOKYO, JAPAN,
JA 146 | 510(k) Number:
K943939 |
2
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 | |
| "VARTA" or similar. Supply voltage | 3 V |
| Number of measurements using one set of feed elements, 1500 | |
| not less | |
| Serviceability, not less | 8 years |
| Weight, not more | 79 g |
| Dimensions, not more | 173,5 õ 25,5 õ 19,5 mm |
3
| FEATURES | TGDc-01 | Goldmann
Tonometer | Shiotz
Tonometer | Air-jet | Tono Pen |
|-----------------------------------------------------|---------|-----------------------|---------------------|---------|----------|
| No direct effect on the cornea | + | | | | |
| Portability | + | | + | | + |
| Displays independence from
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
4
- 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.
5
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.
6
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 (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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
7
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