(15 days)
No
The summary does not mention any AI/ML terms, image processing, or descriptions of training/test sets, which are common indicators of AI/ML use in medical devices. The description focuses on a unique measurement method.
Yes
The device is described as an aid in diagnosis and for monitoring, which are functions of a therapeutic device.
Yes
The device explicitly states it is "intended for use as an aid in the diagnosis of glaucoma."
No
The device description explicitly mentions a "Tonometer diaton" and a "new IOP measuring method through the eyelid in the sclera area, unique to our device," implying a physical device is used for measurement. The comparison study also references "comparison medical tests of Tonometer diaton and Goldmann tonometer," further indicating a hardware component.
Based on the provided information, the Diaton Tonometer is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The Diaton Tonometer measures intraocular pressure (IOP) directly on the eye, through the eyelid. It does not analyze any biological samples like blood, urine, or tissue.
- The intended use describes a direct measurement on the patient. The description focuses on measuring IOP through the eyelid in the sclera area, which is a physical measurement on the living eye.
Therefore, the Diaton Tonometer falls under the category of a non-IVD medical device.
N/A
Intended Use / Indications for Use
The Diaton Tonometer is intended to measure intraocular pressure (IOP). The device is intended for use as an aid in the diagnosis of glaucoma and for monitoring IOP.
Product codes
HKX
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 results of the comparison medical tests of Tonometer diaton and Goldmann tonometer 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
K060780 2. 510 (k) Summary
6 2006 APR
2.1. Common
2.1.1. Regulatory Code
21 CFR 886.1930
2.1.2. Company Name/Contact
510(k) owner/holder:
Ryazan State Instrument-Making Enterprise 32 Kalyaev St. Ryazan, 390 000 Russia
Agent for Ryazan and Contact Person:
Boris Kun Bicom, Inc. 151 East Walnut Street Long Beach, NY 11561
phone: 516-431-3859 facsimile: 888-260-0606
2.1.3. Medical Specialty
Ophthalmic
2.1.4. Name of Device
Trade name: Common Name: Tonometer diaton Tonometer and accessories subpart B - Diagnostic devices
2.1.5. Product Code
HKX
1
2.1.6. Device Class
Class II
2.1.7. Regulation Number
21 C.F.R. § 886.1930
2.1.8. Predicate Devices
Diaton is substantially equivalent to the following legally marketed devices:
| Goldman Manual Tonometer
(Golden Vision, Inc.) | 510(k) Number:
K981432 |
|---------------------------------------------------|---------------------------|
| TGDC-01 "PRA"
(Truevision Instruments) | 510(k) Number:
K021937 |
2.2. 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 diaton 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.
- 1 Painless diagnostics without anesthetics and antiseptics
- 1 Elimination of infection risk
- 1 Measuring results independent of cornea's crookedness
- 1 Evaluation of IOP in patients after any operations on cornea
- 10 IOP measurement in children
- 1 Monitoring of Glaucoma treatment
2.3. Technological Characteristics
| Measurement range, mm Hg | 5-60 |
|---|---|
| The time of a single measurement, sec., not more | 3 |
| Autonomous power supply: feed element CR2032 “VARTA” or | |
| similar. Supply voltage, V | 3 |
| Number of measurements using one feed element, not less | 1500 |
| Serviceability, years | 5 |
| Weight, g, not more | 89 |
| Dimensions, mm, not more | 173,5x25,5x19,5 |
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2.4. Conclusion
The results of the comparison medical tests of Tonometer diaton and Goldmann tonometer 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 diaton advantages (anesthetics and antiseptics are not necessary; elimination of infection risk; shorttime measurement; results independent of cornea's crookedness) its wide application in ophthalmology is recommended alongside with Goldmann tonometer, esvecially 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 diaton represents an improvement to existing 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 diaton ideal for a wide range of application:
- 1 for mass examination of the population
- 1 at the patient's bedside
- 1 in geriatrics homes
- 10 in children hospitals
- 10 at the army
- 10 at home.
Tonometer diaton is not only good for determining the potential for glaucoma onset. It can also be used for monitoring treatment effectiveness throughout the day. Unlike other Tonometers, diaton can be used repeatedly during the day with no effect on the eve,
Tonometer diaton 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 non ition. The IOP measurement is displayed on an LCD screen of the device. To test the tonomoneters operational integrity there is a pressure control device provided.
Tonometer diaton uses the latest technologies, which provide it high reliability, quality and longevity.
3
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, in the center. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The seal is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 6 2006
Ryazan State Instrument-Making Enterprise c/o Mr. Neil E. Devine Jr. Intertek Testing Services NA, Inc. 2307 East Aurora Rd., Unit B7 Twinsburg, OH 44087
Re: K060780
Trade/Device Name: Diaton Tonometer Regulation Number: 21 CFR 886.1930 Regulation Name: Tonometer & Accessories Regulatory Class: Class II Product Code: HKX Dated: March 21, 2006 Received: March 22, 2006
Dear Mr. Devine:
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.
4
Page 2 - Mr. Neil E. Devine Jr.
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 Office of Compliance at (301) 827-8910. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
MB Eychhus - MD
Malvina B. Eydelman, M.D. Division Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Statement of Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Diaton Tonometer
Indications for Use:
The Diaton Tonometer is intended to measure intraocular pressure (IOP). The device is intended for use as an aid in the diagnosis of glaucoma and for monitoring IOP.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON A NOTHER PAGE IF NEEDED) www.rada.com/w/index.com/w/index.com/w/index.php?title=1900","includes":nullance":nullance.com
Concurrence of CDRH, Office of Device Evaluation (ODE)
Denis L. McCarthy
510(k) Number K060780
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