(85 days)
K-950986
Not Found
No
The description focuses on basic temperature sensing, recording, and graphing, with no mention of AI/ML terms or functionalities like pattern recognition, prediction, or automated interpretation beyond simple thermal differential calculation.
No
The device is indicated for detecting, measuring, recording, and graphing skin surface temperature, specifically for monitoring patient response to care before and after therapy. It does not provide any therapeutic function itself.
Yes
The device is described as "detecting, measuring, recording, and graphing the skin surface temperature" to monitor a patient's response to care, which aligns with the definition of a diagnostic device that identifies or measures physical signs.
No
The device description explicitly states it is a "hand held paraspinal thermographic scanning system" consisting of "two probes which each contain infrared sensors," indicating it includes hardware components beyond just software.
Based on the provided information, the TyTron C-3000 is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions.
- TyTron C-3000 function: The TyTron C-3000 directly measures the skin surface temperature on the patient's body (in vivo) using infrared sensors. It does not analyze samples taken from the body.
Therefore, the TyTron C-3000 falls under the category of a medical device used for physiological measurement, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The TyTron C-3000 is indicated for use in detecting, measuring, recording, and graphing the skin surface temperature on both sides of the spine of adults and children by professional health care providers. It is to be used before and after therapy is rendered as part of monitoring the patient's response to care.
Product codes (comma separated list FDA assigned to the subject device)
84HCS
Device Description
The TyTron C-3000 is a hand held paraspinal thermographic scanning system. It consists of two probes which each contain infrared sensors designed to be placed on either side of the spinal column to detect temperatures. With the aid of a computer assisted program the system is capable of recording and graphing thermal differentials (right to left thermal asymmetries) on a horizontal scale. It also records direct temperatures on the vertical scale.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Spine (skin surface temperature on both sides of the spine)
Indicated Patient Age Range
adults and children
Intended User / Care Setting
professional health care providers
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)
| Test | Thermatrax | C-3000 |
|---|---|---|
| Accuracy | +/- 1°C | +/- 1°C |
| Orientation of sensors | parallel, 2" centers | parallel, 1.85" centers |
| Filtering circuit | yes | yes |
| Sensitivity | +/- 0.05°C | +/- 0.01°C |
| Reproducibility | +/- 0.10°C | +/- 0.05°C |
| Accuracy, odometer | not applicable | +/- 0.25 cm |
| Sensor Wavelength | must contact skin | 6 - 14 micrometers |
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity: +/- 0.01°C
Reproducibility: +/- 0.05°C
Accuracy: +/- 1°C
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K-950986
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 882.1570 Powered direct-contact temperature measurement device.
(a)
Identification. A powered direct-contact temperature measurement device is a device which contains a power source and is used to measure differences in temperature between two points on the body.(b)
Classification. Class II (performance standards).
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FEB 3 1998
SUMMARY OF SAFETY AND EFFECTIVENESS XIV.
TyTron C-3000
દર્દર
| Manufacturer: | Titronics Research and Development Company
2046 Redwing Hollow S.W.
Oxford, IA 52322-9112 |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Joseph Roger Titone, B.S.M.E.
Same address as above |
| Telephone:
Fax: . | (319) 683-2702
(319) 683-2862 |
| Date Summary Prepared: | October 26, 1997 |
| Product Trade Name: | TyTron C-3000 |
| Common Name: | Computer Aided Paraspinal Thermographic
Scanning System |
| Classification: | Powered direct-contact temperature measurement device
Neurological Devices Classification Panel
21 Code of Federal Regulations 882.1570 |
| Class: | II |
| Panel: | 84 |
| Procode: | 84HCS |
| Predicate Device: | Thermatrax submitted by Artronics K-950986 |
Description:
The TyTron C-3000 is a hand held paraspinal thermographic scanning system. It consists of two probes which each contain infrared sensors designed to be placed on either side of the spinal column to detect temperatures. With the aid of a computer assisted program the system is capable of recording and graphing thermal differentials (right to left thermal asymmetries) on a horizontal scale. It also records direct temperatures on the vertical scale.
1
Indications For Use:
The TyTron C-3000 is indicated for use in detecting, measuring, recording, and graphing the skin surface temperature on both sides of the spine of adults and children by professional health care providers. It is to be used before and after therapy is rendered as part of monitoring the patient's response to care.
Substantial Equivalence:
The TyTron C-3000 is substantially equivalent to Thermatrax in that it provides the following characteristics:
- -Thermocouple material used in the sensors -Physical characteristics are essentially the same -Material composition is essentially the same -Same indications for use -Same presentation of paraspinal temperature data -Both use microprocessors to process data -Both powered by isolated low voltage power supplies
Summary of Testing:
| Test | Thermatrax | C-3000 |
|---|---|---|
| Accuracy | $\pm$ 1°C | $\pm$ 1°C |
| Orientation of sensors | parallel, 2" centers | parallel, 1.85" centers |
| Filtering circuit | yes | yes |
| Sensitivity | $\pm$ 0.05°C | $\pm$ 0.01°C |
| Reproducibility | $\pm$ 0.10°C | $\pm$ 0.05°C |
| Accuracy, odometer | not applicable | $\pm$ 0.25 cm |
| Sensor Wavelength | must contact skin | 6 - 14 micrometers |
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, formed by three human profiles facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 3 1998
Mr. Joseph R. Titone, BSME President Titronics Research & Development Company 2046 Redwing Hollow S.W. Oxford, Iowa 52322
Re: K974208 Trade Name: Tytron C-3000 Regulatory Class: II Product Code: HCS Dated: October 28, 1997 Received: November 10, 1997
Dear Mr. Titone:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the .... current Good Manufacturing Practice requirements , as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for
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Page 2 - Mr. Titone
devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 vour device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
6
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Titronics Research & Development Co. TyTron C-3000 PARASPINAL INFRARED TEMPERATURE RECORDER PREMARKET NOTIFICATION 510(k)
974208
INDICATIONS FOR USE IX.
The TyTron C-3000 is indicated for use in detecting, measuring, recording, and graphing the skin surface temperature on both sides of the spine of adults and children by chiropractors. It is to be used before and after therapy is rendered as part of monitoring the patient's response to care, similar to a common thermometer. ( Exhibit K - COMMENTS ON THE CLINICAL APPLICATION OF THE C-3000)
Prescription Use
(Per 21 CFR 801.109)
Ascotter