TYTRON C-3000

K974208 · Titronics Research & Development Co. · HCS · Feb 3, 1998 · Neurology

Device Facts

• Record ID: K974208
• Device Name: TYTRON C-3000
• Applicant: Titronics Research & Development Co.
• Product Code: HCS · Neurology
• Decision Date: Feb 3, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1570
• Device Class: Class 2
• Attributes: Pediatric

Intended 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.

Device Story

TyTron C-3000 is a handheld paraspinal thermographic scanning system. Device features two probes with infrared sensors placed on either side of the spinal column. Sensors detect skin surface temperature; system records and graphs thermal differentials (right-to-left asymmetries) and direct temperatures. Operated by professional health care providers (chiropractors) in clinical settings. System utilizes a computer-assisted program to process thermal data. Output is presented as a graph of thermal differentials and direct temperatures. Used before and after therapy to monitor patient response to care; provides objective thermal data to assist clinical decision-making regarding treatment efficacy.

Clinical Evidence

Bench testing only. Comparative performance data provided against the Thermatrax predicate. Metrics include: Accuracy (±1°C for both), Sensitivity (±0.01°C for C-3000 vs ±0.05°C for predicate), and Reproducibility (±0.05°C for C-3000 vs ±0.10°C for predicate).

Technological Characteristics

Handheld paraspinal thermographic scanner. Uses infrared sensors (6-14 micrometers wavelength) with thermocouple material. Powered by isolated low-voltage power supplies. Features a filtering circuit and microprocessor-based data processing. Sensor orientation is parallel with 1.85-inch centers. Includes an odometer for spatial tracking (accuracy ±0.25 cm).

Indications for Use

Indicated for detecting, measuring, recording, and graphing paraspinal skin surface temperature in adults and children. Used by professional health care providers to monitor patient response to therapy.

Regulatory Classification

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.

Predicate Devices

• Thermatrax (K950986)

Submission Summary (Full Text)

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## FEB 3 1998

#### SUMMARY OF SAFETY AND EFFECTIVENESS XIV.

TyTron C-3000

K974208

દર્દર

| Manufacturer: | Titronics Research and Development Company<br>2046 Redwing Hollow S.W.<br>Oxford, IA 52322-9112 |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Joseph Roger Titone, B.S.M.E.<br>Same address as above |
| Telephone:<br>Fax: . | [phone]<br>[phone] |
| Date Summary Prepared: | October 26, 1997 |
| Product Trade Name: | TyTron C-3000 |
| Common Name: | Computer Aided Paraspinal Thermographic<br>Scanning System |
| Classification: | Powered direct-contact temperature measurement device<br>Neurological Devices Classification Panel<br>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.

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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 [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" (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 [phone] or [phone] 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