TYTRON C-500IR CLINICAL INFRARED IMAGING SYSTEM

K032471 · Titronics Research & Development Co. · LHQ · Oct 10, 2003 · Obstetrics/Gynecology

Device Facts

• Record ID: K032471
• Device Name: TYTRON C-500IR CLINICAL INFRARED IMAGING SYSTEM
• Applicant: Titronics Research & Development Co.
• Product Code: LHQ · Obstetrics/Gynecology
• Decision Date: Oct 10, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.2980
• Device Class: Class 1

Intended Use

The TyTron C-500IR Clinical Infrared Imaging System is intended for adjunctive diagnostic screening for the detection of breast cancer and other uses such as: peripheral vascular disease, neuromusculoskeletal disorders, extracranial cerebral and facial vascular disease, thyroid gland abnormalities, and various other neoplastic, metabolic, and inflammatory conditions. Use of the TyTron C-500IR System is not intended to be the sole diagnostic procedure for these diseases and conditions.

Device Story

TyTron C-500IR is a non-contact, non-invasive, non-radiating clinical infrared imaging system. Device captures thermal (infrared) patterns from the human body surface via an infrared camera. Data is transmitted to an interfaced computer for digital storage and visualization. Used in clinical settings to assist healthcare providers in identifying thermal anomalies associated with various pathologies. Output serves as an adjunctive diagnostic tool; does not replace primary diagnostic procedures. Benefits include non-invasive assessment of physiological thermal variations.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological characteristics and intended use.

Technological Characteristics

Non-contact infrared camera system. Interfaces with a computer for digital image storage and display. Operates as a telethermographic system (21 CFR 884.2980).

Indications for Use

Indicated for adjunctive diagnostic screening of patients for breast cancer, peripheral vascular disease, neuromusculoskeletal disorders, extracranial cerebral and facial vascular disease, thyroid gland abnormalities, and other neoplastic, metabolic, and inflammatory conditions. Not intended as a sole diagnostic procedure.

Regulatory Classification

Identification

A telethermographic system for adjunctive diagnostic screening for detection of breast cancer or other uses is an electrically powered device with a detector that is intended to measure, without touching the patient's skin, the self-emanating infrared radiation that reveals the temperature variations of the surface of the body. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

• Spectrum 9000MB (K020783)

Submission Summary (Full Text)

{0}------------------------------------------------

KO3247/

### Titronics Research & Development Co. TyTron C-500IR CLINICAL INFRARED IMAGING SYSTEM OCT 1 0 2003 PREMARKET NOTIFICATION 510(k)

## XIV. SUMMARY OF SAFETY AND EFFECTIVENESS

## TyTron C-3000

| 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: | June 14. 2003 | |
| Product Trade Name: | TyTron C-500IR Clinical Infrared Imaging System | |
| Common Name: | Clinical Thermographic Imaging System | |
| Classification: | Telethermographic system | |
| | Obstetrics/Gynecology Classification Panel | |
| | 21 Code of Federal Regulations 884.2980 | |
| | Class: | I |
| | Panel: | 90 |
| | Procode: | 90 LHQ |
| Predicate Device: | Spectrum 9000MB, submitted by Telesis<br>Technologies, Inc. K020783. | |
| Description: | The TyTron C-500IR is a non-contact, non-invasive,<br>non-radiating, thermal (infrared) imaging system<br>composed of an infrared camera which is interfaced<br>to a computer with the intent of viewing and<br>digitally storing thermal patterns generated by the<br>surface of the human body. | |

{1}------------------------------------------------

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# OCT 1 0 2003

Mr. Joseph R. Titone, BSME President Titronics Research & Develpoment Co. 2046 Redwing Hollow S.W. OXFORD IA 52322-9112

Re: K032471

Trade/Device Name: TyTron C-500IR Clincial Infrared Imaging System Regulation Number: 21 CFR 884.2980 Regulation Name: Telethermographic system Regulatory Class: I Product Code: 90 LHQ Dated: August 4, 2003 Received: August 11, 2003

Dear Mr. Titone:

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 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.

{2}------------------------------------------------

Page 2

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 one of the following numbers, based on the regulation number at the top of the letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [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) you may obtain. 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 http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely vours.

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

## Titronics Research & Development Co. TyTron C-500IR CLINICAL INFRARED IMAGING SYSTEM PREMARKET NOTIFICATION 510(k)

#### IX. INDICATIONS FOR USE

The TyTron C-500IR Clinical Infrared Imaging System is intended for adjunctive diagnostic screening for the detection of breast cancer and other uses such as: peripheral vascular disease, neuromusculoskeletal disorders, extracranial cerebral and facial vascular disease, thyroid gland abnormalities, and various other neoplastic, metabolic, and inflammatory conditions. Use of the TyTron C-500IR System is not intended to be the sole diagnostic procedure for these diseases and conditions.

*Prescription Use*

✓

Nancy C. hogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510

510(k) Number

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------