DOREX SPECTRUM 9000MB THERMOGRAPHY SYSTEM

K023434 · Dorex, Inc. · LHQ · Nov 14, 2002 · Obstetrics/Gynecology

Device Facts

• Record ID: K023434
• Device Name: DOREX SPECTRUM 9000MB THERMOGRAPHY SYSTEM
• Applicant: Dorex, Inc.
• Product Code: LHQ · Obstetrics/Gynecology
• Decision Date: Nov 14, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 884.2980
• Device Class: Class 1

Intended Use

Thermal Imaging is a noninvasive diagnostic technique that allows a practitioner to quantify and visualize skin surface temperature changes. The Spectrum 9000 MB allows the user to graphically map the body temperature and display the image on a monitor. The Spectrum 9000MB will be used as an aid for diagnosis as well as to follow up therapy on such areas as orthopedics, pain management, neurology and diabetic foot care. The intended use for the Spectrum 9000 MB is similar to what is being used currently on the Dorex DTI-16 thermal imager. Images are captured and stored on a computer that can be used to diagnose problem areas.

Device Story

Spectrum 9000MB is a telethermographic system; captures skin surface temperature data; transforms thermal inputs into graphical body temperature maps; displays images on a monitor; used by clinicians in clinical settings; aids diagnosis and therapy monitoring in orthopedics, pain management, neurology, and diabetic foot care; images stored on computer for diagnostic review; noninvasive; provides visual and quantitative temperature data to support clinical decision-making.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use comparison to predicate device.

Technological Characteristics

Telethermographic system; noninvasive thermal imaging; graphical temperature mapping; computer-based image capture and storage; Class I device per 21 CFR 884.2980.

Indications for Use

Indicated for use by practitioners as an aid in diagnosis and therapy follow-up for patients requiring skin surface temperature assessment in orthopedics, pain management, neurology, and diabetic foot care.

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

• Dorex DTI-16 thermal imager

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 4 2002

Mr. Mel Kutas President DOREX, Inc. 954 North Lemon St. ORANGE CA 92867 Re: K023434 Trade/Device Name: Dorex Spectrum 9000MB Thermography System Regulation Number: 21 CFR 884.2980 Regulation Name: Telethermographic system Regulatory Class: I Product Code: 90 LHQ Dated: October 15, 2002 Received: October 15, 2002

Dear Mr. Kutas:

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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

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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 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 this 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" (21 CFR 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsmamain.html.

Sincerely yours,

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

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INTENDED USE FOR SPECTRUM 9000 MB

Thermal Imaging is a noninvasive diagnostic technique that allows a practitioner to quantify and visualize skin surface temperature changes. The Spectrum 9000 MB allows the user to graphically map the body temperature and display the image on a monitor. The Spectrum 9000MB will be used as an aid for diagnosis as well as to follow up therapy on such areas as orthopedics, pain management, neurology and diabetic foot care.

The intended use for the Spectrum 9000 MB is similar to what is being used currently on the Dorex DTI-16 thermal imager. Images are captured and stored on a computer that can be used to diagnose problem areas.

Jamil h. hyson

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number

Prescription Use
(Per 21 CFR 801.109)