MARK I THERMAL IMAGER

K023925 · Ix-Dr, Inc. · LHQ · Feb 11, 2003 · Obstetrics/Gynecology

Device Facts

• Record ID: K023925
• Device Name: MARK I THERMAL IMAGER
• Applicant: Ix-Dr, Inc.
• Product Code: LHQ · Obstetrics/Gynecology
• Decision Date: Feb 11, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.2980
• Device Class: Class 1

Intended Use

Thermal Imaging is a medical imaging modality for use as an adjunctive procedure to support other diagnostic modalities. For example, thermal imaging of breasts can demonstrate a temperature variance as a method to help clarify findings indicated by mammography or some other diagnostic procedure. Thermal imaging in general is a determination of physiologic rather than anatomic change. Neoangioenesis accompanies turnor growth and typically produces an alteration in blood vessels. Any changes in blood vessel activity generally introduce a change in temperature in the immediate area of the affected blood vessel. Thermography is incapable of visualizing anatomic matter unless it is accompanied by an alteration in surface temperature. Hence, thermography is an adjunctive medical imaging modality.

Device Story

Mark I Thermal Imager is a telethermographic system; captures surface temperature variations to identify physiologic changes; functions as an adjunctive diagnostic tool; detects temperature shifts associated with neoangiogenesis and altered blood vessel activity; provides visual representation of thermal data to clinicians; supports clinical decision-making by clarifying findings from primary modalities like mammography; intended for use in clinical settings; operated by healthcare professionals.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on regulatory classification and intended use as an adjunctive imaging modality.

Technological Characteristics

Telethermographic system; detects surface temperature variances; Class I device; 21 CFR 884.2980; Product Code LHQ.

Indications for Use

Indicated for use as an adjunctive medical imaging modality to support other diagnostic procedures, such as mammography, by detecting temperature variances associated with physiologic changes like neoangiogenesis in tumor growth.

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.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized human figure with three overlapping profiles facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## FEB 1 1 2003

Mr. William J. O'Neil IX-DR, Inc. 120 State HOWELL MI 48843

Re: K023925

Trade/Device Name: Mark I Thernal Imager Regulation Number: 21 CFR 884.2980 Regulation Name: Telethermographic system Regulatory Class: I Product Code: 90 LHQ Dated: November 19, 2002 Received: November 25, 2002

Dear Mr. O'Neil:

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.

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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 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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023925

12/09/02

## IX-DR, Inc. 120 State, Howell, MI 48843 Phone [phone] WJO Cell [phone] E mail [e-mail]

To: Loren Zaremba @ FDA Fax # [phone] Phone # [phone] X 137 From: Bill O'Neill Re: Indications for use

## INDICATIONS FOR USE

Thermal Imaging is a medical imaging modality for use as an adjunctive procedure to support other diagnostic modalities. For example, thermal imaging of breasts can demonstrate a temperature variance as a method to help clarify findings indicated by mammography or some other diagnostic procedure.

Thermal imaging in general is a determination of physiologic rather than anatomic change. Neoangioenesis accompanies turnor growth and typically produces an alteration in blood vessels. Any changes in blood vessel activity generally introduce a change in temperature in the immediate area of the affected blood vessel.

Thermography is incapable of visualizing anatomic matter unless it is accompanied by an alteration in surface temperature. Hence, thermography is an adjunctive medical imaging modality.

Signed: Will O'Neil Dated: 12/09/02

William J. O'Neill

*Prescription Use*

David te Bezem