THERMATREK IRIS-IV INFRARED IMAGING SYSTEM

K030165 · Thermatrek · LHQ · Apr 16, 2003 · Obstetrics/Gynecology

Device Facts

• Record ID: K030165
• Device Name: THERMATREK IRIS-IV INFRARED IMAGING SYSTEM
• Applicant: Thermatrek
• Product Code: LHQ · Obstetrics/Gynecology
• Decision Date: Apr 16, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.2980
• Device Class: Class 1

Intended Use

The IRIS-IV Infrared Imaging System is a non-contact, non-invasive, non-radiating, thermal (infrared) imaging device intended for viewing heat patterns generated by the relative surface temperature of human heart tissue and vessels during coronary bypass surgery. Images of the exposed heart may be captured as black and white video images using a digital frame grabber and computer hard-drive. Digitally stored images may then be transferred from the hard-drive to a CD-ROM for portability. The IRIS-IV Infrared Imaging System may be used to perform the viewing and documenting of temperature differences prior to grafting, cooling of the myocardial, and perfusion of the tissue distal to the anastomosis after grafting.

Device Story

IRIS-IV Infrared Imaging System; non-contact, non-invasive, non-radiating thermal imaging device. Inputs: infrared heat patterns from exposed heart tissue/vessels during coronary bypass surgery. Processing: digital frame grabber captures black and white video images; computer hard-drive storage; transfer to CD-ROM. Usage: OR environment; operated by surgical team. Output: visual thermal heat patterns; documentation of temperature differences. Clinical utility: assessment of myocardial cooling and perfusion distal to anastomosis post-grafting. Benefit: real-time visualization of tissue temperature to assist surgical decision-making during bypass procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Infrared thermal imaging system; non-contact; non-radiating. Components include digital frame grabber, computer hard-drive, and CD-ROM storage. System is designed for intraoperative use in the OR.

Indications for Use

Indicated for use during coronary bypass surgery to view and document heat patterns and temperature differences of exposed human heart tissue and vessels; specifically for pre-grafting assessment, myocardial cooling, and post-grafting perfusion monitoring.

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 shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three lines representing the branches of government. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## APR 1 6 2003

Thermatrek % Mr. David R. Blazer Official Correspondent Biocare Medical Technology, LLC 660 Main Street South, Suite 7 WOODBURY CT 06798

Re: K030165

Trade/Device Name: IRIS-IV Infrared Imaging System Regulation Number: 21 CFR 884.2980 Regulation Name: Telethermographic system Regulatory Class: I Product Code: 90 LHO Dated: January 9, 2003 Received: January 16, 2003

Dear Mr. Blazer:

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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## STATEMENT of INDICATIONS for USE

510(k) NUMBER (IF KNOWN) : _ | |

DEVICE NAME: IRIS-IV Infrared Imaging System

INDICATIONS FOR USE:

The IRIS-IV Infrared Imaging System is a non-contact, non-invasive, non-radiating, thermal (infrared) imaging device intended for viewing heat patterns generated by the relative surface temperature of human heart tissue and vessels during coronary bypass surgery. Images of the exposed heart may be captured as black and white video images using a digital frame grabber and computer hard-drive. Digitally stored images may then be transferred from the hard-drive to a CD-ROM for portability.

The IRIS-IV Infrared Imaging System may be used to perform the viewing and documenting of temperature differences prior to grafting, cooling of the myocardial, and perfusion of the tissue distal to the anastomosis after grafting.

(Please do not write under this line-continue on another page if needed.)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use<br>(Per 21 CRF 801.109) | OR Over-The-Counter-Use<br>(Optional Format 1-2-96) |
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Nancy Brogdon

(Division Sign-Off)

Division of Reproductive, Abdominal,
and Radiological Devices

| 510(k) Number | K030165 |
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