THERMATREK IRIS-3 INFRARED IMAGING SYSTEM

K982112 · Thermatrek, Inc. · LHQ · Aug 20, 1998 · Obstetrics/Gynecology

Device Facts

• Record ID: K982112
• Device Name: THERMATREK IRIS-3 INFRARED IMAGING SYSTEM
• Applicant: Thermatrek, Inc.
• Product Code: LHQ · Obstetrics/Gynecology
• Decision Date: Aug 20, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.2980
• Device Class: Class 1

Intended Use

The IRIS-3 Infrared Imaging System is a thermal camera based imaging device intended for use during coronary bypass surgery. Thermal imaging of the exposed heart, using the IRIS-3, permits the viewing and recording of changes in tissue temperature prior to grafting, cooling of the myocardial, and perfusion of the tissue distal to the anastomosis after grafting. Recording of the temperature difference may be obtained using the videocassette recorder.

Device Story

IRIS-3 Infrared Imaging System; thermal camera-based device for intraoperative use during coronary bypass surgery. Input: infrared thermal signals from exposed heart tissue. Operation: captures real-time thermal data to monitor temperature variations; enables visualization of myocardial cooling and perfusion distal to anastomosis sites. Output: visual thermal imaging displayed and recorded via external videocassette recorder. Used by surgeons in OR settings. Benefit: provides objective thermal feedback to assess graft patency and myocardial status during bypass procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Thermal camera-based imaging system; infrared sensing technology; outputs to external videocassette recorder for data storage; intended for intraoperative use.

Indications for Use

Indicated for use during coronary bypass surgery to visualize and record tissue temperature changes on the exposed heart, including pre-grafting, myocardial cooling, and post-grafting perfusion assessment.

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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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 20 1998

David R. Balzer, Jr. Thermatrek, Inc. 660 Main Street South, Suite 7 Woodbury, Connecticut 06798 Re:

K982112

Thermatrek Iris-3 Infrared Imaging System Dated: June 15, 1998 Received: June 16, 1998 Regulatory class: I 21 CFR 884.2980/Procode: 90 LHQ

Dear Mr. Balzer:

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 Rederal 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 (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 (QS) for Medical Devices: General regulation (2) 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 542 of the Act for 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 5100k) premarket notification. The FDA finding of substantial equivalence of your device to a legally market 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 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/dsmarain.html".

Sincerely yours,.

Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) NUMBER (IF KNOWN) : K982112

IRIS-3 Thermographic System DEVICE NAME:

INDICATIONS FOR USE:

The IRIS-3 Infrared Imaging System is a thermal camera based imaging device intended for use during coronary bypass surgery. Thermal imaging of the exposed heart, using the IRIS-3, permits the viewing and recording of changes in tissue temperature prior to grafting, cooling of the myocardial, and perfusion of the tissue distal to the anastomosis after grafting. Recording of the temperature difference may be obtained using the videocassette recorder.

Note: If you have any questions, please call Dave Balzer at [phone]. Thank-you.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter-Use (Optional Format 1-2-96)

David h. haysom

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