(65 days)
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No
The summary describes a thermal imaging system for visualizing temperature changes during surgery. There is no mention of AI, ML, or any advanced image processing that would suggest the use of these technologies.
No
The device is an imaging system used to record temperature changes, which aids in viewing and assessing physiological changes during surgery, but it does not directly treat or prevent a disease or condition.
Yes
The device permits viewing and recording of changes in tissue temperature, which are physiological parameters, to inform decisions during surgery (prior to grafting, during cooling, and after grafting) and supports assessment of tissue perfusion. This use of physiological data to inform clinical assessment and decision-making during a medical procedure qualifies it as a diagnostic device.
No
The device description explicitly states it is a "thermal camera based imaging device," indicating it includes hardware components (the thermal camera).
Based on the provided information, the IRIS-3 Infrared Imaging System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body.
- IRIS-3 Function: The IRIS-3 is used during coronary bypass surgery to image the exposed heart in vivo (within the living body). It directly observes and records temperature changes of the tissue.
Therefore, the IRIS-3 operates on the patient's body during surgery, not on specimens taken from the body. This clearly places it outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
90 LHQ
Device Description
The IRIS-3 Infrared Imaging System is a thermal camera based imaging device.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Infrared Imaging
Anatomical Site
Exposed heart (during coronary bypass surgery)
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 884.2980 Telethermographic system.
(a)
Telethermographic system intended for adjunctive diagnostic screening for detection of breast cancer or other uses —(1)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.(2)
Classification. Class I (general controls).(b)
Telethermographic system intended for use alone in diagnostic screening for detection of breast cancer or other uses —(1)Identification. A telethermographic system for use as the sole diagnostic screening tool 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.(2)
Classification. Class III.(3)
Date PMA or notice of completion of a PDP is required. As of the enactment date of the amendments, May 28, 1976, an approval under section 515 of the act is required before the device described in paragraph (b)(1) may be commercially distributed. See § 884.3.
0
Image /page/0/Picture/0 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter of the circle. In the center of the circle is a stylized image of three lines that resemble a person.
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:
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 (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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
1
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 (203) 263-5951. 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