(90 days)
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No
The summary describes a system for capturing and storing thermal images. There is no mention of any analytical or interpretive functions that would typically involve AI/ML, such as automated pattern recognition, diagnosis, or prediction based on the images. The image processing described is limited to capturing, digitizing, and storing the images.
No.
The device is described as an imaging system intended for viewing and documenting heat patterns and temperature differences, not for treating a condition or disease.
No
The device is intended for viewing and documenting heat patterns and temperature differences to aid in surgical procedures, not for diagnosing a disease or condition. Its purpose is to provide visual information during surgery rather than to determine the presence or absence of a medical condition.
No
The device description explicitly mentions hardware components like an "infrared imaging device," "digital frame grabber," "computer hard-drive," and "CD-ROM." This indicates it is a system with both hardware and software, not a software-only device.
Based on the provided information, the IRIS-IV Infrared Imaging System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- IRIS-IV Function: The IRIS-IV is a non-contact, non-invasive imaging device that views heat patterns on the surface of the human heart tissue and vessels during surgery. It does not analyze samples taken from the body.
- Intended Use: The intended use is for viewing and documenting temperature differences on the exposed heart during coronary bypass surgery, not for analyzing biological samples.
Therefore, the IRIS-IV falls under the category of a medical imaging device used for visualization and documentation during a surgical procedure, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
90 LHO
Device Description
The IRIS-IV Infrared Imaging System is a non-contact, non-invasive, non-radiating, thermal (infrared) imaging device. It captures black and white video images of heat patterns using a digital frame grabber and a computer hard-drive. These stored digital images can then be transferred to a CD-ROM.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Thermal (infrared) imaging
Anatomical Site
Human heart tissue and vessels (specifically, the 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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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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/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.
1
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 | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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" (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 (800) 638-2041 or (301) 443-6597 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
Page 2
2
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
(Per 21 CRF 801.109) | OR Over-The-Counter-Use
(Optional Format 1-2-96) |
| ------------------------------------------ | ----------------------------------------------------- |
|---|
Nancy Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
| 510(k) Number | K030165 |
|---|---|
| --------------- | --------- |