THERMATREK IRIS-IV INFRARED IMAGING SYSTEM by THERMATREK

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 Description

Not Found

AI/ML Overview

Here's an analysis based on the provided document. It's important to note that this document is a 510(k) clearance letter, which focuses on substantial equivalence to a predicate device, rather than a detailed study report proving specific acceptance criteria. Therefore, much of the requested information regarding specific acceptance criteria, study design, and performance metrics is not available in this type of FDA communication.

Here's what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

This document (a 510(k) clearance letter) does not provide explicit acceptance criteria or detailed reported device performance data. The FDA's 510(k) clearance process focuses on demonstrating substantial equivalence to a legally marketed predicate device, not necessarily on proving specific performance metrics against pre-defined acceptance criteria in the same way a PMA (Premarket Approval) process would. The "performance" here is implied to be similar to the predicate device because of the substantial equivalence determination.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not available in the provided document. A 510(k) clearance letter typically summarizes the FDA's finding and does not include details on the specific studies, sample sizes, or data provenance used in the substantial equivalence determination.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not available in the provided document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not available in the provided document.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable/not available in the provided document. The IRIS-IV Infrared Imaging System is described as a "viewing and documenting" device for heat patterns, primarily for use during coronary bypass surgery by the surgical team. There is no mention of "human readers" or "AI assistance" in the context of diagnostic interpretation, which is typically where MRMC studies and AI effect sizes are relevant. This device appears to be for direct visualization and documentation by the surgeon.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable/not available in the provided document. As noted above, this device is for direct visualization and documentation by a human operator, not an autonomous algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not available in the provided document. Given the device's function (viewing heat patterns for surgeons), the "ground truth" during its development would likely relate to the accuracy of temperature measurement and spatial representation, verified against established thermal imaging principles or perhaps clinical observation during surgery, but the document does not specify this.

8. The sample size for the training set

This information is not available in the provided document. This device does not appear to be an AI/machine learning device that would typically involve a "training set."

9. How the ground truth for the training set was established

This information is not available in the provided document. Again, this device does not appear to be an AI/machine learning device.

Summary of what can be gleaned from the document:

The document is an FDA 510(k) clearance letter for the IRIS-IV Infrared Imaging System. It states that the device is "substantially equivalent" to legally marketed predicate devices.

Indications for Use:
- 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.
- 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.

The "study that proves the device meets the acceptance criteria" in the context of this 510(k) is the submission and review of information by the manufacturer to the FDA demonstrating substantial equivalence to a predicate device. This process does not typically involve the detailed performance data and acceptance criteria as outlined in your request for new, novel device approvals (like PMAs). The FDA's substantial equivalence determination implies that the device performs as safely and effectively as a legally marketed predicate device for its intended use.

Summary

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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	(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

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STATEMENT of INDICATIONS for USE

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

DEVICE NAME: IRIS-IV Infrared Imaging System

INDICATIONS FOR USE:

(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)
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Nancy Brogdon

(Division Sign-Off)

Division of Reproductive, Abdominal,
and Radiological Devices

510(k) Number	K030165
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Regulation Number and Section

§ 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.