The InfraCAM-MED is a non-contact, non-invasive, non-radiating, thermal (infrared) imaging video camera intended as an adjunctive diagnostic device for viewing heat patterns generated by the relative surface temperature of human heart tissue and vessels during coronary artery bypass graft surgery. Images of the exposed heart may be captured as a black/white video image using VHS/SVHS videotape, or a black/white still image using a thermal image printer. The InfraCAM-MED Thermal Coronary Angiography imaging camera may be used to perform the following:

Viewing and documenting temperature differences between myocardium, graft . and vessels distal to the anastomotic site generated by the injection of cold or warm fluid into the proximal end of a vein graft.
Viewing and documenting temperature differences between myocardium, graft . and vessels distal to the anastomotic site generated by blood flow after release of the cross clamp(s) on a arterial graft.
Viewing and documenting temperature changes to the myocardium during the . retrograde or antegrade perfusion of warm or cold cardioplegia.

Device Description

The InfraCAM-MED is a small infrared camera with integral high-resolution CRT viewfinder. It is a battery operated thermal imaging system that is completely self contained with integral TV compatible display. The InfraCAM-MED is qualified to MIL STD 810E. The camera head houses the thermal image camera. During surgery, the camera is situated outside the sterile field therefore it is not covered by a sterile drape.

AI/ML Overview

The provided text does not contain specific acceptance criteria or detailed results from a study that a medical device (Inframetrics InfraCAM-MED) needs to meet. It mentions that "both animal and clinical testing were performed using the InfraCAM-MED which showed that the InfraCAM-MED performs as intended," but it does not elaborate on what "performs as intended" quantitatively means or provide any performance metrics.

Therefore, I cannot populate the requested table or answer most of the questions because the necessary information is not present in the given document.

Here's what I can extract and what is missing:

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

Acceptance Criteria	Reported Device Performance
Not specified	"Performs as intended"

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

Sample Size: Not specified.
Data Provenance: Not specified (animal and clinical testing mentioned, but no details on location or study design type).

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):

Not specified.

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

Not specified.

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:

Not applicable. The device described (InfraCAM-MED) is a thermal imaging system, not an AI diagnostic tool that assists human readers.

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

Not applicable in the context of an algorithm. The device itself is a standalone imaging system for viewing and documenting thermal patterns.

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

Not specified.

8. The sample size for the training set:

Not applicable. This is typically relevant for machine learning models, which is not the primary function of this thermal imaging device.

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

Not applicable.

Summary

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AUG 1 8 1998

510(k) Summary for Inframetrics InfraCAM-MED

COMPANY NAME AND ADDRESS 1.

Applicant Name and Address

Inframetrics, Inc. 16 Esquire Road North Billerica, MA 01862-2598

Contact Person

Michael Paulding, Medical Products Manager 781-670-5555

Date of Summary Preparation

July 1, 1998

1. DEVICE NAME
  Proprietary Name: Common/Usual Name: Classification Name:

Inframetrics InfraCAM-MED Thermographic Camera System Telethermographic System Surgical Camera and Accessories

3. IDENTIFICATION OF THE PREDICATE OR LEGALLY MARKETED DEVICE(S) TO WHICH EQUIVALENCE IS BEING CLAIMED

The Inframetrics InfraCAM-MED is substantially equivalent to several legally marketed infrared thermography systems, such as the Opgal IVA-2000 distributed by OPGAL (K951806), and the Inframetrics Model 535 Infrared Medical Thermography System (K822729).

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DEVICE DESCRIPTION 4.

INTENDED USE ನ.

Viewing and documenting temperature differences between myocardium, graft . and vessels distal to the anastomotic site generated by the injection of cold or warm fluid into the proximal end of a vein graft.
Viewing and documenting temperature differences between myocardium, graft . and vessels distal to the anastomotic site generated by blood flow after release of the cross clamp(s) on a arterial graft.
Viewing and documenting temperature changes to the myocardium during the . retrograde or antegrade perfusion of warm or cold cardioplegia.

A Statement of How the Technological Characteristics of the Device Compare 6. to Those of the Predicate or Legally Marketed Device(s) Cited

The Inframetrics InfraCAM-MED is substantially equivalent to the Opgal IVA-2000 and the Inframetrics Model 535 Infrared Medical Thermography System in intended use in that they all are intended to visualize and document temperature

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patterns and temperature changes in tissue temperature during coronary artery bypass surgeries. In addition, the InfraCAM-MED is intended to view and document temperature differences between myocardium, graft and vessels distal to the anastomotic site generated by the injection of cold or warm fluid into the proximal end of a vein graft, view and document temperature differences between myocardium, graft and vessels distal to the anastomotic site generated by blood flow after release of the cross clamp(s) on an arterial graft, and view and document temperature changes to the myocardium during the retrograde or antegrade perfusion of warm or cold cardioplegia.

All three systems have various design features in common. Neither the InfraCAM-MED, the Model 535 Infrared Medical Thermography System nor the IVA-2000 is in direct contact with the patient. The systems vary in components and accessories. All three include a thermal image camera. The IVA-2000 and Model 535 include a CCD camera, videocassette recorder, and thermal printer while the InfraCAM-MED includes only the camera.

Unlike the IVA-2000 and the Model 535, the Inframetrics InfraCAM-MED does not allow image capture and storage for subsequent retention and/or review. The Inframetrics InfraCAM-MED and both predicate devices display images in real time with the capability for printing and recording. The IVA-2000 and the Model 535 use keyboard entry of relevant procedural data, such as patient identifiers. The Inframetrics InfraCAM-MED does not provide for data entry or overlay of information on the image whereas both the Model 535 and the IVA-2000 do both.

The InfraCAM-MED displays the thermal image in 256 shades of Black and White, whereas the IVA 2000 uses 256 shades of Black/White or Red/White. No color bar is utilized. The Model 535 is color selectable in 6, 10, 14, or 20 colors. Neither the proposed InfraCAM-MED nor the IVA-2000 displays the temperature of the target whereas the Model 535 displays temperature in degrees. The IVA-2000 is software controlled. The Inframetrics InfraCAM-MED and the Model 535 do not utilize a microprocessor for any function.

Additionally, both animal and clinical testing were performed using the InfraCAM-MED which showed that the InfraCAM-MED performs as intended.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized symbol resembling three human profiles facing right, stacked on top of each other, with wavy lines below them. The symbol is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

18 1998 AUG

Inframetrics, Inc. c/o Mary McNamara-Cullinane Medical Device Consultants 49 Plain Street North Attleboro. MA 02760

Re:

K982327

Inframetrics InfraCAM-MED Dated: July 1, 1998 Received: July 2, 1998 Regulatory class: I 21 CFR 884.2980/Procode: 90 LQH

Dear Ms. McNamara-Cullinane:

We have reviewed your Section 510%) 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 Federal 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 (Special Controls) or class III (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 equivaliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 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 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 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/dsmaldsmamain.html".

Sincerely yours,

Kilian Yin
Lillian Yin, Ph.D.

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): _

Device Name: __Inframetrics InfraCAM-MED

Indications For Use:

The InfraCAM-MED is a non-contact, non-invasive, non-radiating, thermal (infrared) imaging video camera intended for viewing heat patterns generated by the relative surface temperature of human heart tissue and vessels during coronary artery bypass surgery. Images of the exposed heart may be captured as black/white video images using VHS/SVHS videotape, or black/white still images using a thermal image printer. The InfraCAM-MED may be used to perform the following:

Viewing and documenting temperature differences between myocardium, graft and . vessels distal to the anastomotic site generated by the injection of cold or warm fluid into the proximal end of a vein graft.
Viewing and documenting temperature differences between myocardium, graft and vessels distal to the anastomotic site generated by blood flow after release of the cross clamp(s) on an arterial graft.
Viewing and documenting temperature changes to the myocardium during the . retrograde or antegrade perfusion of warm or cold cardioplegia.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K982327

Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)

Inframetrics, Inc. 510(k) Inframetrics InfraCAM-MED 7/1/98

CONFIDENTIAL Page vi

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.