(47 days)
No Reference Devices
No
The summary describes a thermal imaging camera and its intended uses for viewing temperature patterns. There is no mention of AI or ML in the device description, intended use, or performance studies. The device appears to be a direct imaging system without advanced analytical capabilities.
No.
The device is described as an "adjunctive diagnostic device for viewing heat patterns" and "may be used to perform viewing and documenting temperature differences", indicating a diagnostic purpose rather than therapeutic.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended as an adjunctive diagnostic device."
No
The device description explicitly states it is a "small infrared camera with integral high-resolution CRT viewfinder" and a "battery operated thermal imaging system," indicating it is a hardware device.
Based on the provided information, the InfraCAM-MED 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. They are performed outside the body (in vitro).
- InfraCAM-MED's Function: The InfraCAM-MED is a thermal imaging camera that directly views and captures images of the exposed human heart tissue and vessels during surgery. This is an in vivo (within the living body) application, not an in vitro test on a sample.
- Intended Use: The intended use clearly describes viewing heat patterns and temperature differences of the heart and vessels during surgery. This is a direct observation of the living organ.
Therefore, the InfraCAM-MED falls under the category of a medical device used for imaging and adjunctive diagnosis in vivo, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
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.
Product codes (comma separated list FDA assigned to the subject device)
90 LQH
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Thermal (infrared) imaging
Anatomical Site
Human heart tissue and vessels
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgical setting (during coronary artery bypass graft surgery)
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Additionally, both animal and clinical testing were performed using the InfraCAM-MED which showed that the InfraCAM-MED performs as intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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
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
-
- DEVICE NAME
Proprietary Name: Common/Usual Name: Classification Name:
- DEVICE 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).
1
DEVICE DESCRIPTION 4.
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.
INTENDED USE ನ.
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.
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
2
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.
3
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:
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
!
4
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