K982327 · Inframetrics, Inc. · LHQ · Aug 18, 1998 · Obstetrics/Gynecology
Device Facts
Record ID
K982327
Device Name
INFRAMETRICS INFRACAM-MED
Applicant
Inframetrics, Inc.
Product Code
LHQ · Obstetrics/Gynecology
Decision Date
Aug 18, 1998
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 884.2980
Device Class
Class 1
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.
Device Story
InfraCAM-MED is a battery-operated, self-contained infrared thermal imaging camera with an integral CRT viewfinder. Used during coronary artery bypass graft surgery; operated by surgical staff; positioned outside the sterile field. Device captures infrared radiation from exposed heart tissue; transforms thermal input into real-time black/white video output (256 shades). Output displayed on integral screen; can be recorded via VHS/SVHS or printed via thermal printer. Provides visual documentation of temperature gradients in myocardium, grafts, and vessels; assists surgeons in assessing graft patency and myocardial temperature during cardioplegia. Non-contact, non-invasive, non-radiating operation.
Clinical Evidence
Animal and clinical testing performed to validate performance. No specific quantitative metrics (e.g., sensitivity, specificity) provided in the summary. Testing confirmed the device functions as intended for visualizing temperature patterns during coronary artery bypass surgery.
Technological Characteristics
Battery-operated infrared thermal imaging camera. Qualified to MIL STD 810E. Features integral high-resolution CRT viewfinder. Displays 256 shades of black and white. Non-microprocessor based (analog/hardwired logic). No data entry or image storage capabilities. Non-contact sensing principle.
Indications for Use
Indicated for use during coronary artery bypass graft surgery to visualize and document heat patterns and temperature differences in human heart tissue, grafts, and vessels. Used by clinicians to monitor myocardial temperature changes during cardioplegia perfusion and blood flow assessment post-anastomosis.
Regulatory Classification
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.
Inframetrics Model 535 Infrared Medical Thermography System (K822729)
Submission Summary (Full Text)
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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
- 2. 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.
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
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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
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
