(265 days)
Not Found
No
The summary describes standard image processing and analysis software, with no mention of AI, ML, or related concepts.
No
The device is described as "for diagnostic imaging for thermally significant indications" and for "reviewing and reporting of temperature patterns". It senses variations in temperature and produces a quantitative image for medical professionals to "review, analyze, investigate, and quantify the temperature". There is no indication that the device provides any form of therapy or treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the system is "for adjunctive use in addition to other clinical diagnostic procedures for diagnostic imaging."
No
The device description explicitly states that the system consists of an off-the-shelf thermal imaging camera, a mount, and a Windows workstation running the software. This indicates the system includes hardware components beyond just software.
Based on the provided information, the Thermidas IR System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The Thermidas IR System uses infrared radiation to image the surface of the human body (skin regions). It does not analyze blood, tissue, urine, or any other bodily fluid or substance.
- The device description explicitly states it is a "non-invasive medical device." IVD procedures typically involve obtaining a specimen, which is an invasive process.
- The intended use is for "diagnostic imaging for thermally significant indications of all skin regions." This describes an imaging modality, not a test performed on a biological sample.
Therefore, the Thermidas IR System falls under the category of a medical imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Thermidas IR System is for adjunctive use in addition to other clinical diagnostic procedures for diagnostic imaging for thermally significant indications of all skin regions of the human body. The system is for reviewing and reporting of temperature patterns and changes. The value of the value of these thermal patterns is determined by professional investigation. The system is not intended for absolute temperature measurements. The Therded for use by trained technical personnel.
Product codes
LHQ
Device Description
The Thermidas IR System consists of an off-the-shelf thermal imaging camera, a mount for the camera and a Windows workstation running the Thermidas Imager software. The Thermidas IR System is a non-invasive medical device which uses infrared radiation naturally emitted by the patient, which senses variations in temperature. The captured data is processed by software producing a quantitative image on the computer screen. The medical professional can use the image to review, analyze, investigate, and quantify the temperature of the objects that are imaged.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Infrared thermography
Anatomical Site
all skin regions of the human body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained technical personnel.
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
Non-Clinical Performance Testing: EN ISO 13485:2016, EN IS 14971:2012, IEC 62304:2015 (Ed 1.1), EN 62366-1:2015, EN 60601-1:2006+A1:2013, EN 606001-1-2:2015, IEC 60601-1-2:2014, ANSI/AAMI ES60601-1:2005/(R)2012, Directive 93/42/EEC on Medical Devices, Annex II for infrared imaging devices for medical diagnostic purposes.
Clinical Performance Testing: Clinical studies are not required for this Class I device and have not been performed.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
January 6, 2021
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym and full name on the right. The FDA acronym is in a blue square, and the full name "U.S. Food & Drug Administration" is in blue text.
Thermidas Americas, Inc. % Samantha L. Prokop, Esq. Attorney Gunster, Yoakley & Stewart, P.A. 225 Water Street. Suite 1750 JACKSONVILLE FL 32202
Re: K200999
Trade/Device Name: Thermidas IR System (ThIR-A615) Regulation Number: 21 CFR 884.2980 Regulation Name: Telethermographic System Regulatory Class: Class I, reserved Product Code: LHQ Dated: November 24, 2020 Received: November 25, 2020
Dear Samantha Prokop:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K200999
Device Name Thermidas IR System (ThIR-A615)
Indications for Use (Describe)
The Thermidas IR System is for adjunctive use in addition to other clinical diagnostic procedures for diagnostic imaging for thermally significant indications of all skin regions of the human body. The system is for reviewing and reporting of temperature patterns and changes. The value of the value of these thermal patterns is determined by professional investigation. The system is not intended for absolute temperature measurements. The Therded for use by trained technical personnel.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ---------------------------------------------- | --------------------------------------------- |
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510(K) SUMMARY K200999
Submitter: Thermidas Americas, Inc. Address: 7912 Sailboat Key Blvd S #508, South Pasadena. FL, 33707 Phone: (727) 460-2507 Fax: (904) 350-6042 E-mail: Karo.kujanpaa@gmail.com Contact Person: Karo Kujanpaa Date Prepared: 12.11.2020
Trade Name: Thermidas IR System (ThIR-A615) Common Name: System, Telethermographic (Adjunctive Use) Product Code/Primary: LHQ Regulation: 21 CFR 884.2980 Classification Name and Class: System, Telethermographic (Adjunctive Use), Class I Reason: New Device
Predicate Device
Manufacturer: Med-Hot Thermal Imaging, Inc. Trade/Proprietary/Model Name: Med-Hot Thermal Imaging Systems 510(k) Number: K171928
Background
The ability to use Infrared technology to measure temperature variations and patterns of the body's service is commonplace technology.
Thermal imaging devices are non-invasive systems that do not touch the patient's body. The devices use infrared radiation technology to detect, measure, and quantify patterns and variations in skin temperature. The data is converted via software using algorithmic derivatives to an image on a computer screen.
Thermal imaging is a technique that can be employed by trained medical professionals and used as an adjunctive diagnostic screening tool (in conjunction with medical examination and other diagnostic tests) to detect skin temperature variation.
Device Description
The Thermidas IR System consists of an off-the-shelf thermal imaging camera, a mount for the camera and a Windows workstation running the Thermidas Imager software. The Thermidas IR System is a non-invasive medical device which uses infrared radiation naturally emitted by the patient, which senses variations in temperature. The captured data is processed by software producing a quantitative image on the computer screen. The medical professional can use the image to review, analyze, investigate, and quantify the temperature of the objects that are
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imaged.
Indications for Use
The Thermidas IR System is for adjunctive use in addition to other clinical diagnostic procedures for diagnostic imaging for thermally significant indications of all skin regions of the human body. The system is for reviewing and reporting of temperature patterns and changes. The significance of the value of these thermal patterns is determined by professional investigation. The system is not intended for absolute temperature measurements. The Thermidas IR system is intended for use by trained technical personnel.
Predicate Device Comparison
| Med-Hot Thermal Imaging System | Thermidas IR-System |
|---|---|
| The Med-Hot Thermal Imaging Systems are | |
| non-contact infrared imaging devices, with | |
| all functions controlled at the computer | |
| screen. | |
| TotalVision is a patented, clinical | |
| personnelfriendly software application, | |
| validated in the | |
| field. | |
| The system is delivered with a computer | |
| including installed and tested software. | Thermidas IR System consists of a mobile |
| workstation, an off-the-shelf IR imaging | |
| camera, a camera arm, a camera mount | |
| providing adjustable fixing point for the | |
| camera, a Windows workstation running the | |
| Thermidas Imager software and a display, a | |
| keyboard and a mouse. | |
| The Med-Hot Thermal Imaging camera is | |
| suitable for high quality imaging of the | |
| human body: | Thermidas IR-System provides the following |
| features: | |
| • The resolution (320 X 240 / 640 X 480) | |
| provides adequate detail to detect and | |
| visualize minute thermal details | • CE-marked setup supports 640x480 |
| resolution. However, technically the system | |
| can also support the 320x240 resolution. In | |
| clinical work the higher resolution is more | |
| feasible. | |
| • Microbolometer technology provides low | |
| power consumption and high temperature | |
| reliability | • 640 x 480 pixel microbolometer that detects |
| temperature differences as small as 50 mK, | |
| for accuracy at longer distances. | |
| • 50-60 Hz image frequency provides realtime | |
| image viewing and capture with no loss | |
| of detail due to movement. | • Stream full-frame 16-bit images at 50 Hz, |
| or in windowed mode as high as 200 Hz, for | |
| high-speed processes. | |
| • Automatic focus option to provide privacy | |
| imaging, a comfort feature for both client and | |
| user | • Automatic and manual focus |
| • Gigabit Ethernet interface-fastest industry | |
| standard for data transfer of data dense files | • Gigabit Ethernet |
| • Factory calibration – temperature | |
| conversion files reside in the camera | • System calibration that is done at the |
| factory during manufacture | |
| firmware, not in the user's computer, | |
| providing reliable, enhanced accuracy. See | |
| explanation below. | |
| • 25 degree standard lens provides the most | |
| practical field of view in a clinical setting | |
| with limited space. | • Lens: 25 degree |
| The TotalVision Capture Software allows for | |
| incoming image data from the camera head | |
| and configures that data in a form that can be | |
| displayed on the computer screen. This | |
| display will include an image of the scene | |
| within the camera's field of view allowing the | |
| user to visualize thermal patterns or analyze | |
| the image in terms relative temperature | |
| values. The software makes no determination | |
| regarding what the thermal patterns or | |
| relative temperature values mean. It will be | |
| left to the user to infer areas of interest based | |
| on his/her visual interpretation of those | |
| patterns or values. | Thermidas Imager software is supplied with |
| a database where user can add new patient | |
| data, and access and modify stored data. |
The images are displayed in real time on the
screen of the computer during the
measurement session.
The acquired IR images and IR video clips
are stored in the database along with patient
data and identifying information such as date
of acquisition. The images are stored as
thermographic maps that visualize the
patterns and variations of the relative skin
temperatures of the patients.
The software provides means for viewing the
IR images stored in the database and
analyzing the data.
The software allows the user to change the
color scales and visualization of the colors to
compare previously recorded images. The
software also provides tool for the user to
e.g. compare variations of relative
temperature values between two or more
regions of interest on the images.
The data analysis is based on the professional
skills and experience of the trained user. The
decision making is not based on the software
itself.
Thermidas Imager software supports:
• Patient records (add and modify)
• Image capture (still images and video
(length: 3,5 or 10 sec.))
• Visualization of acquired and stored
images
• Addition of text comments as annotations |
| | • Placement and modification of Regions of
Interest including display of statistical
information (min value, max value, average
value, radius)
• Storage of images in png and jpg file
formats |
| | • Reporting tool to pdf file format |
| The new device consists of: | The device consists of: |
| 1. Infrared Camera | 1. Infrared Camera |
| ► MAX 076 320 x 240 array detector
► MAX 307 640 x 480 array detector | ► ThIR-A615 640x480 array detector
(certified) |
| | ► ThIR-A615 320 x 480 array detector (non-
certified) |
| 2. TotalVision Software | 2. Thermidas Imager software |
| 3. Laptop or desktop computer | 3. Camera arms, Medical PC and monitor in
a battery-operated mobile workstation |
| | 4. Remote data analysis using a laptop PC |
| The Med-Hot Thermal Imaging Systems are
intended to review, measure and record skin
temperature patterns and variations emitted
from the human body. They are intended for
use as adjunctive diagnostic imaging for
thermally significant indications in the
regions of the head and neck, breast, chest,
abdomen, back and extremities. The
significance of the value of these thermal
patterns is determined by professional
investigation. This device is intended for use
by qualified technical personnel trained in its
use. | The Thermidas IR System is for adjunctive
use in addition to other clinical diagnostic
procedures for diagnostic imaging for
thermally significant indications of all skin
regions of the human body. The system is for
reviewing and reporting of temperature
patterns and changes. The significance of the
value of these thermal patterns is determined
by professional investigation. The system is
not intended for absolute temperature
measurements. The Thermidas IR system is
intended for
use by trained technical
personnel. |
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6
Comparison of Intended Use and Principle of Operation:
Thermal sensor technology is essentially the same among various products regardless of technical specifications or applications used. Thermal imaging captures and records objects within the view of the camera using the captured object's naturally emitted infrared radiation.
The devices use infrared radiation technology to detect, measure, and quantify patterns and variations in skin temperature. The data is converted via software using algorithmic derivatives to an image on a computer screen.
As used in the medical field the information from infrared devices are strictly limited to thermal findings. The medical professional/reviewer may use information gathered from the devices and subsequent image such as location of findings, distribution of thermal patterns, and intensity to
7
make a thermal correlation with expected or abnormal patterns for the imaged region of the body.
The Thermidas IR System is substantially equivalent to the intended use, principle operation and similar software features the already FDA-cleared red-Hot Thermal Imaging Systems (K171928). Please refer to 510(k) summary, premarket notification and additional information for the Med-Hot Thermal Imaging Systems predicate device as set forth in Section 12 of this application.
Non-Clinical Performance Testing
EN ISO 13485:2016
EN IS 14971:2012
IEC 62304:2015 (Ed 1.1)
EN 62366-1:2015
EN 60601-1:2006+A1:2013
EN 606001-1-2:2015
IEC 60601-1-2:2014
ANSI/AAMI ES60601-1:2005/(R)2012
Directive 93/42/EEC on Medical Devices, Annex II for infrared imaging devices for medical diagnostic purposes.
Clinical Performance Testing
Clinical studies are not required for this Class I device and have not been performed.
Compatibility
The Thermidas IR System is compatible with Flir, Inc.'s A615 infrared camera.
Conclusion
Based on the foregoing, the Thermidas IR System is substantially equivalent in terms of technology, safety, performance testing, and indications for use as the predicate devices Med-Hot Thermal Imaging Systems and is as safe and effective as the predicate device, raising no new issues of safety or effectiveness.