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.

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.

AI/ML Overview

The Thermidas IR System (ThIR-A615) is a Class I, reserved telethermographic system. Since it is a Class I device, clinical studies were not required and were not performed. Therefore, information regarding acceptance criteria based on clinical performance, sample sizes for test and training sets, expert qualifications, ground truth establishment, adjudication methods, or multi-reader multi-case studies is not available in the provided text.

The substantial equivalence determination was based on non-clinical performance testing against several international and national standards.

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

Since clinical performance testing was not required or performed, the "reported device performance" in terms of clinical metrics (e.g., sensitivity, specificity) is not available. The acceptance criteria were met by demonstrating compliance with the following non-clinical testing standards:

Acceptance Criteria (Standard Compliance)	Reported Device Performance (Compliance Statement)
EN ISO 13485:2016	Compliance with this standard for Medical devices - Quality management systems
EN IS 14971:2012	Compliance with this standard for Medical devices - Application of risk management to medical devices
IEC 62304:2015 (Ed 1.1)	Compliance with this standard for Medical device software - Software life cycle processes
EN 62366-1:2015	Compliance with this standard for Medical devices - Application of usability engineering to medical devices
EN 60601-1:2006+A1:2013	Compliance with this standard for Medical electrical equipment - General requirements for basic safety and essential performance
EN 606001-1-2:2015	Compliance with this standard for Medical electrical equipment - Electromagnetic disturbances - Requirements and tests
IEC 60601-1-2:2014	Compliance with this standard for Medical electrical equipment - Electromagnetic disturbances - Requirements and tests
ANSI/AAMI ES60601-1:2005/(R)2012	Compliance with this standard for Medical electrical equipment - General requirements for basic safety and essential performance
Directive 93/42/EEC on Medical Devices	Compliance with Annex II for infrared imaging devices for medical diagnostic purposes

Discussion on Device Features Compared to Predicate (Found in the "Predicate Device Comparison" Table):

While not formal performance metrics, the device's technical specifications and features were compared to the predicate to establish substantial equivalence. These comparisons highlight attributes that contribute to the device's functional performance:

Resolution: Both the predicate and proposed device support high resolution (e.g., 640x480). The proposed device explicitly states it uses a "640 x 480 pixel microbolometer that detects temperature differences as small as 50 mK, for accuracy at longer distances."
Image Frequency: Both devices offer high image frequency (e.g., 50-60 Hz) for real-time viewing. The proposed device specifies "Stream full-frame 16-bit images at 50 Hz, or in windowed mode as high as 200 Hz, for high-speed processes."
Focus: Both offer automatic focus.
Connectivity: Both use Gigabit Ethernet.
Calibration: Both are factory calibrated.
Lens: Both use a 25-degree standard lens.
Software Features: Both provide software for capturing, displaying, and analyzing thermal patterns (e.g., patient records, image capture, visualization, ROI analysis, reporting).

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

Not Applicable. Clinical studies were not required or performed for this Class I device. The testing involved compliance with non-clinical engineering and quality standards.

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 Applicable. Clinical studies were not required or performed. There was no clinical ground truth established for a test set.

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

Not Applicable. No clinical test set requiring adjudication was used.

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. No MRMC study was conducted. The device is a telethermographic system for adjunctive diagnostic imaging, and the provided documentation does not indicate it uses AI for image interpretation or for assisting human readers in a comparative effectiveness study.

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

Not Applicable. Clinical studies were not performed. The device is a system for reviewing and reporting temperature patterns, with the interpretation by trained technical personnel. The software itself "makes no determination regarding what the thermal patterns or relative temperature values mean" and "The decision making is not based on the software itself."

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

Not Applicable. No clinical ground truth was established as clinical studies were not performed. For the non-clinical testing, compliance with standards served as the "ground truth" for safety and performance according to those standards.

8. The sample size for the training set

Not Applicable. As clinical studies were not performed, there was no clinical training set.

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

Not Applicable. As clinical studies were not performed, there was no clinical training set or associated ground truth establishment.

Summary

{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

{2}------------------------------------------------

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)
----------------------------------------------	---------------------------------------------

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

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

{4}------------------------------------------------

imaged.

Indications for Use

Predicate Device Comparison

Med-Hot Thermal Imaging System	Thermidas IR-System
The Med-Hot Thermal Imaging Systems arenon-contact infrared imaging devices, withall functions controlled at the computerscreen.TotalVision is a patented, clinicalpersonnelfriendly software application,validated in thefield.The system is delivered with a computerincluding installed and tested software.	Thermidas IR System consists of a mobileworkstation, an off-the-shelf IR imagingcamera, a camera arm, a camera mountproviding adjustable fixing point for thecamera, a Windows workstation running theThermidas Imager software and a display, akeyboard and a mouse.
The Med-Hot Thermal Imaging camera issuitable for high quality imaging of thehuman body:	Thermidas IR-System provides the followingfeatures:
• The resolution (320 X 240 / 640 X 480)provides adequate detail to detect andvisualize minute thermal details	• CE-marked setup supports 640x480resolution. However, technically the systemcan also support the 320x240 resolution. Inclinical work the higher resolution is morefeasible.
• Microbolometer technology provides lowpower consumption and high temperaturereliability	• 640 x 480 pixel microbolometer that detectstemperature differences as small as 50 mK,for accuracy at longer distances.
• 50-60 Hz image frequency provides realtimeimage viewing and capture with no lossof detail due to movement.	• Stream full-frame 16-bit images at 50 Hz,or in windowed mode as high as 200 Hz, forhigh-speed processes.
• Automatic focus option to provide privacyimaging, a comfort feature for both client anduser	• Automatic and manual focus
• Gigabit Ethernet interface-fastest industrystandard for data transfer of data dense files	• Gigabit Ethernet
• Factory calibration – temperatureconversion files reside in the camera	• System calibration that is done at thefactory during manufacture
firmware, not in the user's computer,providing reliable, enhanced accuracy. Seeexplanation below.• 25 degree standard lens provides the mostpractical field of view in a clinical settingwith limited space.	• Lens: 25 degree
The TotalVision Capture Software allows forincoming image data from the camera headand configures that data in a form that can bedisplayed on the computer screen. Thisdisplay will include an image of the scenewithin the camera's field of view allowing theuser to visualize thermal patterns or analyzethe image in terms relative temperaturevalues. The software makes no determinationregarding what the thermal patterns orrelative temperature values mean. It will beleft to the user to infer areas of interest basedon his/her visual interpretation of thosepatterns or values.	Thermidas Imager software is supplied witha database where user can add new patientdata, and access and modify stored data.The images are displayed in real time on thescreen of the computer during themeasurement session.The acquired IR images and IR video clipsare stored in the database along with patientdata and identifying information such as dateof acquisition. The images are stored asthermographic maps that visualize thepatterns and variations of the relative skintemperatures of the patients.The software provides means for viewing theIR images stored in the database andanalyzing the data.The software allows the user to change thecolor scales and visualization of the colors tocompare previously recorded images. Thesoftware also provides tool for the user toe.g. compare variations of relativetemperature values between two or moreregions of interest on the images.The data analysis is based on the professionalskills and experience of the trained user. Thedecision making is not based on the softwareitself.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 storedimages• Addition of text comments as annotations
	• Placement and modification of Regions ofInterest including display of statisticalinformation (min value, max value, averagevalue, radius)• Storage of images in png and jpg fileformats
	• 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 ina battery-operated mobile workstation
	4. Remote data analysis using a laptop PC
The Med-Hot Thermal Imaging Systems areintended to review, measure and record skintemperature patterns and variations emittedfrom the human body. They are intended foruse as adjunctive diagnostic imaging forthermally significant indications in theregions of the head and neck, breast, chest,abdomen, back and extremities. Thesignificance of the value of these thermalpatterns is determined by professionalinvestigation. This device is intended for useby qualified technical personnel trained in itsuse.	The Thermidas IR System is for adjunctiveuse in addition to other clinical diagnosticprocedures for diagnostic imaging forthermally significant indications of all skinregions of the human body. The system is forreviewing and reporting of temperaturepatterns and changes. The significance of thevalue of these thermal patterns is determinedby professional investigation. The system isnot intended for absolute temperaturemeasurements. The Thermidas IR system isintended foruse by trained technicalpersonnel.

{5}------------------------------------------------

{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.

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.