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 value 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.

Device Description

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 personnel friendly software application, validated in the field. The system is delivered with a computer including installed and tested software. The Med-Hot Thermal Imaging camera is suitable for high quality imaging of the human body. 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. The new device consists of: 1. Infrared Camera (MAX 076 320 x 240 array detector or MAX 307 640 x 480 array detector), 2. TotalVision Software, 3. Laptop or desktop computer.

AI/ML Overview

Here's an analysis of the provided information regarding the Med-Hot Thermal Imaging Systems:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not contain a table of acceptance criteria or reported device performance in the traditional sense of a clinical or performance study. The submission is a 510(k) premarket notification for a Class I device (Telethermographic System, Product Code LHO).

For Class I devices with a predicate, the primary focus is often on demonstrating substantial equivalence to a legally marketed predicate device, rather than meeting specific performance metrics from a de novo clinical study. The "performance" described here relates to the technical specifications of the imaging system and software capabilities, and how they compare to the predicate.

Here's an attempt to structure the information, recognizing it's not a typical performance table found in a clinical study report:

Feature/Criterion (Implied)	Reported Device Performance (Med-Hot Thermal Imaging Systems)
Intended Use	Review, measure, and record skin temperature patterns/variations for adjunctive diagnostic imaging in various body regions.
Principle of Operation	Non-contact infrared imaging, capturing and recording objects for evaluation of thermal variations.
Resolution	320 x 240 / 640 x 480 array detector (adequate detail for minute thermal features).
Microbolometer Technology	Provides low power consumption and high temperature reliability.
Image Frequency	50-60 Hz (real-time viewing/capture with no loss of detail due to movement).
Focus	Automatic focus option (for privacy and comfort).
Data Transfer Interface	Gigabit Ethernet (fastest industry standard for data-dense files).
Calibration	Factory calibration; temperature conversion files in camera firmware (reliable, enhanced accuracy).
Lens	25-degree standard lens (practical field of view in clinical settings).
Software Functionality	TotalVision Capture Software displays incoming image data, visualizes thermal patterns, analyzes relative temperature values, determines no meaning (left to user).
Comparison to Predicate (MTI 2000)	Intended use, principle of operation, and similar software features are substantially equivalent. Both view live imagery, record snapshots, include post-processing of fast thermal events, provide region of interest analysis, and save information. Software is an evolution of predicate's.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not applicable. No clinical or performance test set (in terms of patient data) was used or described in this submission for defining "acceptance criteria" or "device performance" in a quantitative sense related to clinical outcomes.
Data Provenance: Not applicable, as no human data (retrospective or prospective) was used for performance evaluation in this 510(k) submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

Not applicable. No ground truth was established by experts for a test set in this context. The device's function is to display thermal patterns, with the interpretation left to the user.

4. Adjudication Method for the Test Set

Not applicable. No adjudication method was used, as there was no test set requiring expert review.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. A MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical studies were conducted."

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This device is not an AI/algorithm-only device with a standalone performance claim. It is an imaging system (camera + software) that captures and displays thermal data for human interpretation. The software's role is to capture and display the image data, not to make diagnostic determinations. The document states: "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."

7. The Type of Ground Truth Used

Not applicable. No ground truth based on expert consensus, pathology, or outcomes data was used for performance evaluation in this 510(k) submission, as it explicitly states that no clinical studies were conducted. The "ground truth" for the device's technical specifications would be its manufacturing and calibration standards.

8. The Sample Size for the Training Set

Not applicable. This device is a telethermographic imaging system, not an AI/machine learning algorithm that requires a training set of patient data. The "TotalVision Capture software" is described as an "evolution of the original Med-Hot software program" with "Improvements and new features added were based on user-driven needs and requests over the years." This suggests an iterative development process driven by user feedback rather than a formal machine learning training paradigm.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there was no formal training set requiring ground truth establishment in the context of machine learning. The software's functionality improvement was "based on user-driven needs and requests."

Summary of Device Nature and Regulatory Context:

It's crucial to understand that this 510(k) submission is for a Class I medical device which primarily relies on demonstrating substantial equivalence to an existing predicate device. The device is a diagnostic imaging tool that measures and records skin temperature patterns; it is explicitly stated to be for "adjunctive diagnostic imaging" and the "value of these thermal patterns is determined by professional investigation." The software's role is to present data, not interpret it.

Therefore, the submission focuses on:

Technical specifications of the hardware (camera resolution, frequency, interface, calibration).
Functional description of the software (capture, display, basic analysis of regions of interest).
Comparison of these features to the predicate device.
Compliance with relevant electrical and environmental safety standards (ISO, IEC, EN, CFR).

The absence of clinical studies, ground truth establishment, or AI-specific performance metrics is typical for this type of device and regulatory pathway.

Summary

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Med-Hot Thermal Imaging, Inc. % E. J. Smith Consultant Smith Associates 1468 Harwell Avenue CROFTON MD 21114

December 8, 2017

Re: K171928

Trade/Device Name: Med-Hot Thermal Imaging Systems Regulation Number: 21 CFR 884.2980 Regulation Name: Telethermographic System Regulatory Class: I Product Code: LHO Dated: October 28, 2017 Received: November 2, 2017

Dear E. J. Smith:

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. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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Page 2 - E. J. Smith

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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K171928

Device Name

Med-Hot Thermal Imaging Systems

Indications for Use (Describe)

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement on last page.

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510(k) Summary

Sponsor:	Med-Hot Thermal Imaging, Inc.
Company Address:	5120 S. Florida Ave., Suite 301
	Lakeland, FL 33813
Telephone:	863-646-1599
Fax:	863-646-1544
Contact Person:	Carol Chandler
Summary Preparation Date:	December 6, 2017
Device Name:
Trade Name:	Med-Hot Thermal Imaging Systems
Common/Usual Name:	System, Telethermographic (Adjunctive Use
Classification Name:	System, Telethermographic (Adjunctive Use
Regulation Number:	21 CFR 884.2980
Device Class:	Class I

Predicate Device:

Manufacturer	Product Name	510(k) Number
Med-Hot Thermal Imaging, Inc.	MTI 2000	K063047

Device Description:

The Med-Hot Thermal Imaging camera is suitable for high quality imaging of the human body:

. The resolution (320 X 240 / 640 X 480) provides adequate detail to detect and visualize minute thermal details
. Microbolometer technology provides low power consumption and high temperature reliability
50-60 Hz image frequency provides real-time image viewing and capture with no loss of detail due to movement.
Automatic focus option to provide privacy imaging, a comfort feature for both client and

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user

. Gigabit Ethernet interface-fastest industry standard for data transfer of data dense files
. Factory calibration - temperature conversion files reside in the camera 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.

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.

The new device consists of:

1. Infrared Camera
- ▲ MAX 076 320 x 240 array detector
- レ MAX 307 640 x 480 array detector
1. TotalVision Software
1. Laptop or desktop computer

Indications for Use:

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.

Predicate Device Comparison:

Synopsis of the comparison analysis:

. Med-Hot Thermal Imaging Systems and the predicate device (MTI 2000) are intended for use as an adjunct to other clinical diagnostic procedures in the diagnosis, quantifying, screening of differences in skin surface temperature changes.
. Both view live imagery from the camera, record snap shots to disk, include postprocessing of fast thermal events, provide analysis by region of interest (spot, line, square) and save the information in a file organizer.
. The Med-Hot TotalVision Capture software is an evolution of the original Med-Hot software program included in K063047. Improvements and new features added were based on user-driven needs and requests over the years.

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Comparison of Intended Use and Principle of Operation:

As thermal sensors, the principle operation of all thermal imaging or infrared cameras is inherently the same, regardless of technical specifications or applications. They capture and record objects within the camera view for evaluation of thermal variations.

For clinical or medical application, the information from and infrared device is strictly limited to thermal findings. The location of these findings on the body, combined with intensity and distribution of thermal patterns may lead the reader/observer to intentionally or incidentally make a thermal correlation with the expected or abnormal patterns to the anatomy in that region of the body.

The Med-Hot Thermal Imaging Systems is substantially equivalent in intended use, principle of operation and similar software features to the FDA cleared Med-Hot Thermal Imaging, Inc. MTI2000.

Non-Clinical Performance Testing:

. ISO 14971, Medical devices - application of risk management to medical Devices
IEC 60068-2-27 Environmental testing - Part 2-27: Tests - Test Ea and guidance: Shock
IEC 60068-2-6 Environmental testing - Part 2-6: Tests - Test Fc: Vibration
IEC 60529 Degrees of protection provided by enclosures (IP Code)
EN 61000-6-3 Electromagnetic compatibility (EMC). Generic standards. Emission standard for residential, commercial and light-industrial environments
EN 61000-6-2 Electromagnetic compatibility (EMC). Generic standards. Immunity for industrial environments
EN 60950 Information technology equipment - Safety - Part 1: General requirements
47 CFR Part 15 RADIO FREQUENCY DEVICES ●
. Software Verification and validation according to FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices

Clinical Studies:

No clinical studies were conducted.

Conclusion:

Based upon the technology characteristics and safety and performance testing, it is the conclusion of Med-Hot Thermal Imaging Inc., that the Med-Hot Thermal lmaging Systems are as safe and effective as the predicate devices and raises no new issues of safety and 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.