The InTouch Thermal Camera is intended to view, measure and record heat patterns and variations. It is intended for use as adjunctive diagnostic imaging for thermally significant indications stemming from heat emitted from the human body. The significance of these thermal patterns and variations is determined by profession. This device is intended for use by qualified technical personnel trained in its use. Clinical judgment and experience are required to review and interpret the information transmitted.

The InTouch Thermal Camera is only for use in addition to other medical devices (i.e. Thermometer, Ultrasound, Mammography). It does not provide any absolute measurement of temperature and should not be used for sole screening or diagnosis for any disease or condition.

Device Description

The InTouch Thermal Camera™ is a hardware and software package that enables thermographic imagery and data during a real-time telemedicine consultation. The system includes a 320-pixel-wide thermal camera and a USB cable that allows connection of the camera to a Windows-based computer, which serves as the patientside InTouch Health Telemedicine Device.

The InTouch Thermal Camera software consists of two components. The first is installed on a Windows-based system to serve as the InTouch Health Telemedicine Device. The second component is installed on a Windows or iOS-based system serving as the InTouch Health Provider Access device, enabling a healthcare professional access to the InTouch Health Telemedicine Device. The core software serves as a telecommunications platform that enables real-time videoconferencing and clinical communications, and provides a means of transmitting, receiving, and storing real-time audio and video data.

The InTouch Health Telemedicine System software provides a real-time link between the patient and the healthcare professional(s). The link occurs over a wired or wireless broadband connection, and includes real-time audio and video to facilitate communication between the patient-side healthcare professionals, and remote healthcare professional(s). The InTouch Health software further provides an ability to toggle between an InTouch Health Telemedicine Device's optical camera and the InTouch Thermal Camera, or to view both simultaneously.

When utilizing the InTouch Thermal Camera, the clinician is provided with interface controls to allow a variety of options in the visualization of the thermal imagery.

The basic purpose of the InTouch Thermal Camera is to allow a physician to view the heat pattern of a patient, while engaged in a telemedicine consultation. When the InTouch Thermal Camera is engaged, the InTouch Health software provides the physician with a variety of controls for visualizing temperature patterns and temperature differences.

AI/ML Overview

Here's the information about the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance (InTouch Thermal Camera)	Predicate Device Performance (Med-Hot Thermal Imaging System)
Imaging
Detector Type	Uncooled VOx microbolometer	Uncooled VOx microbolometer
Array Format	320 x 256	320 x 240
Pixel Pitch	12 μm	25 μm (Detector Pitch)
Spectral Range	Longwave infrared; 7.5 μm to 13.5 μm	Longwave infrared; 7.5 um to 13 um
Frame Rate	60 Hz	60 Hz
Thermal Sensitivity	< 60 mK (Consumer grade)	< 50 mK
Accuracy (Temp. Difference)	+/- 1.1 °C (at 99% confidence)	+ 2 °C or + 2 % of Reading
Optics
Array Format with FoV	320 x 256 with 24° field of view	320 x 240
Electrical
Video Channels	USB-2	Gig E
Control Channels	USB	Gig E
Input Voltage	3.3 VDC	110/220VAC
Power Dissipation	Varies by configuration; as low as 500 mW	Not stated
Environmental
Operating Temp. Range	-40°C to 80°C	-40 °C to 150 °C (40 °F to 302 °F)
Non-operating Temp. Range	-50°C to 105°C	-40 °C to 150 °C (40 °F to 302 °F)

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

The document describes non-clinical testing for accuracy, stating: "data was collected over multiple cameras, multiple users, and multiple temperatures ranging from 22-48 ℃." It does not specify an exact numerical sample size for the test set or the country of origin. The test was conducted as part of demonstrating substantial equivalence, implying it was a laboratory-based evaluation rather than a clinical study with patient data. Therefore, the data provenance is likely internal testing data.

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

The document states: "Traceable certified reference black body calibrators and thermocouples were employed in order to establish the temperature difference accuracy and bias". This indicates that the ground truth for temperature measurements was established through certified reference instruments, not human experts. Therefore, no human experts were used for ground truth establishment in this specific accuracy test.

4. Adjudication Method for the Test Set:

Not applicable. The ground truth was established by certified reference instruments, eliminating the need for expert adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:

No, an MRMC comparative effectiveness study was not done. The device is a thermal camera, and the provided document details non-clinical testing for its technical specifications and accuracy, not its impact on human reader performance or AI assistance. 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:

The accuracy testing described ("The InTouch Thermal Camera temperature difference accuracy was calculated and verified to be +/- 1.1 °C at 99% confidence with a measurement bias within +/-0.1 °C. To determine these values, data was collected over multiple cameras, multiple users, and multiple temperatures ranging from 22-48 ℃.") can be considered a standalone performance evaluation of the device's measurement capabilities. It assesses the device's inherent ability to measure temperature differences accurately, independent of a human interpreter or an AI algorithm.

7. The type of ground truth used:

The ground truth used for the accuracy assessment was traceable certified reference black body calibrators and thermocouples. This is an instrumental, objective ground truth for temperature measurements.

8. The sample size for the training set:

The document does not provide information about a training set. The device is a thermal camera and its performance evaluation focused on its intrinsic measurement accuracy and technical specifications, not on a machine learning model that would require a distinct training set.

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

Not applicable, as no training set for a machine learning model is mentioned in the provided text.

Summary

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March 25, 2019

InTouch Technologies, Inc., d.b.a. InTouch Health % Ms. Karen Mullin Manager Regulatory Affairs 7402 Hollister Avenue GOLETA CA 93117

Re: K181716

Trade/Device Name: InTouch Thermal Camera™ Regulation Number: 21 CFR 884.2980 Regulation Name: Telethermographic System Regulatory Class: Class I Product Code: LHO Dated: February 19, 2019 Received: February 21, 2019

Dear Ms. Mullin:

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 vou, 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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,

Hole 2. Nils

Thalia Mills, 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) K181716

Device Name InTouchThermal Camera

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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5. 510(k) Summary:

Name of 510(k) sponsor:	InTouch Technologies, Inc., d.b.a. InTouch Health
Address:	7402 Hollister Ave.Goleta, CA 93117
Contact information:	Karen MullinManager Regulatory AffairsInTouch Health7402 Hollister Ave.Goleta, CA 93117Phone: 805 562 8686 (ext. 370)Fax: 805 562 8663
Date summary prepared:	June 25, 2018 (updated February 18, 2019 andMarch 18, 2019)
Proprietary name of device:	InTouch Thermal Camera™
Generic/classification name:	System, Telethermographic (Adjunctive Use)
Product code (classification):	21 CFR § 884.2980, Product Code LHQ; Class I
Legally marketed predicate device:	Med-Hot Thermal Imaging System (Max 76)FLIR, K171928, December 8, 2017

5.1 Device Description and Technological Characteristics:

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When utilizing the InTouch Thermal Camera, the clinician is provided with interface controls to allow a variety of options in the visualization of the thermal imagery.

5.2 Indications for Use:

The InTouch Thermal Camera is intended to view, measure and record heat patterns and variations. It is intended for use as adjunctive diagnostic imaging for thermally significant indications stemming from heat emitted from the human body. The significance of these thermal patterns and variations is determined by professional investigation. This device is intended for use by qualified technical personnel trained in its use. Clinical judgment and experience are required to review and interpret the information transmitted.

WARNING:

The InTouch Thermal Camera should not be used as the sole device to diagnose or screen for breast cancer or any other condition. The InTouch Thermal Camera should not be used in place of mammography and is only for use in addition to other diagnostic or screening devices. Incorrect use of the InTouch Thermal Camera carries the risks of a delayed or missed diagnosis, or unnecessary additional tests.

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5.3 Comparison with Predicate Device:

A substantial equivalence table comparing the InTouch Thermal Camera (proposed device) to the predicate device is provided in Table 5-1 below.

Table 5-1: Comparison of the Proposed Device to the Predicate Device
Product	InTouch Thermal Camera(proposed device)	Med-Hot Thermal ImagingSystem (Max 76)(predicate device)
Manufacturer	InTouch Health	Med-Hot Thermal Imaging, Inc.
Indications forUse	The InTouch Thermal Camera isintended to view, measure andrecord heat patterns and variations. Itis intended for use as adjunctivediagnostic imaging for thermallysignificant indications stemming fromheat emitted from the human body.The significance of these thermalpatterns and variations is determinedby professional investigation. Thisdevice is intended for use byqualified technical personnel trainedin its use. Clinical judgment andexperience are required to reviewand interpret the informationtransmitted.	The Med-Hot Thermal ImagingSystems are intended to review,measure and record skintemperature patterns andvariations emitted from the humanbody. They are intended for useas adjunctive diagnostic imagingfor thermally significant indicationsin the regions of the head andneck, breast, chest, abdomen,back and extremities. Thesignificance of the value of thesethermal patterns is determined byprofessional investigation. Thisdevice is intended for use byqualified technical personneltrained in its use.
Device Class
510(k) Clearance	K181716	K171928
Predicate	K171928	K063047
Imaging
Detector Type	Uncooled VOx microbolometer	Uncooled VOx microbolometer
Array Format	320 x 256	320 x 240
Pixel Pitch	12 μm	25 μm (Detector Pitch)
Spectral Range	Longwave infrared; 7.5 μm to 13.5 μm	Longwave infrared; 7.5 um to 13 um
Frame Rate	60 Hz	60 Hz
ThermalSensitivity	< 60 mK (Consumer grade)	< 50 mK
Accuracy	+/- 1.1 °C (for temperaturedifference)	+ 2 °C or + 2 % of Reading
Table 5-1: Comparison of the Proposed Device to the Predicate Device, cont.
Optics
Array Format	320 x 256 with 24° field of view	320 x 240
Electrical
Video Channels	USB-2	Gig E
ControlChannels	USB	Gig E
Input Voltage	3.3 VDC	110/220VAC
PowerDissipation	Varies by configuration;as low as 500 mW	Not stated
Environmental
OperatingTemperatureRange	-40°C to 80°C	-40 °C to 150 °C (40 °F to 302 °F)
Non-operatingTemperatureRange	-50°C to 105°C	-40 °C to 150 °C (40 °F to 302 °F)

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5.4 Non-Clinical Testing:

IEC 60601-1-2:2014 4th Edition Medical electrical equipment-Part 1-2: General . requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
IEC 62366:2007 Ed. 1+A1 Medical Electrical Equipment Part 1: General . Requirements for Basic Safety & Essential Performance
IEC 60601-1-6:2010 Ed. 3+A1 Medical Electrical Equipment - Part 1-6: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Usability
IEC 60601-1:2005 Ed. 3+A1 Medical Electrical Equipment Part 1: General . Requirements for Basic Safety and Essential Performance
. AAMI ES60601-1:2005+A1 Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance
. Software verification and validation according to FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices

5.4.1 Summary of Accuracy:

The InTouch Thermal Camera temperature difference accuracy was calculated and verified to be +/- 1.1 °C at 99% confidence with a measurement bias within +/-0.1 °C. To determine these values, data was collected over multiple cameras, multiple users, and multiple temperatures ranging from 22-48 ℃. Traceable certified reference black body

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calibrators and thermocouples were employed in order to establish the temperature difference accuracy and bias, and a Gage Repeatability & Reproducibility was run to assess the variation of the measurement system. The root sum of squares method was employed to compute the overall uncertainty of the system at the given confidence interval.

5.5 Clinical Studies:

No clinical studies were conducted.

5.6 Conclusion:

Based on the technology characteristics and non-clinical testing, it is the conclusion of InTouch Health that the InTouch Thermal Camera is substantially equivalent to the predicate device and raises no new issues of safety.

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.