InTouch Thermal Camera

K181716 · Intouch Technologies, Inc., D.B.A. Intouch Health · LHQ · Mar 25, 2019 · Obstetrics/Gynecology

Device Facts

• Record ID: K181716
• Device Name: InTouch Thermal Camera
• Applicant: Intouch Technologies, Inc., D.B.A. Intouch Health
• Product Code: LHQ · Obstetrics/Gynecology
• Decision Date: Mar 25, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.2980
• Device Class: Class 1

Intended 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. 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 Story

InTouch Thermal Camera captures longwave infrared heat patterns from human body; utilizes uncooled VOx microbolometer (320x256 array). Device connects via USB to Windows-based telemedicine system. Software enables real-time transmission of thermal imagery/data to remote healthcare professional during telemedicine consultation. Clinician uses interface controls to visualize temperature patterns and differences. Output is visual thermal imagery; used by physicians to support clinical assessment. Does not provide absolute temperature measurement; intended as adjunctive tool only. Benefits include remote visualization of thermal variations to aid diagnostic decision-making.

Clinical Evidence

No clinical data. Bench testing only. Accuracy verified to +/- 1.1 °C at 99% confidence with bias within +/- 0.1 °C using traceable black body calibrators and thermocouples across 22-48 °C range. Gage Repeatability & Reproducibility study performed.

Technological Characteristics

Uncooled VOx microbolometer detector; 320x256 array; 12 μm pixel pitch; 7.5-13.5 μm spectral range; 60 Hz frame rate. USB-2 connectivity. Input voltage 3.3 VDC. Software-based visualization on Windows/iOS platforms. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 62366.

Indications for Use

Indicated for adjunctive diagnostic imaging of heat patterns/variations emitted from the human body. For use by qualified technical personnel. Not for sole screening or diagnosis of any disease or condition; must be used with other medical devices.

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.

Predicate Devices

• Med-Hot Thermal Imaging System (Max 76) (K171928)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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.

| 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.<br>Goleta, CA 93117 | |
| Contact information: | Karen Mullin<br>Manager Regulatory Affairs<br>InTouch Health<br>7402 Hollister Ave.<br>Goleta, CA 93117<br>Phone: [phone] (ext. 370)<br>Fax: [phone] | |
| Date summary prepared: | June 25, 2018 (updated February 18, 2019 and<br>March 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)<br>FLIR, K171928, December 8, 2017 | |

# 5.1 Device Description and Technological Characteristics:

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.

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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.

### 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.

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.

### 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<br>(proposed device) | Med-Hot Thermal Imaging<br>System (Max 76)<br>(predicate device) |
| Manufacturer | InTouch Health | Med-Hot Thermal Imaging, Inc. |
| Indications for<br>Use | The InTouch Thermal Camera is<br>intended to view, measure and<br>record heat patterns and variations. It<br>is intended for use as adjunctive<br>diagnostic imaging for thermally<br>significant indications stemming from<br>heat emitted from the human body.<br>The significance of these thermal<br>patterns and variations is determined<br>by professional investigation. This<br>device is intended for use by<br>qualified technical personnel trained<br>in its use. Clinical judgment and<br>experience are required to review<br>and interpret the information<br>transmitted. | The Med-Hot Thermal Imaging<br>Systems are intended to review,<br>measure and record skin<br>temperature patterns and<br>variations emitted from the human<br>body. They are intended for use<br>as adjunctive diagnostic imaging<br>for thermally significant indications<br>in the regions of the head and<br>neck, breast, chest, abdomen,<br>back and extremities. The<br>significance of the value of these<br>thermal patterns is determined by<br>professional investigation. This<br>device is intended for use by<br>qualified technical personnel<br>trained 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 |
| Thermal<br>Sensitivity | < 60 mK (Consumer grade) | < 50 mK |
| Accuracy | +/- 1.1 °C (for temperature<br>difference) | + 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 |
| Control<br>Channels | USB | Gig E |
| Input Voltage | 3.3 VDC | 110/220VAC |
| Power<br>Dissipation | Varies by configuration;<br>as low as 500 mW | Not stated |
| Environmental | | |
| Operating<br>Temperature<br>Range | -40°C to 80°C | -40 °C to 150 °C (40 °F to 302 °F) |
| Non-operating<br>Temperature<br>Range | -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.