ThermPix Thermovisual Camera

K213650 · Usa Therm, Inc. · LHQ · Apr 12, 2022 · Obstetrics/Gynecology

Device Facts

• Record ID: K213650
• Device Name: ThermPix Thermovisual Camera
• Applicant: Usa Therm, Inc.
• Product Code: LHQ · Obstetrics/Gynecology
• Decision Date: Apr 12, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.2980
• Device Class: Class 1

Intended Use

The ThermPix Thermovisual 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. Clinical judgement and experience are required to review and interpret the information transmitted. The ThermPix Thermovisual Camera is only for use in addition to other diagnostic medical devices. It does not provide any absolute measurement of temperature and should not be used for sole screening or diagnosis for any disease or condition. The system is not intended to be used as a thermometry device.

Device Story

Telethermographic system comprising infrared/visual cameras and touch-screen display; captures passive infrared emission to visualize temperature distribution patterns. Used in clinical settings (hospitals, clinics) by qualified technical personnel. Data uploaded via Wi-Fi to secure ThermPix Cloud for clinician review/augmentation. Provides adjunctive diagnostic imaging; does not provide absolute temperature measurements. Assists clinicians in identifying thermally significant indications; requires clinical judgment for interpretation. Benefits include non-contact, non-invasive, non-radiating thermal monitoring as an adjunct to other diagnostic tools.

Clinical Evidence

No clinical data. Bench testing only. Accuracy verified using traceable certified reference black body calibrators and thermocouples across 20-40°C range. Gage Repeatability & Reproducibility (R&R) assessment performed. Device demonstrated ability to distinguish 1°C temperature differences with 99% confidence.

Technological Characteristics

Uncooled VOx microbolometer detector; longwave infrared (7.8-14 µm); 320x240 array; 56°(H) x 42°(V) FOV. Connectivity via Wi-Fi to cloud repository. Powered by 3.3-5 VDC. Complies with IEC 60601-1 (safety) and IEC 60601-1-2 (EMC). Software developed per IEC 62304.

Indications for Use

Indicated for adjunctive diagnostic imaging of heat patterns and variations emitted from the human body in adult patients. Intended for use by qualified technical personnel in clinical environments. Not for sole screening or diagnosis; not a thermometry device.

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

• InTouch Thermal Camera (K181716)

Submission Summary (Full Text)

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April 12, 2022

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

USA Therm, Inc. % Mary Vater 510(k) Consultant Medical Device Academy 345 Lincoln Hill Road SHREWSBURY VT 05738

### Re: K213650

Trade/Device Name: ThermPix Thermovisual Camera Regulation Number: 21 CFR 884.2980 Regulation Name: Telethermographic system Regulatory Class: Class I, reserved Product Code: LHQ Dated: March 3, 2022 Received: March 3, 2022

### Dear Mary Vater:

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

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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/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 ([e-mail]) or phone [phone] 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) K213650

Device Name ThermPix Thermovisual Camera

### Indications for Use (Describe)

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

The ThermPix Thermovisual Camera is only for use in addition to other diagnostic medical devices. It does not provide any absolute measurement of temperature and should not be used for sole screening or diagnosis for any disease or condition. The system is not intended to be used as a thermometry device.

| 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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# 510(k) SUMMARY - K213650

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR §807.92:

| I. SUBMITTER | |
|-------------------------------------------------------------------------------------------------------------------|------------------------------|
| USA Therm, Inc.<br>21550 Biscayne Boulevard, Suite 133<br>Aventura, Florida 33180<br>Tel: [phone]<br>Fax: | |
| Contact Person: | Ariel Soffer, MD, CEO |
| Date Prepared: | November 18, 2021 |
| II. DEVICE | |
| Name of Device: | ThermPix Thermovisual Camera |
| Classification Name: | Telethermographic System |
| Regulation: | 21 CFR §884.2980 |
| Regulatory Class: | Class I |
| Product Classification Code: | LHQ |
| III. PREDICATE DEVICE | |
| Predicate Manufacturer: | InTouch Health |

Predicate 510(k): K181716

No reference devices were used in this submission.

#### DEVICE DESCRIPTION IV.

Predicate Trade Name:

The ThermPix Thermovisual Camera is a Telethermographic system which consists of infrared and visual cameras and a touch-screen display. It is a non-contact, non-invasive, and non-radiating infrared system capable of imaging and storing thermal patterns generated by the human body. These images along with other patient-specific data are uploaded via Wifi to the ThermPix Cloud, a secure repository where clinicians can access and augment data from a 3rd party device or computer.

InTouch Thermal Camera™

It employs passive infrared emission sensing technology to capture the thermal data and uses proprietary software to display the temperature distribution pattern as an image. It is suitable for imaging adult human targets and can be used in hospitals, acute and sub-acute healthcare settings, clinics, and any environment where is provided by a healthcare professional.

#### V. INDICATIONS FOR USE

The ThermPix Thermovisual 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. Clinical judgement and experience are required to review and interpret the information transmitted.

The ThermPix Thermovisual Camera is only for use in addition to other diagnostic medical devices. It does not provide any absolute measurement of temperature and should not be used for sole screening or diagnosis for any disease or condition. The system is not intended to be used as a thermometry device.

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## VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVCE

The following characteristics were compared between the subject device and the predicate device in order to demonstrate substantial equivalence:

| | ThermPix Thermovisual<br>Camera | InTouch Thermal Camera<br>(K181716) | Comments on<br>Substantial<br>Equivalence |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The ThermPix<br>Thermovisual Camera is<br>intended to view, measure,<br>and record heat patterns<br>and variations. It is<br>intended for use as<br>adjunctive diagnostic<br>imaging for thermally<br>significant indications<br>stemming from heat<br>emitted from the human<br>body.<br>The significance of these<br>thermal patterns and<br>variations is determined by<br>professional investigation.<br>This device is intended for<br>use by qualified technical<br>personnel.<br>Clinical judgement and<br>experience are required to<br>review and interpret the<br>information transmitted. | The InTouch<br>Thermal Camera is<br>intended to view, measure<br>and record heat patterns<br>and variations. It is<br>intended for use as<br>adjunctive diagnostic<br>imaging for thermally<br>significant indications<br>stemming from heat<br>emitted from the human<br>body.<br>The significance of these<br>thermal patterns and<br>variations is determined by<br>professional investigation.<br>This device is intended for<br>use by qualified technical<br>personnel trained in its use.<br>Clinical judgment and<br>experience are required to<br>review and interpret the<br>information transmitted. | Both devices are<br>indicated to view,<br>measure, and<br>record heat<br>patterns and<br>variations as an<br>adjunctive<br>diagnostic imaging<br>device for<br>thermally<br>significant<br>indications<br>stemming from<br>heat emitted from<br>the human body.<br>The significance<br>of these thermal<br>patterns and<br>variations is<br>determined by<br>professional<br>investigation. |
| | The ThermPix<br>Thermovisual Camera<br>is only for use in addition<br>to other diagnostic medical<br>devices.<br><br>It does not provide any<br>absolute measurement of<br>temperature and should not<br>be used for sole screening<br>or diagnosis for any disease<br>or condition. The system is<br>not intended to be used as a<br>thermometry device. | The InTouch Thermal<br>Camera<br>is only for use in addition<br>to other medical devices<br>(i.e. Thermometer,<br>Ultrasound,<br>Mammography).<br>It does not provide any<br>absolute measurement of<br>temperature and should not<br>be used for sole screening<br>or diagnosis for any disease<br>or condition. | Both devices also<br>indicate that they<br>are not intended<br>for absolute<br>temperature<br>measurement or<br>sole screening. |
| Intended User | Healthcare Professionals | Healthcare Professionals | Identical |
| Environment of Use | Clinical Environment | Clinical Environment | Identical |
| Imaging | | | |
| Detector Type | Uncooled VOx<br>microbolometer | Uncooled VOx<br>microbolometer | Identical |
| Spectral Range | Longwave infrared; 7.8 µm to 14 µm | Longwave infrared; 7.5 µm to 13.5 µm | Substantially Equivalent |
| Frame Rate | 9 Hz and 27 Hz | 60 Hz | Substantially Equivalent |
| Thermal Sensitivity | 65 mK (typical) | < 60 mK (Consumer grade) | Substantially Equivalent |
| Accuracy | +/- 1°C (for temperature difference) | +/- 1.1 °C (for temperature difference) | Substantially Equivalent |
| Optics | | | |
| Array Format | 320 x 240 with 56° (H) and 42° (V) field of view | 320 x 256 with 24° field of view | The subject device has a wider field of view that allows the user to be closer to areas of interest than the predicate, otherwise no practical difference |
| Electrical | | | |
| Video Channels | USB-2 | USB-2 | Identical |
| Control Channels | USB | USB | Identical |
| Input Voltage | 3.3 VDC to 5 VDC (5V used) | 3.3 VDC | Results in no practical performance difference |
| Power Dissipation | 300 mW | Varies by configuration; as low as 500 mW | Lower power consumption than predicate is of no practical difference |
| Environmental | | | |
| Operating Temperature Range | -10°C to +60°C (15°C to 24°C recommended for best results) | -40°C to 80°C | Differences due to use of Lithium polymer rechargeable battery that looses capacity at low temperatures. Of no practical consequence because intended use location is in a doctor's office or hospital. |
| Non-Operating Temperature Range | -40°C to 60°C | -50°C to 105°C | |
| Performance Testing | | | |
| Temperature Difference Accuracy | The ThermPix Thermovisual Camera temperature difference accuracy was calculated and verified to be +/- 0.68°C at 95% confidence (1.02°C at 99%) with a | The InTouch Thermal Camera temperature difference accuracy was calculated and verified to be +/- 1.1 °C at 99% confidence with a measurement bias within | Near identical:<br>- The accuracy of the subject device is slightly better than predicate |
| measurement bias within<br>+/-0.1 °C. To determine<br>these values, data was<br>collected over multiple<br>cameras, multiple users,<br>and multiple temperatures<br>ranging from 20-40 °C. A<br>traceable certified reference<br>black body calibrator and<br>thermocouples were<br>employed in order to<br>establish the temperature<br>difference accuracy and<br>bias, and a Gage<br>Repeatability &<br>Reproducibility was run to<br>assess the variation of the<br>measurement system. The<br>root sum of squares method<br>was employed to compute<br>the overall uncertainty of<br>the system at the given<br>confidence interval. | +/-0.1 °C. To determine<br>these values, data was<br>collected over multiple<br>cameras, multiple users,<br>and multiple temperatures<br>ranging from 22-48 °C.<br>Traceable certified<br>reference black body<br>calibrators and<br>thermocouples were<br>employed in order to<br>establish the temperature<br>difference accuracy and<br>bias, and a Gage<br>Repeatability &<br>Reproducibility was run to<br>assess the variation of the<br>measurement system. The<br>root sum of squares method<br>was employed to compute<br>the overall uncertainty of<br>the system at the given<br>confidence interval. | but the<br>difference is<br>within the +/-<br>0.1 certainty<br>interval.<br><br>- Subject device<br>assessment<br>was in the<br>range between<br>10-40°C as<br>this is deemed<br>closer to the<br>temperatures<br>of human skin<br>than the<br>predicate's 22-<br>48°C. | |

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## VII. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination.

## 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 60601-1:2005 Ed. 3+A1 Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance
- Software verification and validation according to IEC 62304 Edition 1.1 2015-06 l Medical device software - Software life cycle processes and FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices

## Summary of Accuracy

## Relative Temperature Difference (thermal sensitivity)

The ability of the ThermPix Thermovisual System to enable users to distinguish temperature differences of 1°C with a thermal image was tested using image data collected from 2 cameras at temperatures ranging from 20℃ to 40℃ in increments of 2℃. Results indicate that with 99% confidence temperature differences in 1°C or more are discernible by a trained user. The results indicate that the device performance is comparable to that of the proposed 510(k) predicate device K181716 with a reported error of 1.1℃ at the 99% confidence level.

## Human Clinical Performance Testing

Clinical testing was not required to demonstrate the safety and effectiveness of the device.

# VIII. CONCLUSIONS

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Based on the technology characteristics and non-clinical testing, it is the conclusion of USA Therm, Inc. that the ThermPix Thermovisual Camera is substantially equivalent to the predicate device and raises no new issues of safety.