ThermPix Thermovisual Camera

K232462 · Usa Therm, Inc. · LHQ · Sep 14, 2023 · Obstetrics/Gynecology

Device Facts

• Record ID: K232462
• Device Name: ThermPix Thermovisual Camera
• Applicant: Usa Therm, Inc.
• Product Code: LHQ · Obstetrics/Gynecology
• Decision Date: Sep 14, 2023
• Decision: SESE
• Submission Type: Special
• 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; captures passive infrared emission via uncooled VOx microbolometer; consists of infrared camera, tablet, and molded case. Input: thermal radiation from human body. Processing: proprietary software converts infrared data into temperature distribution images. Output: thermal images displayed on tablet; data uploaded to secure cloud repository for clinician review. Used in hospitals, clinics, and healthcare settings by qualified technical personnel. Output serves as adjunctive diagnostic information; clinicians use images to identify thermal patterns requiring further investigation. Benefits: provides non-contact, non-invasive visualization of thermal variations to support clinical decision-making.

Clinical Evidence

Bench testing only. Validation performed using 2 cameras across 20°C-40°C range. Results confirmed 1°C temperature differences are discernible by trained users with 99% confidence. Accuracy verified at +/- 0.68°C (95% CI) and +/- 1.02°C (99% CI) with bias within +/- 0.1°C.

Technological Characteristics

Uncooled VOx microbolometer; 12 μm pixel pitch; 7.8-14 μm spectral range; 320x240 array; 56°(H)x42°(V) FOV; 65 mK thermal sensitivity; +/- 1°C accuracy. Connectivity: WIFI to cloud. Power: 5VDC. Standards: IEC 60601-1, IEC 60601-1-2, IEC 62304.

Indications for Use

Indicated for adjunctive diagnostic imaging of heat patterns/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

• ThermPix Thermovisual Camera (K213650)

Submission Summary (Full Text)

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September 14, 2023

Image /page/0/Picture/1 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration. The Department of Health & Human Services logo is on the left and features a stylized human figure. The FDA logo is on the right and features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

USA Therm, Inc. % Mary Vater 510(k) Consultant Medical Device Academy 345 Lincoln Hill Rd. SHREWSBURY VT 05387

Re: K232462

Trade/Device Name: ThermPix Thermovisual Camera Regulation Number: 21 CFR 884.2980 Regulation Name: Telethermographic system Regulatory Class: Class II Product Code: LHQ Dated: August 14, 2023 Received: August 15, 2023

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

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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 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 (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 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,

# Yanna S. Kang -S

Yanna Kang Assistant Director Mammography and Ultrasound Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

Submission Number (if known)

K232462

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 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.

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)

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#### 510(k) SUMMARY K232462

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

#### . SUBMITTER

USA Therm, Inc. 3100 Ray Ferrero Jr. Blvd, 5th Floor Fort Lauderdale FL 33314 United States Tel: [phone] Contact Person: Mr. Eric Heil Date Prepared: August 15, 2023

#### II. DEVICE

| Device Trade Name: | ThermPix Thermovisual Camera |
|------------------------------|------------------------------|
| Classification Name: | Telethermographic System |
| Regulation: | 21 CFR §884.2980 |
| Regulatory Class: | Class II |
| Device Panel: | Radiology |
| Product Classification Code: | LHQ |

#### PREDICATE DEVICE =

Predicate Manufacturer: USA Therm, Inc. Predicate Trade Name: ThermPix Thermovisual Camera Predicate 510(k): K213650

No reference devices were used in this submission.

#### DEVICE DESCRIPTION IV.

The ThermPix Thermovisual Camera is a Telethermographic system which consists of an infrared camera embedded in a Tablet case and a Commercial Off the Shelf Tablet (WIFF only). 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 patientspecific 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.

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 healthcare is provided by a healthcare professional.

#### > 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

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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.

#### COMPARISON WITH PREDICATE VI.

| | Predicate Device: | Subject Device: | Comments on<br>Substantial<br>Equivalence |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | ThermPix Thermovisual<br>Camera | ThermPix Thermovisual<br>Camera | |
| 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. The significance of<br>these thermal patterns and<br>variations is determined by<br>professional investigation.<br>This device is intended for<br>use by qualified technical<br>personnel. Clinical<br>judgement and experience<br>are required to review and<br>interpret the information<br>transmitted.<br><br>The ThermPix<br>Thermovisual Camera<br>is only for use in addition<br>to other diagnostic medical<br>devices. It does not provide<br>any absolute measurement<br>of temperature and should<br>not be used for sole<br>screening or diagnosis for<br>any disease or condition. | The ThermPix<br>Thermovisual Camera is<br>intended to view, measure,<br>and record heat patterns and<br>variations. It is intended for<br>use as adjunctive diagnostic<br>imaging for thermally<br>significant indications<br>stemming from heat<br>emitted from the human<br>body. The significance of<br>these thermal patterns and<br>variations is determined by<br>professional investigation.<br>This device is intended for<br>use by qualified technical<br>personnel. Clinical<br>judgement and experience<br>are required to review and<br>interpret the information<br>transmitted.<br><br>The ThermPix<br>Thermovisual Camera<br>is only for use in addition to<br>other diagnostic medical<br>devices. It does not provide<br>any absolute measurement<br>of temperature and should<br>not be used for sole<br>screening or diagnosis for<br>any disease or condition. | Identical |
| | The system is not intended<br>to be used as a<br>thermometry device. | The system is not intended<br>to be used as a thermometry<br>device. | |
| Intended User | Healthcare Professionals | Healthcare Professionals | Identical |
| Environment of Use | Clinical Environment | Clinical Environment | Identical |
| Device Components | Camera Swivel Drum Micro SD Card Infrared Camera Visual Camera Touch Screen and Screen<br>Driver Computing PCB Lithium Polymer Battery Anti-Bacterial Case | Commercial Off the<br>Shelf Tablet (WIFI<br>Only). Testing to be<br>performed on<br>Samsung Galaxy S6<br>Lite WIFI Only<br>(Model SM-<br>P610NZAAXAR) SEEK Infrared<br>camera Molded Tablet case USB C Hub Pen Stylus | The device<br>components are<br>the key differences<br>between device<br>generations.<br>The changes to<br>design do not<br>impact the<br>device's<br>performance<br>capabilities or the<br>user's interactions<br>with the device. |
| Imaging | | | |
| Detector Type | Uncooled VOx<br>microbolometer | Uncooled VOx<br>microbolometer | Identical |
| Pixel Pitch | 12 μm | 12 μm | Identical |
| Spectral Range | Longwave infrared; 7.8 µm<br>to 14 μm | Longwave infrared; 7.8 µm<br>to 14 μm | Identical |
| Frame Rate | 9 Hz and 27 Hz | 9 Hz | Substantially<br>Equivalent |
| Thermal Sensitivity | 65 mK (typical) | 65 mK (typical) | Identical |
| Accuracy | +/- 1°C (for temperature<br>difference) | +/- 1°C (for temperature<br>difference) | Identical |
| Optics | | | |
| Array Format | 320 x 240 with 56° (H) and<br>42° (V) field of view | 320 x 240 with 56° (H) and<br>42° (V) field of view | Identical |
| Electrical | | | |
| Video Channels | USB-2 | USB-2 | Identical |
| Control Channels | USB | USB | Identical |
| Input Voltage | 3.3 VDC to 5 VDC (5V<br>used) | 5VDC | Results in no<br>practical<br>performance<br>difference |
| Environmental | | | |
| Operating<br>Temperature Range | -10°C to +60°C (15°C to<br>24°C recommended for<br>best results) | -10°C to +60°C (15°C to<br>24°C recommended for best<br>results) | Identical |
| Non-Operating<br>Temperature Range | -40°C to 60°C | --40°C to 60°C | |
| Performance Testing | | | |
| Temperature<br>Difference Accuracy | The ThermPix<br>Thermovisual Camera<br>temperature difference | The subject device was<br>validated using identical<br>methods. | Identical |

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| accuracy was calculated | |
|-------------------------------|--|
| and verified to be +/- | |
| 0.68°C at 95% confidence | |
| (1.02°C at 99%) 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 20-40 ℃. A | |
| traceable certified reference | |
| black body calibrator 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. | |

# VII. PERFORMANCE DATA

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

# Electrical safety and electromagnetic compatibility (EMC)

The subject device passed equivalent electrical safety and EMC testing in accordance with:

- । IEC 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- -IEC 60601-1 Edition 3.2 2020-08 CONSOLIDATED VERSION Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance IEC 60601-1-6 Edition 3.2 2020-07 CONSOLIDATED VERSION

### Software Verification and Validation Testing

Software verification and validation according to IEC 62304 Edition 1.1 2015-06 Medical device software - Software life cycle processes and FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices

### Performance Validation Testing

The subject device was validated using identical methods to the predicate device. The ability of

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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°C to 40°C in increments of 2°C. 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.

### VIII. CONCLUSIONS

Based on the technological 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.