(30 days)
No reference devices were used in this submission.
No
The summary does not mention AI, ML, or any related terms like deep learning or neural networks. The device description focuses on passive infrared sensing and proprietary software for image display, not advanced analytical algorithms.
No
The device is intended for diagnostic imaging to view, measure, and record heat patterns, not for treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states "It is intended for use as adjunctive diagnostic imaging for thermally significant indications stemming from heat emitted from the human body." It further notes that "Clinical judgement and experience are required to review and interpret the information transmitted," indicating its role in providing information for a diagnosis. It also clarifies that it is "only for use in addition to other diagnostic medical devices," solidifying its diagnostic support function.
No
The device description explicitly states it consists of an infrared camera embedded in a Tablet case and a Commercial Off the Shelf Tablet, indicating it includes hardware components beyond just software.
Based on the provided information, the ThermPix Thermovisual Camera is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- ThermPix Function: The ThermPix Thermovisual Camera is a non-contact, non-invasive device that measures and records heat patterns emitted from the human body. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it is for "adjunctive diagnostic imaging for thermally significant indications stemming from heat emitted from the human body." This is an imaging modality, not an in vitro test.
Therefore, the ThermPix Thermovisual Camera falls under the category of a medical imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
LHQ
Device Description
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 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.
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Infrared
Anatomical Site
Human body
Indicated Patient Age Range
Adult human targets
Intended User / Care Setting
qualified technical personnel. Clinical judgement and experience are required to review and interpret the information transmitted.
Hospitals, acute and sub-acute healthcare settings, clinics, and any environment where healthcare is provided by a healthcare professional.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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°C to 40°C in increments of 2°C.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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, IEC 60601-1 Edition 3.2 2020-08, and IEC 60601-1-6 Edition 3.2 2020-07.
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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Thermal Sensitivity: 65 mK (typical)
Accuracy: +/- 1°C (for temperature difference)
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 measurement bias within +/-0.1 °C.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
No reference devices were used in this submission.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
Indications for Use
Submission Number (if known)
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: +1.844.998.4376 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
4
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
Substantial
Equivalence |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | ThermPix Thermovisual
Camera | ThermPix Thermovisual
Camera | |
| 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 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. | Identical |
| | The system is not intended
to be used as a
thermometry device. | The system is not intended
to be used as a thermometry
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
Driver Computing PCB Lithium Polymer Battery Anti-Bacterial Case | Commercial Off the
Shelf Tablet (WIFI
Only). Testing to be
performed on
Samsung Galaxy S6
Lite WIFI Only
(Model SM-
P610NZAAXAR) SEEK Infrared
camera Molded Tablet case USB C Hub Pen Stylus | The device
components are
the key differences
between device
generations.
The changes to
design do not
impact the
device's
performance
capabilities or the
user's interactions
with the device. |
| Imaging | | | |
| Detector Type | Uncooled VOx
microbolometer | Uncooled VOx
microbolometer | Identical |
| Pixel Pitch | 12 μm | 12 μm | Identical |
| Spectral Range | Longwave infrared; 7.8 µm
to 14 μm | Longwave infrared; 7.8 µm
to 14 μm | Identical |
| Frame Rate | 9 Hz and 27 Hz | 9 Hz | Substantially
Equivalent |
| Thermal Sensitivity | 65 mK (typical) | 65 mK (typical) | Identical |
| Accuracy | +/- 1°C (for temperature
difference) | +/- 1°C (for temperature
difference) | Identical |
| Optics | | | |
| Array Format | 320 x 240 with 56° (H) and
42° (V) field of view | 320 x 240 with 56° (H) and
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
used) | 5VDC | Results in no
practical
performance
difference |
| Environmental | | | |
| Operating
Temperature Range | -10°C to +60°C (15°C to
24°C recommended for
best results) | -10°C to +60°C (15°C to
24°C recommended for best
results) | Identical |
| Non-Operating
Temperature Range | -40°C to 60°C | --40°C to 60°C | |
| Performance Testing | | | |
| Temperature
Difference Accuracy | The ThermPix
Thermovisual Camera
temperature difference | The subject device was
validated using identical
methods. | Identical |
5
6
| 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
7
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.