(144 days)
No
The summary describes a standard thermovisual camera system that captures and displays thermal images. There is no mention of AI, ML, or any advanced algorithms for image analysis or interpretation beyond basic display of temperature distribution. The interpretation is explicitly stated to require clinical judgment and experience.
No
The device is described as an adjunctive diagnostic imaging tool to view, measure, and record heat patterns. It doesn't treat, alleviate, or prevent any disease or condition; therefore, it is not a therapeutic device.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended for use as adjunctive diagnostic imaging for thermally significant indications stemming from heat emitted from the human body." It also mentions "Clinical judgement and experience are required to review and interpret the information transmitted," further indicating its role in the diagnostic process.
No
The device description explicitly states it consists of infrared and visual cameras and a touch-screen display, which are hardware components. The software processes data from these hardware components.
No, this device 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. They are used to examine these samples outside of the body.
- ThermPix Function: The ThermPix Thermovisual Camera is a non-contact, non-invasive device that measures heat patterns emitted from the human body. It does not analyze samples taken from the body.
The ThermPix is a medical imaging device that uses infrared technology to visualize and measure surface temperature variations. While it is used for diagnostic purposes (as adjunctive imaging), it does so by observing the body directly, not by analyzing in vitro samples.
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 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.
Product codes
LHQ
Device Description
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.
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.
Mentions image processing
Not Found
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 / Hospitals, acute and sub-acute healthcare settings, clinics, and any environment where 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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Thermal Sensitivity: 65 mK (typical)
- Accuracy: +/- 1°C (for temperature difference)
- Temperature Difference Accuracy: +/- 0.68°C at 95% confidence (1.02°C at 99%) with a measurement bias within +/-0.1 °C.
Predicate Device(s)
Reference Device(s)
No reference devices were used in this submission.
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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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3
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. | |
| 21550 Biscayne Boulevard, Suite 133 | |
| Aventura, Florida 33180 | |
| Tel: +1.844.998.4376 | |
| 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.
4
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
Camera | InTouch Thermal Camera
(K181716) | Comments on
Substantial
Equivalence |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 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. | Both devices are
indicated to view,
measure, and
record heat
patterns and
variations as an
adjunctive
diagnostic imaging
device 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. |
| | 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. | 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. | Both devices also
indicate that they
are not intended
for absolute
temperature
measurement or
sole screening. |
| Intended User | Healthcare Professionals | Healthcare Professionals | Identical |
| Environment of Use | Clinical Environment | Clinical Environment | Identical |
| Imaging | | | |
| Detector Type | Uncooled VOx
microbolometer | Uncooled VOx
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) |