(30 days)
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.
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.
Here's a breakdown of the acceptance criteria and study information for the ThermPix Thermovisual Camera, based on the provided document:
Acceptance Criteria and Device Performance Study
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Temperature Difference Accuracy: Ability to distinguish temperature differences | With 99% confidence, temperature differences of 1°C or more are discernible by a trained user. |
| Electrical Safety and EMC: Compliance with relevant standards | Passed IEC 60601-1-2 Ed 4.1, IEC 60601-1 Ed 3.2, IEC 60601-1-6 Ed 3.2. |
| Software Verification and Validation: Compliance with relevant standards | Compliant with IEC 62304 Ed 1.1 and FDA Guidance for Software in Medical Devices. |
2. Sample Size for Test Set and Data Provenance
The document mentions that for the Performance Validation Testing, image data was collected from 2 cameras.
The temperatures ranged from 20°C to 40°C in increments of 2°C.
The provenance of this data (e.g., country of origin, retrospective/prospective) is not explicitly stated in the provided text.
3. Number of Experts and Qualifications for Ground Truth Establishment
The document states: "Results indicate that with 99% confidence temperature differences in 1 °C or more are discernible by a trained user."
The number of such "trained users" and their specific qualifications (e.g., radiologist with X years of experience) are not specified.
4. Adjudication Method for the Test Set
The document does not mention any adjudication method used for the test set.
5. Multi-Reader, Multi-Case (MRMC) Comparative Effectiveness Study
A multi-reader, multi-case (MRMC) comparative effectiveness study was not conducted or reported in this document. The study focuses on the device's ability to discern temperature differences by a "trained user" rather than comparing human reader performance with and without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance
The device is described as a "Thermovisual Camera" intended to "view, measure, and record heat patterns." The performance validation assesses its ability to allow users to distinguish temperature differences. This indicates a device-only performance test, where the device itself is producing the thermal images, and a human user then interprets them. The study focuses on how well the device enables a trained user, implying a standalone performance in terms of image quality and accuracy for interpretation. However, there isn't a direct "algorithm-only" performance metric separate from human observation.
7. Type of Ground Truth Used
The ground truth for the "Temperature Difference Accuracy" appears to be based on known temperature differences created using a "traceable certified reference black body calibrator and thermocouples." This represents a highly controlled and objective physical measurement.
8. Sample Size for the Training Set
The document does not provide information about a specific training set or its sample size. The performance validation describes testing the device's ability to allow users to distinguish temperature differences, not the training of an AI algorithm from a specific dataset.
9. How the Ground Truth for the Training Set Was Established
Since there is no mention of a training set for an AI algorithm, there is no information on how its ground truth was established. The focus of the provided document is on the device's physical and functional performance, rather than an AI/ML component that requires a training set.
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September 14, 2023
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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 (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
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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
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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 onSubstantialEquivalence | |
|---|---|---|---|
| ThermPix ThermovisualCamera | ThermPix ThermovisualCamera | ||
| Indications for Use | The ThermPixThermovisual Camera isintended to view, measure,and record heat patternsand variations. It isintended for use asadjunctive diagnosticimaging for thermallysignificant indicationsstemming from heatemitted from the humanbody. The significance ofthese thermal patterns andvariations is determined byprofessional investigation.This device is intended foruse by qualified technicalpersonnel. Clinicaljudgement and experienceare required to review andinterpret the informationtransmitted.The ThermPixThermovisual Camerais only for use in additionto other diagnostic medicaldevices. It does not provideany absolute measurementof temperature and shouldnot be used for solescreening or diagnosis forany disease or condition. | The ThermPixThermovisual Camera isintended to view, measure,and record heat patterns andvariations. It is intended foruse as adjunctive diagnosticimaging for thermallysignificant indicationsstemming from heatemitted from the humanbody. The significance ofthese thermal patterns andvariations is determined byprofessional investigation.This device is intended foruse by qualified technicalpersonnel. Clinicaljudgement and experienceare required to review andinterpret the informationtransmitted.The ThermPixThermovisual Camerais only for use in addition toother diagnostic medicaldevices. It does not provideany absolute measurementof temperature and shouldnot be used for solescreening or diagnosis forany disease or condition. | Identical |
| The system is not intendedto be used as athermometry device. | The system is not intendedto be used as a thermometrydevice. | ||
| 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 ScreenDriver Computing PCB Lithium Polymer Battery Anti-Bacterial Case | Commercial Off theShelf Tablet (WIFIOnly). Testing to beperformed onSamsung Galaxy S6Lite WIFI Only(Model SM-P610NZAAXAR) SEEK Infraredcamera Molded Tablet case USB C Hub Pen Stylus | The devicecomponents arethe key differencesbetween devicegenerations.The changes todesign do notimpact thedevice'sperformancecapabilities or theuser's interactionswith the device. |
| Imaging | |||
| Detector Type | Uncooled VOxmicrobolometer | Uncooled VOxmicrobolometer | Identical |
| Pixel Pitch | 12 μm | 12 μm | Identical |
| Spectral Range | Longwave infrared; 7.8 µmto 14 μm | Longwave infrared; 7.8 µmto 14 μm | Identical |
| Frame Rate | 9 Hz and 27 Hz | 9 Hz | SubstantiallyEquivalent |
| Thermal Sensitivity | 65 mK (typical) | 65 mK (typical) | Identical |
| Accuracy | +/- 1°C (for temperaturedifference) | +/- 1°C (for temperaturedifference) | Identical |
| Optics | |||
| Array Format | 320 x 240 with 56° (H) and42° (V) field of view | 320 x 240 with 56° (H) and42° (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 (5Vused) | 5VDC | Results in nopracticalperformancedifference |
| Environmental | |||
| OperatingTemperature Range | -10°C to +60°C (15°C to24°C recommended forbest results) | -10°C to +60°C (15°C to24°C recommended for bestresults) | Identical |
| Non-OperatingTemperature Range | -40°C to 60°C | --40°C to 60°C | |
| Performance Testing | |||
| TemperatureDifference Accuracy | The ThermPixThermovisual Cameratemperature difference | The subject device wasvalidated using identicalmethods. | 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.
§ 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.