(155 days)
The TP500 Infrared Thermometer is intended to measure human body temperature by measuring from 1-3cm distance to the forehead. The device can be used on people of all ages. It is recommended that the device be operated by an adult. The device is intended to be used in the hospital and other clinical environments.
The Infrared thermometer (model TP500) is a hand-held, battery powered, electronic thermometer that converts a subject's forehead temperature, using the infrared energy emitted in the area around the subject's forehead to an oral equivalent temperature when measured from 1-3cm to the center of the subject's forehead with no contact. The device can be used on people of all ages and is intended to be used in the hospital and other clinical environments.
Here's an analysis of the acceptance criteria and study that proves the device meets them, based on the provided FDA 510(k) summary for the Contec Medical Systems Co., Ltd. Infrared Thermometer (Model TP500).
This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed report of all raw study data. Therefore, some information, especially regarding the specifics of how the ground truth was established for the training set, might not be fully elaborated.
1. Table of Acceptance Criteria and Reported Device Performance
The core performance of an infrared thermometer relates to its accuracy and repeatability. The primary standard for this, as cited, is ASTM E1965-98. The acceptance criteria are implicit in meeting this standard and are explicitly stated in the "Accuracy" row of the comparison table.
| Acceptance Criterion (Standard/Requirement) | Reference | Reported Device Performance (TP500) |
|---|---|---|
| Accuracy | ASTM E1965-98 / User Manual Claim | ±0.3°C (0.5°F) |
| Clinical Bias | ASTM E1965-98 | Evaluated and met performance parameters claimed |
| Clinical Uncertainty | ASTM E1965-98 | Evaluated and met performance parameters claimed |
| Clinical Repeatability | ASTM E1965-98 | Evaluated and met performance parameters claimed |
| Electrical Safety | IEC 60601-1 | Complies |
| Electromagnetic Compatibility (EMC) | IEC 60601-1-2 | Complies |
| Performance (General) | ISO 80601-2-56 | Complies |
| Biocompatibility | ISO 10993-5:2009 & ISO 10993-10:2010 | Complies (materials tested and shown not to affect effectiveness/safety) |
| Software Verification & Validation | FDA Guidance (May 11, 2005) | Met requirements |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: A "controlled human clinical study" was conducted with 108 subjects. These subjects included three age groups:
- Age 0-1 (35 subjects)
- Age 1-5 (33 subjects)
- Age above 5 (40 subjects)
- The study included both febrile and afebrile persons.
- Data Provenance: Not explicitly stated, but given the manufacturer is China-based, it is highly probable the data was collected in China. The study is described as a "controlled human clinical study," implying a prospective design for gathering the clinical accuracy data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This detail is not provided in the summary. For a thermometer, the "ground truth" would typically be established by a highly accurate reference thermometer (e.g., a rectal thermometer or an oral thermometer operated by a trained healthcare professional, depending on the body site), rather than "experts" in the sense of multiple radiologists reviewing images. The summary states that "clinical bias, clinical uncertainty and clinical repeatability have been evaluated per clinical validation for infrared thermometer." This implies a comparison to a gold standard measurement, but the specifics of how many personnel were involved in taking these gold standard measurements or their specific qualifications are not detailed.
4. Adjudication Method for the Test Set
Adjudication methods (like 2+1, 3+1) are typically used for subjective assessments, such as image interpretation, to resolve discrepancies among experts. For objective measurements like temperature, an adjudication method is generally not applicable. Instead, the ground truth is established by a primary, highly accurate measurement method. The summary does not mention any adjudication process.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. MRMC studies are typically for medical imaging systems where human readers interpret images with and without AI assistance. This device is an infrared thermometer, not an imaging system designed for human interpretation with AI assistance. The study conducted was a clinical accuracy study comparing the device to a gold standard measurement, and implicitly, to the predicate device's performance per the equivalence claim.
6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done
The device itself is a standalone thermometer. Its "performance" is inherently "algorithm only" in the sense that it provides a temperature reading directly. The clinical study evaluated the direct performance of the device's sensor and internal processing (algorithm) against a gold standard. So, yes, a standalone performance evaluation of the device's measurement capabilities was performed.
7. The Type of Ground Truth Used
The type of ground truth used was comparative measurements against a reference standard. The clinical study states that "clinical bias, clinical uncertainty and clinical repeatability have been evaluated per clinical validation for infrared thermometer." This means the device's readings were compared against highly accurate, established methods of temperature measurement to determine its accuracy and precision. While not explicitly stated as "rectal temperature" or "oral temperature," for a clinical thermometer, these are the typical gold standards depending on the population and clinical context. The study was conducted in accordance with ASTM E1965-98, which outlines the methodology for such clinical validations including the use of reference thermometers.
8. The Sample Size for the Training Set
Not applicable/Not explicitly stated for an AI training set. This device is a traditional medical device (infrared thermometer), not an AI/ML-based device that learns from a large training dataset in the same way, for example, a diagnostic imaging AI would. Its "algorithm" is based on physics (infrared radiation) and calibrated against known standards, not trained on patient data in an iterative machine learning process. Therefore, there is no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As explained in point 8, this is not an AI/ML device that requires a training set and associated ground truth in that context. The device's internal calibration and performance are established through engineering design, component selection, and adherence to performance standards like ISO 80601-2-56 and ASTM E1965-98, which involve physical calibrations, not data-driven machine learning training.
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December 18, 2020
Contec Medical Systems Co., Ltd. % Ray Wang General Manager Beijing Believe-Med Technology Service Co., Ltd. Rm.912. Building #15. XiYueHui. No.5. YiHe North Rd., FangShan District, BeiJing 102401 China
Re: K201980
Trade/Device Name: Infrared Thermometer Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: November 16, 2020 Received: November 19, 2020
Dear Ray Wang:
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/cfpmr/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,
Alan M.
Stevens -
S3
CAPT Alan M. Stevens Acting Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices 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) K201980
Device Name Infrared Thermometer
Indications for Use (Describe)
The TP500 Infrared Thermometer is intended to measure by measuring from 1-3cm distance to the forehead. The device can be used on people of all ages. It is recommended that the device be operated by an adult. The device is intended to be used in the hospital and other clinical environments.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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Tab #4 510(k) Summary
This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.
The assigned 510(k) Number: K201980
-
- Date of Preparation: 12/18/2020
-
- Sponsor Identification
Contec Medical Systems Co., Ltd.
No.112 Qinhuang West Street, Economic & Technical Development Zone, Qinhuangdao, Hebei Province, 066004,China
Establishment Registration Number: 3006979678 Contact Person: Xueyong Li Position: Quality Manager Tel: +86-355-8015490 Fax: +86-355-8015490 Email: lxy1011@163.com
-
- Designated Submission Correspondent
Ray Wang General Manager
- Designated Submission Correspondent
Beijing Believe-Med Technology Service Co., Ltd. Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District, BeiJing, China 102401
Tel: +86-18910677558 Fax: +86-10-56335780 Email: ray.wang@believe-med.com
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4. Identification of Proposed Device
Trade Name: Infrared Thermometer Common Name: Infrared Thermometer Model(s): TP500
Regulatory Information
Classification Name: Clinical electronic thermometer Classification:II Product Code:FFLL Regulation Number: CFR 880.2910 Review Panel:General Hospital;
Indication for Use Statement:
The TP500 Infrared Thermometer is intended to measure human body temperature by measuring from 1-3cm distance to the forehead. The device can be used on people of all ages. It is recommended that the device be operated by an adult. The device is intended to be used in the hospital and other clinical environments.
Device Description
The Infrared thermometer (model TP500) is a hand-held, battery powered, electronic thermometer that converts a subject's forehead temperature, using the infrared energy emitted in the area around the subject's forehead to an oral equivalent temperature when measured from 1-3cm to the center of the subject's forehead with no contact. The device can be used on people of all ages and is intended to be used in the hospital and other clinical environments.
The Infrared thermometer has the following features
- Non-Contact Design. (1)
- (2) One-button operation.
- (3) Quick to get data for just 1 second.
- (4) Memory function; Memory recall of 30 reading.
- (5) Switching between mute and un-mute.
- (6) Switching between Fahrenheit and Celsius.
(7) Power management: automatic shutdown, low power consumption control; power display; low power reminder
- Automatically power-off, if left idle for 5 seconds. (8)
- Prompt for 37.6℃ (99. 6 °F) high temperature. (9)
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న. Identification of Predicate Device(s)
Primary Predicate Device 510(k) Number: K182597 Product Name: Infrared thermometer Model Name: PG-IRT1602 Manufacturer: Shenzhen Pango Electronic Co., Ltd -
Non-Clinical Test Conclusion 6.
The test results demonstrated that the proposed device complies with the following standards: -
ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, Medical electrical equipment Part 1: General a. requirements for basic safety and essential performance (IEC 60601-1:2005, MOD)
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IEC 60601-1-2 Edition 4.0 2014-02, Medical Electrical Equipment Part 1-2: General b. Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements and Tests.
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ISO 80601-2-56 Second edition 2017-03 Medical electrical equipment Part 2-56: Particular C. requirements for basic safety and essential performance of clinical thermometers for body temperature measurement. [Including: Amendment 1 (2018)].
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ASTM E1965-98 (Reapproved 2016) Standard Specification for Infrared Thermometers for d. Intermittent Determination of Patient Temperature
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ISO 10993-5:2009 Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity e.
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ISO 10993-10:2010 Biological evaluation of medical devices -- Part 10: Tests for irritation and f. skin sensitization
The software verification and validation were conducted in accordance with the "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," dated May 11, 2005. The test results demonstrated the software function met the requirements.
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- Clinical Test Conclusion
Controlled human clinical studies were conducted on proposed device with predicates in accordance with ASTM E1965-98, clinical bias, clinical uncertainty and clinical repeatability have been evaluated per clinical validation for infrared thermometer. The clinical trial results verify that the clinical accuracy of the proposed device is not inferior to that of predicate device.
- Clinical Test Conclusion
Total 108 subjects and three age groups, including age 01 (35 subjects), age 15 (33 subjects) and age above 5 (40 subjects) are included in each clinical study, including febrile and afebrile persons.
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The statistical results of clinical bias and clinical repeatability of two comparison groups were assessed and the results of the proposed device meet the performance parameters claimed in user manual, and the proposed device complies with ASTM E1965-98.
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8. Substantially Equivalent (SE) Comparison
Table 1 Comparison of Technology Characteristics
| Item | Proposed Device(s) K201980 | Predicate Device(s) K182597 | Remark |
|---|---|---|---|
| Device name | TP500 Infrared Thermometer | PG-IRT1602 Infra-red Ear Thermometer | SE |
| Classification Name | Clinical electronic thermometer | Clinical electronic thermometer | SE |
| Product Code | FLL | FLL | SE |
| Regulation Number | CFR 880.2910 | CFR 880.2910 | SE |
| ComparisonStatement | The proposed device has same classification information as the predicate device. | ||
| Indications for Use | The TP500 Infrared Thermometer is intended to measurehuman body temperature by measuring from 1-3cm distance tothe forehead. The device can be used on people of all ages. It isrecommended that the device be operated by an adult. Thedevice is intended to be used in the hospital and other clinicalenvironments. | PG-IRT1602 Infrared Forehead Thermometer is intendedto measure human body temperature by measuringforehead.The device can be used on people of all ages. | Analysis 1 |
| Principle ofOperation | Non-contacting,Infrared Temperature Measurement | Non-contacting,Infrared Temperature Measurement | SE |
| ComparisonStatement | The proposed device has a similar indication for Use and the same Principle of Operation as the predicate device. | ||
| Main Unit Technical Specifications | |||
| Measurement Range | 32°C | 34.0°C-43.0°C | Analysis 2 |
| Accuracy | ±0.3°C (0.5°F) | ±0.2°C at 35.0 °C-42.0°C | Analysis 2 |
| Others ±0.3°C | |||
| Measurement | 1-3cm | 3~5cm | Analysis 2 |
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| distance | |||
|---|---|---|---|
| Activation | Scan button | Scan button | SE |
| Power | Two pieces of 1.5V | Two pieces of 1.5V | SE |
| requirements | AAA (number seven) batteries | AAA (number seven) batteries | SE |
| MeasurementSite | Forehead | Forehead | SE |
| Measuringinterval | About 1 s | About 2 s | Analysis 2 |
| Scale selection | °C/°F | °C/°F | SE |
| Display screen | LCD | LCD | SE |
| Display Resolution | 0.1°C/0.2°F | Not Available | Analysis 3 |
| Measurement Mode | Adjusted | Adjusted | SE |
| Reference Body Site | Oral | Not Available | Analysis 3 |
| OperationalEnvironmentalconditions | 16°C | Not Available | Analysis 3 |
| Storage Environmentalconditions | -20°C | Not Available | Analysis 3 |
| Intended UseEnvironment | Professional Healthcare Environment | Not Available | Analysis 4 |
| Temperature rangesused for theidentification of “BodyTemp Lo” and “BodyTemp Hi” | When the temperature measured is less than or equal to32.0°C (89.6°F), displays “Body Temp Lo”;When the temperature measured is greater than or equal to37.6°C (99.6 °F) and less than 38.4°C, it displays “BodyTemp Hi” and the screen backlight is yellow;When the temperature measured is greater than 38.4°C(101.1°F), it displays “Body Temp Hi” and the screenbacklight is red. | Not Available | Analysis 5 |
| Memory | Save last measured 30 sets memories | 9 sets | Analysis 2 |
| Fever Prompt | Yes | Yes | SE |
| Back light | Yes | Yes | SE |
| Auto power-off | 5 seconds after no operation | Auto shut off: 30 seconds without operation | Analysis 2 |
| Sterile | No | No | SE |
| Single Use | No | No | SE |
| Materials | PC, white ABS, gray ABS | Not Available | Analysis 6 |
| ComparisonStatement: | The proposed device has the similar main unit specifications with the predicate device and for those characteristics not available, thesubject device meets applicable standards. | ||
| Biocompatibility | ISO10993-5&ISO10993-10 | ISO10993-5&ISO10993-10 | SE |
| Electrical Safety | IEC60601-1 | IEC60601-1 | SE |
| EMC | IEC60601-1-2 | IEC60601-1-2 | SE |
| Performance | ISO 80601-2-56 | ISO 80601-2-56 | SE |
| ASTM E1965-98 | ASTM E1965-98 | ||
| ComparisonStatement | The proposed probe has same applied Standards with the predicate device. |
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510(k) Summary
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- Substantially Equivalent (SE) Conclusion
The subject device has same classification information, similar indication for use, similar product design, similar specification, similar applied Standards as predicate device. The differences are included as followings:
Analysis 1: The proposed device and predicate device are similar in the Indication for Use, with the proposed device being more specific in its indications. The differences do not raise new questions of safety or effectiveness and are evaluated through the testing.
Analysis 2 : The Measurement Range, Accuracy, Measurement distance, Measuring interval, Memory, and Auto power-off are similar with the predicate device, both of them meet the requirement of safety and essential performance ISO 80601-2-56. The differences between the predicate device and subject device will not affect the effectiveness and safety of the subject device.
Analysis 3: The Display Resolution, Reference Body Site, Operational and Storage Environmental Conditions, cannot be compared to with the predicate device since these characteristics of the predicate device are not available; however, the subject device meets the requirement of safety and essential performance ISO 80601-2-56. These characteristics will not affect the effectiveness and safety of the subject device.
Analysis 4: The Intended Use environment is similar to the predicate but limited to only the Professional Healthcare Environment. This limitation in Intended Use Environment will not affectiveness and safety of the subject device since the subject device passes IEC60601-1-2 related to its specific usage environment.
Analysis 5: The Temperature ranges used for the identification of "Body Temp Lo" and "Body Temp Hi", are not available for the predicate device and cannot be compared with the subject; however, the subject device passes the software validation and the ranges presented will not affectiveness and safety of the subject device.
Analysis 6: The materials used cannot be compared to the predicate device since these are not available; however, the materials of the subject device pass the necessary biocompatibility testing per ISO10993-5 and ISO10993-10 and the materials are shown to not affect the effectiveness and safety of the subject device.
Conclusion: Based on the safety and performance testing and compliance with acceptable voluntary standards, we believe that the Infrared Thermometer (Model TP500) is Substantially Equivalent (SE) to the predicate device (K182597) which is a legally marketed device and does not raise any new safety and effectiveness issues.
§ 880.2910 Clinical electronic thermometer.
(a)
Identification. A clinical electronic thermometer is a device used to measure the body temperature of a patient by means of a transducer coupled with an electronic signal amplification, conditioning, and display unit. The transducer may be in a detachable probe with or without a disposable cover.(b)
Classification. Class II (performance standards). The device is exempt from the premarket notification procedures in part 807, subpart E of this chapter, subject to the limitations in § 880.9 and the following conditions for exemption:(1) Device is not a clinical thermometer with telethermographic functions;
(2) Device is not a clinical thermometer with continuous temperature measurement functions; and
(3) Appropriate analysis and testing (such as that outlined in the currently FDA-recognized editions, as appropriate, of ISO 80601-2-56, “Medical electrical equipment—Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement,” or ASTM E1965, “Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature,” or ASTM E1112, “Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature,” or ASTM E1104, “Standard Specification for Clinical Thermometer Probe Covers and Sheaths”) must validate specifications and performance of the device.