(311 days)
The infrared thermometer is intended for the measurement and monitoring of human body temperature by doctors or customers in the hospital or at home.
EFT-16 series (Model: EFT-161, EFT-162, EFT-164, EFT-165, EFT-166) measure the body temperature through receiving the infrared energy radiation from the surface of objects. It is with forehead temperature mode, and ear temperature mode, directly show on the LCD screen. The device is widely used for home healthcare, medical institutes and many other occasions. The product is mainly composed with infrared temperature sensors, signal receiving processor, buttons, buzzer, LCD display, battery, etc. It focuses the infrared from the human's forehead or ear by the Fresnel lens.
The provided documentation describes the acceptance criteria and the study conducted for the Shenzhen Brav Electronic Technologies Co., Ltd. Infrared Thermometer models EFT-162, EFT-163, EFT-164, EFT-165, EFT-166.
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (from predicate/standards) | Reported Device Performance (EFT-16 series) |
|---|---|---|
| Accuracy (Body Temperature) | Predicate: ±0.2°C / 0.4°F @ 35.5-42.0°C (95.9-107.6°F); ±0.3°C / 0.5°F @ 32.0-35.4°C (89.6-95.7°F) & 42.1-42.9°C (107.8-109.2°F) | Proposed Device: ±0.2°C (0.4°F) for the whole measurement range (32.0°C-42.9°C) |
| Measurement Range | 32.0°C ~ 42.9°C (89.6°F ~ 109.2°F) | 32.0°C ~ 42.9°C (89.6°F ~ 109.2°F) |
| Resolution of Display | 0.1°C/°F | 0.1°C/°F |
| Operating Environment | 10°C ~ 40°C (60.8°F to 95°F), RH 80% or below | 15°C ~ 35°C (59°F to 95°F) ≤85% moisture condensation |
| Storage Environment | -25°C ~ 55°C (-13°F to 131°F), RH 80% or below | -20°C ~ 55°C (-4°F ~ 131°F) ≤90% moisture condensation |
| Biocompatibility | Compliance with ISO 10993-5 and ISO 10993-10 | Proposed Device: Tested per ISO 10993-5 and ISO 10993-10, demonstrating biocompatibility (for ABS and PE patient-contacting materials). Necessary testing included Cytotoxicity, Skin Sensitization and Irritation. |
| Electrical Safety & EMC | Compliance with ANSI/AAMI ES60601-1 and IEC 60601-1-2 | Proposed Device: Complies with ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012, and IEC 60601-1-2: 2014. |
| Bench Testing | Compliance with IEC 60601-1-11 and ISO 80601-2-56 | Proposed Device: Complies with IEC 60601-1-11: 2010 and ISO 80601-2-56: 2009. |
| Software V&V | Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (FDA) | Proposed Device: Software verification and validation testing conducted, documentation provided. Software considered a "Moderate" level of concern. |
| Clinical Performance | Compliance with ASTM E 1965-98 Standard Specification For Infrared Thermometers For Intermittent Determination Of Patient Temperature | Proposed Device: Clinical testing conducted per ASTM E 1965-98. "Results show PASS for all test." |
Note on Accuracy: The proposed device actually reports a tighter accuracy range (±0.2°C across the entire measurement range) compared to the predicate device which had a wider tolerance (±0.3°C) at the extreme ends of its measurement range. This is presented as meeting the requirements of international standards ISO 80601-2-56:2019 and ASTM E 1965-98.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not explicitly state the sample size used for the clinical test set. It only mentions "Clinical testing is conducted per ASTM E 1965-98". ASTM E 1965-98 specifies requirements for clinical accuracy but does not dictate a fixed sample size. Typically, clinical studies for thermometers involve a certain number of subjects to demonstrate accuracy against a reference.
- Data Provenance: Not explicitly stated. The manufacturer is based in Shenzhen, China. The document does not specify if the clinical testing was conducted in China or another country, nor if it was retrospective or prospective. Given the device's intended use in both hospital and home settings, it would likely be prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- The document does not mention the number of experts or their qualifications for establishing ground truth in the clinical testing. For a thermometer, ground truth is typically established by comparative measurements against a highly accurate reference thermometer (e.g., a laboratory standard thermometer or a rectal/oral mercury thermometer in a clinical setting) using established protocols, not expert consensus in the same way an imaging AI algorithm might be evaluated.
4. Adjudication Method for the Test Set
- The document does not mention any adjudication method for the clinical test set. Given the nature of a thermometer's performance evaluation (direct measurement comparison), an adjudication method in the context of multiple human readers/reviewers is generally not applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging algorithms where human readers interpret images with and without AI assistance. This is not relevant for a clinical electronic thermometer.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Yes, the performance evaluation for the Infrared Thermometer is inherently a standalone performance evaluation. The device itself performs the temperature measurement and displays the result. There is no "human-in-the-loop" component for its core function of temperature determination that would require a separate study to evaluate. The "clinical data" section describes testing the device's accuracy in measuring patient temperature.
7. Type of Ground Truth Used
- The ground truth for the clinical accuracy evaluation would be established by comparison against a reference standard in a clinical setting. ASTM E 1965-98 typically requires comparison of the device's readings with core body temperature measurements obtained using a validated, highly accurate reference thermometer (e.g., a standard mercury-in-glass thermometer or a highly accurate electronic reference thermometer) in a controlled environment, often involving simultaneous measurements. The document states "Clinical testing is conducted per ASTM E 1965-98 Standard Specification For Infrared Thermometers For Intermittent Determination Of Patient Temperature," which implies this method of ground truth establishment.
8. Sample Size for the Training Set
- The document does not provide information on a training set sample size. Infrared thermometers are typically calibrated and validated through engineering and clinical performance testing, not through machine learning model training in the same way an AI algorithm would be. While there might be firmware or algorithms for signal processing, the document does not describe a machine learning-based approach requiring a "training set" in the conventional sense.
9. How the Ground Truth for the Training Set Was Established
- As there is no mention of a "training set" in the AI/machine learning sense, there is no information on how ground truth for such a set was established. Device calibration and internal processing logic are developed based on physics principles, sensor specifications, and empirical validation against known temperature references.
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March 2, 2018
Shenzhen Brav Electronic Technologies Co., Ltd. Wenhui Cha QA Manager 4/F, Block 11, Tongfuyu Industrial District Lezhujiao, Huangmabu Community, Xixiang, Baoan Shenzhen, Guandong, 518102 China
Re: K171214
Trade/Device Name: Infrared Thermometer, Models EFT-162, EFT-163, EFT-164, EFT-165, EFT-166 Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: January 24, 2018 Received: January 31, 2018
Dear Wenhui Cha:
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. 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
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801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
for
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Enclosure
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Indications for Use
510(k) Number (if known) K171214
Device Name
Infrared thermometer, models EFT-161, EFT-162, EFT-164, EFT-165, EFT-166
Indications for Use (Describe)
The infrared thermometer is intended for the measurement and monitoring of human body temperature by doctors or customers in the hospital or at home.
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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K171214
510(k) Summary
1. Submitter:
Submitter (Owner) and Contact Information
| Company / Institution Name | |||
|---|---|---|---|
| Shenzhen Brav Electronic Technologies Co., Ltd. | |||
| Phone Number (including area code) | FAX Number (including area code) | ||
| +86 0755 29781489 | +86 0755 29569480 | ||
| Street Address | |||
| 4/F, Block 11, Tongfuyu Industrial District, Lezhujiao, Huangmabu Community, Xixiang, Baoan | |||
| City | State / Province | ZIP/Postal Code | Country |
| Shenzhen | Guangdong | 518102 | China |
| Contact Name | |||
| Wenhui Cha | |||
| Contact Title | Contact E-mail Address | ||
| QA Manager | 1281130583@qq.com |
Date Prepared: 2018-01-24
This summary of 510(k) information is being submitted in accordance with the requirements of 21 CFR §807.92.
2. Device Information:
Type of 510(k) submission: Traditional Trade Name: Infrared Thermometer, Models EFT-161, EFT-162, EFT-163, EFT-164, EFT-165, EFT-166. Classification name: thermometer, electronic, clinical Review Panel: General Hospital Product Code: FLL Device Class: II Regulation Number: 880.2910
3. Predicate device:
Sponsor: Famidoc Technology Co., Ltd. Device: Famidoc Infrared Thermometer Model: FDIR-V2, FDIR-V4, FDIR-V5, FDIR-V6, FDIR-V7, FDIR-V9, FDIR-V9-3, FDIR-V10, FDIR-V15 510(K) Number: K113761
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4. Indications for Use
The infrared thermometer is intended for the measurement and monitoring of human body temperature by doctors or customers in the hospital or at home.
5. Basic principle
Any object in which temperature is higher than absolute zero degree will transmit some infrared radiation energy according to its own temperature. The radiation energy and its distribution per wavelength are closely associated with its surface temperature. Based on the principle, it is possible to measure the forehead or ear temperature and then adjust the offset between forehead or ear temperature and actual body temperature, which will result in the correct display of body temperature.
6. Device Description
EFT-16 series (Model: EFT-161, EFT-162, EFT-164, EFT-165, EFT-166) measure the body temperature through receiving the infrared energy radiation from the surface of objects. It is with forehead temperature mode, and ear temperature mode, directly show on the LCD screen.
- . The device is widely used for home healthcare, medical institutes and many other occasions.
- . The product is mainly composed with infrared temperature sensors, signal receiving processor, buttons, buzzer, LCD display, battery, etc.
- It focuses the infrared from the human's forehead or ear by the Fresnel lens.
7. Performance Data
Performance data includes "Non-Clinical Data" and "Clinical Data", brief description of which are shown as below.
Non-Clinical Data:
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing
The biocompatibility evaluation for the EFT-16 series Infrared thermometer were conducted in accordance with the International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. Since the worst case of the whole system is considered tissue contacting for duration of less than 24 hours. And the necessary testing necessary for this contacting category material include Cytotoxicity, Skin Sensitization and Irritation per the Annex A Biological evaluation tests of ISO 10993-1, which have been conducted on the EFT-16 series Infrared thermometer device.
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Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the EFT-16 series Infrared thermometer device, consisting of all the modules and accessories in the system. The system complies with the ANSI/AAMI ES60601-1:2005/(R)2012and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 Medical electrical equipment Part 1: General requirements for basic safety and essential performance for safety and the IEC 60601-1-2: 2014 Medical electrical equipment –Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests standard for EMC.
Bench Testing
Bench testing was conducted on the EFT-16 series Infrared thermometer device, consisting of all the accessories in the system. The system complies with the IEC 60601-1-11: 2010 MEDICAL ELECTRICAL EQUIPMENT –Part 1-11: General requirements for basic safety and essential performance –Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment, ISO 80601-2-56: 2009 Medical electrical equipment — Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement standards for performance effectiveness.
Software Verification and Validation Testing
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff. "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "Moderate" level of concern, since a failure or latent flaw in the software could directly result in serious injury or death to the patient or operator.
Clinical data:
Clinical testing is conducted per ASTM E 1965-98 Standard Specification For Infrared Thermometers For Intermittent Determination Of Patient Temperature.
Summary
Based on the non-clinical and clinical performance as documented in the device development, the subject devices were found to have a performance that is substantially equivalent to the predicate device.
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8. Comparison to predicate device
| ITEM | Proposed Device | Predicate DeviceK113761 | ComparisonResult |
|---|---|---|---|
| Manufacture | Shenzhen Brav ElectronicTechnologies Co., Ltd. | Famidoc Technology Co.,Ltd. | --- |
| Model | EFT-161, EFT-162,EFT-163, EFT-164,EFT-165, EFT-166 | FDIR-V2, FDIR-V4,FIDIR-V5, FDIR-V6,FDIR-V7,FIDIR-V9,FDIR-V9-3, FDIR-V10,FDIR-V15 | --- |
| Indications for Use | The infrared thermometer isintended for themeasurement andmonitoring of human bodytemperature by doctors orcustomers in the hospital orat home. | Famidoc InfraredThermometers are intendedfor intermittent measurementand monitoring of humanbody temperature byconsumers in the home. | Different1 |
| Measuringposition | Forehead and ear | Forehead and ear | Same |
| Measuringdistance | 0cm, Contact | 0cm, Contact | Same |
| Measuring mode | Forehead temperaturemode and ear temperaturemode | Forehead temperature mode,and ear temperature mode | Same |
| Detection method | Temperature is detected bythermistor and calculated. | Temperature is detected bythermistor and calculated. | Same |
| Material contact topatient | ABS and PE lens filters | ABS | Different2 |
| Design principle | Based on Infrared Sensortechnology | Based on Infrared Sensortechnology | Same |
| MeasurementRange | 32.0°C | 32.0°C | Same |
| Accuracy for bodytemperaturemeasurement | Body Mode: ±0.2°C(0.4°F) | ±0.2°C / 0.4°F @35.5-42.0°C(95.9-107.6°F )±0.3°C / 0.5°F@ 32.0-35.4°C(89.6-95.7°F )+0.3°C / 0.5°F | Different3 |
| @ | |||
| 42.1-42.9°C(107.8-109.2°F) | |||
| Resolution ofDisplay | 0.1°C/°F | 0.1°C/°F | Same |
| OperatingEnvironment | 15°C ~ 35°C ( 59°F to95 °F) ≤85% moisturecondensation | 10° C ~ 40 ° C (60.8°F to95 °F) , RH 80% or below | Different4 |
| StorageEnvironment | -20°C | - 25 ° ~ 55 ° C (-13° F to131° F) RH 80% or below | Different5 |
| Power supply | 3Vdc battery | 3Vdc battery | Same |
| Applicablestandards | AAMI ANSI ES60601-1,IEC 60601-1-2, IEC60601-1-11, and ASTME1965-98 | ASTM E1965-98, IEC60601-1 and IEC 60601-1-2 | Different6 |
| Biocompatibilityinformation | ISO 10993-5, ISO10993-10 | ISO 10993-5, ISO 10993-10 | Same |
| Memory DataLimit | memorize 20measurementsautomatically | memorize 19 measurementsautomatically | Different7 |
| Productconfiguration | It is mainly composed withinfrared sensor, signalreceiving processor,buttons, buzzer, LCDdisplay, battery and etc. | It is mainly composed withinfrared sensor, signalreceiving processor, buttons,buzzer, LCD display, batteryand etc. | Same |
| Temperature unitand conversion | Dual temperature units "°C"and "°F" optional, and thetwo units can convert by theconversion keyautomatically | Dual temperature units "°C"and "°F" optional and the twounits can convert by theconversion key automatically | Same |
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Justification for the differences:
-
- Different Indications for Use
As indicated in the comparison table, the subject device can be used both in hospital and home, which the predicate can be used at home only. But the scenario where the device is intended to use require the same performance and clinical requirement considering the usage of such general public device. Moreover, the EFT-16 series Infrared thermometer has been verified and the results show PASS for all test, so the different extra hospital scenario will not introduce any new questions of safety and effectiveness.
- Different Indications for Use
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-
- Different patient-contacting
The patient-contacting materials of the subject include ABS and PE, and both materials show biocompatible after tested per the international standards ISO10993-5 and ISO 10993-10.
- Different patient-contacting
-
- Different accuracy
The difference accuracy is that the subject shows the accuracy is ±0.2°C(0.4°F) for the whole measurement range, while the accuracy of the predicate is the same when the temperature is 35.5-42.0°C(95.9-107.6°F ) , and minor different accuracy when lower than 35.5°C(95.9°F ) or higher than 42.0°C(107.6°F ). The critical feature meets the requirements of the international standards ISO 80601-2-56:2019 and the FDA recognized specific standard ASTM E 1965-98.
- Different accuracy
-
- Different Operating Environment
The subject can operate in a narrower environment condition range than the predicate, while can store in wider environment condition range, but both are minor. More important is that such testing has been verified during the design and development process for the environmental testing, and the results show PASS, so such different will not cause any new safety and effectiveness questions.
- Different Operating Environment
-
- Different Storage Environment
Same explanation as the justification for 4# difference.
- Different Storage Environment
-
- Different Applicable Standards
The difference is that the subject device and the predicate refer to different standard, the former uses the US standard AAMI ANSI ES60601-1, while the predicate uses the international standard IEC60601-1.
- Different Applicable Standards
-
- Different Memory Data Limit
The subject can store one more data than the predicate, which is verified during all the testing, and the function shows stable.
- Different Memory Data Limit
As seen in the comparison tables, the subject and predicate devices have similar design features and performance specifications. The main technological differences between the subject and predicate devices are minor differences, including only the appearance, control keys, and operating/storage environment which do not raise different questions of safety or effectiveness. Moreover, as demonstrated in the non-clinical testing, the different technological characteristics do not affect the performance of the EFT-16 series Infrared thermometer system.
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9 Conclusion
Based on the above considerations table, the Proposed Device, the EFT-16 series Infrared thermometer is substantially equivalent to the predicate device Famidoc Infrared thermometer (K113761).
§ 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.