(311 days)
Not Found
No
The device description and performance studies focus on standard infrared temperature measurement technology and do not mention any AI or ML components.
No
The device is used for measurement and monitoring of body temperature, which is a diagnostic function, not a therapeutic one. It does not treat or alleviate any condition.
No.
The device is an infrared thermometer for measuring and monitoring human body temperature, not for diagnosing a medical condition. While doctors can use it, its function is measurement, not diagnosis.
No
The device description explicitly lists hardware components such as infrared temperature sensors, signal receiving processor, buttons, buzzer, LCD display, and battery. It also mentions focusing infrared energy with a Fresnel lens. The performance studies include electrical safety, EMC, and bench testing, which are relevant to hardware.
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.
- Device Function: The infrared thermometer described measures body temperature by receiving infrared energy radiation from the surface of the forehead or ear. This is a direct measurement of a physical property of the body, not an analysis of a biological sample taken from the body.
- Intended Use: The intended use is for "measurement and monitoring of human body temperature," which aligns with a non-IVD medical device.
The information provided clearly indicates that the device is an infrared thermometer used for external body temperature measurement, not for testing biological samples.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
FLL
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Forehead and ear
Indicated Patient Age Range
Not Found
Intended User / Care Setting
doctors or customers in the hospital or at home.
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)
Performance data includes "Non-Clinical Data" and "Clinical Data".
Non-Clinical Data:
- Biocompatibility testing: Conducted in accordance with ISO 10993-1. Testing included Cytotoxicity, Skin Sensitization and Irritation.
- Electrical safety and electromagnetic compatibility (EMC): 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: Complies with IEC 60601-1-11: 2010 and ISO 80601-2-56: 2009.
- Software Verification and Validation Testing: Conducted as recommended by FDA's Guidance for Industry and FDA Staff. "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." Software considered "Moderate" level of concern.
Clinical data: - Clinical testing 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, the subject devices were found to have a performance that is substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy for body temperature measurement: Body Mode: ±0.2°C(0.4°F)
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".
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
1
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
Image /page/1/Picture/5 description: This image shows a formal letter. The letter is signed by Alan M. Stevens and Tina Kiang, Ph.D., Acting Director of the Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices, Office of Device Evaluation, Center for Devices and Radiological Health. There is also a digital signature from Alan M. Stevens with the date 2018.03.02 07:49:17-05'00'.
Enclosure
2
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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3
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
4
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.
5
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 Device
K113761 | Comparison
Result |
|-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| Manufacture | Shenzhen Brav Electronic
Technologies 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 is
intended for the
measurement and
monitoring of human body
temperature by doctors or
customers in the hospital or
at home. | Famidoc Infrared
Thermometers are intended
for intermittent measurement
and monitoring of human
body temperature by
consumers in the home. | Different1 |
| Measuring
position | Forehead and ear | Forehead and ear | Same |
| Measuring
distance | 0cm, Contact | 0cm, Contact | Same |
| Measuring mode | Forehead temperature
mode and ear temperature
mode | Forehead temperature mode,
and ear temperature mode | Same |
| Detection method | Temperature is detected by
thermistor and calculated. | Temperature is detected by
thermistor and calculated. | Same |
| Material contact to
patient | ABS and PE lens filters | ABS | Different2 |
| Design principle | Based on Infrared Sensor
technology | Based on Infrared Sensor
technology | Same |
| Measurement
Range | 32.0°C42.9°C109.2°F) | 32.0°C
(89.6°F42.9°C109.2°F) | Same |
(89.6°F
| Accuracy for body
temperature
measurement | 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 of
Display | 0.1°C/°F | 0.1°C/°F | Same |
| Operating
Environment | 15°C ~ 35°C ( 59°F to
95 °F) ≤85% moisture
condensation | 10° C ~ 40 ° C (60.8°F to
95 °F) , RH 80% or below | Different4 |
| Storage
Environment | -20°C55°C (-4°F131°F)
≤90% moisture
condensation | - 25 ° ~ 55 ° C (-13° F to
131° F) RH 80% or below | Different5 |
| Power supply | 3Vdc battery | 3Vdc battery | Same |
| Applicable
standards | AAMI ANSI ES60601-1,
IEC 60601-1-2, IEC
60601-1-11, and ASTM
E1965-98 | ASTM E1965-98, IEC
60601-1 and IEC 60601-1-2 | Different6 |
| Biocompatibility
information | ISO 10993-5, ISO
10993-10 | ISO 10993-5, ISO 10993-10 | Same |
| Memory Data
Limit | memorize 20
measurements
automatically | memorize 19 measurements
automatically | Different7 |
| Product
configuration | It is mainly composed with
infrared sensor, signal
receiving processor,
buttons, buzzer, LCD
display, battery and etc. | It is mainly composed with
infrared sensor, signal
receiving processor, buttons,
buzzer, LCD display, battery
and etc. | Same |
| Temperature unit
and conversion | Dual temperature units "°C"
and "°F" optional, and the
two units can convert by the
conversion key
automatically | Dual temperature units "°C"
and "°F" optional and the two
units can convert by the
conversion key automatically | Same |
7
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
8
-
- 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).