Infrared Thermometer

{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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {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. {6}------------------------------------------------ # 8. Comparison to predicate device | ITEM | Proposed Device | Predicate Device<br>K113761 | Comparison<br>Result | |-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------| | Manufacture | Shenzhen Brav Electronic<br>Technologies Co., Ltd. | Famidoc Technology Co.,<br>Ltd. | --- | | Model | EFT-161, EFT-162,<br>EFT-163, EFT-164,<br>EFT-165, EFT-166 | FDIR-V2, FDIR-V4,<br>FIDIR-V5, FDIR-V6,<br>FDIR-V7,FIDIR-V9,<br>FDIR-V9-3, FDIR-V10,<br>FDIR-V15 | --- | | Indications for Use | The infrared thermometer is<br>intended for the<br>measurement and<br>monitoring of human body<br>temperature by doctors or<br>customers in the hospital or<br>at home. | Famidoc Infrared<br>Thermometers are intended<br>for intermittent measurement<br>and monitoring of human<br>body temperature by<br>consumers in the home. | Different1 | | Measuring<br>position | Forehead and ear | Forehead and ear | Same | | Measuring<br>distance | 0cm, Contact | 0cm, Contact | Same | | Measuring mode | Forehead temperature<br>mode and ear temperature<br>mode | Forehead temperature mode,<br>and ear temperature mode | Same | | Detection method | Temperature is detected by<br>thermistor and calculated. | Temperature is detected by<br>thermistor and calculated. | Same | | Material contact to<br>patient | ABS and PE lens filters | ABS | Different2 | | Design principle | Based on Infrared Sensor<br>technology | Based on Infrared Sensor<br>technology | Same | | Measurement<br>Range | 32.0°C~42.9°C<br>(89.6°F~109.2°F) | 32.0°C~42.9°C<br>(89.6°F~109.2°F) | Same | | Accuracy for body<br>temperature<br>measurement | Body Mode: ±0.2°C(0.4°F) | ±0.2°C / 0.4°F @<br>35.5-42.0°C(95.9-107.6°F )<br>±0.3°C / 0.5°F<br>@ 32.0-35.4°C(89.6-95.7°F )<br>+0.3°C / 0.5°F | Different3 | | | | @ | | | | | 42.1-42.9°C(107.8-109.2°F) | | | Resolution of<br>Display | 0.1°C/°F | 0.1°C/°F | Same | | Operating<br>Environment | 15°C ~ 35°C ( 59°F to<br>95 °F) ≤85% moisture<br>condensation | 10° C ~ 40 ° C (60.8°F to<br>95 °F) , RH 80% or below | Different4 | | Storage<br>Environment | -20°C~55°C (-4°F~131°F)<br>≤90% moisture<br>condensation | - 25 ° ~ 55 ° C (-13° F to<br>131° F) RH 80% or below | Different5 | | Power supply | 3Vdc battery | 3Vdc battery | Same | | Applicable<br>standards | AAMI ANSI ES60601-1,<br>IEC 60601-1-2, IEC<br>60601-1-11, and ASTM<br>E1965-98 | ASTM E1965-98, IEC<br>60601-1 and IEC 60601-1-2 | Different6 | | Biocompatibility<br>information | ISO 10993-5, ISO<br>10993-10 | ISO 10993-5, ISO 10993-10 | Same | | Memory Data<br>Limit | memorize 20<br>measurements<br>automatically | memorize 19 measurements<br>automatically | Different7 | | Product<br>configuration | It is mainly composed with<br>infrared sensor, signal<br>receiving processor,<br>buttons, buzzer, LCD<br>display, battery and etc. | It is mainly composed with<br>infrared sensor, signal<br>receiving processor, buttons,<br>buzzer, LCD display, battery<br>and etc. | Same | | Temperature unit<br>and conversion | Dual temperature units "°C"<br>and "°F" optional, and the<br>two units can convert by the<br>conversion key<br>automatically | Dual temperature units "°C"<br>and "°F" optional and the two<br>units can convert by the<br>conversion key automatically | Same | {7}------------------------------------------------ #### Justification for the differences: - 1) 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. {8}------------------------------------------------ - 2) 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. - 3) 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. - 4) 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. - 5) Different Storage Environment Same explanation as the justification for 4# difference. - 6) 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. - 7) 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. 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. {9}------------------------------------------------ ## 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).