Non-contact Infrared Body Thermometer, model:HTD8823US

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January 5, 2021 HeTaiDa Technology Co., Ltd. % You Yijie Manager Oimmig Medical Consulting Service Co., Ltd RM.1711, Building K, NO.101 Science Ave International Creative Valley Development Zone Guangzhou, 510663 China Re: K200159 Trade/Device Name: Infrared Body Thermometer, Model: HTD8823US Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: December 7, 2020 Received: December 7, 2020 Dear You Yijie: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. 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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) 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 (QS) 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, CAPT Alan 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 {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K200159 Device Name Infrared Body Thermometer, Model: HTD8823US Indications for Use (Describe) The Infrared Body Thermometer, Model: HTD8823US, is an electronic clinical thermometer using an infrared sensor to detect body temperature from the forehead in people of all ages for home setting use. 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}------------------------------------------------ # 510(K) Summary K200159 ## 1. Submitter's Information ## Establishment Reqistration Information Name: HeTaiDa Technology Co., Ltd Address: 4F, BaiShiDa High-Tech Park, XiangDong Industrial Area, DaLingShan Town, DongGuan City, Guangdong, China. 523820 ## Contact Person of applicant Name: Tom Chen Address: 4F, BaiShiDa High-Tech Park, XiangDong Industrial Area, DaLingShan Town, DongGuan City, Guangdong, China TEL: +86 769-82658050 FAX: +86 769-82658050 Email: tomchen@hetaida.com.cn ## Contact Person of the Submission: Name: Yijie You Address: RM.1711, Building K, NO.101 Science Ave International Creative Valley Development Zone, Guangzhou China TEL: +86 020-8224 5821 FAX: +86 020-8224 5821 Email: Jet.you@qimmiq-med.com Date prepared: Dec. 16, 2020 ## 2. Device Information | Device Common Name: | Clinical electronic thermometer | |---------------------|---------------------------------| | Trade Name: | Infrared Body Thermometer | | Model: | HTD8823US | | Regulation name: | Clinical electronic thermometer | | Review Panel: | General Hospital | | Product Code: | FLL | | Regulation Class: | II | | Regulation Number: | 880.2910 | ## 3. Predicate Device Information #### Primary predicate device: 510(k) submitter/holder: KAZ USA, Inc., A Helen of Troy Company 510(K) Number: K163516 Model: Braun No Touch + Forehead NTF3000 Thermometer Trade name: Infrared Thermometer Review Panel: General Hospital Product Code: FLL {4}------------------------------------------------ Requlation Class: . Requlation Number: 880.2910 #### Secondary predicate device: 510(k) submitter/holder: Exergen Corporation 510(K) Number: K011291 Trade name: TemporalScanner Thermometer, SensorTouch Review Panel: General Hospital Product Code: FLL Regulation Class: -Regulation Number: 880.2910 ## 4. Device description Infrared (IR) Body Thermometer, model: HTD8823US, is a hand-held, battery powered, infrared thermometer that measures human body temperature from forehead. The reference body site is oral. The device can measure temperature with two modes, forehead mode and forehead scan mode, and both modes measure forehead temperature. The forehead mode measures temperature from center of the forehead. Forehead scan mode measures temperature by gently positioning the probe flush (flat) on the center of the forehead, midway between the eyebrow and the hairline, press and hold the On/Scan button. Lightly slide the thermometer across the forehead keeping the sensor flat and in contact with the skin until reaching the right hairline, release the On/Scan button and remove the thermometer from the forehead, then the temperature will display on the screen, the whole process takes 3~10 seconds. ## Principle of operation: Infrared Body Thermometer, model: HTD8823US, is an electronic thermometer uses IR sensor (thermopile) to detect infrared radiation emitting from forehead. The IR sensor outputs electrical signal which is fed to circuit for amplification and then inputted to the microcontroller unit (MCU). For forehead mode, the MCU captures the temperature measured from center of forehead. The measured temperature will finally appear on LCD display. For forehead scan mode, the MCU captures the highest temperature during scanning sampling process and calculation, finally the measured temperature will appear on LCD display. ## 5. Indications for Use The Infrared Body Thermometer, Model: HTD8823US, is an electronic clinical thermometer using an infrared sensor to detect body temperature from the forehead in people of all ages for home setting use. ## 6. Summary of technological characteristics of device compared to the predicate devices (K163516 and K011291) | SE<br>Comparisons | Subject device | Primary predicate device | Secondary predicate<br>device | Discussion<br>of difference | |-------------------|---------------------------|-------------------------------------------------|-------------------------------|-----------------------------| | | K200159<br>(Infrared Body | (K163516, Infrared<br>Thermometer, Model: Braun | (K011291, | | {5}------------------------------------------------ | | Thermometer,<br>model: HTD8823US) | No Touch + Forehead<br>NTF3000 Thermometer)<br>(compared with Forehead<br>mode of HTD8823US) | TemporalScanner<br>Thermometer,<br>SensorTouch)<br>(compared with Forehead<br>scan mode of<br>HTD8823US) | | |----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------| | Classification | 21CFR 880.2910 | 21CFR 880.2910 | 21CFR 880.2910 | Same | | Product Code | FLL | FLL | FLL | Same | | FDA Class | II | II | II | Same | | Intended Use | The Infrared Body<br>Thermometer, Model:<br>HTD8823US, is an<br>electronic clinical<br>thermometer using an<br>infrared sensor to detect<br>body temperature from the<br>forehead in people of all<br>ages for home setting use. | The Braun No Touch +<br>Forehead NTF3000<br>Thermometer is a non-sterile,<br>reusable clinical thermometer<br>intended for the intermittent<br>determination of human body<br>temperature in a touch and no<br>touch mode on the center of<br>the forehead as the<br>measurement site on people<br>of all ages. | The TemporalScanner<br>Thermometer is an<br>infrared thermometer<br>intended for the<br>intermittent<br>measurement of human<br>body temperature of<br>people of all ages | Similar<br>(Discussion is<br>indicated in<br>D1) | | Principle of<br>operation | Forehead mode: Measure<br>temperature by reading<br>infrared radiation emitting<br>from the forehead when<br>the thermometer is placed<br>within few centimeters of<br>forehead. | Measure temperature by<br>reading infrared radiation<br>emitting from the forehead<br>when the thermometer is<br>placed within few centimeters<br>of forehead. | NA | Same | | | Forehead scan mode:<br>Measure temperature by<br>reading infrared radiation<br>emitting from the forehead<br>when the thermometer is<br>placed on the forehead. | NA | Measure temperature by<br>reading infrared radiation<br>emitting from the<br>forehead when the<br>thermometer is placed<br>on the forehead. | Same | | target<br>population | people of all ages | people of all ages | people of all ages | Same | | Measurement<br>site | forehead | forehead | forehead | Same | | Material of<br>Patient<br>contact<br>components | ABS (device housing/ handle<br>and power button);<br>PMMA(LCD screen) | ABS (device housing/ handle and<br>power button); TPR (temperature<br>button and nose / forehead touch<br>bumper). | ABS | Similar<br>(Discussion is<br>indicated in<br>D2) | | Biocompability<br>testing | Meets ISO 10993- 5<br>ISO 10993-10 | Meets ISO 10993 and<br>FDA Bluebook memo<br>G95-1 | Not public | Similar<br>(Discussion is<br>indicated in<br>D3) | | Environment | home | home | home | Same | | Design | Handheld | Handheld | Handheld | Same | | Measurement<br>method | Infrared radiation<br>detection | Infrared radiation detection | Infrared radiation<br>detection | Same | | Display Type | LCD | LCD | LCD | Same | | Measurement | Forehead mode | Forehead mode | NA | Same | | Mode | Forehead scan mode | NA | Forehead scan mode | Same | | Key | One button(ON/Scan | Two button(Power button, | One button(SCAN | Similar<br>(Discussion is<br>indicated in<br>D4) | | | button) | Temperature button) | Button) | indicated in<br>D4) | | Scale<br>selection | °C/°F | °C/°F | °C/°F | Same | | Display unit | °C/°F | °C/°F | °C/°F | Same | | High<br>temperature<br>warning | Yes | Yes | Yes | Same | | Low battery<br>indicator | Yes | Yes | Yes | Same | | Case Material | ABS | ABS | ABS | Same | | Sensor Type | Thermopile | Thermopile | Thermopile | Same | | Performance<br>Testing | Meets ASTM E1965-98<br>and ISO 80601-2-56 | Meets ASTM E1965-98 and<br>ISO 80601-2-56 | Meets ASTM E1965-98 | Similar<br>(Discussion is<br>indicated in D5) | | Electrical<br>Safety | ANSI AAMI ES60601-1 | ANSI AAMI ES60601-1 | ANSI AAMI ES60601-1 | Same | | EMC Meets | IEC 60601-1-2 | IEC 60601-1-2 | IEC 60601-1-2 | Same | | Measuring<br>Range for<br>Forehead<br>mode | 34.0°C ~ 43.0°C<br>(93.2°F ~109.4°F) | 34.4°C ~42.2°C<br>(93.9°F to 108.0°F) | NA | Similar<br>(Discussion is<br>indicated in D6) | | Measuring<br>Range for<br>Forehead<br>scan mode | 34.0°C ~ 43.0°C<br>(93.2°F ~109.4°F) | NA | Forehead scan:<br>15.5°C to 42°C<br>(60°F to 107.6°F) | Similar<br>(Discussion is<br>indicated in<br>D7) | | Display<br>resolution | 0.1°F (0.1°C) | 0.1°F (0.1°C) | 0.1°F (0.1°C) | Same | | Measuring<br>accuracy | ±0.2°C (0.4°F) within<br>35°C ~ 42°C<br>(95°F~107.6°F);<br>±0.3°C (0.5°F) for other<br>range | ±0.2°C (0.4°F) within 35°C<br>~42°C (95°F ~107.6°F);<br>±0.3°C (0.5°F) for other<br>range | ±0.2°C (0.4°F) within<br>35~42°C (95°F ~107.6°F);<br>±0.3°C (0.5°F) for other<br>range | Same | | Measure time | ≤2S for Forehead mode;<br>3~10s for Forehead scan<br>mode; | ≤2S | Seconds | Similar<br>(Discussion is<br>indicated in D8) | | Color<br>Indication | Green: ≥ 35.8°C -<br>37.4 °C (96.4°F -99.3°F)<br>Yellow: ≥ 37.5°C- 38.5°C<br>(99.5°F -101.3°F)<br>Orange: ≥ 38.6°C - 43.0°C<br>(≥101.5°F -109.4°F) | Green: > 35.7 °C -37.4 °C<br>(> 96.3°F - 99.3 °F)<br>Yellow: > 37.4 °C - 38.5 °C<br>(> 99.4°F - 101.3 °F)<br>Red: > 38.5 °C - 42.2 °C<br>(> 101.3°F - 108.0 °F) | NA | Similar<br>(Discussion is<br>indicated in D9) | | Measuring<br>Distance for<br>forehead<br>mode | 1 CM -5CM | 1 CM -5CM | NA | Same | | Measuring<br>Distance for<br>forehead scan<br>mode | 0 cm | NA | 0 cm | Same | {6}------------------------------------------------ {7}------------------------------------------------ | Power source | 3 V d.c. (2X AAA batteries) | Two (2) AA batteries | 9 volt Alkaline | Similar<br>(Discussion is<br>indicated in<br>D10) | |---------------------|------------------------------------------------------------------------------|------------------------------------------------------------------|--------------------------------------------------------------------------------|-----------------------------------------------------| | Operating condition | Temperature: 5°C ~40°C<br>(41°F ~104°F)<br>Humidity: ≤ 95%(no<br>condensing) | Temperature: 15°C ~40°C<br>(59°F ~104°F)<br>Humidity: Not public | Temperature:15.5°C<br>~40°C (60°F ~104°F)<br>Humidity: ≤ 95%(no<br>condensing) | Different<br>(Discussion is<br>indicated in<br>D11) | ## The discussion of differences exist between the subject and predicate devices is listed in followina: - D1: There is only difference in description, all three devices are infrared electronic clinical thermometer used to measure body temperature of all ages from forehead. - D2: The proposed device has been validated for cytotoxicity per ISO 10993- 5 and Irritation as well as Sensitization per ISO 10993-10. The difference will not affect the safety and effectiveness. - D3: The proposed device has been validated for the lasted version of ISO 10993-5: 2009 and ISO 10993-10:2010. the difference will not affect the safety and effectiveness. - D4: The different button number will not affect the safety and effectiveness. - D5: The proposed device conducted performance testing in accordance with ASTM E1965-98. ISO 80601-2-56 to demonstrate the difference does not affect the safety and effectiveness. - D6: The proposed device conducted performance testing in accordance with ASTM E1965-98, ISO 80601-2-56 to demonstrate the difference does not affect the safety and effectiveness. - D7: The proposed device conducted performance testing in accordance with ASTM E1965-98, ISO 80601-2-56 to demonstrate the difference does not affect the safety and effectiveness. - D8: The Measure time of proposed device was validated through performance testing in accordance with ASTM E1965-98, ISO 80601-2-56 to demonstrate the difference does not affect the safety and effectiveness. - D9: The Color Indication of proposed device in upper temperature range ≥ 38.6℃ 43.0℃ is orange and the predicate is red in upper temperature range > 38.6℃ - 42.2℃, it's only different in visual effect of color, this difference does not affect the safety and effectiveness. - D10: The proposed device was electromagnetic compatility and electrical safety in accordance with IEC 60601-1-2 and ANSI AAMI ES60601-1. The difference does not affect the safety and effectiveness. - D11: The operating condition of subject device has passed the safety test, and the subject device complies the standard IEC 60601-1-11, so the difference between the operating conditions of subject device and predicate device will not affect the safety and effectiveness. ## 7. Discussion of Non-Clinical Tests Performed for Safety and effectiveness are as follows: The recognized consensus standards for safety of medical equipment: ANSI AAMI ES60601-1, IEC 60601-1-11 for safety, IEC 60601-1-2 for electromagnetic compatibility, ASTM E 1965-98 and ISO 80601-2-56 for performance and IEC 62304 are complied, and see below table for details. | Standards | Standards Name | |----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | ANSI AAMI<br>ES60601-1:2005/(R)2012 and<br>A1:2012 | Medical Electrical Equipment - Part 1: General Requirements For<br>Basic Safety And Essential Performance | | IEC 60601-1-2: 2014 | Medical Electrical Equipment -- Part 1-2: General Requirements For<br>Basic Safety And Essential Performance -- Collateral Standard:<br>Electromagnetic Disturbances -- Requirements And Tests | {8}------------------------------------------------ | IEC 60601-1-11: 2015 | Medical Electrical Equipment - Part 1-2: General Requirements For<br>Basic Safety And Essential Performance - Collateral Standard:<br>Electromagnetic Disturbances - Requirements And Tests | |------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | ISO 80601-2-56: 2017 | Medical Electrical Equipment - Part 2-56: Particular Requirements<br>For Basic Safety And Essential Performance Of Clinical<br>Thermometers For Body Temperature Measurement. | | ASTM E1965-98:2016 | Standard Specification For Infrared Thermometers For Intermittent<br>Determination Of Patient Temperature | | IEC 62304:2006+A1:2015 | Medical device software - Software life cycle processes | Software verification and validation was performed for the subject device in accordance with Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices - Guidance for Industry and FDA Staff, May 2005. ## 8. Discussion of Clinical Accuracy Testing Performed: The clinical accuracy test report and data analysis followed the requirements of the ASTM E 1965-98 (2016). The clinical accuracy testing evaluated 140 of subjects. Each model was evaluated in 0 up to 3 months, 3 months up to one year, older than 1 year and younger than 5 years, and older than 5 years age groups. The test data showed the clinical accuracy of the subject device complied with the requirements of ASTM E1965-98 (2016). ## 9. Conclusions Based on performance testing, comparison and analysis, the subject device Infrared Body Thermometer, model HTD8823US is substantially equivalent to the predicate devices.