Non-contact Infrared Thermometer (Models WL-301, WL-501, WL-601, WL-701)

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March 18, 2022 Sichuan YOUKEDE Medical Equipment Co.,Ltd Yolanda Lan Regulatory Affair Consultant 2F, North Wing, No.102 Building, Mianyang Export Processing Zone, No.261 East Section of Feiyun Road, Mianyang Hi-Tech Mianvang, SiChuan 621000 China Re: K210171 Trade/Device Name: Non-contact Infrared Thermometer (Models WL-301, WL-601, WL-701) Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: February 16, 2022 Received: February 16, 2022 Dear Yolanda Lan: 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 {1}------------------------------------------------ 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, Gang Peng for Payal Patel Assistant 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) K210171 #### Device Name Non-contact Infrared Thermometer (Model: WL-301, WL-501, WL-601, WL-701) #### Indications for Use (Describe) The Non-contact Infrared Thermometer (Models WL-301, WL-501, WL-701) is an electronic thermometer using an infrared sensor to detect human body temperature from forehead on people of one month old and above. The device is reusable for home and clinical 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}------------------------------------------------ #### Section 5 510(K) Summary # 1. Prepared Date: 2021/06/18 ### 2. Submitter Information | Name | Sichuan YOUKEDE Medical Equipment Co.,Ltd. | |----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Address | 2F, North Wing, No.102 Building, Mianyang Export<br>Processing Zone, No.261 East Section of Feiyun Road,<br>Mianyang Hi-Tech Zone, 621000 Mianyang City,<br>Sichuan Province, P.R.China | | Contact person | Sukey Chia | | Tel | +86 0816 2296641 | | E-mail | 3004729718@qq.com | ## 3. Submission Correspondent | Contact person | Yolanda Lan | |----------------|--------------------------| | E-mail | yolanda.bleu@foxmail.com | | Tel | +86-13713938991 | # 4. Subject Device Information | Proprietary Name | Non-contact Infrared thermometer (Model:WL-<br>301,WL-501,WL-601,WL-701) | |------------------------|--------------------------------------------------------------------------| | Common Name | Infrared thermometer | | Model | WL-301, WL-501, WL-601, WL-701 | | Classification | Thermometer, Electronic, Clinical | | Regulation Description | Clinical electronic thermometer | | Review Panel | General Hospital | | Product Code | FLL | | Regulation Number | 21 CFR 880.2910 | | Regulatory Class | II | #### 5. Predicate Device Infrared Forehead Thermometer, Model DPT-IFT100, (CONMO, K202420) {4}------------------------------------------------ # 6. Description The Infrared thermometers are hand-held, battery powered devices designed to measure human body temperature from the central forehead. Its operation is based on measuring the natural thermal radiation from central forehead. The thermometers use a thermopile sensor with integrated thermistor for the target reading, a thermistor mounted in the head of the thermometer for ambient temperature readings, a parabolic mirror to help focus the infrared energy emitted from the forehead, and an infrared distance sensor for detection of no-contact use and compensation of the temperature reading. The device mainly consists of infrared sensor, microprocessor, embedded software (Identified Software version is No: V1), memory, electro-acoustic components, LED display and the device is powered by 2AAA alkaline batteries. The non-contact infrared thermometer included WL-301, WL-501, WL-601, WL-701. They can be selected calibration mode, body temperature mode and surface mode. ## 7. Indications for Use The Non-contact Infrared Thermometer (Models WL-301, WL-501, WL-601, WL-701) is an electronic thermometer using an infrared sensor to detect human body temperature from forehead on people of one month old and above. The device is reusable for home and clinical use. ## 8. Summary of technological characteristics of device compared to the predicate devices, see the table A comparison of key similarities and differences between the proposed devices (WL-301, WL-501, WL-601, WL-701) and the predicate devices (K202420) is provided below: {5}------------------------------------------------ ★ | SE Comparisons | Propose device | Predicate device | Note | |--------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------| | | YOUKEDE (WL-301, WL-501, WL-601, WL-701) | CONMO DPT-IFT100 | | | 510K number | K210171 | K202420 | -- | | Regulation number | 21 CFR 880.2910 | 21 CFR 880.2910 | Identical | | Product code | FLL | FLL | Identical | | Indications for use | The Non-contact Infrared Thermometer (Models WL-301, WL-501, WL-601, WL-701) is an electronic thermometer using an infrared sensor to detect human body temperature from forehead on people of one month old and above. The device is reusable for home and clinical use. | The infrared forehead Thermometer DPT-IFT100 is a non-contact thermometer intended for the intermittent measurement of human body temperature from forehead for people of one month old and above. The device is reusable for home use and clinical use. | Different¹ | | Measurement Method | Infrared radiation detection | Infrared radiation detection | Identical | | Measurement Range | 34°C ~42°C | 34°C ~43°C | Different, but meets ISO 80601-2-56:2017/A md.1:2018 | | Accuracy | 34°C~42°C( $\pm$ 0.3°C) | $\pm$ 0.2°C: 35.0°C ~ 42.0°C<br>$\pm$ 0.3°C: 34.0°C ~ 34.9°C, 42.1°C ~ 43°C | Different² | | Display | 0.1°C (0.1°F) | 0.1°C(0.1°F) | Identical | | Measurement<br>mode<br>(adjusted/direct<br>mode) | Adjusted | Adjusted | Identical | | Measurement<br>distance | 3~5cm | 3~5cm | Identical | | Measurement<br>Site | Forehead | Forehead | Identical | | Response time | <6S | 1S | Different3 | | Sensor type | Thermopile | Thermopile | Identical | | Scale Selection | °C /°F | °C /°F | Identical | | Buzzer | No, vibrate instead | Yes | Different3 | | Display screen | LED | LCD | Different3 | | Memory | 1sets | 60sets | Different3 | | Auto<br>power-off<br>while<br>no<br>operation | Yes | Yes | Identical | | Power supply | 3.0V DC with 2 AAA batteries | 3.0V DC with 2 AAA batteries | Identical | | Contact materials | ABS | ABS | Identical | | Operation<br>Environment | 15~40°C (59°F~104 °F)<br>RH ≤ 95% | 10~40°C (50°F~104 °F)<br>15-85% RH | Different4 | | Storage<br>Environment | -20°C ~+55°C(-4~+131°F)<br>RH≤95% | -20~ +55°C ( -4~+131°F )<br>RH≤90% | Different4 | | Dimension | 146*35*41 mm | 145*38*35mm | Different5 | | Weight | 68g | 78.2g (with batteries),<br>56.6g (w/o batteries) | Different5 | | | IEC 60601-1(Safety), IEC60601-1-<br>2(EMC),<br>IEC 60601-1-11<br>ASTM E1965-98,<br>ISO 10993-1<br>ISO 10993-5: 2009<br>ISO 10993-10: 2010 | EN60601-1(Safety),<br>IEC60601-1-2(EMC),<br>IEC 60601-1-11<br>ASTM E1965-98<br>ISO 10993-1<br>ISO 10993-5: 2009<br>ISO 10993-10: 2010 | Identical | | Conformance<br>standard | ISO80601-2-56(performance),<br>Exceptions: The following<br>clause/collaterals:<br>Clause 201.11.7, Biocompatibility of<br>ME EQUIPMENT and ME SYSTEMS.<br>Clause 201.12.2 and 206, Usability,<br>not evaluated in this report, Refer<br>to IEC 60601-1-6 test Report,<br>Clause 202, EMC, not evaluated in<br>this report, Refer to IEC 60601-1-2<br>test report.<br>Clause 201.102, Clinical Accuracy<br>VAIDATION, evaluated in ASTM E<br>1965-98 report. | ISO80601-2-56(performance) | Different6 | {6}------------------------------------------------ ★ {7}------------------------------------------------ # Analysis From the comparison table, the propose device and predicate device have the same working principle, Measurement place, Measurement Method, Scale selection, Auto poweroff while no operation & Conformance standard. There are slightly differences between the devices as follow: | Difference clause | Discussion | |-------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | The wording for the subject device is slightly different from the predicate<br>device but they are both non-contact thermometers for the intermittent<br>measurement of human body temperature via forehead. The subject device<br>addresses the target population based on the clinical study conducted, and<br>they both conform to the same performance standard - ISO 80601-2-56,<br>Particular requirements for basic safety and essential performance of<br>clinical thermometers for body temperature measurement.<br>The subject device added the "measurement distance" claim, and described<br>detail of the intended use scenario. The above<br>wording differences between the subject device and predicate device will | {8}------------------------------------------------ | Measurement Accuracy | Both devices have different measurement accuracy, but they meet the<br>requirements of ISO80601-2-56. And the accuracy of the subjected device<br>has demonstrated through the clinical accuracy trial, which will not affect<br>the device's safety and effectiveness. | |---------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Response<br>time/Buzzer/Display<br>screen/ Memory | The response time, buzzer, display screen and memory capability of<br>predicate devices are difference from subject devices,<br>However, the software has been validated according to FDA's software<br>guidance. The performance testing shows that the<br>subject device complies with performance standard during performance<br>testing ISO 80601-2-56 and ASTM E1965-98 and clinical testing. Therefore,<br>we considered that the difference does not raise any issues on the device<br>safety and effectiveness of the subject device. | | Operation<br>&Storage Environment | Both devices have slightly different Operation<br>&Storage Environment, but the subject device has been demonstrated to<br>comply with the requirements of standards IEC 60601-1 and ISO 80601-2-<br>56. Therefore, we considered that the difference does not raise any<br>issues on the device safety and effectiveness. | | Dimension & Weight | The dimension and weight of subject device is different from the subject<br>device. The difference is caused by their different appearance and<br>construction, but the electrical safety, electromagnetic compatibility,<br>performance of subject device has been evaluated to meet the<br>requirements of the standards IEC 60601-1, IEC 60601-1-2, ASTM E1965-98<br>and ISO 80601-2-56. Therefore, we considered that the difference does not<br>raise any issues on the device safety and effectiveness. | | Conformance standard | Both devices conform to IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, ASTM<br>E1965-98, ISO 10993-1; though the device not all clauses conform to ISO<br>80601-2-56, but exceptions was evaluated in the other reports which does<br>not raise issued on the safety and effectiveness of the subject device. | ★ {9}------------------------------------------------ Performance Data - . Compliance to applicable standards includes ISO80601-2-56(not all clauses), as well as IEC 60601-1, IEC 60601-1-2 and IEC60601-1-11 requirements. - . Biocompatibility Evaluation for contacting patient components meets the requirements of ISO 10993-5 and ISO10993-10. - . According to the standard of AAMI TIR30:2011, Effectiveness validation of cleaning method referenced in the User's Manual. - . Shelf-life test result shows the subject device will be safe and effective using under the specified condition within 2 years. - . And then the following performance is verified. - -Measurement Range& Accuracy - -Measurement distance - -Response time ### Clinical data According to the ASTM E 1965-98, the clinical trial was performed for people of one month old and up. Reference clinical thermometer was a Glass thermometer, Model: CRW-23, Yuwell-Jiangsu medical equipment & supply Co. 150 patients were evaluated for both ear and forehead patients. ## Conclusion Based on performance testing and compliance with acceptable voluntary standards, we believe that the Non-contacted Infrared thermometers (WL-301, WL-501, WL-701) are substantially equivalent to its predicate devices in K202420.