Infrared Forehead Thermometer, Model LFR30B, LFR50, LFR60

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February 18, 2021 Shenzhen LEPU Intelligent Medical Equipment Co., Ltd. % Arthur Goddard President FDA Regulatory and Ouality Systems Consultant 31853 Cedar Road Mayfield Heights, Ohio 44124-4445 Re: K202687 Trade/Device Name: Infrared Forehead Thermometer, Model LFR30B, LFR50, LFR60 Regulation Number: 21 CFR 21 CFR 880.2910 Regulation Name: Clinical Electrical Thermometer Regulatory Class: Class II Product Code: FLL Dated: September 3, 2020 Received: September 15, 2020 Dear Arthur Goddard: 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. 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 {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, For Payal Patel Acting 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) K202687 #### Device Name Infrared Forehead Thermometer, Model LFR30B, LFR50, LFR60 Indications for Use (Describe) The Infrared Forehead Thermometer is a non-contact infermometer intended for the intermittent measurement of human body temperature from forehead for people of all ages. The device is reusable for home use 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 This summary of 510(K) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR 807.92. The assigned 510(K) Number: K202687 #### ನ. 510(K) Summary #### 5.1. Date of Preparation: February 18, 2021 #### 5.2. Sponsor Shenzhen LEPU Intelligent Medical Equipment Co., Ltd. North side of floor 3, BLD 9 BaiWangxin High-Tech Industrial Park Songbai Road, Xili Street, Nanshan District 518055 Shenzhen, Guangdong, CHINA Tel: +86 0755-86952278 Fax: +86 0755-86952278 Contact Person: Aaron Lin Position: General Manager Email: aaron.lin(@lepu-medical.com #### 5.3. Subject Device Identification Subject Device Name: Infrared Forehead Thermometer, Model LFR30B, LFR50, LFR60 Common name: Infrared Forehead Thermometer Regulation Name: Clinical Electronic Thermometer Product Code: FLL Regulation Number: 21 CFR 880.2910 Review Panel: General Hospital Classification: II #### 5.4. Predicate Device 510(k) Number: K191251 Device Name: Infrared Thermometer (DT-8836T, DT-8836P) Manufacturer: Shenzhen Calibeur Industries Co., Ltd. #### 5.5. Indications for use: The Infrared Forehead Thermometer is a non-contact infrared thermometer intended for the intermittent measurement of human body temperature from forehead for people of all ages. The device is reusable for home use and clinical use. {4}------------------------------------------------ # 5.6. Device Description The subject device Infrared Forehead Thermometer has three models: LFR30B, LFR50 and LFR60. The three modes have same operation principle. A thermopile sensor is employed to detect the infrared energy emitted from the surface of the skin of the forehead which is converted into temperature measurement with the unit of ℃ or ºF. The results can be displayed on LCD. The measurement is non-contact with the patient. The measuring distance is 0~5 cm to the forehead and the measuring time is 1s. The Infrared Forehead Thermometer is battery powered. | Item | Subject Device<br>Infrared Forehead<br>Thermometer | Predicate Device<br>Infrared Thermometer<br>(DT-8836T, DT-8836P)<br>K191251 | Remark | |---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------| | Device<br>Common/Usual<br>Name | Infrared Forehead<br>Thermometer | Infrared Thermometer | / | | Device Class | Class II | Class II | SE | | Product Code/<br>Regulation<br>Number | FLL<br>21 CFR 880.2910 | FLL<br>21 CFR 880.2910 | SE | | Classification<br>Name(s) | Clinical Electronic<br>Thermometer | Clinical Electronic<br>Thermometer | SE | | Indications for<br>Use | The Infrared Forehead<br>Thermometer is a non-contact<br>infrared thermometer intended<br>for the intermittent<br>measurement of human body<br>temperature from forehead for<br>people of all ages. The device<br>is reusable for home use and<br>clinical use. | The Infrared thermometer is a<br>non-contact infrared<br>thermometer intended for the<br>intermittent measurement of<br>human body temperature<br>from forehead for people of<br>all ages. The device is<br>reusable for home use and<br>clinical use. | SE | | Intended Users | Lay user and professional | Lay user and professional | SE | | Measurement<br>Method | Infrared radiation detection | Infrared radiation detection | SE | | Measuring Site | Forehead | Forehead | SE | #### 5.7. Predicate Devices and Subject Device Comparison {5}------------------------------------------------ | Item | Subject Device<br>Infrared Forehead<br>Thermometer | Predicate Device<br>Infrared Thermometer<br>(DT-8836T, DT-8836P)<br>K191251 | Remark | |-----------------|----------------------------------------------------|-----------------------------------------------------------------------------|--------------| | Scale Selection | °C/°F | °C/°F | SE | | Measuring Range | 32-43°C/89.6-109.4°F | 32.0°C ~42.5°C<br>(89.6 to 108.5 °F) | Discussion 1 | #### Discussion 1 : The measuring range of subject device is different with predicate device. The performance testing shows that the subject device complies with performance standard IEC 80601-2-56. The difference with predicate device K191251 doesn't raise any new issues of safety or efficacy. | Display<br>Resolution | 0.1°C/0.1°F | 0.1°C/0.1°F | SE | |-----------------------|------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|--------------| | Measuring<br>Accuracy | ±0.3°C (±0.5°F) within<br>34.0~43°C (93.2~109.4°F),<br>±0.4°C (±0.7°F) within<br>32.0~33.9°C (89.6~93.0°F) | ±0.2°C (0.4°F) within<br>35.0°C ~ 42.0°C<br>(95.0°F ~ 107.6°F),<br>±0.3°C(0.5°F) other range | Discussion 2 | # Discussion 2: The measuring accuracy of subject device is different with predicate device. The performance testing shows that the subject device complies with performance standard IEC 80601-2-56 and ASTM E 1965. The difference with predicate device K191251 doesn't raise any new issues of safety or efficacy. | Measure Time | 1s | 1s | SE | |------------------|-------|------|--------------| | Measure Distance | 0~5cm | ≤3cm | Discussion 3 | #### Discussion 3: The measure distance of subject device is different with predicate device. The performance testing shows that the subject device complies with performance standard IEC 80601-2-56 and ASTM E 1965. The difference with predicate device K191251 doesn't raise any new issues of safety or efficacy. | Sensor | Thermopile | Thermopile | SE | |----------------|---------------|------------|--------------| | Audio Reminder | Buzzer | Buzzer | SE | | Data Storage | Up to 99 sets | 60 sets | Discussion 4 | # Discussion 4: The data storage of subject device is different with predicate device. However, the software was validation according to FDA's software guidance. The performance testing shows that the subject device complies with performance standard IEC 80601-2-56 and ASTM E 1965. The difference with predicate device K191251 doesn't raise any new issues of safety or efficacy. | Power Supply | Batterv | Batterv | CITY | |----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|------| | Display Screen | C | T AT | CTT | | | ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤ | UND | DI | {6}------------------------------------------------ | Item | Subject Device<br>Infrared Forehead<br>Thermometer | Predicate Device<br>Infrared Thermometer<br>(DT-8836T, DT-8836P)<br>K191251 | Remark | |--------------------------------|----------------------------------------------------|-----------------------------------------------------------------------------|--------------| | Operating<br>Condition | 5°C~40°C, Relative<br>Humidity 24~90% | 10~40°C (50°F ~104 °F)<br>RH 15~95% | | | Storage/transport<br>Condition | -20°C~+55°C, Relative<br>Humidity < 95% | -25 ~+55°C (-13~+131°F)<br>RH:15~95% | Discussion 5 | # Discussion 5: The operating and storage/transport condition of subject device are different with predicate device. The performance testing shows that the subject device complies with performance standard IEC 80601-2-56 and ASTM E 1965. The difference with predicate device K191251 doesn't raise any new issues of safety or efficacy. | Human-<br>contacting<br>Material | ABS, PC, PMMA | ABS | Discussion 6 | |----------------------------------|---------------|-----|--------------| |----------------------------------|---------------|-----|--------------| # Discussion 6: The human-contacting material of subject device is different with predicate device. PC and PMMA are widely used in medical device. The biocompatibility evaluation of the subject device was conducted according to FDA Guidance for Industry and Food and Drug Administration Staff: Use of International Standard ISO 10993-1. "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". Cytotoxicity, sensitization tests are performed. The test reports addressed during the biocompatibility studies (Section 15: Biocompatibility) did not raise any new issues of biocompatible safety. The difference with predicate device K191251 doesn't raise any new issues of safety or efficacy. | Biocompatibility<br>Information | ISO 10993-5<br>ISO 10993-10 | ISO 10993-5<br>ISO 10993-10 | SE | |---------------------------------|--------------------------------------------------------------|--------------------------------------------------------------|----| | Reference Body<br>Site | Axilla | Axilla | SE | | Measuring Mode | Adjusted (Body mode) | Adjusted (Forehead mode) | SE | | Conformance<br>Standard | ISO 80601-2-56<br>IEC 60601-1<br>IEC 60601-1-2<br>ASTM E1965 | ISO 80601-2-56<br>IEC 60601-1<br>IEC 60601-1-2<br>ASTM E1965 | SE | {7}------------------------------------------------ #### 5.8. Performance Test Summary Bench test were conducted to verify that the subject device met all design specifications, as was Substantially Equivalent (SE) to the predicate device. ### 5.8.1. Biocompatibility Testing The Infrared Forehead Thermometer was assessed against the International Standard ISO 10993-1, "Biological evaluation of medical devices. Part 1. Guidance on selection of tests." The subject device would be classified as a Surface Medical Device in contact with the intact skin for a Limited Duration (<24 hours). The following test were performed for any user contacting material: | Test | Standard | Results | |-------------------------------------------------------------|--------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | In Vitro Cytotoxicity<br>Study (MTT Method) | ISO 10993-5 | Under the conditions of this study, the MEM<br>test extracts would be considered no<br>cytotoxicity potential. The negative controls,<br>blank controls, and the positive controls<br>performed as anticipated. | | Skin Sensitization Study<br>Guinea Pig Maximization<br>Test | ISO 10993-10 | Under the conditions of this study, the test<br>article extracts showed no evidence of<br>causing delayed dermal contact sensitization<br>in the guinea pig. The test article was not<br>considered a sensitizer in the guinea pig<br>maximization test. | | Skin Irritation Study | ISO 10993-10 | Under the conditions of this study, the<br>irritation response category of the test article<br>is classified as Negligible for polar extract and<br>Negligible for non-polar extract. | #### 5.8.2. Non-clinical Tests The Infrared Forehead Thermometer is tested per the following standard, to evaluate its performance. The test results demonstrated that the proposed device comply with the standard requirements. IEC 60601-1:2005+AMD1:2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance 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 IEC 60601-1-11:2015 medical electrical equipment - part 1-11: general requirements {8}------------------------------------------------ for basic safety and essential performance - collateral standard: requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment ISO 80601-2-56:2017+A1:2018 Medical electrical equipment - Particular requirements for the basic safety and essential performance of clinical thermometers for body temperature measurement. ASTM E1965-98 (2016) Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature #### 5.8.3. Clinical Data A comparison study and clinical repeatability testing was performed on the following four age groups: 0 up to 3 months, 3 months up to 1 year, older than 1 year and younger than 5 years and older than 5 years in accordance with ISO 80601-2-56 to compare the Infrared Forehead Thermometer with Mercury thermometer. This clinical comparison study demonstrated that the temperatures obtained with the Infrared Forehead Thermometer were highly related when compared to the Mercury thermometer, the clinical bias with stated uncertainty and clinical repeatability as defined in the ISO 80601-2-56 standard were within clinical acceptability. #### 5.8.4. Software The software embedded in Infrared Forehead Thermometer has been developed, documented and validated in accordance with industry standards (IEC 62304 - Medical device software - Software life cycle processes) and FDA guidance (GUIDANCE FOR CONTENT OF PRE-MARKET SUBMISSIONS FOR SOFTWARE THE CONTAINED IN DEVICES). #### 5.9. Substantially Equivalent Conclusion The subject device, Infrared Forehead Thermometer, is determined to be Substantially Equivalent (SE) to the predicate device, K191251, in respect of safety and effectiveness.