Body Infrared Thermometer HT-820D

{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 and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text. March 9, 2021 Dongguan Xintai Instrument Co., Ltd. % Ray Wang General Manager Beijing Believe-Med Technology Service Co., Ltd. Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District. Beijing, Beijing 102401 China Re: K202591 Trade/Device Name: Body Infrared Thermometer HT-820D Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical electronic thermometer Regulatory Class: Class II Product Code: FLL Dated: February 5, 2021 Received: February 10, 2021 Dear Ray Wang: 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. {1}------------------------------------------------ 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 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. 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) K202591 #### Device Name Body Infrared Thermometer HT-820D ### Indications for Use (Describe) The HT-820D Body Infrared Thermometer is intended to measure human body temperature by measuring the forehead from a distance of 5-8 cm. The device can be used on the home and professional healthcare facilities. | 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}------------------------------------------------ # K202591 510(k) Summary This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92. - 1. Date of Preparation: 03/08/2021 - Sponsor Identification 2. Dongguan Xintai Instrument Co., Ltd. Bld. F, No. 13-16, Hongye Industrial Zone, Tangxia Community, Tangxia Town, Dongguan City, GuangDong Province, 523710 China Contact Person: Wei Wang, Certification Commissioner Tel: +86-769-82612006 Fax: +86-769-82612005 Email: 24340474@qq.com - 3. Designated Submission Correspondent Ray Wang, General Manager Beijing Believe-Med Technology Service Co., Ltd. Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District, BeiJing, China 102401 Tel: +86-18910677558 Fax: +86-10-56335780 Email: ray.wang@believe-med.com #### 4. Identification of Subject Device Trade Name: Body Infrared Thermometer Model(s): HT-820D Common Name: Clinical Electronic Thermometer (Infrared Thermometer) Classification Name: Thermometer, Electronic, Clinical Regulation Number: 21 CFR 880.2910 Product Code: FLL Device Class: Class II #### Identification of Predicate Device(s) ട്. 510(k) Number: K182597 Product Name: Infrared thermometer Model Name: PG-IRT1602 Manufacturer: Shenzhen Pango Electronic Co., Ltd Classification Name: Thermometer, Electronic, Clinical Product Code: FLL #### Indication for Use Statement: 6. The HT-820D Body Infrared Thermometer is intended to measure human body temperature by measuring the forehead from a distance of 5-8 cm. The device can be used on all ages in the home and professional healthcare facilities. {4}------------------------------------------------ 510(k) Summary #### 7. Device Description The Infrared thermometer is an electronic thermometer using an infrared sensor to detect human body temperature by measuring forehead. The device can be used on people of all ages. The Infrared thermometer has the following features - 1 Non-Contact Design. - 2 Quick results response time less than 1 second. - Memory function; Memory recall of 34 reading. 3 - 4) Switching between mute and un-mute. - கு Switching between Fahrenheit and Celsius. - Power management: auto power off; power display; low power reminder 6 - (7) Automatically power-off, if no operation for 7 seconds. - Different temperature range display different backlight, over 37.5℃ signals warning tone (8) - இ Prompt for high temperature. | Item | Subject Device(s): K202591<br>HT-820D Body Infrared Thermometer | Predicate Device: K182597<br>PG-IRT1602 Infrared Forehead<br>Thermometer | Remark | |-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------| | Classification Name | Thermometer, Electronic, Clinical | Thermometer, Electronic, Clinical | Same | | Product Code | FLL | FLL | Same | | Regulation Number | CFR 880.2910 | CFR 880.2910 | Same | | Indication for Use | The HT-820D Body Infrared<br>Thermometer is intended to measure<br>human body temperature by measuring<br>the forehead from a distance of 5-8 cm.<br>The device can be used on people of all<br>ages in the home and professional<br>healthcare facilities. | PG-IRT1602 Infrared Forehead<br>Thermometer is intended to measure<br>human body temperature by measuring<br>forehead. The device can be used on<br>people of all ages. | Difference<br>Analysis 1 | | Principle of Operation | Non-contacting, Infrared Temperature<br>Measurement | Non-contacting, Infrared Temperature<br>Measurement | Same | | Measurement Range | 34°C-43°C | 34.0°C-43.0°C | Same | | Accuracy | ±0.3°C | ±0.2°C at 35.0 °C-42.0°C<br>Others ±0.3°C | Difference<br>Analysis 2 | | Measurement distance | 5~8cm | 3~5cm | Difference<br>Analysis 2 | | Measurement Mode | Adjusted | Adjusted | Same | | Reference Body Site | Oral | Not Available | Difference<br>Analysis 3 | | Operational<br>environmental | 10°C-40°C (50°F-104°F), 15-85 %RH | Not Available | Difference<br>Analysis 3 | | Storage Environmental<br>conditions | -10°C-60°C (50°F-140°F), 15-85 %RH | Not Available | Difference<br>Analysis 3 | | Intended Use<br>Environment | Home and Professional Healthcare<br>Environment | Not Available | Difference<br>Analysis 4 | | 510(k) Summary | | | | | Display Resolution | 0.1 | 0.1 | Same | | Patient Contact<br>Materials | ABS + PC | Shell Material: ABS<br>Lens: PMMA<br>Button: High density polyethylene<br>(HDPE)<br>Color additives | Difference<br>Analysis 5 | | Temperature prompts | ≤37.5°C(99.5°F) Green<br>37.6°C-38.0°C (99.6°F-100.4°F) : Orange<br>≥38.1°C (100.5°F) Red | Not Available | Difference<br>Analysis 6 | | Activation | Scan button | Scan button | Same | | Power requirements | Two pieces of 1.5V AA (number five)<br>batteries | Two pieces of 1.5V AAA (number seven)<br>batteries | Difference<br>Analysis 4 | | Measurement Site | Forehead | Forehead | Same | | Measuring interval | Less than 1 s | About 2 s | Difference<br>Analysis 6 | | Scale selection | °C/°F | °C/°F | Same | | Display screen | LCD | LCD | Same | | Memory | Save last measured 34 sets memories | 9 sets | Difference<br>Analysis 6 | | High Temperature<br>Prompt | Yes | Yes | Same | | Back light | Yes | Yes | Same | | Auto power-off | 7 seconds after no operation | 30 seconds after no operation | Difference<br>Analysis 6 | | Sterile | No | No | Same | | Single Use | No | No | Same | | Size | 168mm(H)*93mm(L)*46mm(w) | Not Available | Difference<br>Analysis 2 | | Weight | 122g | Not Available | Difference<br>Analysis 2 | | Biocompatibility | ISO10993-5<br>ISO10993-10 | ISO10993-5<br>ISO10993-10 | Same | | Electrical Safety | IEC60601-1 | IEC60601-1 | Same | | EMC | IEC60601-1-2 | IEC60601-1-2 | Same | | Performance | ISO 80601-2-56<br>ASTM E1965-98<br>IEC60601-1-11 | ISO 80601-2-56<br>ASTM E1965-98 | Same | #### Substantially Equivalent (SE) Comparison 8. {5}------------------------------------------------ The differences are included as followings: # Analysis 1: The measurement distance and applicable user environment are identified in the Indications for Use for the subject device, while not included in that of the predicate. Both devices measure without contact, however, the subject device adds the detail of its prescribed measuring distance to its indication. The Indication for Use of the subject device also presents the intended user environment of home or health care facilities for more {6}------------------------------------------------ #### 510(k) Summary These differences in Indication for Use do not raise any additional concerns of safety clarification to the user. or effectiveness of the subject device, only add more detail to the indication for use which is already similar to the predicate. ### Analysis 2: The subject device and predicate device have differences in accuracy, measurement distance, size and weight, but the subject device has passed both the non-clinical testing requirements of the ISO80601-2-56 and ASTM E1965-98 testing standards for infrared thermometers and therefore does not raise additional concerns of safety and effectiveness when compared with the predicate device. ### Analysis 3: The Reference Body Site and Operational, and Storage Environmental Conditions of the subject device cannot be compared to with the predicate device since these characteristics of the predicate device are not available; however, the subject device meets the requirement of safety and essential performance standard ISO 80601-2-56. These characteristics will not affect the effectiveness and safety of the subject device. ### Analysis 4: The Intended Use Environment of the subject device cannot be compared to with the predicate device since this characteristic of the predicate device is not available; however, the subject device passes IEC60601-1-2 and IEC60601-1-11 testing related to its specific usage environment and therefore does not raise any additional concerns of safety and effectiveness. ### Analysis 5: The subject device and predicate device have different Patient Contacting Materials, which could raise questions of biocompatibility; however, the materials of the subject device pass the necessary biocompatibility testing per ISO10993-5 and ISO10993-10 and the materials are shown to not affect the safety of the subject device. #### Analvsis 6: The subject device has software differences in measuring interval, memory, auto power-off, and temperature ranges used for the identification of "Body Temp Hi" when compared to the predicate device; however, the subject device passed the necessary performance testing and software validation which demonstrated the compliance of subject device with these specifications and these differences therefore will not affect the effectiveness and safety compared with the predicate device. #### 9. Non-Clinical Test Conclusion The test results demonstrated that the subject device complies with the following standards: - . ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) - . IEC 60601-1-2 Edition 4.0 2014-02, Medical Electrical Equipment - Part 1-2: General Requirements for Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Disturbances -Requirements And Tests. - . ISO 80601-2-56 Second edition 2017-03 Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement. [Including: Amendment 1 (2018)]. {7}------------------------------------------------ #### 510(k) Summary - ASTM E1965-98 (Reapproved 2016) Standard Specification for Infrared Thermometers for . Intermittent Determination of Patient Temperature - ISO 10993-5:2009 Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity . - ISO 10993-10:2010 Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization - . IEC 60601-1-11:2015 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 The software verification and validation were conducted in accordance with the "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," dated May 11, 2005. The test results demonstrated the software function met the requirements. ### 10. Clinical Test Conclusion Controlled human clinical studies were conducted on subject device with predicates in accordance with ASTM E1965-98, clinical bias, clinical uncertainty and clinical repeatability have been evaluated per clinical validation for infrared thermometer. The clinical trial results verify that the clinical accuracy of the subject device is not inferior to that of predicate device. Total 161 subjects and three age groups, including age 0~1 (40 subjects), age 1~5 (36 subjects) and age above 5 (85 subjects) are included in each clinical study, including febrile and afebrile persons. Compared statistical result of clinical bias and clinical repeatability of two comparison groups, the results of subject device meet the performance parameters claimed in user manual, and the subject device complies with ASTM E1965-98. ### 11. Conclusion: Based on the safety and performance testing and compliance with acceptable voluntary standards, we believe that the Infrared Thermometer (Model HT-820D) is Substantially Equivalent (SE) to the predicate device (K182597) which is US legally market device and does not raise any new safety and effectiveness issues.