ThermArt (Model IR-EFT)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left side of the image is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. September 28, 2021 Comper Chuangxiang (Beijing) technology Co., Ltd. Han Du Manager Building 1, Unit 4, Room 102, 103 1st Floor, No.1 Kangding Street, Beijing Economic Technological Development Area Beijing, 100176 China Re: K202481 Trade/Device Name: ThermArt (Model IR-EFT) Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: August 17, 2021 Received: August 27, 2021 Dear Han Du: 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 {1}------------------------------------------------ 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 medical devices and radiation-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 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 Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ #### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. 510(k) Number (if known) K202481 Device Name ThermArt (Model IR-EFT) #### Indications for Use (Describe) This device is a non-sterile reusable, contact thermometer, intermittent determination of human body temperature through on the ear canal or forehead as the measurement site on people of all age. The ThermArt (Model IR-EFT) can be used in clinical and home environment. 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}------------------------------------------------ # K202481 510(K) Summary Prepared in accordance with the requirements of 21 CFR Part 807.92 #### Prepared Date: 28 September, 2021 #### 1. Submitter's Information The submitter of this pre-market notification is: | Name: | Comper Chuangxiang (Beijing) technology Co., Ltd. Address: Room 102-103 1st Floor, Building 4 No.1 Kangding Street, Daxing District Beijing, CHINA 100176 | |-----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact person: | Han Du | | Title: | Manager | | E-mail: | registration@comper.com | | Tel: | +86-10-57480968 | #### 2. Device Identification | Trade/Device Name: | ThermArt | |--------------------|---------------------------------| | Models: | IR-EFT | | Common Name: | Clinical Electronic Thermometer | | Regulation Number: | 21 CFR 880.2910 | | Regulation Name: | Clinical electronic thermometer | | Regulation Class: | Class II | | Product Code: | FLL | #### 3. Predicate Device | 510(K) number: | K190873 | |--------------------|-----------------------------------| | Device Name: | Infrared Ear/Forehead Thermometer | | Manufacturer: | Joytech Healthcare Co., Ltd. | | Regulation Number: | 21 CFR 880.2910 | | Regulation Name: | Clinical electronic thermometer | | Regulation Class: | Class II | | Product Code: | FLL | ### 4. Device Description The ThermArt (Model IR-EFT) is a hand-held, battery powered device designed to measure human body temperature. This Thermometer takes the body temperature the infrared energy emitted from the forehead skin or the ear canal. The Thermometer adopts gentle-touch, user friendly and non-invasive measurement design. It instantly displays the accurate reading of the body temperature with just a gentle touch. 510(k) Summary {4}------------------------------------------------ # 5. Indications for use This device is a non-sterile reusable, contact thermometer, intended for intermittent determination of human body temperature through on the ear canal or forehead as the measurement site on people of all age. The ThermArt (Model IR-EFT) can be used in clinical and home environment. # 6. Substantial Equivalence Discussion Comparison to the predicate devices, the subject device has same indications for use, similarproduct design, same performance effectiveness, performance safety as the predicate device as summarized in the following table | Feature | Subject device | Predicate device | Discussion | |-----------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Number | K202481 | K190873 | / | | Regulation<br>number | 21 CFR 880.2910 | 21 CFR 880.2910 | Same | | Product Code | FLL | FLL | Same | | Indications for<br>Use | This device is a non-sterile<br>reusable, contact<br>thermometer, intended for<br>intermittent determination of<br>human body temperature<br>through on the ear canal or<br>forehead as the measurement<br>site on people of all age. The<br>ThermArt (Model IR-EFT)<br>can be used in clinical and<br>home environment. | Infrared Ear/Forehead<br>Thermometer DET-218 is<br>intended for the intermittent<br>measurement of human body<br>temperature by people of all ages.<br>The devices are reusable for<br>home use only. | Our indications for use is<br>different from the<br>description of the predicate<br>device, but the means is<br>essentially the same. | | Patient population | people of all ages | people of all ages | Same | | Measure Method | Infrared radiation detection | Infrared radiation detection | Same | | Key Temperature<br>Sensor | Thermopile Sensor | Thermopile Sensor | Same | | Materials | Enclosure: PC;<br>Probe: glass & ABS | Enclosure: ABS;<br>Probe: Stainless steel & ABS; | Different, but both of our<br>device and predicate device<br>have performed the<br>Biocompatibility test<br>according to the ISO 10993-<br>1, both two devices meet the<br>requirements of ISO 10993.<br>therefore it is substantially<br>equivalent on<br>Biocompatibility risk. | | Temperature<br>range | 32.0°C ~43.0°C (89.6°F -<br>109.4°F) | 34.0°C to 43.0°C<br>(93.2°F to 109.4°F) | Our measurement range is<br>greater than predicate<br>device, but we performed<br>accuracy test according to | | Accuracy | $\pm0.4°F/\pm0.2°C$ (95°F<br>107.6 °F/35.0°C -42°C)<br>$\pm0.5°F/\pm0.3°C$ (outside this<br>temperature range) | Ear/Forehead mode:<br>$\pm0.2°C$ (0.4°F) during 35.5°C<br>~42.0°C (95.9°F ~107.6°F ) at 15°C<br>~35°C (59.0°F ~95.0°F ) operating<br>temperature range $\pm0.3°C$ (0.5°F )<br>for other measuring and operating<br>temperature range. | the ASTM E1965,<br>therefore it is substantially<br>equivalent on performance.<br>Our accuracy is greater than<br>predicate device, but we<br>performed accuracy test<br>according to the ASTM<br>E1965, therefore it is<br>substantially equivalent on<br>performance. | | Operating<br>environment | Temperature: 15°C -40°C (59°F -<br>104°F)<br>relative humidity: ≤ 95%;<br>atmospheric pressure: 70<br>kPa~106 kPa | Temperature:<br>10°C~40°C(50°F~104°F),<br>relative humidity: 15%~85%RH<br>non-condensing<br>Atmospheric Pressure : 700hPa ~<br>1060hPa | Our operating temperature<br>and relative humidity are<br>different from predicate<br>device, but we performed<br>accuracy test according to<br>the ISO 80601-2-56 and<br>ASTM E1965, therefore it is<br>substantially equivalent on<br>performance. | | Transportation and<br>storage conditions | Temperature: -20°C~+ 55°C(-<br>4°F -131°F); relative humidity:<br>95%;<br>atmospheric pressure: 70<br>kPa~106 kPa | -25°C~ 55°C (-13°F~131°F),<br>≤15%~95%RH, non-condensing<br>Atmospheric Pressure : 700hPa ~<br>1060hPa | Our operating temperature<br>and relative humidity are<br>different from predicate<br>device, but we performed<br>accuracy test according to the<br>ISO 80601-2-56 and ASTM<br>E1965, therefore it is<br>substantially equivalent on<br>performance. | | The<br>contact/noncontact<br>use of the device | Contact<br>Ear: the ear probe cover<br>contacts with skin;<br>Forehead: the forehead probe<br>cover contacts with skin | Contact | Same | | The use of a<br>probe cover | Ear: use the ear probe cover<br>Forehead: use the forehead<br>probe cover | Ear: use the ear probe cover<br>Forehead: use the forehead cap | Same | | Measuring time | 1s | 1s | Same | | Resolution of<br>display | 0.1°C / 0.1°F | 0.1°C / 0.1°F | Same | | Measurement<br>Place | Forehead<br>Ear | Forehead<br>Ear | Same | | Scale Selection | °C /°F | °C /°F | Same | | Signal output and<br>display | LED<br>Transfer transmit data to<br>mobile device for secondary<br>display | -Internal firmware and local LCD<br>display<br>-Also able to transfer transmit<br>data to mobile device for | Different type of screen<br>display, but both of our<br>device and predicate device<br>have performed the | | | | secondary display | Medical electrical safety test<br>according to the IEC<br>60601-1 and IEC 60601-1-2<br>both two devices meet the<br>requirements. therefore it is<br>substantially equivalent on<br>Electrical risk. | | Wireless Interface | Not applicable | Bluetooth Low Energy (BLE) | Different , Do not affect the<br>use and precision<br>measurement | | Signal<br>transmission | Not applicable | Bluetooth 4.0 | Different , Do not affect the<br>use and precision<br>measurement | | Receiver (mobile<br>terminal) | Not applicable | iOS9.0 or above mobile device<br>Android5.0 or above mobile<br>device | Different, Do not affect the<br>use and precision<br>measurement | | Auto power-off<br>while no<br>operation | Yes | Yes | Same | | Power Source | DC3V(2×AAA battery) | DC3V(2×AAA battery) | Same | | Biocompatibility | Cytotoxicity, Skin irritation,<br>Skin sensitization | Cytotoxicity, Skin irritation,<br>Skin sensitization | Same | | Voluntary<br>standards for<br>Clinical<br>Electronic<br>Thermometers, | ASTM E1965<br>ISO 80601-2-56 | ASTM E 1965 and<br>ISO 80601-2-56 | Same | | Medical Electrical<br>Safety and<br>EMC | IEC 60601-1, IEC 60601-1-<br>2 | IEC 60601-1, IEC 60601-1-2 | Same | {5}------------------------------------------------ # Comper Chuangxiang (Beijing) Technology Co., Ltd {6}------------------------------------------------ # Comper Chuangxiang (Beijing) Technology Co., Ltd # Discussion Here is a summary of the difference and the tests performed on these differences to address the safety and effectiveness of the subject device. | No. | Difference | Tests performed | |-----|------------------------------------------|--------------------------------------------------------------------------------------| | 1. | Materials | Biocompatibility test according to the ISO 10993-1, ISO<br>10993-5 and ISO 10993-10. | | 2. | temperature range | Accuracy test according to the ASTM E1965. | | 3. | accuracy | | | 4. | operating environment | Accuracy test according to the ISO 80601-2-56 and<br>ASTM E1965. | | 5. | transportation and storage<br>conditions | | | 6. | signal output and display | Medical electrical safety test according to the IEC<br>60601-1 and IEC 60601-1-2. | {7}------------------------------------------------ | 7. | wireless interface | No test performed because the subject device does not contain these functions. | |----|----------------------------|--------------------------------------------------------------------------------| | 8. | signal transmission | | | 9. | receiver (mobile terminal) | | # Comper Chuangxiang (Beijing) Technology Co., Ltd The required testing demonstrated that different do not raise new questions of safety and effectiveness between the subject and the predicate device. # 8. Performance Data # Non-clinical data Cleaning validation: We performed the cleaning validation according to the method if instruction for use, the validation result shows that the method of cleaning meets the cleaning requirements. # Safety: - 1. ANSI/AAMI ES60601-1:(R) 2012 AND A1:2012 Medical electrical equipment Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) - 2. AAMI/ANSI ES60601-1-2:2014 Medical electrical equipment -- Part 1-2: General requirements for basic safety and essential performance -- Collateral Standard: Electromagnetic disturbances -- Requirements and tests - 3. 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 Performance: - ISO 80601-2-56:2017 Medical electrical equipment Part 2-56: Particular requirements for basic safety and 4. essential performance of clinical thermometers for body temperature measurement. - 5. ASTM E1965 (2016) Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature Biocompatibility: - 6. ISO 10993-1:2018 Biological evaluation of medical devices Part 1: Evaluation and testing within arisk management process - 7. ISO 10993-5:2009 Biological evaluation of medical devices Part 5: Tests for in vitrocytotoxicity - 8. ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation andskin sensitization The tests were selected to show substantial equivalence between the subject device and the predicate. # 9. Conclusion The differences between the predicate and the subject device do not raise any new or different questions of safety or effectiveness. Based on the safety and performance testing and compliance with performance 510(k) Summary {8}------------------------------------------------ Comper Chuangxiang (Beijing) Technology Co., Ltd standards, the ThermArt (Model IR-EFT) is substantially equivalent to the Infrared Ear/Forehead Thermometer cleared under K190873 with respect to the indications for use, target populations, treatment method, and technological characteristics.