Infrared Forehead Thermometer, model: HS-9802D

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & 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. September 19, 2022 Jiaxing Shangjia Intelligence Technology Co., Ltd. % You Yijie Manager Oimmig Medical Consulting Service Co., Ltd. RM.1711, Building K, NO.101 Science Ave International Creative Valley Guangzhou, Guangdong 510663 China Re: K213038 Trade/Device Name: Infrared Forehead Thermometer, model: HS-9802D Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical electronic thermometer Regulatory Class: Class II Product Code: FLL Dear You Yijie: The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated March 10, 2022. Specifically, FDA is updating this SE Letter typo in the trade name as an administrative correction. Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Payal Patel, OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices, 240-402-6029, payal.patel(@fda.hhs.gov. Sincerely, Danil WalloscheR David Wolloscheck, Ph.D. 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 {1}------------------------------------------------ Image /page/1/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. March 10, 2022 Jiaxing Shangjia Intelligence Technology Co., Ltd. You Yijie Manager Oimmig Medical Consulting Service Co., Ltd. RM.1711. Building K. NO.101 Science Ave International Creative Valley Guangzhou, Guangdong 510663 China Re: K213038 Trade/Device Name: Infrared Forehead Thermometer, model: HS-98020 Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: January 31, 2022 Received: January 31, 2022 Dear You Yijie: We have reviewed vour 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 {2}------------------------------------------------ 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, FDA 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 {3}------------------------------------------------ Section 4: Indications for Use Statement (Form FDA 3881) {4}------------------------------------------------ #### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration #### Indications for Use 510(k) Number (if known) K213038 Device Name Infrared Forehead Thermometer, model: HS-9802D Indications for Use (Describe) Infrared Forehead Thermometer, model: HS-9802D is intended for the intermittent measurement and monitoring of human body temperature. The device is indicated for use by people of all ages in the home. 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 maintein 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." {5}------------------------------------------------ # Section 5: 510(k) Summary ## 1. Submitter's Information #### Establishment Registration Information Name: Jiaxing Shangjia Intelligence Technology Co., Ltd. Address: Room 102 and Room 202, Building No.9, Jiaxing Intelligence & Innovation Park, No.36, South Changsheng Road, Jiaxing, Zhejiang, China ### Contact Person of applicant Name: Lou Yongwei Address: Room 102 and Room 202, Building No.9, Jiaxing Intelligence & Innovation Park, No.36, South Changsheng Road, Jiaxing, Zhejiang, China TEL: +86 0573 89978800 Email: 100831552@qq.com ### 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: Sep. 8, 2021 ## 2. Device Information | Device Common Name: | Clinical electronic thermometer | |---------------------|----------------------------------| | Trade Name: | Infrared Forehead<br>Thermometer | | Model: | HS-9802D | | Regulation name: | Clinical electronic thermometer | | Review Panel: | General Hospital | | Product Code: | FLL | | Regulation Class: | II | | Regulation Number: | 880.2910 | ## 3. Predicate Device Information | 510(k) submitter/holder: | Microlife Intellectual Property GmbH, Switzerland. | |--------------------------|------------------------------------------------------| | 510(K) Number: | K191829 | | Trade Name: | Microlife Non-Contact Infrared Forehead Thermometer. | {6}------------------------------------------------ Model: FR1DG1 (NC200) Clinical electronic thermometer Classification name: Review panel: General Hospital Product code: FLL Regulation Class: Regulation Number: 880.2910 ## 4. Device description Infrared Forehead Thermometer, model: HS-9802D is a hand-held, battery powered, infrared thermometer that measures human body temperature from forehead. The reference body site is oral. The device measures temperature from center of the forehead. ### Principle of operation: Infrared Forehead Thermometer, model: HS-9802D is an electronic thermometer uses IR sensor (thermopile) to detect infrared radiation emitting from forehead, after then, the IR sensor outputs electrical signal which is fed to circuit for amplification and then being inputted to MCU, the MCU captures the temperature measured from center of forehead. The measured temperature will finally appear on LCD display. ## 5. Indications for Use Infrared Forehead Thermometer, model: HS-9802D is intended for the internittent measurement and monitoring of human body temperature. The device is indicated for use by people of all ages in the home. #### Summary of technological characteristics of device compared to 6. the predicate device | SE<br>Comparisons | Subject device<br>(Infrared Forehead Thermometer,<br>model: HS-9802D) | Primary predicate device<br>(K191829, Microlife Non-Contact Infrared<br>Forehead Thermometer, Model: FR1DG1<br>(NC200)) | Discussion of<br>difference | |-------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------| | Classification | 21CFR 880.2910 | 21CFR 880.2910 | Same | | Product Code | FLL | FLL | Same | | FDA Class | II | II | Same | | Intended Use | Infrared Forehead Thermometer, model:<br>HS9802D is intended for the intermittent<br>measurement and monitoring of human body<br>temperature. The device is indicated for use<br>by people of all ages in the home. | The Microlife Non-Contact Infrared<br>Forehead Thermometer, Model FR1DG1<br>(NC200) is intended for the intermittent<br>measurement and monitoring of human<br>body temperature. The device is<br>indicated for use by people of all ages in<br>the home. | Same | {7}------------------------------------------------ | Principle of<br>operation | Measure temperature by reading infrared radiation emitting from the forehead when | Measure temperature by reading infrared radiation emitting from the forehead when | Same | |---------------------------|-----------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|------| | | the | | | | | thermometer is placed within few<br>centimeters of forehead. | the thermometer is placed within few<br>centimeters of forehead. | | |----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|----------------------------------------------------| | target<br>population | people of all ages | people of all ages | Same | | Measurement<br>site | forehead | forehead | Same | | Material of<br>Patient contact<br>components | Probe: ABS<br>Cap: PS<br>Liquid crystal display (LCD): Glass<br>ON/Scan button: ABS<br>Battery Cover (shell has same material):<br>ABS<br>Memory button: Silica gel | Housing and battery cover material:<br>ABS707<br>Patient-Contact Button material: PMMA | Different<br>(Discussion is<br>indicated in D1) | | Biocompability<br>testing | Meets ISO 10993- 5<br>ISO 10993-10 | Meets ISO 10993- 5<br>ISO 10993-10 | Same | | Environment | home | home | Same | | Design | Handheld | Handheld | Same | | Measurement<br>method | Infrared radiation detection | Infrared radiation detection | Same | | Display Type | LCD | LCD | Same | | Measurement<br>Mode | Forehead mode | Forehead mode | Same | | Reference site | Oral | Oral | Same | | Key | Two buttons (ON/Scan button, Memory<br>button) | Two buttons (M-button, START I/O<br>button) | Same | | Scale selection | °C/°F | °C/°F | Same | | Display unit | °C/°F | °C/°F | Same | | High<br>temperature<br>warning | Yes | Yes | Same | | Low battery<br>indicator | Yes | Yes | Same | | Sensor Type | Thermopile | Thermopile | Same | | Performance<br>Testing | Meets ASTM E1965-98 and ISO 80601-2-<br>56 | Meets ASTM E1965-98 and ISO 80601-<br>2-56 | Same | | Electrical Safety | ANSI AAMI ES60601-1 | ANSI AAMI ES60601-1 | Same | | EMC Meets | IEC 60601-1-2 | IEC 60601-1-2 | Same | | Measuring<br>Range | 34.0 to 42.0 °C (93.2 to 107.6 °F). | 32.0-43.0 °C (89.6-109.4 °F) | Different<br>(Discussion is<br>indicated in D2) | | Display<br>resolution | 0.1°F (0.1ć) | 0.1°F (0.1ć) | Same | | Measuring<br>accuracy | ±0.3°C (0.5°F): 34.0 to 42.0 °C (93.2 to<br>107.6 °F). | ±0.2 °C: 35.0 ~ 42.0 °C<br>±0.3 °C: 34.0 ~ 34.9 °C, 42.1 ~ 43.0 °C | Different<br>(Discussion is<br>indicated in D3) | | Measuring<br>Distance | < 2.5cm | < 5cm | Different<br>(Discussion is<br>indicated in D4) | | Measurement<br>data memories | 6 sets memories | 30 sets memories | Different<br>(Discussion is<br>indicated in D5) | | Backlight | Yes | Yes | Same | | Auto-off time | 15 seconds | Approx. 1min second after last<br>measurement has been taken | Different<br>(Discussion is<br>indicated in D6) | | Beeper indication | Yes | Yes | Same | | Operation<br>Condition | 5-40ć;<br>20%-95%R.H., noncondensing | Ambient Temperature: 15°C~40°C<br>(59°F~104°F) Relative humidity:<br>15%~95%RH (noncondense) | Different<br>(Discussion is<br>indicated in D7) | | Storage and<br>transportation<br>condition | -20 - 50ć;<br>10%-95%R.H., noncondensing, 70-106kPa | -25 ~ 55 °C (-13°F ~131°F) 15-95<br>% relative maximum humidity | Different<br>(Discussion is<br>indicated in D8) | | Physical<br>dimension | 134x76.5x38 mm | 156.7 x 43 x 47 mm | Different<br>(Discussion<br>is<br>indicated in D9) | | High temperature<br>alarm | Yes | Yes | Same | | Power source | 3 V d.c. (2X AAA batteries) | 3.0V DC with 2 AAA batteries | Same | {8}------------------------------------------------ ### The discussion of differences exist between the subject and predicate device is listed in following: D1: 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. {9}------------------------------------------------ - D2&D3: 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. - D4: The Measuring Distance range of proposed device is in the range of the predicate device. The difference will not affect the safety and effectiveness. - D5: The different memory number will not affect the safety and effectiveness. - D6: The different Auto-off time will not affect the safety and effectiveness. - D7: The operating condition of subject device has passed the safety test and comply with the requirement of ASTM E1965-98, 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. - D8: The operating condition of subject device has passed the tests of ASTM E1965-98 and ISTA 2A, so the difference between the operating conditions of subject device and predicate device will not affect the safety and effectiveness. - D9: The different dimension will not affect the safety and effectiveness. #### Discussion of Non-Clinical Tests Performed for Safety and 7. ### effectiveness are as follows The recognized consensus standards for safety of medical electrical 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 ES60601-<br>1:2005/(R)2012 and A1:2012 | Medical Electrical Equipment - Part 1: General Requirements<br>For Basic Safety And Essential Performance | | IEC 60601-1-2: 2014 | Medical Electrical Equipment -- Part 1-2: General<br>Requirements<br>For Basic Safety And Essential Performance -- Collateral<br>Standard: Electromagnetic Disturbances -- Requirements And<br>Tests | | IEC 60601-1-11: 2015 | Medical Electrical Equipment - Part 1-2: General Requirements<br>For Basic Safety And Essential Performance - Collateral<br>Standard: Electromagnetic Disturbances - Requirements And<br>Tests | | ISO 80601-2-56:<br>2017+A1:2018 | Medical Electrical Equipment - Part 2-56: Particular<br>Requirements For Basic Safety And Essential Performance Of<br>Clinical Thermometers For Body Temperature Measurement. | | ASTM E1965-98:2016 | Standard Specification For Infrared Thermometers For<br>Intermittent Determination Of Patient Temperature | {10}------------------------------------------------ | IEC 62304:2006+A1:2015 | Medical device software - Software life cycle processes | |------------------------|----------------------------------------------------------------------------------------------------| | ISO 10993-5:2009 | Biological evaluation of medical devices - Part 5: Tests for in<br>vitro cytotoxicity | | ISO 10993-10:2010 | Biological evaluation of medical devices - Part 10: Tests for<br>irritation and skin sensitization | 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 196598 (2016). The clinical accuracy testing evaluated 105 of subjects, division of all subjects into (1) infantsnewborn up to one year, (2) children- greater than one to five years; and (3) adults-greater than five years ol. The test data showed the clinical accuracy of the subject device complied with the requirements of ASTM E1965-98 (2016). Summary of reference equipment: | Name | Digital Thermometer | Microlife Non-Contact Infrared<br>Forehead Thermometer | |------------------|-------------------------------------|--------------------------------------------------------| | Model | KFT-03 | FR1DG1 (NC200) | | Manufacturer | Kangfu Medical Equipment<br>Factory | Microlife Intellectual Property<br>GmbH, Switzerland | | Measuring Method | Contact | Non-Contact Infrared<br>Forehead | | K Number | K182652 | K191829 | ## 9. Conclusions Based on performance testing, comparison and analysis, the subject device Infrared Forehead Thermometer, model HS-9802D is substantially equivalent to the predicate device. {11}------------------------------------------------