Infrared thermometer, models KFT-22M, KFT-22, KFT-23, KFT-24, KFT-25, KFT-26, KFT-27, KFT-28

{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 & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration". December 10, 2021 Kangfu Medical Equipment Factory Jixiang Zhang Quality Manager No.380 Ningkang East Road, Lecheng Town, Yueqing Wenzhou, ZheJiang 325699 China Re: K201600 Trade/Device Name: Infrared thermometer, models KFT-22, KFT-23, KFT-24, KFT-24, KFT-25, KFT-26, KFT-27, KFT-28 Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: November 7, 2021 Received: November 10, 2021 Dear Jixiang Zhang: 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, 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) K201600 Device Name Infrared thermometer, models KFT-22M, KFT-22, KFT-24, KFT-25, KFT-26, KFT-27, KFT-28 Indications for Use (Describe) The infrared thermometer, models KFT-22M, KFT-22, KFT-24, KFT-25, KFT-26, KFT-27, KFT-28 is designed to measuring human body temperature through ear or forehead in the healthcare environments or home use and is nonsterile. The thermometer is a reusable device intended for people of all ages except neonates/newborns. | 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}------------------------------------------------ # 510(k) Summary ### 1. Submitter: #### Table 1 Submitter {Owner) and Contact Information | Company / Institution Name | | | | |--------------------------------------------------|----------------------------------|-----------------|---------| | Kangfu Medical Equipment Factory | | | | | Phone Number {including area code) | FAX Number {including area code) | | | | +86 0577-62579618 | N.A. | | | | Street Address | | | | | No.380 Ningkang East Road, Lecheng Town, Yueqing | | | | | City | State/Province | ZIP/Postal Code | Country | | Wenzhou | Zhejiang | 325699 | China | | Contact Name | | | | | Jixiang Zhang | | | | | Contact Title | Contact E-mail Address | | | | Quality Manager | 416548914@qq.com | | | Date Prepared: 2021-12-07 This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR §807.92. ## 2. Device Information: Type of 510(k) submission: Traditional Device Name: Infrared Thermometer Models: KFT-22M, KFT-22, KFT-23, KFT-24, KFT-25, KFT-26, KFT-27, KFT-28. Classification name: thermometer, electronic, clinical Review Panel: General Hospital Product Code: FLL Device Class: ווו Requlation Number: 880.2910 In Vitro Diagnostic Device: Not applicable, the subject device is not an In Vitro Diagnostic Device per the classification defined above. Class III Device Statement: Not applicable, the subject device is Class II per the classification defined above. ## 3. Predicate device: Sponsor: Shenzhen Brav Electronic Technologies Co., Ltd Product Name/ Model: Infrared Thermometer, Model EFT-165 Classification name: thermometer, electronic, clinical Device Class: II Regulation Number: 880.2910 510(K) Number: K171214 {4}------------------------------------------------ ## 4. Indications for Use The infrared thermometer, models KFT-22M, KFT-22, KFT-24, KFT-24, KFT-25, KFT-26, KFT-27, KFT-28 is designed to measure human body temperature through ear or forehead in healthcare environments or home use and is non-sterile. The thermometer is a reusable device intended for people of all ages except neonates/newborns. ## 5. Basic principle Any object in which temperature is higher than absolute zero degree will transmit some infrared radiation energy according to its own temperature. The radiation energy and its distribution per wavelength are closely associated with its surface temperature. Based on this principle, it is possible to measure the forehead or ear temperature and then adjust the offset between forehead or ear temperature and actual body temperature, which will result in the correct display of body temperature. ## 6. Device Description The KFT series infrared thermometer measures the body temperature through receiving the infrared energy radiation from the surface of human body. It is capacified with forehead mode and ear temperature mode, directly shown on the LCD screen. - The device is widely used for home healthcare and medical environment. - . The product is mainly comprised of infrared temperature sensors, signal receiving processor, buttons, buzzer, LCD display, battery, etc. - . It focuses the infrared from the human's forehead or ear by the Fresnel lens. ## 7. Comparison to predicate device | Table 2 Similarity and difference analysis between Subject Device and Predicate Device | | | | |----------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------| | | | | | | ITEM | Subject Device | Predicate Device<br>K171214 | Comparison<br>Result | | Manufacture | Kangfu Medical Equipment<br>Factory | Shenzhen Brav Electronic<br>Technologies Co., Ltd. | | | Model | KFT-22M, KFT-22, KFT-23, KFT-24, KFT-25, KFT-26, KFT-27,<br>KFT-28 | EFT-165 | | | Regulation<br>information | Product Code: FLL<br>Device Class: II<br>Regulation Number: 880.2910<br>Classification name: thermometer,<br>electronic, clinical | Product Code: FLL<br>Device Class: II<br>Regulation Number: 880.2910<br>Classification name:<br>thermometer, electronic, clinical | Same | | Type of use | Over-the-counter Use | Over-the-counter Use | Same | | Indications for Use | The infrared thermometer, models<br>KFT-22M, KFT-22, KFT-23, KFT-24, KFT-25, KFT-26, KFT-27,<br>KFT-28 is designed to measuring<br>human body temperature through<br>ear or forehead in the healthcare | The infrared thermometer is<br>intended for the measurement<br>and monitoring of human body<br>temperature by doctors or<br>customers in the hospital or<br>at home. | Different 1 | | | environments or home use and is<br>non-sterile. The thermometer is a<br>reusable device intended for<br>people of all ages except<br>neonates/newborns. | | | | Intended patient<br>population | People of all ages except<br>neonates/newborns | People of all ages more than<br>three months | | | Measuring<br>position | Forehead and ear | Forehead and ear | Same | | Measuring mode | Forehead temperature<br>mode and ear temperature<br>mode | Forehead temperature mode,<br>and ear temperature mode | Same | | Measuring<br>Distance for<br>forehead mode | 3 cm, Non - Contact | 0cm, Contact | Different ² | | Measuring<br>Distance for ear<br>mode | 0cm, Contact | 0cm, Contact | Same | | Measurement time | 10 s | 10 s | Same | | Measurement time<br>between<br>measurements | 5s | 5s | Same | | Use of forehead<br>probe cover | YES, switch to the forehead mode<br>when attach the probe cover | YES, switch to the forehead<br>mode when attach the probe<br>cover | Same | | Detection method | Temperature is detected by<br>The sensor and calculated. | Temperature is detected by<br>The sensor and calculated. | Same | | Design principle | Based on Infrared Sensor<br>technology | Based on Infrared Sensor<br>technology | Same | | Sensor Type | Infrared sensor | Infrared sensor | Same | | Measurement<br>Range | 32.0°C 42.9°C<br>C89.6°F~109.2°F) | 32.0°C 42.9°C<br>(89.6°F~109.2°F) | Same | | Accuracy for body<br>temperature<br>measurement | 32.0°C~34.9°C: ±0.3°C /0.5°F<br>35.0°C~42.0°C: ±0.2°C /0.4°F<br>42.1°C~42.9°C: ±0.3°C / 0.5°F | 32.0°C~34.9°C: ±0.3°C /0.5°F<br>35.0°C~42.0°C: ±0.2°C /0.4°F<br>42.1°C~42.9°C: ±0.3°C /0.5°F | Same | | Resolution of<br>Display | 0.1°C/°F | 0.1°C/°F | Same | | Operating<br>Environment | 15°C ~ 35°C<br>15%~85% moisture<br>condensation | 15°C ~ 35°C<br>85% moisture condensation | Different 3 | | Storage<br>Environment | -25°C~55°C C-4°F~131°F)<br>10%~90% moisture<br>condensation | -20°C~55°C C-4°F~131°F)<br>90% moisture<br>condensation | | | Power supply | 2*1.5V de AAA battery | 2*1.5V de AAA battery | Same | | Applicable<br>standards | IEC 60601-1, IEC 60601-1-2,<br>IEC 60601-1-11, and ASTM<br>E1965-98, ISO80601-2-56 | IEC 60601-1, IEC 60601-1-<br>2, IEC 60601-1-11, and<br>ASTM E1965-98, ISO80601-<br>2-56 | Same | | Memory<br>records | 10 sets | 20 sets | Different 4 | | Product<br>configuration | It is mainly composed with<br>infrared sensor, signal receiving<br>processor, buttons, buzzer,<br>LCD display, battery and etc. | It is mainly composed with<br>infrared sensor, signal receiving<br>processor, buttons, buzzer, LCD<br>display, battery<br>and etc. | Same | | Temperature unit<br>and conversion | Dual temperature units "°C" and<br>"°F" optional, and the two units<br>can convert by the conversion key<br>automatically | Dual temperature units "°C" and<br>"°F" optional and the two units<br>can convert by the conversion<br>key automatically | Same | | Physical Dimension | 145mm * 37mm*35mm | 30mm * 44mm *152mm | Different 5 | | Weight | 53 g(Including batteries) | About 72 g(without battery) | Different 5 | | Device Materials of<br>the main unit | ABS | ABS | Same | | Patient contact<br>material | ABS | ABS+PE | Different 6 | | Bio-compatibility | ISO 10993-5, | ISO 10993-5, | Same | | Complied standards | ISO 10993-10 | ISO 10993-10 | Same | | Display screen | LCD | LED | Different 7 | | Sound from the<br>device with<br>successful<br>measurement | When the measurement is<br>complete, the result will show on<br>the display screen after one long<br>beep | When the measurement is<br>complete, the result will show on<br>the display screen after short<br>beeps | Same | {5}------------------------------------------------ {6}------------------------------------------------ #### Justification for the differences: 1) Different Indications for Use and Intended patient population The predicate and subject device share similar indications for use as shown in their labeling, and the difference is the subject is for people of all ages except neonates/newborns, while the predicate can only be used for people over three months. This difference has been verified by internal verification and an external clinical accuracy study, so this difference will not cause any safety or effectiveness problem. #### 2) Different Measuring Distance for forehead mode The predicate device is contacting type for forehead mode, but the subject device is non-contact type. The software and hardware for the subject device is verified to be supportive of the safety and performance declared in the labeling, which will not cause any safety or effectiveness problem. #### 3) Different Operating/Transport conditions Minor difference to operation/transport environment for the subject device, but the system has been {7}------------------------------------------------ proven to be safe and effective based on the safety testing conducted under the suggested environment. Environment testing data shows the device can function as intended under the suggested conditions. So those changes will not cause any safety or effectiveness problem. 4) Different Memory Data Limit The subject KFT series thermometer can store 10 sets of data less than the predicate, which is verified through device testing. - 5) Different Patient contact material The patient contacting materials of the predicate and the subject devices are ABS+PE and ABS, respectively. Both are compliant with international standards ISO 10993-5/ISO10993-10, and the corresponding test reports provided demonstrate material safety. - 6) Different Physical Dimension and weight The dimension and weight of the subject device are different from the predicate device. The physical characteristics differences have been verified during the design and development and will not raise any safety or effectiveness problem . 7) Different display screen and Sound from the device with successful measurement The predicate and subject device differs in nonessential characteristics. The differences have been verified before product release, including hardware and software. No safety or effectiveness problem observed. As seen in the comparison tables, the subject and predicate devices have similar design features and performance specifications. The main technological differences between the subject and predicate devices are minor differences, including appearance, control keys, and operating/storage environment, which do not raise different questions of safety or effectiveness. Moreover, as demonstrated in the non-clinical testing, the different technological characteristics do not affect the safety and effectiveness of the KFT series Infrared thermometer system. ### 8. Performance Data Performance data includes "Non-Clinical Data" and "Clinical Data", brief description of which are shown as below. #### Non-Clinical Data: The following performance data were provided in support of the substantial equivalence determination. #### Biocompatibility testing The biocompatibility evaluation for the KFT series Infrared thermometer were conducted in accordance with the International Standard ISO 10993-1 "Biological Evaluation of Medical Devices -Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The worst case of the whole system is considered tissue contacting for duration of less than 24 hours. The testing necessary for this contact category include Cytotoxicity, Skin Sensitization and Irritation per the Annex A Biological evaluation tests of ISO 10993-1, which have been conducted on the IT series Infrared thermometer device. {8}------------------------------------------------ ### Electrical safety and electromagnetic compatibility (EMC) Electrical safety and EMC testing were conducted on the KFT series Infrared thermometer device, consisting of all the modules and accessories in the system. The system complies with the ANSI/AAMI ES60601-1:2005/(R)2012and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 Medical electrical equipment Part 1: General requirements for basic safety and essential performance for safety and the 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 standard for EMC. ### Bench Testing Bench testing was conducted on the KFT series Infrared thermometer device, consisting of all the accessories in the system. The system complies with the 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, ISO 80601-2-56: 2009 Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement standards for performance effectiveness. ### Software Verification and Validation Testing Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "Moderate" level of concern, since a failure or latent flaw in the software could directly result in serious injury or death to the patient or operator. ### Clinical data: Clinical testing is conducted per ISO 80601-2-56 Clause 201.102 Clinical Accuracy Validation, where 116 patients are included in the testing, and with grouping shown below. Both forehead and ear measurement modes are evaluated with accuracy results. | Age | Number of tested group | Febrile/ Non-febrile | |------------------|------------------------|----------------------| | 1~3 month | 17 | 6/11 | | 3 months ~1 year | 25 | 12/13 | | 1~5 years | 38 | 17/21 | | Above 5 years | 36 | 13/23 | ### Summary Based on the non-clinical and clinical performance as documented in the device development, the subject devices were found to have a performance that is similar to the predicate device. ## 9. Conclusion {9}------------------------------------------------ Based on the above considerations table, the Proposed Device, the KFT series Infrared thermometer is substantially equivalent to the predicate device EFT-16 series Infrared thermometer (K171214).