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 non-sterile. The thermometer is a reusable device intended for people of all ages except neonates/newborns.

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.

AI/ML Overview

The provided document is a 510(k) summary for an infrared thermometer, focusing on its substantial equivalence to a predicate device. It contains information about performance data, including clinical and non-clinical testing. However, it does not describe an AI/ML-enabled device or a study involving human readers or expert consensus for ground truth establishment. Therefore, I cannot provide details on acceptance criteria and a study proving device performance in the context of an AI/ML device per your request.

The document discusses the following:

Device: Kangfu Medical Equipment Factory Infrared thermometer, models KFT-22, KFT-23, KFT-24, KFT-25, KFT-26, KFT-27, KFT-28.
Predicate Device: Shenzhen Brav Electronic Technologies Co., Ltd Infrared Thermometer, Model EFT-165 (K171214).
Indication for Use: Measuring human body temperature through ear or forehead in healthcare environments or home use, intended for people of all ages except neonates/newborns.
Performance Data: Non-clinical (biocompatibility, electrical safety/EMC, bench testing, software V&V) and clinical data.

Regarding the clinical study for this specific device (an infrared thermometer):

The clinical study mentioned is for the accuracy validation of the thermometer itself, not for an AI/ML component or human reader performance.

Acceptance Criteria for Infrared Thermometer Accuracy (Implied from "Accuracy for body temperature measurement" table):
- 32.0°C~34.9°C: ±0.3°C /0.5°F
- 35.0°C~42.0°C: ±0.2°C /0.4°F
- 42.1°C~42.9°C: ±0.3°C / 0.5°F
Reported Device Performance (Implicit from "Comparison to predicate device" and "Performance Data" sections): The document states that the "system complies with the ... ISO 80601-2-56: 2009 ... standards for performance effectiveness," and the "subject devices were found to have a performance that is similar to the predicate device," which shares the same accuracy specifications. This implies the subject device meets the listed accuracy criteria.
Sample Size for the test set (Clinical Data): 116 patients. The data seems to be prospective as it's a "clinical accuracy validation." Country of origin is not explicitly stated but implied to be China (Kangfu Medical Equipment Factory is in China).
Number of experts used to establish the ground truth for the test set and qualifications: Not applicable/not specified. For thermometer accuracy, ground truth is typically established using a highly accurate reference thermometer, not expert human readers.
Adjudication method for the test set: Not applicable/not specified, as it's not an image reading study.
Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. This study focuses on the inherent accuracy of a temperature measurement device, not on AI assistance to human readers.
Standalone (algorithm only) performance: Performance data is for the device itself, which includes its internal algorithm for temperature measurement. This can be considered the standalone performance of the thermometer.
Type of ground truth used: For clinical accuracy validation of a thermometer, the ground truth is typically established by simultaneous measurement using a highly accurate, calibrated reference thermometer (e.g., rectal thermometer for core body temperature, or a blackbody calibrator for infrared devices), sometimes referred to as a "master thermometer" or "reference method." This is an objective measurement, not expert consensus, pathology, or outcomes data in this context.
Sample size for the training set: Not applicable/not specified. Infrared thermometers use established physical principles and calibration, not machine learning models that require training data in the AI sense.
How the ground truth for the training set was established: Not applicable, as it's not an AI/ML device requiring a training set with established ground truth labels in the typical sense.

In summary, the provided text describes a traditional medical device (infrared thermometer), not an AI/ML-enabled device. Therefore, many of the requested details pertaining to AI/ML device studies (like MRMC studies, expert ground truth, training sets) are not found in this document.

Summary

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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

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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

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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)

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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

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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 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 DeviceK171214	ComparisonResult
Manufacture	Kangfu Medical EquipmentFactory	Shenzhen Brav ElectronicTechnologies Co., Ltd.
Model	KFT-22M, KFT-22, KFT-23, KFT-24, KFT-25, KFT-26, KFT-27,KFT-28	EFT-165
Regulationinformation	Product Code: FLLDevice Class: IIRegulation Number: 880.2910Classification name: thermometer,electronic, clinical	Product Code: FLLDevice Class: IIRegulation Number: 880.2910Classification name:thermometer, electronic, clinical	Same
Type of use	Over-the-counter Use	Over-the-counter Use	Same
Indications for Use	The infrared thermometer, modelsKFT-22M, KFT-22, KFT-23, KFT-24, KFT-25, KFT-26, KFT-27,KFT-28 is designed to measuringhuman body temperature throughear or forehead in the healthcare	The infrared thermometer isintended for the measurementand monitoring of human bodytemperature by doctors orcustomers in the hospital orat home.	Different 1
	environments or home use and isnon-sterile. The thermometer is areusable device intended forpeople of all ages exceptneonates/newborns.
Intended patientpopulation	People of all ages exceptneonates/newborns	People of all ages more thanthree months
Measuringposition	Forehead and ear	Forehead and ear	Same
Measuring mode	Forehead temperaturemode and ear temperaturemode	Forehead temperature mode,and ear temperature mode	Same
MeasuringDistance forforehead mode	3 cm, Non - Contact	0cm, Contact	Different ²
MeasuringDistance for earmode	0cm, Contact	0cm, Contact	Same
Measurement time	10 s	10 s	Same
Measurement timebetweenmeasurements	5s	5s	Same
Use of foreheadprobe cover	YES, switch to the forehead modewhen attach the probe cover	YES, switch to the foreheadmode when attach the probecover	Same
Detection method	Temperature is detected byThe sensor and calculated.	Temperature is detected byThe sensor and calculated.	Same
Design principle	Based on Infrared Sensortechnology	Based on Infrared Sensortechnology	Same
Sensor Type	Infrared sensor	Infrared sensor	Same
MeasurementRange	32.0°C 42.9°CC89.6°F~109.2°F)	32.0°C 42.9°C(89.6°F~109.2°F)	Same
Accuracy for bodytemperaturemeasurement	32.0°C~~34.9°C: ±0.3°C /0.5°F35.0°C~~42.0°C: ±0.2°C /0.4°F42.1°C~42.9°C: ±0.3°C / 0.5°F	32.0°C~~34.9°C: ±0.3°C /0.5°F35.0°C~~42.0°C: ±0.2°C /0.4°F42.1°C~42.9°C: ±0.3°C /0.5°F	Same
Resolution ofDisplay	0.1°C/°F	0.1°C/°F	Same
OperatingEnvironment	15°C ~ 35°C15%~85% moisturecondensation	15°C ~ 35°C85% moisture condensation	Different 3
StorageEnvironment	-25°C~~55°C C-4°F~~131°F)10%~90% moisturecondensation	-20°C~~55°C C-4°F~~131°F)90% moisturecondensation
Power supply	2*1.5V de AAA battery	2*1.5V de AAA battery	Same
Applicablestandards	IEC 60601-1, IEC 60601-1-2,IEC 60601-1-11, and ASTME1965-98, ISO80601-2-56	IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, andASTM E1965-98, ISO80601-2-56	Same
Memoryrecords	10 sets	20 sets	Different 4
Productconfiguration	It is mainly composed withinfrared sensor, signal receivingprocessor, buttons, buzzer,LCD display, battery and etc.	It is mainly composed withinfrared sensor, signal receivingprocessor, buttons, buzzer, LCDdisplay, batteryand etc.	Same
Temperature unitand conversion	Dual temperature units "°C" and"°F" optional, and the two unitscan convert by the conversion keyautomatically	Dual temperature units "°C" and"°F" optional and the two unitscan convert by the conversionkey 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 ofthe main unit	ABS	ABS	Same
Patient contactmaterial	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 thedevice withsuccessfulmeasurement	When the measurement iscomplete, the result will show onthe display screen after one longbeep	When the measurement iscomplete, the result will show onthe display screen after shortbeeps	Same

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Justification for the differences:

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

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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.

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.

1. 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.
1. 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 .

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.

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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

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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).

Regulation Number and Section

§ 880.2910 Clinical electronic thermometer.

(a)
Identification. A clinical electronic thermometer is a device used to measure the body temperature of a patient by means of a transducer coupled with an electronic signal amplification, conditioning, and display unit. The transducer may be in a detachable probe with or without a disposable cover.(b)
Classification. Class II (performance standards). The device is exempt from the premarket notification procedures in part 807, subpart E of this chapter, subject to the limitations in § 880.9 and the following conditions for exemption:(1) Device is not a clinical thermometer with telethermographic functions;
(2) Device is not a clinical thermometer with continuous temperature measurement functions; and
(3) Appropriate analysis and testing (such as that outlined in the currently FDA-recognized editions, as appropriate, of ISO 80601-2-56, “Medical electrical equipment—Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement,” or ASTM E1965, “Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature,” or ASTM E1112, “Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature,” or ASTM E1104, “Standard Specification for Clinical Thermometer Probe Covers and Sheaths”) must validate specifications and performance of the device.