The Infrared Thermometer is intended for the measurement of human body temperatures. The forehead mode is indicated for people of all ages and the tympanic mode is indicated for people above three months old. The device can be used in the home setting and medical institutes.

Device Description

FC-IR series infrared thermometers (Models: FC-IR100, FC-IR101, FC-IR200, FC-IR300, FC-IR400) measure the body temperature through receiving infrared energy radiation via the ear or forehead. These thermometers have the capability to measure temperature via forehead temperature mode or ear temperature mode, and the temperature is directly shown on the LCD display.
The device is intended to be used in the home setting and medical institutes.
The product is mainly composed of infrared temperature sensors, signal receiving processor, buttons, buzzer, LCD display. It is powered by 2 X 1.5 AAA batteries.
It focuses the infrared energy received from the human's forehead or ear by using the Fresnel lens of the thermometer.
In addition, when measuring the ear temperature, the ear cover must be used by all thermometer models except for the FC-IR200. FC-IR101 model incorporates Bluetooth technology to wirelessly transmit temperature reading to an APP.

AI/ML Overview

The provided text describes the 510(k) premarket notification for the Shenzhen Finicare Co., Ltd. Infrared Thermometer (models FC-IR100, FC-IR101, FC-IR200, FC-IR300, FC-IR400). The documentation focuses on demonstrating substantial equivalence to a predicate device (Shenzhen Brav Electronic Technologies Co., Ltd., EFT-165 Infrared Thermometer /K171214), rather than presenting a standalone study proving the device meets specific acceptance criteria for a novel AI/ML-based diagnostic/screening tool.

Therefore, the information requested in the prompt (specifically regarding acceptance criteria, expert opinion, MRMC studies, standalone algorithm performance, and ground truth establishment for AI/ML) is not applicable to this traditional medical device clearance. The document outlines a performance study for a thermometer, not an AI/ML-driven diagnostic device.

However, I can extract the information relevant to the performance testing of the Infrared Thermometer as described:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily relies on adherence to recognized standards and comparative equivalence to a predicate device rather than presenting a specific table of device-specific acceptance criteria with corresponding performance numbers in the way one would for an AI/ML system.
The key "acceptance criteria" for this type of device are primarily compliance with accuracy standards and other regulatory requirements.

Acceptance Criteria (Standard Compliance / Equivalence)	Reported Device Performance / Compliance
Accuracy (Body Mode)	±0.2°C (0.4°F) - Same as predicate
Measurement Range	32.0°C ~ 42.9°C (89.6°F ~ 109.2°F) - Same as predicate
Biocompatibility	Complies with ISO 10993-1 (Cytotoxicity, Skin Sensitization, Skin Irritation tests conducted)
Reprocessing (Cleaning and Disinfection)	Validation testing results are adequate and acceptable
Electrical Safety and EMC	Complies with ANSI/AAMI ES60601-1, IEC 60601-1-11, and IEC 60601-1-2
Bench Testing (Performance Effectiveness)	Complies with ISO 80601-2-56
Software Verification and Validation	Complies with FDA Guidance for "moderate level of concern" software
Risk Analysis	Conducted in accordance with ISO 14971: 2007
Clinical Performance (Patient Temperature Measurement)	Conducted per ASTM E 1965-98 (2009)

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size for Clinical Study: A minimum of 144 subjects across various age groups.
Data Provenance: The document does not explicitly state the country of origin for the clinical study. It implies a prospective clinical study given "clinical testing was conducted".

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not applicable / Not explicitly stated. For a clinical thermometer, true core body temperature obtained via a reference method (e.g., rectal thermometer for infants, oral or axillary for adults where appropriate) serves as the ground truth. This is not a diagnostic device requiring expert consensus for image interpretation.

4. Adjudication Method for the Test Set:

Not applicable. This device measures temperature, and its accuracy is validated against established temperature measurement methods, not through an adjudication process of human interpretation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No. This type of study is for evaluating human reader performance with and without AI assistance for diagnostic tasks. This is a thermometer, not an AI diagnostic tool.

6. If a Standalone (algorithm only without human-in-the-loop performance) was done:

Not applicable directly as an "algorithm." The core "algorithm" is the thermometer's internal processing for temperature conversion. The bench testing and clinical testing evaluate the device's standalone performance in measuring temperature.

7. The Type of Ground Truth Used:

Clinical temperature measurements from subjects (presumably against a reference standard thermometer). The clinical study was conducted per ASTM E 1965-98 (2009) "Standard Specification for Infrared Thermometers For Intermittent Determination Of Patient Temperature," which outlines methods for establishing this ground truth.

8. The Sample Size for the Training Set:

Not applicable. This is a hardware device with embedded software, not a machine learning model developed with a distinct "training set" in the AI sense.

9. How the Ground Truth for the Training Set was Established:

Not applicable. (See point 8).

Summary

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January 2, 2019

Shenzhen Finicare Co., Ltd. Chao Li General Manager Room 201, A Building NO. 1 Qianwan Road Shengang Cooperative Zone, Qianhai Shenzhen, 518052 China

Re: K181215

Trade/Device Name: Infrared Thermometer Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: July 17, 2018 Received: August 13, 2018

Dear Chao Li:

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 avare 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.

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Geeta K. Pamidimukkala -S

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K181215

Device Name

Infrared thermometer, models FC-IR100, FC-IR101, FC-IR200, FC-IR300, FC-IR400

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

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K181215

510(k) Summary

Prepared in accordance with the requirements of 21 CFR Part 807.92

1. Submitter:	Shenzhen Finicare Co., Ltd.
	Room 201, A Building, NO.1 Qianwan Road, Shengang Cooperative Zone, Qianhai, Shenzhen,
	China, 518052, Shenzhen, P.R. China
	Tel.: +86 -755-23013503
	Fax: +86 -755-23574425
ContactPerson:	Chao Li
Preparedate:	2018-03-31
2. Devicename andclassification:	Device Name: Infrared Thermometer
	Models: FC-IR100, FC-IR101, FC-IR200, FC-IR300, FC-IR400
	Classification Name:
	21 CFR 880.2910
	Clinical Electronic Thermometers-Temperature Monitor with Probe
	Product code: FLL
	Regulatory Class: Class II
3. Reason forSubmission	New Application.
4. PredicateDevice(s):	Shenzhen Brav Electronic Technologies Co., Ltd., EFT-165 Infrared Thermometer /K171214
5. DeviceDescription:	FC-IR series infrared thermometers (Models: FC-IR100, FC-IR101, FC-IR200, FC-IR300, FC-IR400) measure the body temperature through receiving infrared energy radiation via the ear or forehead. These thermometers have the capability to measure temperature via forehead temperature mode or ear temperature mode, and the temperature is directly shown on the LCD display.
	The device is intended to be used in the home setting and medical institutes.The product is mainly composed of infrared temperature sensors, signal receiving processor, buttons, buzzer, LCD display. It is powered by 2 X 1.5 AAA batteries.It focuses the infrared energy received from the human's forehead or ear by using the Fresnel lens of the thermometer.

In addition, when measuring the ear temperature, the ear cover must be used by all thermometer models except for the FC-IR200. FC-IR101 model incorporates Bluetooth technology to wirelessly transmit temperature reading to an APP.

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Model(s)Configuration	FC-IR100	FC-IR101	FC-IR200	FC-IR300	FC-IR400
Internal Battery	√	√	√	√	√
°C/°F Transaction	√	√	√	√	√
Forehead Measurement	√	√	√	×	×
TympanicMeasurement	√	√	×	√	√
Ear Cover	√	√	×	√	√
Bluetooth	×	√	×	×	×
High Temperature Hint	√	√	√	√	√
Backlight	√	√	√	√	√

6. Indications for Use:

7. Predicate Device Comparison

In comparison to the predicate device, the subject device has the same intended use, similar product design, same performance effectiveness, and performance safety as the predicate device.

Please refer to the following table that notes differences between the subject device and predicate device. All the differences do not affect the basic design principle, usage, effectiveness and safety of the subject device. No new questions are raised regarding effectiveness and safety.

ITEM	Proposed DeviceFC-IR series	Predicate DeviceEFT-165/K171214	ComparisonResult
Manufacture	Shenzhen Finicare Co., Ltd.	Brav Electronic TechnologiesCo., Ltd.	---
Indications forUse	The Infrared Thermometer isintended for the measurement ofhuman body temperatures. Theforehead mode is indicated forpeople of all ages and thetympanic mode is indicated forpeople above three months old.The device can be used in thehome setting and medicalinstitutes.	The infrared thermometer isintended for the measurementand monitoring of human bodytemperature by doctor orcustomers in the hospital orhome.	Different
Operational Specifications
OperationalPrinciple	Infrared radiation detection	Infrared radiation detection	Same
Measuring Mode	Forehead and ear	Forehead and ear	Same

MeasurementRange	$32.0°C~~42.9°C$$(89.6°F~~109.2°F)$	$32.0°C~~42.9°C$$(89.6°F~~109.2°F)$	Same
MeasurementDistance	0 cm	0 cm	Same
Accuracy	Body Mode: ±0.2°C(0.4°F)	Body Mode: ±0.2°C(0.4°F)	Same
Memory DataLimit	memorize 20 measurementsautomatically	memorize 20 measurementsautomatically	Same
Productconfiguration	It is mainly composed withinfrared sensor, signal receivingprocessor, buttons, buzzer, LCDdisplay, battery and etc.	It is mainly composed withinfrared sensor, signal receivingprocessor, buttons, buzzer, LCDdisplay, battery and etc.	Same
Temperature unitand conversion	Dual temperature units “°C” and“°F” optional, and the two unitscan convert by the conversionkey automatically	Dual temperature units “°C” and“°F” optional, and the two unitscan convert by the conversionkey automatically	Same
BluetoothCompatible	YES (FC-IR 101 only)	YES	Same
ApplicableStandards	AAMI ANSI ES60601-1, IEC60601-1-2, IEC 60601-1-11, andASTM E1965-98, ISO 10993-5,ISO 10993-10	AAMI ANSI ES60601-1, IEC60601-1-2, IEC 60601-1-11, andASTM E1965-98, ISO 10993-5,ISO 10993-10	Same
Display	$0.1°C/°F$ , LCD	$0.1°C/°F$ , LCD	Same
OperatingEnvironment	15°C ~ 35°C (59°F to 95 °F)<85% moisture condensation	15°C ~ 35°C (59°F to 95 °F)<85% moisture condensation	Same
StorageEnvironment	-20°C~~55°C(-4°F~~131°F)≤90%moisture condensation	-20°C~~55°C(-4°F~~131°F)≤90%moisture condensation	Same
Power supply	2 X 1.5V AAA	2 X 1.5V AAA	Same
Physical Specifications
Weight	70g (without battery)	72 g (without battery)	Different
Dimensions(length x width xheight)	FC-IR100:163 mm 39 mm 39mmFC-IR101:163 mm 39 mm 39mmFC-IR200:166 mm 53 mm 41 mmFC-IR300:122 mm 59 mm 41mmFC-IR400:161 mm 68 mm 43mm	152mm * 44 mm *30mm
Biological Specifications
PatientContactingMaterials	ABS	ABS	Same
PatientContacting	Surface-contacting,Less than 24 h	Surface-contacting,Less than 24 h	Same

Table 1 Comparison between the main predicate device EFT-165 and the subject device

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As seen in the comparison tables, the subject and predicate devices have almost the same design features and performance specifications. The only differences between the subject and predicate devices are the indications for use (which link specific age groups with specific modes of temperature reading) and the appearance and operating/storage environment, which do not raise different questions of safety or effectiveness. Moreover, as demonstrated in the non-clinical testing, the different indications and

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technological characteristics do not affect the safety and effectiveness of the FC-IR series Infrared thermometer system.

8. Performance Testing:

Performance data includes "Non-Clinical Data" and "Clinical Data". Summary of the data provided is below:

Non-Clinical Data:

The following performance data were provided in support of the substantial equivalence determination.

Biocompatibility testing

The biocompatibility evaluation for the FC-IR series Infrared thermometer was 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 a duration of less than 24 hours. The following tests were conducted: |Cytotoxicity

■Skin Sensitization

Skin Irritation

Reprocessing: Cleaning and Disinfection

The sterilization and shelf life information provided are acceptable because the subject devices are non-sterile devices. The validation testing results for cleaning and disinfection of the subject devices are adequate and acceptable.

Electrical safety and electromagnetic compatibility (EMC)

Electrical safety and EMC testing were conducted on the FC-IR series Infrared thermometer device. consisting of all the modules and accessories in the system complies with 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, IEC 60601-1-11: 2010 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, 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 FC-IR series Infrared thermometer device, consisting of all the accessories in the system. The system complies with 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 for performance effectiveness.

Software Verification and Validation Testing

Software documentation including verification was provided in accordance with FDA Guidance: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices for software with a moderate level of concern.

Risk Analysis

A risk analysis was conducted in accordance with ISO 14971: 2007 - Medical devices - Application of risk management to medical devices.

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Clinical data:

Clinical testing was conducted per ASTM E 1965-98 (2009) Standard Specification for Infrared Thermometers For Intermittent Determination Of Patient Temperature. This clinical study was randomized, with a simple blind homologous control, which consisted of a minimum of 144 subjects with the various age groups as referenced in Section 201.102 of ISO 80601-2-56.

9. Substantial Equivalence Conclusion:

Differences between the indications for use and technological characteristics of the subject device compared to the predicate do not raise different questions of safety and effectiveness. The performance of the device is supported by non-clinical testing, clinical testing, and risk management activities. The Shenzhen Finicare Co., Ltd. FC-IR Series Infrared Thermometer is Substantially Equivalent (SE) to the Shenzhen Brav Electronic Technologies Co., Ltd., EFT-165 Infrared Thermometer, cleared under 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.