Infrared Thermometer is intended to detect body temperature from forehead in the population including infant (above 6 months), child, adolescent, and adult.

Device Description

The proposed device, Infrared Thermometers, which includes model FR800 and FR850 are hand-held, reusable, battery powered device, which are intended to detect body temperature from forehead for infant (above 6 months), child, adolescent, and adult.

The proposed device is intended for non-contacting infrared temperature measurement. The distance of the measurement is 3cm~5cm.

The proposed device uses a temperature sensor, which can detect the object temperature [human body temperature], environment temperature and temperature of sensor itself; these temperatures are then transfer to electronic signal and amplified; and then it is transferred to digital signal by AD module in MCU of the proposed device. MCU will calculate the body temperature, and then transfer to screen for display.

AI/ML Overview

The Infrared Thermometer, Models FR800 and FR850, underwent non-clinical and clinical testing to demonstrate its substantial equivalence to the predicate device, Microlife Digital Infrared Forehead Thermometer, Model FR1MN1-1 (K161728).

1. Acceptance Criteria and Reported Device Performance:

Criteria	Acceptance Criteria	Reported Device Performance
Accuracy	Proposed device accuracy:	Demonstrated compliance with ISO 80601-2-56 and ASTM E 1965-98 (R 2016). Specific accuracy data not provided in this summary, but the conclusion states "the clinical accuracy of the proposed device is not inferior to that of predicate device."
-	±0.2°C at 35.0°C-42.0°C
-	±0.4°F at 95°F-107.6°F
-	±0.3°C at other temperatures
-	±0.5°F at other temperatures
Measurement Range	Proposed device range: 32.0°C-42.9°C	Bench testing confirmed the proposed device can accurately measure within this wider range.
Electrical Safety	Compliance with IEC 60601-1	Complied with AAMI / ANSI ES60601-1:2005/(R) 2012 and A1:2012, c1:2009/(R)2012 and A2:2010/(R)2012.
EMC	Compliance with IEC 60601-1-2	Complied with IEC 60601-1-2:2014.
Performance Standard	Compliance with ISO 80601-2-56 and ASTM E 1965-98 (R 2016)	Complied with ISO 80601-2-56 First Edition 2009-10-01 and ASTM E 1965-98 (R 2016).
Biocompatibility	Compliance with ISO 10993-5 (in vitro cytotoxicity) and ISO 10993-10 (irritation and skin sensitization)	Complied with ISO 10993-5:2009 and ISO10993-10:2010.
Software V&V	Compliance with FDA guidance for software in medical devices.	Software verification and validation data was completed as recommended in the FDA guidance document.
Clinical Accuracy	Not inferior to predicate device (Microlife Digital Infrared Forehead Thermometer, Model FR1MN1-1). Clinical bias, clinical uncertainty, and clinical repeatability evaluated per clinical validation for infrared thermometer.	The clinical trial results verify that the clinical accuracy of the proposed device is not inferior to that of predicate device. Specific numerical results for clinical bias, uncertainty, or repeatability were not provided in this summary.
Intended Use	Detect body temperature from forehead in population including infant (above 6 months), child, adolescent, and adult.	Successfully demonstrated suitability for its stated intended use. Acknowledged that the subject device's user population (above 6 months) is a subset of the predicate's (all ages), concluding this difference does not raise new safety or effectiveness questions.

2. Sample Size for Test Set and Data Provenance:

Sample Size: Not explicitly stated in the provided text for the clinical study. It mentions "Controlled human clinical studies were conducted," but not the number of subjects.
Data Provenance: Not explicitly stated (e.g., country of origin). The testing was conducted in accordance with ASTM E 1965-98(2003) which is an American standard, implying the study might adhere to practices commonly found in regions where this standard is adopted, but specific origin is not mentioned. The sponsor and correspondent are based in China, suggesting the possibility of data collection there or involvement of Chinese entities in the study.

3. Number of Experts and Qualifications:

This information is not provided in the given document. The document refers to non-clinical and clinical testing, but does not detail the specific involvement or qualifications of experts for establishing ground truth within the clinical trial context.

4. Adjudication Method for the Test Set:

This information is not provided in the given document.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned or performed. The clinical testing focused on the standalone performance of the device ("clinical accuracy of the proposed device is not inferior to that of predicate device") rather than its effect on human reader performance.

6. Standalone Performance Study:

Yes, a standalone (algorithm only without human-in-the-loop performance) study was done. The non-clinical tests (Electrical Safety, EMC, Performance standards, Biocompatibility, Software V&V) and the clinical accuracy evaluation directly assess the device's inherent performance. The clinical study evaluated the device's standalone ability to measure body temperature accurately, comparing it to the performance requirements in standards and to the predicate device.

7. Type of Ground Truth Used:

For the clinical study, the ground truth was based on clinical validation for infrared thermometer following ASTM E 1965-98(2003). This standard typically involves comparing the device's readings against a highly accurate reference thermometer (e.g., a mercury-in-glass or electronic contact thermometer in a controlled environment), often with a core body temperature measurement as the gold standard. The document states "clinical bias, clinical uncertainty and clinical repeatability have been evaluated per clinical validation."

8. Sample Size for the Training Set:

This information is not applicable as this device (Infrared Thermometer) is a hardware medical device that directly measures a physical parameter. It does not use algorithms that require a "training set" in the context of machine learning. The "software verification and validation" mentioned refers to traditional software engineering processes, not machine learning model training.

9. How Ground Truth for Training Set Was Established:

This information is not applicable for the same reason as point 8.

Summary

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July 12, 2018

Shenzhen Jiacom Technology Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co., Ltd. P.O Box 120-119 Shanghai, 200120 China

Re: K172874

Trade/Device Name: Infrared Thermometer, Model FR800 and FR850 Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: June 5, 2018 Received: June 14, 2018

Dear Diana Hong:

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. 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 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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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. Digitally signed by Alan M. Alan M. Stevens -S DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, 0.9.2342.19200300.100.1.1=1300 Stevens 189211, cn=Alan M. Stevens -S Date: 2018.07.12 14:55:51 -04'00' 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) K172874

Device Name Infrared Thermometer Model: FR800 and FR850

Indications for Use (Describe)

Infrared Thermometer is intended to detect body temperature from forehead in the population including infant (above 6 months), child, adolescent, and adult.

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

This 510(k) Summary is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.

The assigned 510(k) Number: K172874

1. Date of Preparation: 6/19/2018
1. Sponsor Identification

Shenzhen Jiacom Technology Co ., Ltd

No. A6 Building, Silicon Valley Power, Qinghu Park, Longhua Street, Bao'an District, Shenzhen, Guangdong, 518109, China

Establishment Registration Number: Not yet registered.

Contact Person: Luo Tianfeng Position: Registration specialist Tel: +86-755-29015600 Fax: +86-755-29575792 Email: zhongjingming@szjiakang.com

1. Designated Submission Correspondent
  Mr. Chengyu Wang (Consulting Engineer) Mid-Link Consulting Co., Ltd P.O. Box 120-119, Shanghai, 200120, China Tel: +86(0)21 2281-5850 Fax: +1(0)360 925-3199 Email: info@mid-link.net
Identification of Proposed Device 4.
Trade Name: Infrared Thermometer, Model(s): FR800 and FR850 Common Name: Clinical electronic thermometer Model(s): FR800 and FR850

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Regulatory Information Classification Name: Clinical electronic thermometer Classification: Class II Product Code: FLL Regulation Number: 21 CFR 880.2910 Review Panel: General Hospital

Indications for Use:

Infrared Thermometer is intended to detect body temperature from forehead in the population including infant (above 6 months), child, adolescent, and adult.

Device Description

The proposed device is intended for non-contacting infrared temperature measurement. The distance of the measurement is 3cm~5cm.

న్. Identification of Predicate Device(s)
510(k) Number: K161728 Device Name: Microlife Digital Infrared Forehead Thermometer, Model FR1MN1-1
Substantially Equivalent (SE) Comparison 6.

ITEM	Proposed device	Predicate Device
	K172874	K161728
Product Code	FLL	FLL
Regulation Number	21 CFR 880.2910	21 CFR 880.2910
Indications for Use	Infrared Thermometer is intended todetect body temperature from foreheadin the population including infant	The Microlife Digital InfraredForehead Thermometer, ModelFR1MN1-1 is intended for the
	(above 6 months), child, adolescent, and adult.	intermittent measurement andmonitoring of human bodytemperature. The device is indicatedfor use by people of all ages in thehome.
Measurement Site	Forehead	Forehead
Principle ofOperation	Non-contacting, Infrared TemperatureMeasurement	Non-contacting, Infrared TemperatureMeasurement
Device features	Display type: LCD	Display type: LCD
	Activation: Scan button	Activation: Scan button
	Have Memory function	Have Memory function
	Have backlight	Have backlight
	Have beeper indication	Have beeper indication
Range	32.0°C-42.9°C	34.0°C-42.2°C
Accuracy	±0.2°C at 35.0°C-42.0°C±0.4°F at 95°F-107.6°F±0.3°C at others±0.5°F at others	0.4 °F, 96.8 ~ 102.2 °F
Display type	LCD	LCD
Activation	Scan button	Scan button
Power requirements	3Vdc	3Vdc.
Electrical Safety	Complied with IEC 60601-1	Complied with IEC 60601-1
EMC	Complied with IEC 60601-1-2	Complied with IEC 60601-1-2
Performance	Complied with ISO 80601-2-56	Complied with ISO 80601-2-56
	Complied with ASTM E 1965 -98(2003)	Complied with ASTM E 1965 -98(2003)
Patient-contactcomponent andmaterial	Enclosure: Acrylonitrile ButadieneStyrene (ABS)Color additive: Titanium dioxide	Unknown
Biocompatibility	Complied with ISO 10993-5Complied with ISO 10993-10	Complied with ISO 10993-5Complied with ISO 10993-10

Table 1 Comparison of Technology Characteristics

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The subject device is used for above 6 months patients. However, the predicate is used for all ages. The user population of the subject device is subset of the predicate. Therefore, this difference does not raise new safety and effectiveness questions.

The measurement range and accuracy of proposed device and predicate device is different.

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Measurement range of proposed device is wider than that of the predicate device. Bench test included in this submission demonstrated that the proposed device can measure this range accurately. The measurement accuracy of proposed device is slightly different from that of the predicate device. However, the specifications of the proposed device comply with the current ISO and ASTM Standards. Therefore, these differences do not raise new questions of safety and effectiveness.

Although we do not know the patient-contact component and material of predicate device, the biocompatibility of proposed device meets ISO 10993 and is equivalent to the predicate.

1. Non-Clinical Tests
  Non clinical tests were conducted to verify that the proposed device met all design specifications and is Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
ISO 10993-5:2009 Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity
ISO10993-10:2010 Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization
AAMI / ANSI ES60601-1:2005/(R) 2012 and A1:2012, c1:2009/(R)2012 and A2:2010/(R)2012 medical electrical equipment - part 1: general requirements for basic safety and essential performance.
A IEC 60601-1-2:2014, Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility -Requirements And Tests.
A ISO 80601-2-56 First Edition 2009-10-01, Medical Electrical Equipment - Part 2-56: Particular Requirements For Basic Safety And Essential Performance Of Clinical Thermometers For Body Temperature Measurement.
ASTM E 1965-98 (R 2016). Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature

Software verification and validation data was completed as recommended in the FDA guidance document, Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.

All the tests results of above tests, complied with the requirements of its pre-defined acceptance criteria and intended uses.

8. Clinical Test Conclusion

Controlled human clinical studies were conducted in accordance with ASTM E 1965-98(2003), clinical bias, clinical uncertainty and clinical repeatability have been evaluated per clinical validation for infrared thermometer. The clinical trial results verify that the clinical accuracy of the proposed device is not inferior to that of predicate device.

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Substantially Equivalent (SE) Conclusion 9.
Based on the comparison and analysis above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate device.

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.