K Number

Device Name

Infrared Thermometer

Manufacturer

Shenzhen Jiacom Technology Co., Ltd

Date Cleared

2018-07-12

(294 days)

Product Code

FLL

Regulation Number

880.2910

Intended 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, 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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K161728

Reference Devices

K161728

AI/ML (Artificial Intelligence / Machine Learning)

No
The description details a standard infrared temperature measurement process using a sensor, signal amplification, and an MCU for calculation, without mentioning any AI/ML algorithms or training/test data.

Therapeutic

No
The device is an infrared thermometer used for detecting body temperature, which is a diagnostic function, not a therapeutic one. It does not treat or cure any condition.

Diagnostic

The device is an infrared thermometer for measuring body temperature. While temperature can be a diagnostic indicator, the device itself is not described as diagnosing a condition, but rather as taking a measurement.

SaMD (Software as a Medical Device)

The device description explicitly states it is a "hand-held, reusable, battery powered device" and details hardware components like a temperature sensor, electronic signal amplification, AD module, and MCU. This indicates it is a physical hardware device, not software-only.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
Device Function: The Infrared Thermometer described here measures body temperature from the forehead. This is a direct measurement of a physiological parameter from the body's surface, not an analysis of a specimen taken from the body.
Intended Use: The intended use is to "detect body temperature from forehead," which aligns with a general medical device for monitoring a vital sign, not an IVD for analyzing biological samples.

Therefore, based on the provided information, this Infrared Thermometer falls under the category of a general medical device, not an In Vitro Diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes

FLL

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

forehead

Indicated Patient Age Range

infant (above 6 months), child, adolescent, and adult.

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

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.

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.

Key Metrics

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 (Proposed Device)
Range: 32.0°C-42.9°C (Proposed Device)

Predicate Device(s)

K161728

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left is the Department of Health & Human Services logo, which features a stylized human figure. To the right of that is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

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);

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

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

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 to
detect body temperature from forehead
in the population including infant	The Microlife Digital Infrared
Forehead Thermometer, Model
FR1MN1-1 is intended for the
	(above 6 months), child, adolescent, and adult.	intermittent measurement and
monitoring of human body
temperature. The device is indicated
for use by people of all ages in the
home.
Measurement Site	Forehead	Forehead
Principle of
Operation	Non-contacting, Infrared Temperature
Measurement	Non-contacting, Infrared Temperature
Measurement
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-contact
component and
material	Enclosure: Acrylonitrile Butadiene
Styrene (ABS)
Color additive: Titanium dioxide	Unknown
Biocompatibility	Complied with ISO 10993-5
Complied with ISO 10993-10	Complied with ISO 10993-5
Complied with ISO 10993-10

Table 1 Comparison of Technology Characteristics

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.

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

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.