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

Device Description

The proposed device, Infrared Thermometers IFR 600 is hand-held, reusable, battery powered device, which is intended to detect body temperature from forehead or auditory canal in the pediatric and adult population.

IFR 600 infrared thermometer can measure human body temperature by both ear and forehead measurement.

AI/ML Overview

The provided document describes the acceptance criteria and a clinical study conducted for the Infrared Thermometer Model IFR 600 by Shenzhen Jiacom Technology Co., Ltd.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally based on compliance with specific international standards and the clinical accuracy of the device. The reported performance confirms this compliance.

Acceptance Criteria for Infrared Thermometer Model IFR 600

Acceptance Criteria Category	Specific Criteria (Standard/Requirement)	Reported Device Performance
Biocompatibility	ISO 10993-5:2009 (Tests for in vitro cytotoxicity)	Complied with ISO 10993-5
	ISO 10993-10:2010 (Tests for irritation and skin sensitization)	Complied with ISO 10993-10
Electrical Safety	AAMI / ANSI ES60601-1:2005/(R) 2012 (General requirements for basic safety and essential performance)	Complied with IEC 60601-1
Electromagnetic Compatibility (EMC)	IEC 60601-1-2:2014 (Requirements and Tests)	Complied with IEC 60601-1-2
Performance (Clinical Thermometers)	ISO 80601-2-56:2009 (Particular Requirements for Basic Safety and Essential Performance of Clinical Thermometers)	Complied with ISO 80601-2-56
Performance (Infrared Thermometers)	ASTM E1965-98 (R 2016) (Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature)	Complied with ASTM E1965-98 (2003)
Clinical Accuracy (Ear Mode)	±0.2°C at 35.5°C-42.0°C; ±0.3°C at 32.0-35.0°C and 42.0°C-42.9°C (Aligned with ASTM E1965-98)	Achieved; clinical accuracy not inferior to predicate device and complies with ASTM E1965-98.
Clinical Accuracy (Forehead Mode)	±0.2°C at 35.5°C-42.0°C; ±0.3°C at 34.0-35.4°C and 42.1°C-42.9°C (Aligned with ASTM E1965-98)	Achieved; clinical accuracy not inferior to predicate device and complies with ASTM E1965-98.
Clinical Bias	Not explicitly stated as a numerical limit, but evaluation per ASTM E 1965-98(2003)	Not inferior to predicate device.
Clinical Uncertainty	Not explicitly stated as a numerical limit, but evaluation per ASTM E 1965-98(2003)	Not inferior to predicate device.
Clinical Repeatability	Not explicitly stated as a numerical limit, but evaluation per ASTM E 1965-98(2003)	Not inferior to predicate device.

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

Sample Size for Clinical Study (Test Set): "40 of each age range of subjects" were included. The document specifies the population as "infant (above 6 months), child, adolescent, and adult". It's unclear how many distinct age ranges were used, so the total exact sample size is not precisely specified but would be 40 multiplied by the number of age ranges. For example, if there were 4 age ranges (infant, child, adolescent, adult), the total would be 160.
Data Provenance: Not explicitly stated (e.g., country of origin). The study is described as "Controlled human clinical studies," suggesting it was prospective research.

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

The document does not provide information on the number of experts used or their qualifications for establishing ground truth for the clinical study. It refers to "clinical validation for infrared thermometer" and compliance with ASTM E 1965-98 for evaluating clinical bias, uncertainty, and repeatability.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method for the test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

A multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned. The study compared the device's clinical accuracy, bias, uncertainty, and repeatability to that of a predicate device, but not in the context of human readers improving with or without AI assistance. The device itself is a standalone infrared thermometer, not an AI-assisted diagnostic tool for human readers.

6. If a Standalone Study Was Done

Yes, a standalone study was done. The clinical tests were performed to evaluate the performance of the Infrared Thermometer Model IFR 600 by itself, specifically its clinical accuracy, bias, uncertainty, and repeatability, in comparison to a predicate device and against the requirements of ASTM E 1965-98.

7. The Type of Ground Truth Used

The ground truth for the clinical study was established by comparison with established methods or references for body temperature measurement, implicitly defined by the clinical validation requirements of ASTM E 1965-98 (Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature). The document refers to evaluating "clinical bias, clinical uncertainty and clinical repeatability." The ASTM standard typically outlines how to establish reference body temperatures against which the infrared thermometer's readings are compared.

8. The Sample Size for the Training Set

This question is not applicable as the device is a medical device (infrared thermometer) and not an AI/Machine Learning algorithm that requires a "training set" in the conventional sense. The "training" here refers to product development and testing, where the device's design is refined to meet the performance standards.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable for the same reason as point 8. The "ground truth" for the device's performance was established through compliance with recognized standards (ISO, ASTM) and clinical validation against these standards.

Summary

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May 17, 2018

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

Re: K172894

Trade/Device Name: Infrared Thermometer Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: April 16, 2018 Received: April 18, 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.

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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); good manufacturing practice requirements as set forth in the quality systems (OS) 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-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.

Tina Kiang
S

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) K172894

Device Name Infrared Thermometer

Indications for Use (Describe)

Infrared Thermometer is intended to detect body temperature from the forehead or auditory canal 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: K172894

1. Date of Preparation: 5/14/2018
Sponsor Identification 2.

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

3. Designated Submission Correspondent

Ms. Diana Hong (Primary Contact Person) Ms. Betty Xiao (Alternative Contact Person)

Mid-Link Consulting Co., Ltd

P.O. Box 120-119, Shanghai, 200120, China

Tel: +86-21-22815850, Fax: 360-925-3199 Email: info@mid-link.net

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4. Identification of Proposed Device

Trade Name: Infrared Thermometer Common Name: Clinical electronic thermometer Model: IFR 600

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

Indication for Use Statement:

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

Device Description

IFR 600 infrared thermometer can measure human body temperature by both ear and forehead measurement.

న్. Identification of Predicate Device(s)
510(k) Number: K111463 Product Name: Valeo VT-601 Series ZR Thermometer
1. Non-Clinical Test Conclusion
  Non clinical tests were conducted to verify that the proposed device met all design specifications as was 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

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A 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.
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.
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.
A ASTM E1965-98 (R 2016), Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature

The proposed device is tested to evaluate its electrical safety and electromagnetic compatibility. The test results demonstrated that the proposed device complies with the standards.

1. 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.

40 of each age range of subjects are included in the clinical studies, the amounts of male subjects are the same with that of female subjects, and 35%~37.5% of total subjects are febrile person. Compared statistical result of clinical bias and clinical repeatability of two comparison groups, the result of proposed device is not being inferior to that of predicate device. The result of proposed device was not inferior to that of predicate device, and the proposed device complies with ASTM E1965-98.

Substantially Equivalent (SE) Comparison 8.

ITEM	Proposed device	Predicate Device
Product Code	FLL	K111463
Regulation Number	21 CFR 880.2910	21 CFR 880.2910
Indications for Use	Infrared Thermometer is intended to detect body temperature from the forehead or auditory canal in the	The Valeo VT-601 Series IR Thermometer, (Model no.: VT-601D, VT-601E, VT-601F) is infrared thermometers intended for the intermittent measurement of human body

Table 1 Comparison of Technology Characteristics

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	population including infant(above 6 months), child,adolescent, and adult.	temperature in people of all ages.
MeasurementSite	Forehead and eardrum		Forehead and eardrum
PrincipleofOperation	Non-contacting,InfraredTemperature Measurement		Non-contacting,InfraredMeasurement
Ear Mode
Range	32.0°C-42.9°C		32.0°C-42.9°C
Accuracy	±0.2°C at 35.5°C-42.0°C		±0.2°C at 36.0°C-39.0°C
	±0.3°C at 32.0-35.0°C and42.0°C-42.9°C		Others ±0.3°C
Forehead Mode
Range	34. 0°C-42.9°C		22.0°C-42.2°C
Accuracy	±0.2°C at 35.5°C-42.0°C±0.3°C at 34.0-35.4°C and42.1°C-42.9°C		±0.3°C at 22.0°C-40.0°C
Display type	LCD		LCD
Activation	Scan button		Scan button
Powerrequirements	3Vdc		3Vdc.
Material	Enclosure and key: ABS(Acrylonitrile ButadieneStyrene)Color additive: Titaniumdioxide and Phthalocyanineblue		Unknown
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 80601-2-56Complied with ASTM E1965-98 (2003)		Complied with ISO 80601-2-56Complied with ASTM E1965 -98 (2003)
Biocompatibility	Cytotoxicity	Compliedwith ISO10993-5	Cytotoxicity	Complied with ISO10993-5

	Irritation	Compliedwith ISO10993-10	Irritation	Complied with ISO10993-10

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	with ISO10993-10	10993-10
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The proposed device and predicate device have the same measurement site, principle of operation and power requirement. Although the measurement range and accuracy are different, they comply with ISO 80601-2-56 and ASTM E 1965-98(2006), thus the difference will not arise the issues related to safety and effectiveness. The materials of predicate are not known, however, the proposed device has been conducted cytotoxicity, irritation and sensitization to demonstrate its biocompatibility. And both the proposed device and predicate device are conducted electrical safety and EMC testing according to IEC 60601-1 and IEC 60601-1-2, the test result shows the proposed device meets the requirements of these standards. Therefore, the proposed device and predicate device can be considered as substantially equivalent.

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

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.