The AT-6XX Series Infrared Thermometer (with models AT-601 and AT-606) is intended for body temperature measurement from the auditory canal for infants and adults without contact to human body. It can be used by consumers in household environment and doctor in clinic as reference.

Device Description

The AT-6XX Series Infrared Thermometer (with models AT-601 and AT-606) is an electronic thermometer using an infrared sensor (thermopile) to detect body temperature from the auditory canal. It uses infrared probe to detect the radiated infrared energy emitted by the object, solid, liquid or gas. The intensity of the emitted energy depends on the temperature of the object. The infrared probe (Thermopile) can recognize it and transfer to the proper electronic signal. The electronic signal can be processed in the Infrared Thermometer to convert to the temperature reading, which is displayed on the LCD. Therefore, the subject device is able to measure the temperature of a person by the energy the person emits. The thermometer consists mainly of two parts - an IR sensor with a built-in ambient temperature sensor and the associated circuit. To measure body temperature, the probe of the thermometer is inserted into a patient's outer ear canal. Pressing the activation button to start the measurement of target's infrared radiation. The electrical signal read out from the detector is fed to the circuit for amplification and calculation. The final measured temperature will be appeared on a LCD display. The total operation takes a few seconds.

AI/ML Overview

The provided 510(k) summary describes the acceptance criteria for the AT-6XX Series Infrared Thermometer (models AT-601 and AT-606) in terms of its accuracy and the study conducted to prove it meets these criteria.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the device's accuracy are directly inherited from the international standard ISO 80601-2-56:2009 for clinical electronic thermometers.

Acceptance Criteria (Accuracy)	Reported Device Performance (Accuracy) *
$\pm$ 0.2°C (35°C~42°C)	$\pm$ 0.2°C (35°C~42°C)
$\pm$ 0.3°C (outside of 35°C~42°C)	$\pm$ 0.3°C (outside of 35°C~42°C)

Note: The document states "Clinical test results demonstrated that the subject device performs substantially equivalent to the predicate device." and lists the same accuracy specifications for the subject device as the predicate device. Therefore, the reported device performance is inferred to meet or exceed these specifications.

2. Sample Size and Data Provenance

The document states that a "clinical accuracy evaluation has been conducted according to clause 201.102 of ISO 80601-2-56:2009." However, the specific sample size used for the test set and the data provenance (e.g., country of origin, retrospective or prospective) are not detailed in this 510(k) summary.

3. Number and Qualifications of Experts for Ground Truth

This information is not provided in the 510(k) summary. For a clinical accuracy evaluation of a thermometer, "ground truth" typically refers to core body temperature measured by a highly accurate reference method (e.g., rectal or arterial catheter temperature). The involvement and qualifications of experts to establish this ground truth are not mentioned.

4. Adjudication Method

The 510(k) summary does not mention an adjudication method. This is usually not applicable for basic device performance studies like thermometer accuracy, where the ground truth is established by a direct measurement.

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

No MRMC comparative effectiveness study was done or mentioned. This type of study is more relevant for diagnostic imaging AI algorithms where human interpretation is involved. The AT-6XX Series Infrared Thermometer is a direct measurement device without human interpretation of complex data.

6. Standalone Performance (Algorithm Only)

The performance described for the device is its standalone performance. The device is an infrared thermometer, and its accuracy ($\pm$ 0.2°C / $\pm$ 0.3°C) refers to the algorithm's ability to convert infrared radiation into a temperature reading without human input in the measurement process itself.

7. Type of Ground Truth Used

The "clinical accuracy evaluation" for a thermometer typically establishes ground truth by comparing the device's readings to a highly accurate and validated reference thermometer or core body temperature measurement method. While the document doesn't explicitly state the exact ground truth method, given the standard followed (ISO 80601-2-56:2009), it would involve comparison to a traceable temperature standard. It is not expert consensus, pathology, or outcomes data.

8. Sample Size for the Training Set

The 510(k) summary does not provide information on the sample size for a training set. For a simple device like an infrared thermometer, there might not be a "training set" in the sense of machine learning. The device's calibration and potentially some internal lookup tables are likely based on engineering and design specifications rather than a distinct training dataset for an algorithm.

9. How Ground Truth for the Training Set Was Established

This information is not provided. As mentioned above, it's unlikely a "training set" with ground truth in the machine learning sense was used. The ground truth for device calibration would have been established through a metrology process using precise temperature standards.

Summary

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510(K) SUMMARY

This summary of 510(k) information is being submitted in accordance with the requirements of 21 CFR 807.87(h) and 21 CFR 807.92.

Submitter:

Xiamen Acurio Instruments Co., Ltd 3rd-4th Floors, Biomedical Industry Park, No.2028, Wengjiao West Road, Haicang District, Xiamen, Fujian, 361026, CHINA

Contact Person: ●

Angel Liu General Manager Assistant Tel: 86-592-6312776 Fax: 86-592-6312776 Email: liushuzhen@acurio.cn

● Date Prepared:

May 12, 2017

Name of the Devices:

Device Common Name: Infrared Thermometer ●
Device Proprietary Name: AT-6XX Series Infrared Thermometer (with models AT-601 and AT-606)
Classification Name: Thermometer, electronic, clinical
Regulation Number:21CFR 880.2910
Product Code: FLL
Review Panel: General Hospital

Legally Marketed Predicate Device(s):

K131243 Non-contact Infrared Thermometer, Model JPD-FR 100

Indications for Use:

The AT-6XX Series Infrared Thermometer (with models AT-601 and AT-606) is

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intended for body temperature measurement from the auditory canal for infants and adults without contact to human body. It can be used by consumers in household environment and doctor in clinic as reference.

Device Description:

The AT-6XX Series Infrared Thermometer (with models AT-601 and AT-606) is an electronic thermometer using an infrared sensor (thermopile) to detect body temperature from the auditory canal.

It uses infrared probe to detect the radiated infrared energy emitted by the object, solid, liquid or gas. The intensity of the emitted energy depends on the temperature of the object. The infrared probe (Thermopile) can recognize it and transfer to the proper electronic signal. The electronic signal can be processed in the Infrared Thermometer to convert to the temperature reading, which is displayed on the LCD. Therefore, the subject device is able to measure the temperature of a person by the energy the person emits.

The thermometer consists mainly of two parts - an IR sensor with a built-in ambient temperature sensor and the associated circuit. To measure body temperature, the probe of the thermometer is inserted into a patient's outer ear canal. Pressing the activation button to start the measurement of target's infrared radiation. The electrical signal read out from the detector is fed to the circuit for amplification and calculation. The final measured temperature will be appeared on a LCD display. The total operation takes a few seconds.

Comparison to Predicate Devices:

The Substantial Equivalence Comparison Chat is provided as follows:

Comparison items	AT-601 infraredthermometer	JPD-FR100 infrareddual-mode thermometer	Comparisonresults
Name	Infrared thermometer	Infrared dual-modethermometer	Similar
Model	AT-601	JPD-FR100
Manufacturer	SHENZHEN ACURIOINSTRUMENTS CO., LTD.	Shenzhen Jumper MedicalEquipment Co., Ltd.
Management category	Ila	Ila	Identical
510(K) Number	/	K131243	N/A
CE Number	/
Structure	Mini body part, probe, lensfilter, LCD screen, batterydoor	Body part, probe, lens filter,LCD screen, battery door	Similar

Table1: Substantial Equivalence Comparison Chat between AT-601 and JPD-FR 100

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	Comparison items	AT-601 infraredthermometer	JPD-FR100 infrareddual-mode thermometer	Comparisonresults
	Materials	ABS plastic is used on theshell, and stainless steelmaterial is used on thetemperature sensor.	ABS plastic is used on theshell, and stainless steelmaterial is used on thetemperature sensor.	Similar
	Basic operating principle	The product providesnoninvasive and rapid bodytemperature measurement bydetecting the infrared energyemitted from the tympanicmembrane, and shows theresults by the LCD.	The product providesnoninvasive and rapid bodytemperature measurement bydetecting the infrared energyemitted from the tympanicmembrane, or forehead andshows the results by the LCD.	Same
	Battery	D.C.3.0V, CR2032	D.C. 3.0V, two 1.5V AAAbatteries	Similar
	Display unit	0.1 °C	0.1 °C	Identical
	Measuringrange	34°C~42.2°C	Forehead mode: 32°C~~42.2°CEar mode: 0°C~~100°C
Primarytechnicalperformanceindexes	Accuracy	$±$ 0.2°C (35°C~~42°C), $±$0.3°C (outside the range of35°C~~42°C)	Ear mode: $±$ 0.2°CForehead mode: $±$ 0.3°C	Similar
	Memoryfunction	9 sets of storage data	20 sets of storage data
	Dimensions(LWH)	58mm×58mm×66mm	N/A	N/A
	Weight	Approx. 80g (includingbatteries )	N/A	N/A
	Intended use	It is intended for theintermittent measurementand monitoring of bodytemperature.	It is intended for theintermittent measurement andmonitoring of bodytemperature.	Same
Measuring site		Ear	Ear, forehead	Samewhenmeasuring eartemperature

Table1: Substantial Equivalence Comparison Chat between AT-606 and JPD-FR 100

Comparison items	AT-606 infraredthermometer	JPD-FR100 infrareddual-mode thermometer	Comparisonresults
Name	Infrared thermometer	Infrareddual-modethermometer	Same
Model	AT-606	JPD-FR401
Manufacturer	ACURIOSHENZHENINSTRUMENTS CO., LTD.	ShenzhenJumperMedicalEquipment Co., Ltd.
Management category	Ila	Ila	Identical
510(K) Number		K131243	N/A
	Comparison items	AT-606 infrared thermometer	JPD-FR100 infrared dual-mode thermometer	Comparison results
	CE Number	/
	Structure	Body part, probe, lens filter, LCD screen, battery door	Body part, probe, lens filter, LCD screen, battery door	Similar
	Materials	ABS plastic is used on the shell, and stainless steel material is used on the temperature sensor.	ABS plastic is used on the shell, and stainless steel material is used on the temperature sensor.	Similar
	Basic operating principle	The product provides noninvasive and rapid body temperature measurement by detecting the infrared energy emitted from the tympanic membrane, and shows the results by the LCD.	The product provides noninvasive and rapid body temperature measurement by detecting the infrared energy emitted from the tympanic membrane or forehead, and shows the results by the LCD.	Same
	Battery	D.C.3.0V, 2*AAA	D.C. 3.0V, two 1.5V AAA batteries	Similar
	Display unit	0.1 °C	0.1 °C	Identical
Primarytechnicalperformanceindexes	Measuring range	34°C~42.2°C	Forehead mode: 32°C~~42.2°CEar mode: 0°C~~100°C
	Accuracy	± 0.2°C (35°C~~42°C), ± 0.3°C (outside the range of 35°C~~42°C)	Ear mode: ± 0.2°CForehead mode: ± 0.3°C	Similar
	Memory function	9 sets of storage data	20 sets of storage data
	Dimensions (LWH)	137mmX40mmX56mm	N/A	N/A
	Weight	Approx. 80g (including batteries)	N/A	N/A
	Intended use	It is intended for the intermittent measurement and monitoring of body temperature.	It is intended for the intermittent measurement and monitoring of body temperature.	Identical
Measuring site		Ear	Ear, forehead	Similar when measuring ear temperature

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510(K) Summary

Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence:

The Sponsor performed a risk assessment based on the differences from the predicate device and determined that the following non-clinical testing was necessary to demonstrate that the changes did not introduce any new risks to the subject device.

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Laboratory testing was conducted to validate and verify that the thermometers continued to meet all requirements of related international standards, including electrical safety, EMC, software, biocompatibility. Results of these tests demonstrated compliance to the requirements of the below consensus standards and FDA Guidance documents.

Electrical Safety and Performance:

1. IEC 60601-1:2005+A1:2012;
1. ISO 80601-2-56:2009.

Medical Electrical Equipment and medical Electrical Systems Used in the Home Healthcare Environment:

IEC 60601-1-11:2010+CORR.1:2011.

Electromagnetic Compatibility:

IEC 60601-1-2:2007.

Biocompatibility:

1. ISO 10993-5:2009
1. ISO 10993-10:2010

Software:

1. General Principles of Software Validation Final Guidance for Industry and FDA Staff.

Clinical Electronic Thermometers Guidance:

1. Guidance on the content of Premarket Notification[510(k)] Submission for clinical electronic thermometers
  Therefore, we conclude that the AT-6XX Series Infrared Thermometer (with models AT-601 and AT-606) is substantially equivalent to the predicate device.

Discussion of Clinical Tests Performed:

In order to demonstrate that the subject device did not introduce any new risks in comparison to the subject device a clinical accuracy evaluation has been conducted according to clause 201.102 of ISO 80601-2-56:2009. Clinical test results demonstrated that the subject device performs substantially equivalent to the predicate device.

Conclusions:

The AT-6XX Series Infrared Thermometer (with models AT-601 and AT-606) has the same intended use and similar characteristics as the predicate device. And based on performance data, we conclude that the AT-6XX Series Infrared Thermometer (with models AT-601 and AT-606) is substantially equivalent to the predicate device.

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February 9, 2018

Xiamen Acurio Instruments Co., Ltd Angel Liu General Manager Assistant 3rd-4th Floors, BI Park, No.2028 Wengjiao West Road, Haicang District Xiamen, Fujian 361026 CHINA

Re: K171455

Trade/Device Name: AT-6XX Series Infrared Thermometer (with models AT-601 and AT-606) Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: December 26, 2017 Received: January 2, 2018

Dear Angel Liu:

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 (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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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.

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

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.