AT-6XX Series Infrared Thermometer

• K Number: K171455
• Device Name: AT-6XX Series Infrared Thermometer
• Manufacturer: Xiamen Acurio Instruments Co., Ltd
• Date Cleared: 2018-02-09 ( 268 days)
• Product Code: FLL
• Regulation Number: 880.2910

Intended Use

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.

Predicate Devices

K131243

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description details a standard infrared thermometer using a thermopile sensor and basic electronic signal processing to convert infrared energy to a temperature reading. There is no mention of AI, ML, or any complex algorithms beyond basic signal conversion and calculation.

Therapeutic

No
The device is an infrared thermometer intended for measuring body temperature. It does not provide treatment or modify any body function, which are characteristics of a therapeutic device.

Diagnostic

Yes

Measuring body temperature can aid in diagnosing various health conditions, distinguishing this device as a diagnostic tool.

SaMD (Software as a Medical Device)

No

The device description explicitly details hardware components like an infrared sensor (thermopile), associated circuitry, and an LCD display, indicating it is a physical device, not software-only.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• IVD devices are used to examine specimens derived from the human body. The intended use and device description clearly state that this thermometer measures body temperature directly from the auditory canal using infrared radiation emitted by the body. It does not analyze any biological samples (like blood, urine, tissue, etc.).
• The measurement is performed in vivo (on the living body), not in vitro (in a test tube or other artificial environment).

Therefore, the AT-6XX Series Infrared Thermometer is a medical device, but it falls under the category of a non-IVD device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes (comma separated list FDA assigned to the subject device)

FLL

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

auditory canal, ear, tympanic membrane

Indicated Patient Age Range

infants and adults

Intended User / Care Setting

consumers in household environment and doctor in clinic

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 (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

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;
2. ISO 80601-2-56:2009.

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

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

Electromagnetic Compatibility:

1. IEC 60601-1-2:2007.

Biocompatibility:

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

Software:

1. General Principles of Software Validation Final Guidance for Industry and FDA Staff.
   Clinical Electronic Thermometers Guidance:
2. 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.

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Accuracy: $±$ 0.2°C (35°C42°C), $±$ 0.3°C (outside the range of 35°C42°C)

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K131243

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

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

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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: [phone] Fax: [phone] Email: [e-mail]

● 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

1

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 infrared
thermometer | JPD-FR100 infrared
dual-mode thermometer | Comparison
results |
|---------------------|--------------------------------------------------------------------|------------------------------------------------------------|-----------------------|
| Name | Infrared thermometer | Infrared dual-mode
thermometer | Similar |
| Model | AT-601 | JPD-FR100 | |
| Manufacturer | SHENZHEN ACURIO
INSTRUMENTS CO., LTD. | Shenzhen Jumper Medical
Equipment Co., Ltd. | |
| Management category | Ila | Ila | Identical |
| 510(K) Number | / | K131243 | N/A |
| CE Number | / | | |
| Structure | Mini body part, probe, lens
filter, LCD screen, battery
door | Body part, probe, lens filter,
LCD screen, battery door | Similar |

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

2

| | Comparison items | AT-601 infrared
thermometer | JPD-FR100 infrared
dual-mode thermometer | Comparison
results |
|------------------------------------------------|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------|
| | 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, CR2032 | D.C. 3.0V, two 1.5V AAA
batteries | Similar |
| | Display unit | 0.1 °C | 0.1 °C | Identical |
| | Measuring
range | 34°C42.2°C | Forehead mode: 32°C42.2°C
Ear mode: 0°C100°C | |
| Primary
technical
performance
indexes | Accuracy | $±$ 0.2°C (35°C42°C), $±$
0.3°C (outside the range of
35°C~42°C) | Ear mode: $±$ 0.2°C
Forehead mode: $±$ 0.3°C | Similar |
| | Memory
function | 9 sets of storage data | 20 sets of storage data | |
| | Dimensions
(LWH) | 58mm×58mm×66mm | 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. | Same |
| Measuring site | | Ear | Ear, forehead | Same
when
measuring ear
temperature |

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

| Comparison items | AT-606 infrared
thermometer | JPD-FR100 infrared
dual-mode thermometer | Comparison
results | |
|------------------------------------------------|---------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|
| Name | Infrared thermometer | Infrared
dual-mode
thermometer | Same | |
| Model | AT-606 | JPD-FR401 | | |
| Manufacturer | ACURIO
SHENZHEN
INSTRUMENTS CO., LTD. | Shenzhen
Jumper
Medical
Equipment 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 |
| Primary
technical
performance
indexes | Measuring range | 34°C42.2°C | Forehead mode: 32°C42.2°C
Ear mode: 0°C100°C | |
| | Accuracy | ± 0.2°C (35°C42°C), ± 0.3°C (outside the range of 35°C~42°C) | Ear mode: ± 0.2°C
Forehead 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.

4

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;
• 2. ISO 80601-2-56:2009.

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

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

Electromagnetic Compatibility:

1. IEC 60601-1-2:2007.

Biocompatibility:

• 1. ISO 10993-5:2009
• 2. 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.

7

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 ([e-mail]) or phone [phone] 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