Infrared thermometer
Device Facts
| Record ID | K171578 |
|---|---|
| Device Name | Infrared thermometer |
| Applicant | Shenzhen Aeon Technology Co., Ltd. |
| Product Code | FLL · General Hospital |
| Decision Date | Nov 30, 2017 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.2910 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Indications for Use
The Infrared thermometer model A200 is a non-contact infrared thermometer intended for the intermittent measurement of human body temperature by Forehead mode for people of all ages. The Infrared thermometer model A201 is a multi-function infrared thermometer intended for the intermittent measurement of human body temperature by Ear mode or Forehead mode for people of all ages.
Device Story
Hand-held, battery-powered infrared thermometers (A200, A201) measure human body temperature via thermal radiation from the tympanic membrane or central forehead. Input: infrared energy focused by a parabolic mirror onto a thermopile sensor; ambient temperature measured by an integrated thermistor; infrared distance sensor compensates for contact/no-contact status. MCU processes signals to calculate temperature. Output: digital temperature reading on LCD; memory stores 25 measurements. Used in clinical or home settings by patients or healthcare providers. Provides rapid, non-invasive temperature monitoring to assist in clinical decision-making regarding fever or health status.
Clinical Evidence
Clinical trial performed per ASTM E 1965-98 on subjects of all ages. Results confirmed clinical accuracy meets manufacturer-claimed ranges and requirements of ISO 80601-2-56. Bench testing verified measurement range, accuracy, response time, and distance compensation.
Technological Characteristics
Hand-held infrared thermometer; thermopile sensor with integrated thermistor; parabolic mirror for infrared focusing; infrared distance sensor; MCU-based processing; LCD display; ABS plastic construction; powered by 2x AAA alkaline batteries. Standards: ISO 80601-2-56 (performance), EN 60601-1 (safety), IEC 60601-1-2 (EMC), ASTM E 1965-98.
Indications for Use
Indicated for intermittent measurement of human body temperature in people of all ages. Model A200: non-contact forehead mode. Model A201: ear or forehead mode.
Regulatory Classification
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.
Special Controls
(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.
Predicate Devices
- Non-contact Clinical Thermometer, Model THB0F (K121428)
- RII Multi-function Infrared Thermometer, Model TH52Z (K162083)
Submission Summary (Full Text)
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# Section 6
510(K) Summary
K171578
# 1. Prepared Date: October 11, 2017
#### 2. Submitter Information
| Name | Shenzhen Aeon Technology Co., Ltd. |
|----------------|------------------------------------------------------------------------------------|
| Address | East 5/F, Block 15 Industrial Zone of majialong<br>Nanshan District, Shenzhen, PRC |
| Contact person | Wendy Wang |
| Tel | +86-755 86182120 |
| Fax | +86-755-86182141 |
| E-mail | wxm@aeon-med.com |
#### 3. Submission Correspondent
| Name | Chonconn Medical Device Consulting Co.LTD. |
|----------------|----------------------------------------------------------------------------------------|
| Address | 22A, HaiJing Square,No.18 Taizi Road, Nanshan District, Shenzhen, Guangdong,P.R.China, |
| Contact person | Mei Tan(RA consultant) |
| E-mail | FDA@chonconn.com/Xinmeitan@chonconn.com |
| Tel | +86-755-33941160 |
#### 4. Subject Device Information
| Trade name | Infrared thermometer (Model A200 & A201) |
|---------------------|------------------------------------------|
| Model | A200 & A201 |
| Common name | Infrared thermometer |
| Classification name | Thermometer, Electronic, Clinical |
| Regulation number | 21 CFR 880.2910 |
| Product code | FLL |
# 5. Predicate Device
Non-contact Clinical Thermometer, Model THB0F. (Radiant Innovation Inc, K121428)
RII Multi-function Infrared Thermometer, Model TH52Z. (Radiant Innovation Inc, K162083)
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Image /page/1/Picture/0 description: The image contains the logo for AEON Technology. The logo features a green circular symbol with a white triangle inside on the left. To the right of the symbol is the company name "AEON" in blue, with the word "TECHNOLOGY" in smaller blue letters underneath.
# 6. Description
The Infrared thermometers are hand-held, battery powered devices designed to measure human body temperature from the auditory canal or central forehead. Its operation is based on measuring the natural thermal radiation from the tympanic membrane or central forehead.
The thermometers use a thermopile sensor with integrated thermistor for the target reading, a thermistor mounted in the head of the thermometer for ambient temperature readings, a parabolic mirror to help focus the infrared energy emitted from the forehead, and an infrared distance sensor for detection of contact or no-contact use and compensation of the temperature reading.
The device consists of the MCU, enclosure and LED and the device is powered by 2 AAA alkaline batteries.
The device has a memory function that automatically stores 25 sets data of the latest measurements. It can also display the latest measurement result.
The Infrared thermometer included A200 & A201. A200 unit is a no- contact Infrared forehead thermometer, A201 unit is multifunction infrared thermometer and it can be selected Ear mode or Forehead mode.
# 7. Indications for Use
The Infrared thermometer model A200 is a non-contact infrared thermometer intended for the intermittent measurement of human body temperature by Forehead mode for people of all ages.
The Infrared thermometer model A201 is a multi-function infrared thermometer intended for the intermittent measurement of human body temperature by Ear mode or Forehead mode for people of all ages.
# 8. Summary of technological characteristics of device compared to the predicate devices, see the table1 and table2
A comparison of key similarities and differences between the subject devices (Model A200 and Model A201) and the predicate devices (K121428 and K162083) is provided below.
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Image /page/2/Picture/0 description: The image shows the logo for AEON Technology. The logo consists of a green circular emblem with a white triangle inside, followed by the word "aeon" in blue, stylized font. Below "aeon" is the word "TECHNOLOGY" in smaller, blue, block letters.
| Table 1 | | | |
|-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| SE Comparisons | Subject device(SD) A200 | Predicate device(PD) Rdiant THBOF | Note |
| 510K number | Present application | K121428 | -- |
| Regulation number | 21 CFR 880.2910 | 21 CFR 880.2910 | Same |
| Product code | FLL | FLL | Same |
| Intended Use&<br>Indications for use | The Infrared thermometer model A200 is a non-contact infrared thermometer intended for the intermittent measurement of human body temperature by Forehead mode for people of all ages. | The Non-contact Clinical Thermometer, Model THBOF is an infrared thermometer intended for the intermittent measurement of human body temperature in people of all ages. | Same |
| Measurement Method | Infrared radiation detection | Infrared radiation detection | Same |
| Measurement Range | Forehead mode:<br>32.0°C ~42.9°C<br>(89.6 to 109.22 ° F)<br>Surface mode:<br>0°C ~99.9°C<br>(32 ~210.2°F) | Forehead mode:<br>34.0°C ~42.2°C<br>(93.2°F ~108.0°F)<br>Surface mode:<br>-22°C ~80°C<br>(-7.6°F ~176°F) | Similar |
| Accuracy | Forehead mode:<br>$\pm$ 0.2°C (0.4°F) within<br>36.0°C ~39.0°C<br>(96.8°F ~102.2°F),<br>$\pm$ 0.3°C(0.5°F) other range<br>Surface mode:<br>$\pm$ 2% of reading<br>or $\pm$ 1°C ( $\pm$ 1.8°F)<br>whichever is greater | Forehead mode:<br>$\pm$ 0.2°C (0.4°F) within<br>36~39°C(96.8~102°F),<br>$\pm$ 0.3°C(0.5°F) other range<br>Surface mode:<br>$\pm$ 4% of reading<br>or $\pm$ 2°C ( $\pm$ 4°F)<br>whichever is greater | Similar |
| Display | 0.1°C(0.1°F) | 0.1°C(0.1°F) | Same |
| Measurement<br>distance | ≤3cm | 2-3cm | Similar |
| Measurement<br>place | Forehead<br>Surface | Forehead<br>Surface | Same |
| Response time | 1S | 1S | Same |
| Sensor type | Thermopile | Thermopile | Same |
| Scale Selection | °C /°F | °C /°F | Same |
| Memory | 25 sets | 60sets | Similar |
| Buzzer | Yes | Yes | Same |
| Auto power-off<br>while no<br>operation | Yes | Yes | Same |
| Power supply | 2 X 1.5V AAA | 2 x AAA | Same |
| Display screen | LCD | LCD | Same |
| Contact<br>materials | ABS | ABS | Same |
| Operation<br>Environment | 10~40°C(50°F<br>~104 °F)<br>RH 15~95% | 10~40°C(50°F<br>~104 °F)<br>15-85% RH | Similar |
| Storage<br>Environment | -25 ~ +55°C (-<br>13~+131°F)<br>RH:15~95% | -20~ +55°C (-<br>4~+131°F)<br>RH≤90% | Similar |
| Dimension | 170*47*53mm | 180.3*47.5*29.2mm | --- |
| Weight | 75g | 104.7g | --- |
| Conformance<br>standard | ISO80601-2-<br>56(performance),<br>EN60601-1(Safety),<br>IEC60601-1-2(EMC)<br>ASTM F1965-98 | ISO80601-2-<br>56(performance),<br>EN60601-1(Safety),<br>IEC60601-1-2(EMC)<br>ASTM F1965-98 | Same |
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Image /page/3/Picture/0 description: The image contains the logo for AEON Technology. The logo consists of a green circular icon with a white triangle inside, followed by the text "AEON" in blue, block letters. Below "AEON" is the word "TECHNOLOGY" in smaller, blue block letters.
Tahle 2
| Table 2 | | | |
|-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| SE Comparisons | Subject device(SD) | Predicate device(PD) | Note |
| | A201 | TH52Z | |
| 510K number | Present application | K162083 | -- |
| Regulation<br>number | 21 CFR 880.2910 | 21 CFR 880.2910 | Same |
| Product code | FLL | FLL | Same |
| Intended Use&<br>Indications for<br>use | The Infrared<br>thermometer model<br>A201 is a multi- | The RII Multi-function<br>Infrared<br>Thermometer, Model | Same |
| | function infrared<br>thermometer<br>intended for the<br>intermittent<br>measurement of<br>human body<br>temperature by Ear<br>mode or Forehead<br>mode for people of<br>all ages. | TH52Z is intended for<br>the intermittent<br>measurement of<br>human body<br>temperatures. The<br>device is intended for<br>the use at home by<br>people of all ages<br>including neonates<br>and it can be selected<br>Ear mode or Forehead<br>mode. | |
| Measurement<br>Method | Infrared radiation<br>detection | Infrared radiation<br>detection | Same |
| Measurement<br>Range | Ear mode: 35.0 °C<br>to 42.9°C (95~<br>109.3°F)<br>Forehead mode:<br>32.0 °C to 42.9°C<br>(89.6~109.3°F) | Ear / Forehead mode:<br>93.2~108°F<br>(34~42.2°C) | Similar |
| Accuracy | ±0.4°F (0.2°C)<br>within<br>96.8~102.2°F<br>(36~39°C),<br>±0.5°F (0.3°C) for<br>other range. | ±0.4°F (0.2°C) within<br>95~107.6°F<br>(35~42°C),<br>±0.5°F (0.3°C) for<br>other range. | Similar |
| Display<br>resolution | 0.1°C(0.1°F) | 0.1°C(0.1°F) | Same |
| Measurement<br>distance | ≤3cm | ≤1cm | Similar |
| Measurement<br>place | Forehead<br>Ear | Forehead<br>Ear | Same |
| Response time | 1S | 1S | Same |
| Sensor type | Thermopile | Thermopile | Same |
| Scale selection | °C /°F | °C /°F | Same |
| Memory | 25 sets | 9sets | Similar |
| Buzzer | Yes | Yes | Same |
| Auto power-off<br>while no<br>operation | Yes | Yes | Same |
| Power supply | 2 X 1.5V AAA | CR2032 *1 | Same |
| Display screen | LCD | LCD | Same |
| Contact<br>materials | ABS | ABS | Same |
| Operation<br>Environment | +5°C to +40 °C<br>(41 °F to 104 °F),<br>humidity: 15 to<br>93% R.H. | 10~40°C(50°F<br>~104 °F)<br>15-85% RH | Similar |
| Storage<br>Environment | -25 °C to +70 °C (-<br>13 °F to 158 °F),<br>humidity: 15 to<br>93 % R.H. | -20~ +55°C (-<br>4~+131°F)<br>RH≤90% | Similar |
| Dimension | 170*47*53mm | 146.4*38.3*54.8mm | --- |
| Weight | 65g | 63.3g | --- |
| Conformance<br>standard | ISO80601-2-<br>56(performance),<br>EN60601-1(Safety),<br>IEC60601-1-2(EMC)<br>ASTM E1965-98 | ISO80601-2-<br>56(performance),<br>EN60601-1(Safety),<br>IEC60601-1-2(EMC)<br>ASTM E1965-98 | Same |
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Image /page/4/Picture/0 description: The image shows the logo for Aeon Technology. The logo consists of a green circular icon with a white triangle inside, followed by the word "aeon" in blue, with the word "TECHNOLOGY" in smaller blue letters underneath. The logo is simple and modern, with a focus on technology.
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Image /page/5/Picture/0 description: The image shows the logo for AEON Technology. The logo consists of a green circular shape with a white triangle inside, followed by the word "AEON" in blue, and the word "TECHNOLOGY" in smaller blue letters below it. The logo is simple and modern, and the colors are bright and eye-catching.
# Analysis
From the comparison table1 and table2, the subject devices and predicate devices have the same Intended use & Indications for Use, Measurement place, Scale selection, Display screen, Auto power-off while no operation & Conformance standard. There are slightly differences between the devices and predicate devices as follows.
| Difference clause | Discussion |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Measurement<br>Range& Accuracy | Both devices have different measurement<br>range, but they have the same accuracy and the<br>measurement range of subject devices meet the<br>requirements of ISO80601-2-56. |
| Measurement<br>distance | Measurement distance of the subject devices is<br>not more than 3 cm, the predicate device's will<br>be in the range of 2-3 cm. But the performance<br>test result of A200 & A201 shows the accuracy<br>meets the requirements within the distance<br>range. |
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Image /page/6/Picture/0 description: The image contains the logo for Aeon Technology. The logo consists of a green circular icon with a white triangle inside, followed by the word "aeon" in blue, with the word "TECHNOLOGY" in smaller blue letters underneath. The logo is simple and modern, with a focus on technology.
| Memory | The memory capacity of predicate devices in<br>K121428 and K162083 is difference from subject<br>devices, but that does not impact on the safety<br>and effectiveness of subject devices. |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Operation<br>& Storage<br>Environment | Both devices have slightly different Operation<br>& Storage Environment, but the A200 & A201<br>meets the requirements of ISO80601-2-56<br>& IEC60601-1. |
#### Performance Data
- Compliance to applicable standards includes ISO80601-2-56, as well ● as IEC 60601-1, IEC 60601-1-2 and IEC60601-1-11 requirements.
- Biocompatibility Evaluation for contacting patient components meets therequirements of ISO 10993-5 and ISO 10993-10.
- According to the standard of AAMI TIR30: 2011,Effectiveness validation of cleaning method referenced in the User's Manual.
- . Shelf life test result shows the subject device will be safe and effective using under the specified condition within 2 years.
- And then the following performance is verified. -Measurement Range& Accuracy -Measurement distance -Response time
# Clinical data
According to the ASTM E 1965-98, the clinical trial was performed for people of all ages. The test report shows clinical accuracy meets the range claimed by manufacturer. It can conclude that the subject devices, model A200 & A201, are acceptable to measure human body's temperature.
#### Conclusion
Based on performance testing and compliance with acceptable voluntary standards, we believe that the Infrared thermometers model A200 & A201 are substantially equivalent to its predicate devices in K121428 & K162083.
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Image /page/7/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 30, 2017
Shenzhen Aeon Technology Co., Ltd. % Mei Tan RA consultant Chonconn Medical Device Consulting Co., Ltd. 22A, HaiJing Square No.18 Taizi Road, Nanshan District Shenzhen, Guangdong, P.R. China, 51800
Re: K171578
Trade/Device Name: Infrared thermometer (Model A200 & A201) Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: October 19, 2017 Received: November 2, 2017
Dear Mei Tan:
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,
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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