(183 days)
Not Found
No
The description focuses on standard infrared thermometry technology and does not mention any AI or ML components or capabilities.
No.
The device is marketed as a thermometer, intended for measuring human body temperature, not for treatment.
No
Explanation: A diagnostic device identifies a disease or condition. This device is a thermometer, which measures a physiological parameter (temperature) but does not, by itself, diagnose a condition. While temperature is a data point often used in diagnosis, the device itself is a measurement tool.
No
The device description explicitly details hardware components such as a thermopile sensor, thermistor, parabolic mirror, infrared distance sensor, MCU, enclosure, LED, and batteries. It is a physical device that measures temperature using infrared radiation.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to examine these samples outside of the body.
- Device Function: The description clearly states that this device measures human body temperature by detecting infrared radiation emitted from the forehead or auditory canal. This is a measurement taken directly from the body, not from a sample taken from the body.
Therefore, based on the provided information, the Infrared thermometer models A200 and A201 are medical devices used for measuring body temperature, but they do not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
FLL
Device 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Infrared radiation detection
Anatomical Site
auditory canal or central forehead, Ear, Forehead
Indicated Patient Age Range
all ages
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
- 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 the requirements 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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
§ 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.
0
Image /page/0/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 blue underneath. The logo is simple and modern, and the colors are bright and eye-catching.
Section 6
510(K) Summary
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 |
| Nanshan District, Shenzhen, PRC | |
| Contact person | Wendy Wang |
| Tel | +86-755 86182120 |
| Fax | +86-755-86182141 |
| 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) |
| 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)
1
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.
2
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| 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& | |||
| 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: | ||
| 32.0°C ~42.9°C | |||
| (89.6 to 109.22 ° F) | |||
| Surface mode: | |||
| 0°C ~99.9°C | |||
| (32 ~210.2°F) | Forehead mode: | ||
| 34.0°C ~42.2°C | |||
| (93.2°F ~108.0°F) | |||
| Surface mode: | |||
| -22°C ~80°C | |||
| (-7.6°F ~176°F) | Similar | ||
| Accuracy | Forehead mode: | ||
| $\pm$ 0.2°C (0.4°F) within | |||
| 36.0°C ~39.0°C | |||
| (96.8°F ~102.2°F), | |||
| $\pm$ 0.3°C(0.5°F) other range | |||
| Surface mode: | |||
| $\pm$ 2% of reading | |||
| or $\pm$ 1°C ( $\pm$ 1.8°F) | |||
| whichever is greater | Forehead mode: | ||
| $\pm$ 0.2°C (0.4°F) within | |||
| 36 | |||
| $\pm$ 0.3°C(0.5°F) other range | |||
| Surface mode: | |||
| $\pm$ 4% of reading | |||
| or $\pm$ 2°C ( $\pm$ 4°F) | |||
| whichever is greater | Similar | ||
| Display | 0.1°C(0.1°F) | 0.1°C(0.1°F) | Same |
| Measurement | |||
| distance | ≤3cm | 2-3cm | Similar |
| Measurement | |||
| place | Forehead | ||
| Surface | Forehead | ||
| 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 | |||
| while no | |||
| operation | Yes | Yes | Same |
| Power supply | 2 X 1.5V AAA | 2 x AAA | Same |
| Display screen | LCD | LCD | Same |
| Contact | |||
| materials | ABS | ABS | Same |
| Operation | |||
| Environment | 10~40°C(50°F | ||
| ~104 °F) | |||
| RH 15~95% | 10~40°C(50°F | ||
| ~104 °F) | |||
| 15-85% RH | Similar | ||
| Storage | |||
| Environment | -25 ~ +55°C (- | ||
| 13~+131°F) | |||
| RH:15~95% | -20~ +55°C (- | ||
| 4~+131°F) | |||
| RH≤90% | Similar | ||
| Dimension | 1704753mm | 180.347.529.2mm | --- |
| Weight | 75g | 104.7g | --- |
| Conformance | |||
| standard | ISO80601-2- | ||
| 56(performance), | |||
| EN60601-1(Safety), | |||
| IEC60601-1-2(EMC) | |||
| ASTM F1965-98 | ISO80601-2- | ||
| 56(performance), | |||
| EN60601-1(Safety), | |||
| IEC60601-1-2(EMC) | |||
| ASTM F1965-98 | Same |
3
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Tahle 2
| Table 2 | |||
|---|---|---|---|
| SE Comparisons | Subject device(SD) | Predicate device(PD) | Note |
| A201 | TH52Z | ||
| 510K number | Present application | K162083 | -- |
| Regulation | |||
| number | 21 CFR 880.2910 | 21 CFR 880.2910 | Same |
| Product code | FLL | FLL | Same |
| Intended Use& | |||
| Indications for | |||
| use | The Infrared | ||
| thermometer model | |||
| A201 is a multi- | The RII Multi-function | ||
| Infrared | |||
| Thermometer, Model | Same | ||
| function infrared | |||
| thermometer | |||
| intended for the | |||
| intermittent | |||
| measurement of | |||
| human body | |||
| temperature by Ear | |||
| mode or Forehead | |||
| mode for people of | |||
| all ages. | TH52Z is intended for | ||
| the intermittent | |||
| measurement of | |||
| human body | |||
| temperatures. The | |||
| device is intended for | |||
| the use at home by | |||
| people of all ages | |||
| including neonates | |||
| and it can be selected | |||
| Ear mode or Forehead | |||
| mode. | |||
| Measurement | |||
| Method | Infrared radiation | ||
| detection | Infrared radiation | ||
| detection | Same | ||
| Measurement | |||
| Range | Ear mode: 35.0 °C | ||
| to 42.9°C (95~ | |||
| 109.3°F) | |||
| Forehead mode: | |||
| 32.0 °C to 42.9°C | |||
| (89.6~109.3°F) | Ear / Forehead mode: | ||
| 93.2~108°F | |||
| (34~42.2°C) | Similar | ||
| Accuracy | ±0.4°F (0.2°C) | ||
| within | |||
| 96.8~102.2°F | |||
| (36~39°C), | |||
| ±0.5°F (0.3°C) for | |||
| other range. | ±0.4°F (0.2°C) within | ||
| 95~107.6°F | |||
| (35~42°C), | |||
| ±0.5°F (0.3°C) for | |||
| other range. | Similar | ||
| Display | |||
| resolution | 0.1°C(0.1°F) | 0.1°C(0.1°F) | Same |
| Measurement | |||
| distance | ≤3cm | ≤1cm | Similar |
| Measurement | |||
| place | Forehead | ||
| Ear | Forehead | ||
| 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 | |||
| while no | |||
| operation | Yes | Yes | Same |
| Power supply | 2 X 1.5V AAA | CR2032 *1 | Same |
| Display screen | LCD | LCD | Same |
| Contact | |||
| materials | ABS | ABS | Same |
| Operation | |||
| Environment | +5°C to +40 °C | ||
| (41 °F to 104 °F), | |||
| humidity: 15 to | |||
| 93% R.H. | 10~40°C(50°F | ||
| ~104 °F) | |||
| 15-85% RH | Similar | ||
| Storage | |||
| Environment | -25 °C to +70 °C (- | ||
| 13 °F to 158 °F), | |||
| humidity: 15 to | |||
| 93 % R.H. | -20~ +55°C (- | ||
| 4~+131°F) | |||
| RH≤90% | Similar | ||
| Dimension | 1704753mm | 146.438.354.8mm | --- |
| Weight | 65g | 63.3g | --- |
| Conformance | |||
| standard | ISO80601-2- | ||
| 56(performance), | |||
| EN60601-1(Safety), | |||
| IEC60601-1-2(EMC) | |||
| ASTM E1965-98 | ISO80601-2- | ||
| 56(performance), | |||
| EN60601-1(Safety), | |||
| IEC60601-1-2(EMC) | |||
| ASTM E1965-98 | Same |
4
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.
5
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 | |
| Range& Accuracy | Both devices have different measurement |
| range, but they have the same accuracy and the | |
| measurement range of subject devices meet the | |
| requirements of ISO80601-2-56. | |
| Measurement | |
| distance | Measurement distance of the subject devices is |
| not more than 3 cm, the predicate device's will | |
| be in the range of 2-3 cm. But the performance | |
| test result of A200 & A201 shows the accuracy | |
| meets the requirements within the distance | |
| range. |
6
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
K121428 and K162083 is difference from subject
devices, but that does not impact on the safety
and effectiveness of subject devices. |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Operation
& Storage
Environment | Both devices have slightly different Operation
& Storage Environment, but the A200 & A201
meets the requirements of ISO80601-2-56
& 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.
7
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.
8
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
9
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