(154 days)
Not Found
No
The summary describes a standard infrared thermometer and does not mention any AI or ML components or capabilities.
No.
Explanation: The device is an infrared thermometer intended for measuring human body temperature, which is a diagnostic function, not a therapeutic one. It does not provide any treatment or therapy.
No
The device is an infrared thermometer used to measure body temperature. While temperature can be an indicator of health, measuring it alone is not a diagnosis. It provides a numerical value (temperature) but does not interpret that value to identify a disease or condition.
No
The device description explicitly states it is a "handheld non-contact infrared thermometer, battery powered," indicating it is a physical hardware device, not software only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the body (in vitro).
- Device Function: The YUWELL® Infrared thermometer measures human body temperature by detecting infrared energy emitted from the forehead. This is a direct measurement of a physiological parameter on the body, not a test performed on a sample taken from the body.
The description clearly states its intended use is for "measuring the human body temperature in non-contact mode on the center of the forehead." This aligns with the function of a clinical thermometer, which is not an IVD.
N/A
Intended Use / Indications for Use
The YUWELL® Infrared thermometer is a nonsterile, reusable clinical thermometer intended for measuring the human body temperature in non-contact mode on the center of the forehead as the measurement site on people of all ages except preterm babies.
Product codes
FLL
Device Description
The YUWELL® infrared thermometer is designed for measuring the body's frontal temperature, is a handheld non-contact infrared thermometer, battery powered, using the infrared energy emitted in the subject's forehead area within 0-5cm that converts a user's forehead temperature. The measurement reference sites is the center of the brow. The temperature measurement takes only 1 second, does not contact human skin. The infrared thermometer is intended for use on people of all ages except pre-term babies.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Forehead
Indicated Patient Age Range
People of all ages except preterm babies.
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)
Performance test according to ASTM E 1965 and ISO80601-2-56
Software verification and validation according to the requirements of FDA "Guidance for the content of premarket submissions for software contained in Medical Devices"
Biocompatibility test according to ISO10993 and FDA Bluebook memo G95-1
Electrical safety test according to IEC60601-1
Electromagnetic compatibility test according to IEC60601-1-2
Home use test according to IEC60601-1-11
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy: +/- 0.2 degrees C (+/- 0.4 degrees F) in the range of 35.0 degrees C - 42.0 degrees C (95.0 degrees F - 107.6 degrees F); +/- 0.3 degrees C (+/- 0.5 degrees F) in the range of 32.5 degrees C - 34.9 degrees C (90.5 degrees F - 94.8 degrees F) and 42.1 degrees C - 43.0 degrees C (107.8 degrees F - 109.4 degrees F)
Resolution of display: 0.1 degrees C / 0.1 degrees F
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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December 6, 2020
Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. Caixia Yang Quality Assurance Yunyang Industrial Park, Danyang, Jiangsu Danyang, 212300 China
Re: K201864
Trade/Device Name: YUWELL Infrared Thermometer Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: June 26, 2020 Received: July 6, 2020
Dear Caixia Yang:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Payal Patel Acting Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K201864
Device Name
YUWELL Infrared Thermometer : YT-1,YT-1 A,YT-1 C,YT-2,YT-2,YT-2A,YT-2B,YT-2C
Indications for Use (Describe)
The YUWELL® Infrared thermometer is a nonsterile, reusable clinical thermometer intended for measuring the human body temperature in non-contact mode on the center of the forehead as the measurement site on people of all ages except preterm babies.
Type of Use (Select one or both, as applicable)
D Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(K) SUMMARY: K201864
This 510(k) Summary is in conformance with 21CFR 807.92
OWNER/SUBMITTER'S INFORMATION
| Company Name: | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd |
|---|---|
| Company Address: | Yunyang Industrial Park, Danyang, Jiangsu, Province,P.R. |
| China,212300 | |
| Contact: | Yuzhuo Wang |
| Phone: | 0511-86900827 |
| Fax: | 0511-86900991 |
| Email: | wang.yz@yuyue.com.cn |
TRADE NAME, COMMON NAME, CLASSIFICATION
Trade Name: YUWELL® Infrared Thermometer, YT-1,YT-I A,YT-IB,YT-I
C,YT-2,YT-2A,YT-2B,YT-2C
Common Name: Infrared Thermometer
| Classification Name: | Thermometer, Clinical, Electronic |
|---|---|
| Product Code: | FLL |
| Regulation Number: | 21 CFR 880.2910 |
| Device Class: | Class II |
IDENTIFICATION OF PREDICATE DEVICES(S)
The identification of predicates within this submission is as follow:
| Manufacturer: | Kaz USA, Inc., a Helen of Troy Company |
|---|---|
| Trade Name: | Braun No touch + Forehead NTF3000 Thermometer |
| Common Name: | Infrared Forehead Thermometer |
| Product Code: | FLL |
| Classification Name: | Thermometer, Clinical, Electronic |
| Regulation Number: | 21 CFR 880.2910 |
| Classification: | Class II |
| FDA 510 (k) #: | K163516 |
5.4 DESCRIPTION OF THE DEVICE
The YUWELL® infrared thermometer is designed for measuring the body's frontal temperature, is a handheld non-contact infrared thermometer, battery powered, using the infrared energy emitted in the subject's forehead area within 0-5cm that converts a user's forehead temperature. The measurement reference sites is the center of the brow.
The temperature measurement takes only 1 second, does not contact human skin. The infrared thermometer is intended for use on people of all ages except pre-term babies.
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5.5 INTENDED USE
The YUWELL® Infrared thermometer is a nonsterile, reusable clinical thermometer intended for measuring the human body temperature in non- contact mode on the center of the forehead as the measurement site on people of all ages except preterm babies.
5.6 TECHNOLOGICAL CHARACTERISTIC
Measure human body temperature. Therefore, once the operator approaches the specific part of the human body (forehead) according to the use method, and presses the measurement key, the infrared radiation receiving sensor can be activated immediately, and the thermal energy generated by the arterial blood flow can be detected quickly through the infrared sensor, so as to accurately measure the human body temperature.
5.7 SUBSTANTIAL EQUIVALENCE
Comparison of technological characteristics
| Subject Device | Predicate Device | SE | |
|---|---|---|---|
| Description | (K201864) | (K163516) | Discussion |
| Device Name | Infrared Thermometer | Infrared Thermometer | Same |
| Product Code | FLL | FLL | Same |
| Regulation No. | 880.2910 | 880.2910 | Same |
| Classification | II | II | Same |
| Intended Use | The YUWELL® Infrared | ||
| thermometer is a | |||
| nonsterile, reusable | |||
| clinical thermometer | |||
| intended for measuring | |||
| the human body | |||
| temperature in non- | |||
| contact mode on the | |||
| center of the forehead | |||
| as the measurement | |||
| site on people of all | |||
| ages except preterm | |||
| babies. | The Braun No Touch |
- Forehead NTF3000
Thermometer is a
nonsterile, reusable
clinical thermometer
intended for the
intermittent determinati
on of human body
temperature in a
touch and no touch
mode on the center of
the forehead as the
measurement site
on people of all ages. | Note No.1 |
| Patient
Population | People of all ages
except preterm
babies. | People of all ages | Note No.2 |
| Technological
Characteristics | The thermometer uses
a thermopile sensor
and thermistor for the
target reading.
A thermistor mounted | The thermometer uses
a thermopile sensor
with integrated
thermistor for the target
reading, a thermistor | Same |
| | in the head of the
thermometer for
ambient temperature
readings and
compensation of the
temperature reading.
A parabolic mirror to
help focus the infrared
energy emitted from
the forehead.
An infrared proximity
sensor for detection of
non-contact use. | 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 proximity
sensor for detection of
contact or non-contact
use and compensation
of the temperature
reading. | |
| 510 (k) Number | K201864 | K163516 | N/A |
| Design Method | Using infrared energy
conversion | Using infrared energy
conversion | Same |
| Display | Backlight LCD Digital
Display | Backlight LCD Digital
Display | Same |
| Sensor | Infrared sensor、
Digital Proximity
Sensor | Infrared sensor、Digital
Proximity Sensor | Same |
| Operation | Hand held-Manually
operated | Hand held-Manually
operated | Same |
| Measurement
Site | Forehead | Forehead | Same |
| Operating Mode | Adjusted Mode | Adjusted Mode | Same |
| Ranging
Function | YT-1, YT-1A, YT-2,
YT-2A have ranging
function, YT-1B, YT-
1C, YT-2B, YT-2C
have no ranging
function. | Have ranging Function | Note No.3 |
| Vibration
Function | YT-1, YT-1B, YT-2,
YT-2B have vibration
function, YT-1A, YT-
1C, YT-2A, YT-2C
have no vibration
function. | No vibration Function | Note No.4 |
| Scale | °C/°F | °C/°F | Same |
| Signal Output
and Display | LCD, Buzzer | LCD, Buzzer | Same |
| Measurement
Range | 32.5°C to 43.0°C
(90.5°F to 109.4°F) | 34.4°C to 42.2°C
(93.9°F to 108.0°F) | Note No.5 |
| Accuracy | $\pm0.2\u00b0C(\pm0.4\u00b0F)$ in the
range of $35.0\u00b0C42.0$107.6\u00b0F)$
$\u00b0C(95.0\u00b0F
$\pm 0.3 \u00b0C (\pm0.5\u00b0F )$ in the
range of $32.5\u00b0C34.9$43.0\u00b0C(107.8$
$\u00b0C (90.5 \u00b0F ~ 94.8$
$\u00b0F )$ and
$42.1\u00b0C
$\u00b0F~109.4\u00b0F)$ | $\pm 0.2\u00b0C/0.4\u00b0F$ for the
range
$35.0\u00b0C$ to $42.0\u00b0C$
$(95.0\u00b0F to 107.6\u00b0F);$
$\pm 0.3\u00b0C /0.5\u00b0F$ (outside
this temperature range) | Note No.6 |
| Resolution of
display | $0.1\u00b0C/0.1\u00b0F$ | $0.1\u00b0C/0.1\u00b0F$ | Same |
| | Temperature: +10 °C ~
+40 °C (50 °F-104 °F) | Temperature: +15°C ~
+40 °C (59 °F-104 °F) | |
| Operating
Environment | Humidity: 15% RH ~
90% RH (no
condensation) | Humidity: 15% RH ~
95% RH (no
condensation) | Note No.7 |
| | Temperature: -20 °C ~
+55 °C (-4 °F-131 °F) | Temperature: -25 °C ~
+60 ℃ (-13 °F-140 °F) | |
| Storage
Environment | Humidity: 15% RH ~
90% RH (no
condensation) | Humidity: 15% RH ~
95% RH (no
condensation) | Note No.8 |
| Memory Size | No data stored for YT-
1, YT-1A, YT-1B, YT-
1C
Up to 10 sets of data
for YT-2, YT-2A, YT-
2B, YT-2C | No data stored | Note No.9 |
| Energy Source | Two (2) AAA batteries | Two (2) AA batteries | Note No.10 |
| Display Content | YT-1 Series:Distance
prompt/Voice
prompt/battery
reminder/result
display/temperature
unit/distance unit
YT- 2 Series:Distance
prompt/Voice
prompt/battery
reminder/result
display/temperature
unit/distance
unit/Memory symbol | Distance prompt/Voice
prompt/battery
reminder/result
display/temperature
unit/distance unit | Note No.11 |
| Controls | YT-1 Series:Power ON
Measurement
button/Prompt tone key
YT-2 Series:Power ON
Measurement
button/Memory button | Power
button/Temperature
button/Silent mode
switch | Note No.12 |
| Measurement
distance | Within 0-5cm | Within 0-5cm | Same |
| Touch aspect | Non contact | Non contact | Same |
| Performance | Meets ASTM E 1965
and ISO 80601-2-56 | Meets ASTM E 1965
and ISO 80601-2-56 | Same |
| Biocompatibility | Meets ISO 10993
and FDA Bluebook
memo G95-1 | Meets ISO 10993
and FDA Bluebook
memo G95-1 | Same |
| Electrical Safety | Meets IEC 60601-1 | Meets IEC 60601-1 | Same |
| EMC | Meets IEC 60601-1-2 | Meets IEC 60601-1-2 | Same |
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6
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5.8 DISCUSSION OF DIFFERENCES
| Note ID | Justification |
|---|---|
| Note No.1 and | |
| Note No.2 | The infrared thermometer produced by our company can meet the |
| requirements of measuring all groups of people, but in order to | |
| reduce the risk of the product, the scope of the applicable group of | |
| people has been narrowed down to exclude: preterm babies. The | |
| products are safe and effective and not affected within the applicable | |
| scope. | |
| Note No.3 and | |
| Note No.4 | Vibration function: After the body temperature is measured, the |
| product body will vibrate to remind the user that the test has been | |
| completed. Ranging function: When the measurement distance is | |
| more than about 5 cm, the word "0- 5"will be displayed on the screen. | |
| When the measurement distance is less than about 5 cm, the device | |
| will automatically measure. The ranging and vibration assist function | |
| of the device is only used as a reminder for measuring distance | |
| requirements and after measurement. This does not affect the safety | |
| or effectiveness of the device. | |
| Note No.5 and | |
| Note No.6 | The measurement range of the subject device is slightly larger than |
| that of the predicate device. At 34.4℃-42.2℃, the accuracy is the | |
| same.Due to the difference in the measurement range, the accuracy | |
| is different: the subject device has a larger measurement range than | |
| the predicate device, so the subject device has increased the | |
| accuracy requirements in the range of 32.5 ℃-34.3℃ and | |
| 42.3 ℃-43.0 ℃. The measurement range and accuracy have been | |
| verified, so the efficacy and safety of the device will not be affected. |
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| Note No.7 and
Note No.8 | The gaps of operating temperature and humidity are verified with
aging testing and transportation simulation testing, the results
demonstrated that the temperature and humidity are met the product
requirements, which will not influence the safety and effectiveness of
the devices. |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Note No.9 | The subject devices have 8 models. The functions of these models
are a little different. But all of the differences would not influence the
safety of the device. In terms of the memory function, it is to help
patients remember and check the previous results, so this would not
raise any safety and efficacy problems. |
| Note No.10 | Passing the aging test, use the new battery for no less than 3000
measurements, which will be enough for the patients. |
| Note No.11 | The main functions of the subject device and predicates are really
similar, so display of contents of the device depends on the functions
of the devices, In terms of the memory display, it is to help patients
remember and check the previous results, given the freedom of
choice to patients does not affect the safety and effectiveness of the
devices. |
| Note No. 12 | The difference of button doesn't influence function of the device,
which will not raise issues in safety and effectiveness. |
5.9 SUMMARY OF NON-CLINICAL TESTING (BENCH):
The design and manufacturing of YUWELL® Infrared Thermometer are subject to verification and validation testing in conformance with regulatory guidance and recognized consensus standards.
- · Performance test according to ASTM E 1965 and ISO80601-2-56
- Software verification and validation according to the requirements of FDA "Guidance for the content of premarket submissions for software contained in Medical Devices"
- · Biocompatibility test according to ISO10993 and FDA Bluebook memo G95-1
- · Electrical safety test according to IEC60601-1
- · Electromagnetic compatibility test according to IEC60601-1-2
- · Home use test according to IEC60601-1-11
5.10 CONCLUSION:
The subject device has same intended use, similar performance, equivalence testing standards, and all testing results have come back as positive results or pass for the subject device, which the subject device is as safety and effectiveness as the predicate device.
The differences above between the subject device and predicate device do not affect the intended use, technology characteristics, safety and effectiveness. And no issues are raised regarding to safety and effectiveness.