(163 days)
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description and performance studies do not indicate the use of AI/ML.
No
The device measures body temperature, which is a diagnostic tool, but does not claim to treat, mitigate, or prevent disease.
No
Explanation: The device is an infrared ear thermometer designed to measure body temperature. While temperature measurement can be an input to a diagnostic process, the device itself only provides a measurement and does not interpret that measurement to diagnose a condition.
No
The device description explicitly states it is a "hand-held non-contact infrared thermometer, battery powered," indicating it is a physical hardware device that uses infrared technology to measure temperature. While it includes software verification and validation, it is not solely software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices that are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The YUWELL® Infrared ear thermometer measures body temperature by detecting infrared radiation emitted from the ear cavity. It does not analyze any biological specimens taken from the body.
- Intended Use: The intended use is to display body temperature, which is a direct measurement of a physiological parameter, not an analysis of a sample.
Therefore, based on the provided information, the YUWELL® Infrared ear thermometer falls under the category of a clinical thermometer, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The YUWELL® Infrared ear thermometer is a non-sterile, reusable clinical thermometer. The device is to display the body temperature in the ear cavity by thermal radiation for people of all ages except preterm babies and newborns (1-29 days old).
Product codes (comma separated list FDA assigned to the subject device)
FLL
Device Description
The YUWELL® Infrared ear thermometer is designed for measuring the body's temperature, is a hand-held non-contact infrared thermometer, battery powered, using the infrared energy emitted in the subject's tympanic membrane that converts a user's body temperature.
The subject device is simple and convenient to use. The temperature measurement takes only 2 second. The YUWELL® Infrared ear thermometer is intended for use on people of all ages except preterm babies and newborns (1-29 days old).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Infrared
Anatomical Site
Ear cavity / Tympanic membrane
Indicated Patient Age Range
all ages except preterm babies and newborns (1-29 days old)
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)
The design and manufacturing of YUWELL® Infrared ear thermometer are subject to verification and validation testing in conformance with requlatory quidance and recognized consensus standards.
- Performance test according to ASTM E 1965 and ISO80601-2-56
- Clinical accuracy test requirements established in the standard ASTM E1965 (Clinical part only) and ISO 80601-2-56 (Clinical accuracy validation only)
- 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
Conclusion: The subject device has similar intended use, 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.
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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The text logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 20, 2021
Jiangsu Yuyue Medical Equipment & Supply Co., Ltd Yuzhuo Wang Medical Device Registered Engineer Yunyang Industrial Park, Danyang, Jiangsu, China Jiangsu, Jiangsu 212300 China
Re: K203583
Trade/Device Name: YUWELL Infrared Ear Thermometer: YHT101, YHT200 Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: April 13, 2021 Received: April 20, 2021
Dear Yuzhuo Wang:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
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 (QS) 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 medical devices and radiation-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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known) K203583
Device Name
YUWELL® Infrared ear thermometer: YHT101,YHT200
Indications for Use (Describe)
The YUWELL® Infrared ear thermometer is a non-sterile, reusable clinical thermometer. The device is to display the body temperature in the ear cavity by thermal radiation for people of all ages except preterm babies and newborns (1-29 days old).
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(K) SUMMARY
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: | Wang, Yuzhuo |
| Phone: | 0511-86900827 |
| Fax: | 0511-86900991 |
| Email: | wang.yz@yuyue.com.cn |
| Date prepared: | November 20, 2020 |
TRADE NAME, COMMON NAME, CLASSIFICATION
| Trade Name: | YUWELL® Infrared ear thermometer |
|---|---|
| Common Name: | Infrared ear thermometer |
| Model: | YHT101, YHT200 |
| Classification Name: | Thermometer, Clinical, Electronic |
| Product Code: | FLL |
| Regulation Number: | 880.2910 |
| Device Class: | Class II |
IDENTIFICATION OF PREDICATE DEVICE(S)
The identification of predicates within this submission is as follow:
| Manufacturer: | KAZ USA, Inc (a Subsidiary of Helen of Troy, Inc) |
|---|---|
| Trade Name: | Braun Thermoscan® PRO 6000 Ear Thermometer |
| Common Name: | Infrared Ear Thermometer |
| Product Code: | FLL |
| Classification Name: | Thermometer, Clinical, Electronic |
| Regulation Number: | 21 CFR 880.2910 |
| Classification: | Class II |
| FDA 510 (k) #: | K152748 |
4
DESCRIPTION OF THE DEVICE
The YUWELL® Infrared ear thermometer is designed for measuring the body's temperature, is a hand-held non-contact infrared thermometer, battery powered, using the infrared energy emitted in the subject's tympanic membrane that converts a user's body temperature.
The subject device is simple and convenient to use. The temperature measurement takes only 2 second. The YUWELL® Infrared ear thermometer is intended for use on people of all ages except preterm babies and newborns (1-29 days old).
INTENDED USE
The YUWELL® Infrared ear thermometer is a non-sterile, reusable clinical thermometer. The device is to display the body temperature in the ear cavity by thermal radiation for people of all ages except preterm babies and newborns (1-29 days old).
TECHNOLOGICAL CHARACTERISTIC
The ear thermometer is equipped with an infrared sensor, which can transform the infrared light released by human ear membrane into corresponding electrical signal. The signal is corrected by the amplifier and signal processing circuit according to the internal algorithm of the instrument and the targeted emissivity, and then transformed into the temperature value of the measured human body.
SUBSTANTIAL EQUIVALENCE
| Description | Subject Device
(K203583) | Predicate Device
(K152748) | SE
Discussion |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|
| Manufacturer | JiangSu YuYue | BRAUN (Germany) | - |
| Product name | Infrared ear thermometer | ThermoScan® Ear
Thermometer | - |
| Model | YHT101, YHT200 | PRO 6000 | - |
| Patients
population | People of all ages except
preterm babies and
newborns (1-29 days old). | People of all ages | Note No. 1 |
| Product Code | FLL | FLL | Same |
| Regulation
No. | 21 CFR 880.2910 | 21 CFR 880.2910 | Same |
| Classification | II | II | Same |
| Intended Use | The YUWELL® Infrared ear
thermometer is a
non-sterile, reusable
clinical thermometer. The
device is to display the | A non-sterile, re-useable
clinical thermometer
intended for the
intermittent determination
of the human's body | Note No. 2 |
| | body temperature in the ear
cavity by thermal radiation
for people of all ages
except preterm babies and
newborns (1-29 days old). | temperature for people of
all ages | |
| Product
principle | The ear thermometer is
equipped with an infrared
sensor, which can
transform the infrared light
released by human ear
membrane into
corresponding electrical
signal. The signal is
corrected by the amplifier
and signal processing
circuit according to the
internal algorithm of the
instrument and the targeted
emissivity, and then
transformed into the
temperature value of the
measured human body. | The ear thermometer is
equipped with an infrared
sensor, which can
transform the infrared light
released by human ear
membrane into
corresponding electrical
signal. The signal is
corrected by the amplifier
and signal processing
circuit according to the
internal algorithm of the
instrument and the
targeted emissivity, and
then transformed into the
temperature value of the
measured human body. | Same |
| Product
structure | Consists of shell, buttons,
circuit board, and batteries | Consists of shell, buttons,
circuit board, and batteries | Same |
| Operation | Hand held-Manually
operated | Hand held-Manually
operated | Same |
| Sensor | Infrared | Infrared | Same |
| Measurement
Range | 34.0°C to 42.2°C (93.2°F
108.0°F) | 20°C to 42.2°C34.9°C (93.2°F
(68°F to 108.0°F) | Note No. 3 |
| Accuracy | 34.0°C
94.8°F), ±0.3°C(±0.5°F)42.0°C(95.0°F
35.0°C
107.6°F), ±0.2°C(±0.4°F)42.2°C(107.7°F
42.1°C
~108.0°F), ±0.3°C(±0.5°F) | 0.3 °C for 42°C | Note No. 4 |
| Display | LCD | LCD | Same |
| Measurement
Site | Ear | Ear | Same |
| Dimensions | YHT101: 145mm x 37 mm
x 57mm
YHT200: 143mm x 39 mm
x 57mm | 150mm x 60 mm x 35mm | Similar |
| Materials | YHT101: Shell: ABS
material
Button: PC material | Common Materials-
including an impact
resistant casing. | Similar -
validated for
cytotoxicity
per |
| | YHT200: Shell: ABS
material
Button: ABS material | resins. | ISO10993-5
and irritation
as well as
sensitization
per ISO
10993-10 |
| Scale | °C/°F | °C/°F | Same |
| Resolution of
display | 0.1°C/0.1°F | 0.1°C/0.1°F | Same |
| Operating
Mode | Adjusted mode | Adjusted mode | Same |
| Energy
Source | Two (2) AAA alkaline
batteries | Two (2) AA batteries or
Custom Nickel Metal
Hydride Battery Pack | Note No. 5 |
| Automatic
power off time | 60s±10s | 10s | Note No. 6 |
| Operating
Environment | Temperature: 10°C-40°C (50
°F-104 °F);
Humidity: 15% RH ~ 90%
RH (non-condensing);
Atmospheric pressure:
70kPa-106kPa; | Temperature: 10°C-40°C
(50 °F-104 °F) and up to
95% RH ; | Note No.7 |
| Storage
Environment | Temperature: -20 °C ~ +55
°C (-4 °F-131 °F)
Humidity: 15% RH ~ 90%
RH (non-condensing)
Atmospheric pressure:
70kPa-106kPa | Temperature: -25 °C ~
+55 °C (-13 °F-131 °F)
Humidity: 15% RH ~ 95%
RH (non-condensing) | Note No.8 |
| Control
button | Measure button
Memory button | Measure button
C/F button
Memory button
Timer button | Note No.9 |
| Memory
function | YHT101: 7 groups of
measured values can be
memorized
YHT200: 10 groups of
measured values can be
memorized | Memorize the last
temperature measured. | Note No.10 |
| Electrical
Safety | Meets IEC 60601-1 | Meets IEC 60601-1 | Same |
| EMC | Meets IEC 60601-1-2 | Meets IEC 60601-1-2 | Same |
| Performance | Meets ASTM E 1965
and ISO 80601-2-56 | Meets ASTM E 1965
and ISO 80601-2-56 | Same |
| Biocompatibili
ty | Meets ISO 10993-1
(includes
US FDA Blue book memo
G95-1-100 Title)
ISO 10993-5
ISO 10993-10 | Meets ISO 10993-1
(includes
US FDA Blue book memo
G95-1-100 Title)
ISO 10993-5
ISO 10993-10 | Same |
Comparison of technological characteristics
5
6
7
DISCUSSION OF DIFFERENCES
| Note ID | Justification |
|---|---|
| Note | |
| and | |
| No.2 | According to the literature 'Temperature Control in Preterm |
| Infants-Effect of Birthweight and Gestational Agenei, preterm | |
| babies has a lower body temperature than a normal fetus just after | |
| birth. Therefore, 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 and newborns (1-29 days old).The | |
| subject device has a narrow applicable population and it will not | |
| raise any new or different safety or effectiveness risks. | |
| Note | |
| and | |
| No.4 | The measurement range of the predicate device is larger than that |
| of the subject device. The scale of clinical thermometer like | |
| Mercury thermometer reads temperature from 35°C to 42°C. The | |
| subject device measurement range is 34.0°C to 42.2°C meet the | |
| normal clinical use. For the normal clinical measurement range of | |
| 34.0°C to 42.2°C, the accuracy of the subject device and the | |
| predicate device are the same. So the measurement range and | |
| accuracy difference does not bring additional clinical risks. | |
| Note No. 5 | The subject device and the predicate device use different batteries. |
| The subject battery-related performance has been tested through | |
| the applicable IEC standards, and the report proves that the subject | |
| equipment powered by two AAA alkaline batteries is qualified. | |
| Note No. 6 | The subject device has about 60 seconds automatic power off time |
| and it's longer than the 10 seconds of the predicate device. The | |
| design purpose is to give the user more time to review or record the | |
| data if needed. The difference will not raise any new safety or | |
| effectiveness risk. | |
| Note | |
| and | |
| No.8 | Although the operation and storage conditions of the subject device |
| are slightly different from the predicate device, they meet the same | |
| standard requirements of ISO 80601-2-56 and IEC 60601-1-11. | |
| Therefore, the operating and storage conditions will not influence | |
| the safety and effectiveness of the product. | |
| Note No.9 | The difference of button doesn't influence function of the device |
| according to the performance test, which will not raise issues in | |
| safety and effectiveness. | |
| Note No.10 | 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. |
8
SUMMARY OF TESTING (BENCH AND CLINICAL PERFORMANCE):
The design and manufacturing of YUWELL® Infrared ear thermometer are subject to verification and validation testing in conformance with requlatory quidance and recognized consensus standards.
- · Performance test according to ASTM E 1965 and ISO80601-2-56
- Clinical accuracy test requirements established in the standard ASTM E1965 (Clinical part only) and ISO 80601-2-56 (Clinical accuracy validation only)
- · 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
CONCLUSION :
The subject device has similar intended use, 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.