(420 days)
Not Found
No
The description details standard infrared thermometry components and a microprocessor with embedded software, but there is no mention of AI, ML, or related concepts like neural networks or training data for algorithmic learning.
No.
The device is a non-contact infrared thermometer designed to measure human body temperature. Its intended use is diagnostic (temperature measurement), not therapeutic.
No
The device is a non-contact infrared thermometer, used to measure body temperature, but it is not described as being used to diagnose a medical condition. While temperature is a vital sign, this device simply measures it rather than providing a diagnosis based on that measurement.
No
The device description explicitly lists multiple hardware components including an infrared sensor, microprocessor, memory, electro-acoustic components, LED display, and batteries. While it mentions embedded software, it is clearly a hardware device with integrated software.
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 living body (in vitro).
- Device Function: The description clearly states that this device is a "Non-contact Infrared Thermometer" that "detect[s] human body temperature from forehead". It measures the natural thermal radiation emitted from the skin.
- No Sample Analysis: The device does not require or analyze any biological samples taken from the patient. It directly measures a physical property (infrared radiation) from the body surface.
Therefore, based on the provided information, this device falls under the category of a medical device but not specifically an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Non-contact Infrared Thermometer (Models WL-301, WL-501, WL-601, WL-701) is an electronic thermometer using an infrared sensor to detect human body temperature from forehead on people of one month old and above. The device is reusable for home and clinical use.
Product codes
FLL
Device Description
The Infrared thermometers are hand-held, battery powered devices designed to measure human body temperature from the central forehead. Its operation is based on measuring the natural thermal radiation from 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 no-contact use and compensation of the temperature reading.
The device mainly consists of infrared sensor, microprocessor, embedded software (Identified Software version is No: V1), memory, electro-acoustic components, LED display and the device is powered by 2AAA alkaline batteries.
The non-contact infrared thermometer included WL-301, WL-501, WL-601, WL-701. They can be selected calibration mode, body temperature mode and surface mode.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
forehead
Indicated Patient Age Range
one month old and above.
Intended User / Care Setting
home and clinical use.
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)
Clinical data: According to the ASTM E 1965-98, the clinical trial was performed for people of one month old and up. Reference clinical thermometer was a Glass thermometer, Model: CRW-23, Yuwell-Jiangsu medical equipment & supply Co. 150 patients were evaluated for both ear and forehead patients.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
March 18, 2022
Sichuan YOUKEDE Medical Equipment Co.,Ltd Yolanda Lan Regulatory Affair Consultant 2F, North Wing, No.102 Building, Mianyang Export Processing Zone, No.261 East Section of Feiyun Road, Mianyang Hi-Tech Mianvang, SiChuan 621000 China
Re: K210171
Trade/Device Name: Non-contact Infrared Thermometer (Models WL-301, WL-601, WL-701) Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: February 16, 2022 Received: February 16, 2022
Dear Yolanda Lan:
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
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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,
Gang Peng for Payal Patel 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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Indications for Use
510(k) Number (if known) K210171
Device Name
Non-contact Infrared Thermometer (Model: WL-301, WL-501, WL-601, WL-701)
Indications for Use (Describe)
The Non-contact Infrared Thermometer (Models WL-301, WL-501, WL-701) is an electronic thermometer using an infrared sensor to detect human body temperature from forehead on people of one month old and above. The device is reusable for home and clinical use.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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Section 5 510(K) Summary
1. Prepared Date: 2021/06/18
2. Submitter Information
| Name | Sichuan YOUKEDE Medical Equipment Co.,Ltd. |
|---|---|
| Address | 2F, North Wing, No.102 Building, Mianyang Export |
| Processing Zone, No.261 East Section of Feiyun Road, | |
| Mianyang Hi-Tech Zone, 621000 Mianyang City, | |
| Sichuan Province, P.R.China | |
| Contact person | Sukey Chia |
| Tel | +86 0816 2296641 |
| 3004729718@qq.com |
3. Submission Correspondent
| Contact person | Yolanda Lan |
|---|---|
| yolanda.bleu@foxmail.com | |
| Tel | +86-13713938991 |
4. Subject Device Information
| Proprietary Name | Non-contact Infrared thermometer (Model:WL-
301,WL-501,WL-601,WL-701) |
|------------------------|--------------------------------------------------------------------------|
| Common Name | Infrared thermometer |
| Model | WL-301, WL-501, WL-601, WL-701 |
| Classification | Thermometer, Electronic, Clinical |
| Regulation Description | Clinical electronic thermometer |
| Review Panel | General Hospital |
| Product Code | FLL |
| Regulation Number | 21 CFR 880.2910 |
| Regulatory Class | II |
5. Predicate Device
Infrared Forehead Thermometer, Model DPT-IFT100, (CONMO, K202420)
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6. Description
The Infrared thermometers are hand-held, battery powered devices designed to measure human body temperature from the central forehead. Its operation is based on measuring the natural thermal radiation from 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
no-contact use and compensation of the temperature reading.
The device mainly consists of infrared sensor, microprocessor, embedded software (Identified Software version is No: V1), memory, electro-acoustic components, LED display and the device is powered by 2AAA alkaline batteries.
The non-contact infrared thermometer included WL-301, WL-501, WL-601, WL-701. They can be selected calibration mode, body temperature mode and surface mode.
7. Indications for Use
The Non-contact Infrared Thermometer (Models WL-301, WL-501, WL-601, WL-701) is an electronic thermometer using an infrared sensor to detect human body temperature from forehead on people of one month old and above. The device is reusable for home and clinical use.
8. Summary of technological characteristics of device compared to the predicate devices, see the table
A comparison of key similarities and differences between the proposed devices (WL-301, WL-501, WL-601, WL-701) and the predicate devices (K202420) is provided below:
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★
| SE Comparisons | Propose device | Predicate device | Note |
|---|---|---|---|
| YOUKEDE (WL-301, WL-501, WL-601, WL-701) | CONMO DPT-IFT100 | ||
| 510K number | K210171 | K202420 | -- |
| Regulation number | 21 CFR 880.2910 | 21 CFR 880.2910 | Identical |
| Product code | FLL | FLL | Identical |
| Indications for use | The Non-contact Infrared Thermometer (Models WL-301, WL-501, WL-601, WL-701) is an electronic thermometer using an infrared sensor to detect human body temperature from forehead on people of one month old and above. The device is reusable for home and clinical use. | The infrared forehead Thermometer DPT-IFT100 is a non-contact thermometer intended for the intermittent measurement of human body temperature from forehead for people of one month old and above. The device is reusable for home use and clinical use. | Different¹ |
| Measurement Method | Infrared radiation detection | Infrared radiation detection | Identical |
| Measurement Range | 34°C ~42°C | 34°C ~43°C | Different, but meets ISO 80601-2-56:2017/A md.1:2018 |
| Accuracy | 34°C~42°C( $\pm$ 0.3°C) | $\pm$ 0.2°C: 35.0°C ~ 42.0°C | |
| $\pm$ 0.3°C: 34.0°C ~ 34.9°C, 42.1°C ~ 43°C | Different² | ||
| Display | 0.1°C (0.1°F) | 0.1°C(0.1°F) | Identical |
| Measurement | |||
| mode | |||
| (adjusted/direct | |||
| mode) | Adjusted | Adjusted | Identical |
| Measurement | |||
| distance | 3~5cm | 3~5cm | Identical |
| Measurement | |||
| Site | Forehead | Forehead | Identical |
| Response time |