(420 days)
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 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.
Here's a breakdown of the acceptance criteria and study information for the Non-contact Infrared Thermometer (Models WL-301, WL-501, WL-601, WL-701), based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Predicate) | Reported Device Performance (Subject Device) | Notes/Differences |
|---|---|---|
| Measurement Range: 34°C ~ 43°C | Measurement Range: 34°C ~ 42°C | Different, but stated to meet ISO 80601-2-56:2017/Amd.1:2018 |
| Accuracy: | Accuracy: | |
| ±0.2°C: 35.0°C ~ 42.0°C | ±0.3°C: 34°C~42°C | Different, but stated to meet ISO80601-2-56 and demonstrated through clinical trial |
| ±0.3°C: 34.0°C ~ 34.9°C, 42.1°C ~ 43°C | ||
| Response time: 1S | Response time: <6S | Different, but software validated and performance testing meets ISO 80601-2-56 and ASTM E1965-98. |
| Buzzer: Yes | Buzzer: No, vibrate instead | Different, but considered not to affect safety/effectiveness. |
| Display screen: LCD | Display screen: LED | Different, but considered not to affect safety/effectiveness. |
| Memory: 60 sets | Memory: 1 set | Different, but considered not to affect safety/effectiveness. |
| Operation Environment: 10~40°C, 15-85% RH | Operation Environment: 15~40°C, RH ≤ 95% | Slightly different, but demonstrated to comply with IEC 60601-1 and ISO 80601-2-56. |
| Storage Environment: -20~+55°C, RH≤90% | Storage Environment: -20°C ~+55°C, RH≤95% | Slightly different, but demonstrated to comply with IEC 60601-1 and ISO 80601-2-56. |
| Conformance Standard: ISO80601-2-56 (performance) | Conformance Standard: ISO80601-2-56 (performance), with some clause exceptions evaluated in other reports. | Differences noted, but overall compliance asserted. |
| Biocompatibility: ISO 10993-1, ISO 10993-5, ISO 10993-10 | Biocompatibility: Meets ISO 10993-5 and ISO10993-10. Also mentions ISO 10993-1 conformance. | Appears to meet or exceed. |
| Cleaning Method Effectiveness: Not explicitly stated as acceptance criterion, but part of predicate's general compliance. | Cleaning Method Effectiveness: Meets AAMI TIR30:2011. | Demonstrated. |
| Shelf-life: Not explicitly stated as acceptance criterion. | Shelf-life: 2 years. | Demonstrated. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: 150 patients
- Data Provenance: Not explicitly stated, but implies a prospective clinical trial conducted for the purpose of validating the device. The text does not specify the country of origin of the data.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. The ground truth was established using a "Reference clinical thermometer: a Glass thermometer, Model: CRW-23, Yuwell-Jiangsu medical equipment & supply Co." It's implied that a medical professional would use this reference thermometer to obtain the ground truth readings, but no specific expert qualifications are given.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not specified. The process simply states that the clinical trial was performed and compared to a reference thermometer.
5. Multi-reader Multi-case (MRMC) Comparative Effectiveness Study:
- MRMC Study: No. This device is a standalone thermometer, not an AI-assisted diagnostic tool that would involve human readers. Therefore, an MRMC study and effect size of AI assistance on human readers are not applicable.
6. Standalone Performance Study:
- Standalone Performance Study: Yes. The clinical trial directly assessed the performance of the device (algorithm only, as it's an infrared thermometer with embedded software) against a reference clinical thermometer. The performance testing and clinical trials mentioned ("Measurement Range & Accuracy", "Measurement distance", "Response time") are all standalone evaluations of the device.
7. Type of Ground Truth Used:
- Type of Ground Truth: Reference clinical thermometer (Glass thermometer, Model: CRW-23, Yuwell-Jiangsu medical equipment & supply Co.). This is considered a clinical reference standard.
8. Sample Size for the Training Set:
- Sample Size for Training Set: Not applicable. This device is a non-contact infrared thermometer. While it contains embedded software (Software version V1), there is no mention of a "training set" in the context of machine learning or AI models. Its functionality is based on established infrared measurement principles and calibration, not a learned model from a dataset.
9. How the Ground Truth for the Training Set Was Established:
- How Ground Truth for Training Set Was Established: Not applicable, as there is no mention of a training set for machine learning. The device's accuracy would have been calibrated and verified during manufacturing and development processes against known thermal standards, but this is distinct from "ground truth for a training set" in the context of AI/ML.
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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 ExportProcessing 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 |
| Measurementmode(adjusted/directmode) | Adjusted | Adjusted | Identical |
| Measurementdistance | 3~5cm | 3~5cm | Identical |
| MeasurementSite | Forehead | Forehead | Identical |
| Response time | <6S | 1S | Different3 |
| Sensor type | Thermopile | Thermopile | Identical |
| Scale Selection | °C /°F | °C /°F | Identical |
| Buzzer | No, vibrate instead | Yes | Different3 |
| Display screen | LED | LCD | Different3 |
| Memory | 1sets | 60sets | Different3 |
| Autopower-offwhilenooperation | Yes | Yes | Identical |
| Power supply | 3.0V DC with 2 AAA batteries | 3.0V DC with 2 AAA batteries | Identical |
| Contact materials | ABS | ABS | Identical |
| OperationEnvironment | 15 | 10 | Different4 |
| StorageEnvironment | -20°C | -20~ +55°C ( -4~+131°F )RH≤90% | Different4 |
| Dimension | 1463541 mm | 1453835mm | Different5 |
| Weight | 68g | 78.2g (with batteries),56.6g (w/o batteries) | Different5 |
| IEC 60601-1(Safety), IEC60601-1-2(EMC),IEC 60601-1-11ASTM E1965-98,ISO 10993-1ISO 10993-5: 2009ISO 10993-10: 2010 | EN60601-1(Safety),IEC60601-1-2(EMC),IEC 60601-1-11ASTM E1965-98ISO 10993-1ISO 10993-5: 2009ISO 10993-10: 2010 | Identical | |
| Conformancestandard | ISO80601-2-56(performance),Exceptions: The followingclause/collaterals:Clause 201.11.7, Biocompatibility ofME EQUIPMENT and ME SYSTEMS.Clause 201.12.2 and 206, Usability,not evaluated in this report, Referto IEC 60601-1-6 test Report,Clause 202, EMC, not evaluated inthis report, Refer to IEC 60601-1-2test report.Clause 201.102, Clinical AccuracyVAIDATION, evaluated in ASTM E1965-98 report. | ISO80601-2-56(performance) | Different6 |
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★
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Analysis
From the comparison table, the propose device and predicate device have the same working principle, Measurement place, Measurement Method, Scale selection, Auto poweroff while no operation & Conformance standard. There are slightly differences between the devices as follow:
| Difference clause | Discussion |
|---|---|
| Intended Use | The wording for the subject device is slightly different from the predicatedevice but they are both non-contact thermometers for the intermittentmeasurement of human body temperature via forehead. The subject deviceaddresses the target population based on the clinical study conducted, andthey both conform to the same performance standard - ISO 80601-2-56,Particular requirements for basic safety and essential performance ofclinical thermometers for body temperature measurement.The subject device added the "measurement distance" claim, and describeddetail of the intended use scenario. The abovewording differences between the subject device and predicate device will |
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| Measurement Accuracy | Both devices have different measurement accuracy, but they meet therequirements of ISO80601-2-56. And the accuracy of the subjected devicehas demonstrated through the clinical accuracy trial, which will not affectthe device's safety and effectiveness. |
|---|---|
| Responsetime/Buzzer/Displayscreen/ Memory | The response time, buzzer, display screen and memory capability ofpredicate devices are difference from subject devices,However, the software has been validated according to FDA's softwareguidance. The performance testing shows that thesubject device complies with performance standard during performancetesting ISO 80601-2-56 and ASTM E1965-98 and clinical testing. Therefore,we considered that the difference does not raise any issues on the devicesafety and effectiveness of the subject device. |
| Operation&Storage Environment | Both devices have slightly different Operation&Storage Environment, but the subject device has been demonstrated tocomply with the requirements of standards IEC 60601-1 and ISO 80601-2-56. Therefore, we considered that the difference does not raise anyissues on the device safety and effectiveness. |
| Dimension & Weight | The dimension and weight of subject device is different from the subjectdevice. The difference is caused by their different appearance andconstruction, but the electrical safety, electromagnetic compatibility,performance of subject device has been evaluated to meet therequirements of the standards IEC 60601-1, IEC 60601-1-2, ASTM E1965-98and ISO 80601-2-56. Therefore, we considered that the difference does notraise any issues on the device safety and effectiveness. |
| Conformance standard | Both devices conform to IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, ASTME1965-98, ISO 10993-1; though the device not all clauses conform to ISO80601-2-56, but exceptions was evaluated in the other reports which doesnot raise issued on the safety and effectiveness of the subject device. |
★
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Performance Data
- . Compliance to applicable standards includes ISO80601-2-56(not all clauses), 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 ISO10993-10.
- . 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 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.
Conclusion
Based on performance testing and compliance with acceptable voluntary standards, we believe that the Non-contacted Infrared thermometers (WL-301, WL-501, WL-701) are substantially equivalent to its predicate devices in K202420.
§ 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.