(154 days)
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 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.
The YUWELL Infrared Thermometer (models YT-1, YT-1A, YT-1B, YT-1C, YT-2, YT-2A, YT-2B, YT-2C) underwent non-clinical (bench) testing to demonstrate substantial equivalence to its predicate device, the Braun No touch + Forehead NTF3000 Thermometer (K163516).
Here's a breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a "table of acceptance criteria and reported device performance" in the typical format of a clinical study report with specific statistical thresholds for metrics like sensitivity, specificity, or accuracy. Instead, the performance is demonstrated by conformity to recognized consensus standards for medical thermometers. The key acceptance criteria are the accuracy specifications described by ASTM E 1965 and ISO 80601-2-56.
The following table summarizes the device's accuracy specifications, which serve as the internal acceptance criteria regarding temperature measurement performance:
| Criterion / Performance Metric | Acceptance Criteria (from device specifications) | Reported Device Performance (implied by "Meets ASTM E 1965 and ISO 80601-2-56") |
|---|---|---|
| Accuracy | ||
| In the range of 35.0°C ~ 42.0°C (95.0°F ~ 107.6°F) | ±0.2°C (±0.4°F) | Meets standard |
| In the range of 32.5°C ~ 34.9°C (90.5°F ~ 94.8°F) and 42.1°C ~ 43.0°C (107.8°F ~ 109.4°F) | ±0.3°C (±0.5°F) | Meets standard |
| Measurement Range | 32.5°C to 43.0°C (90.5°F to 109.4°F) | Meets standard |
| Resolution of Display | 0.1°C / 0.1°F | Meets standard |
Beyond accuracy, other "criteria" for acceptance are successfully meeting the requirements of various international standards as listed in Section 5.9, including:
- Software verification and validation (FDA Guidance for software in medical devices)
- Biocompatibility (ISO 10993 and FDA Bluebook memo G95-1)
- Electrical safety (IEC 60601-1)
- Electromagnetic compatibility (IEC 60601-1-2)
- Home use (IEC 60601-1-11)
The document states, "all testing results have come back as positive results or pass for the subject device," indicating that these criteria were met.
2. Sample size used for the test set and the data provenance
The document describes non-clinical (bench) testing. Therefore, there is no "test set" of patient data in the context of a clinical study, nor data provenance (country of origin, retrospective/prospective). The performance testing was conducted according to ASTM E 1965 and ISO 80601-2-56, which are standards for infrared thermometers' performance. These standards involve laboratory testing with controlled temperature sources, not human subjects in a clinical setting. The specific sample sizes (e.g., number of measurements) for these bench tests are not provided in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This was a non-clinical (bench) study involving physical and electrical performance measurements against established standards, not interpretation by medical experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As this was non-clinical bench testing, no adjudication of expert opinions was required.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI-powered device, nor does it involve human "readers" or case interpretation. It is a standalone infrared thermometer.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the testing described is a standalone performance assessment of the device itself (the "algorithm" in a sense, refers to the device's internal measurement and processing capabilities) without human interpretation in the loop influencing the measurement output. The device functions as a direct measurement tool. The "Performance test according to ASTM E 1965 and ISO80601-2-56" is a standalone evaluation of the device's ability to accurately measure temperature under controlled conditions.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the "performance test" was established by calibrated reference temperature sources, as is standard for testing medical thermometers according to ASTM E 1965 and ISO 80601-2-56. These standards dictate precise methods for measuring the accuracy of temperature readings against known, stable temperatures.
8. The sample size for the training set
Not applicable. This is a traditional medical device (infrared thermometer), not an AI/Machine Learning device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is a traditional medical device, not an AI/Machine Learning device.
{0}------------------------------------------------
Image /page/0/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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
{2}------------------------------------------------
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperw ork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information . Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperw ork Reduction Act (PRA) Staff PRAStaff @fda.hhs .gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Form Approved: 0MB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
{3}------------------------------------------------
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.
{4}------------------------------------------------
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® Infraredthermometer is anonsterile, reusableclinical thermometerintended for measuringthe human bodytemperature in non-contact mode on thecenter of the foreheadas the measurementsite on people of allages except pretermbabies. | The Braun No Touch+ Forehead NTF3000Thermometer is anonsterile, reusableclinical thermometerintended for theintermittent determination of human bodytemperature in atouch and no touchmode on the center ofthe forehead as themeasurement siteon people of all ages. | Note No.1 |
| PatientPopulation | People of all agesexcept pretermbabies. | People of all ages | Note No.2 |
| TechnologicalCharacteristics | The thermometer usesa thermopile sensorand thermistor for thetarget reading.A thermistor mounted | The thermometer usesa thermopile sensorwith integratedthermistor for the targetreading, a thermistor | Same |
| in the head of thethermometer forambient temperaturereadings andcompensation of thetemperature reading.A parabolic mirror tohelp focus the infraredenergy emitted fromthe forehead.An infrared proximitysensor for detection ofnon-contact use. | mounted in the head ofthe thermometer forambient temperaturereadings, a parabolicmirror to help focus theinfrared energy emittedfrom the forehead, andan infrared proximitysensor for detection ofcontact or non-contactuse and compensationof the temperaturereading. | ||
| 510 (k) Number | K201864 | K163516 | N/A |
| Design Method | Using infrared energyconversion | Using infrared energyconversion | Same |
| Display | Backlight LCD DigitalDisplay | Backlight LCD DigitalDisplay | Same |
| Sensor | Infrared sensor、Digital ProximitySensor | Infrared sensor、DigitalProximity Sensor | Same |
| Operation | Hand held-Manuallyoperated | Hand held-Manuallyoperated | Same |
| MeasurementSite | Forehead | Forehead | Same |
| Operating Mode | Adjusted Mode | Adjusted Mode | Same |
| RangingFunction | YT-1, YT-1A, YT-2,YT-2A have rangingfunction, YT-1B, YT-1C, YT-2B, YT-2Chave no rangingfunction. | Have ranging Function | Note No.3 |
| VibrationFunction | YT-1, YT-1B, YT-2,YT-2B have vibrationfunction, YT-1A, YT-1C, YT-2A, YT-2Chave no vibrationfunction. | No vibration Function | Note No.4 |
| Scale | °C/°F | °C/°F | Same |
| Signal Outputand Display | LCD, Buzzer | LCD, Buzzer | Same |
| MeasurementRange | 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 therange of $35.0\u00b0C | $\pm 0.2\u00b0C/0.4\u00b0F$ for therange$35.0\u00b0C$ to $42.0\u00b0C$$(95.0\u00b0F to 107.6\u00b0F);$$\pm 0.3\u00b0C /0.5\u00b0F$ (outsidethis temperature range) | Note No.6 |
| Resolution ofdisplay | $0.1\u00b0C/0.1\u00b0F$ | $0.1\u00b0C/0.1\u00b0F$ | Same |
| Temperature: +10 °C ~+40 °C (50 °F-104 °F) | Temperature: +15°C ~+40 °C (59 °F-104 °F) | ||
| OperatingEnvironment | Humidity: 15% RH ~90% RH (nocondensation) | Humidity: 15% RH ~95% RH (nocondensation) | Note No.7 |
| Temperature: -20 °C ~+55 °C (-4 °F-131 °F) | Temperature: -25 °C ~+60 ℃ (-13 °F-140 °F) | ||
| StorageEnvironment | Humidity: 15% RH ~90% RH (nocondensation) | Humidity: 15% RH ~95% RH (nocondensation) | Note No.8 |
| Memory Size | No data stored for YT-1, YT-1A, YT-1B, YT-1CUp to 10 sets of datafor 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:Distanceprompt/Voiceprompt/batteryreminder/resultdisplay/temperatureunit/distance unitYT- 2 Series:Distanceprompt/Voiceprompt/batteryreminder/resultdisplay/temperatureunit/distanceunit/Memory symbol | Distance prompt/Voiceprompt/batteryreminder/resultdisplay/temperatureunit/distance unit | Note No.11 |
| Controls | YT-1 Series:Power ONMeasurementbutton/Prompt tone keyYT-2 Series:Power ONMeasurementbutton/Memory button | Powerbutton/Temperaturebutton/Silent modeswitch | Note No.12 |
| Measurementdistance | Within 0-5cm | Within 0-5cm | Same |
| Touch aspect | Non contact | Non contact | Same |
| Performance | Meets ASTM E 1965and ISO 80601-2-56 | Meets ASTM E 1965and ISO 80601-2-56 | Same |
| Biocompatibility | Meets ISO 10993and FDA Bluebookmemo G95-1 | Meets ISO 10993and FDA Bluebookmemo 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 |
{5}------------------------------------------------
{6}------------------------------------------------
{7}------------------------------------------------
5.8 DISCUSSION OF DIFFERENCES
| Note ID | Justification |
|---|---|
| Note No.1 andNote No.2 | The infrared thermometer produced by our company can meet therequirements of measuring all groups of people, but in order toreduce the risk of the product, the scope of the applicable group ofpeople has been narrowed down to exclude: preterm babies. Theproducts are safe and effective and not affected within the applicablescope. |
| Note No.3 andNote No.4 | Vibration function: After the body temperature is measured, theproduct body will vibrate to remind the user that the test has beencompleted. Ranging function: When the measurement distance ismore 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 devicewill automatically measure. The ranging and vibration assist functionof the device is only used as a reminder for measuring distancerequirements and after measurement. This does not affect the safetyor effectiveness of the device. |
| Note No.5 andNote No.6 | The measurement range of the subject device is slightly larger thanthat of the predicate device. At 34.4℃-42.2℃, the accuracy is thesame.Due to the difference in the measurement range, the accuracyis different: the subject device has a larger measurement range thanthe predicate device, so the subject device has increased theaccuracy requirements in the range of 32.5 ℃-34.3℃ and42.3 ℃-43.0 ℃. The measurement range and accuracy have beenverified, so the efficacy and safety of the device will not be affected. |
{8}------------------------------------------------
| Note No.7 andNote No.8 | The gaps of operating temperature and humidity are verified withaging testing and transportation simulation testing, the resultsdemonstrated that the temperature and humidity are met the productrequirements, which will not influence the safety and effectiveness ofthe devices. |
|---|---|
| Note No.9 | The subject devices have 8 models. The functions of these modelsare a little different. But all of the differences would not influence thesafety of the device. In terms of the memory function, it is to helppatients remember and check the previous results, so this would notraise any safety and efficacy problems. |
| Note No.10 | Passing the aging test, use the new battery for no less than 3000measurements, which will be enough for the patients. |
| Note No.11 | The main functions of the subject device and predicates are reallysimilar, so display of contents of the device depends on the functionsof the devices, In terms of the memory display, it is to help patientsremember and check the previous results, given the freedom ofchoice to patients does not affect the safety and effectiveness of thedevices. |
| 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.
§ 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.