(163 days)
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).
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 provided document describes the safety and effectiveness of the YUWELL Infrared Ear Thermometer (Models YHT101, YHT200) based on comparisons to a predicate device (Braun Thermoscan® PRO 6000 Ear Thermometer) and compliance with various standards.
Here's an analysis of the acceptance criteria and study information, based on the provided text:
1. Table of Acceptance Criteria and the Reported Device Performance
The document does not present a formal table of "acceptance criteria" for the device, but rather compares the subject device's specifications and performance to a predicate device and states compliance with recognized standards. The "Performance" row in the "Substantial Equivalence" table (page 4) indicates the key performance standards met.
Here's a table based on the key performance and accuracy criteria mentioned:
| Acceptance Criteria (Standard Reference) | Reported Device Performance (YUWELL Infrared Ear Thermometer) | Comment/Predicate Comparison |
|---|---|---|
| Accuracy (ASTM E 1965, ISO 80601-2-56) | 34.0°C | Same as predicate device for clinical measurement range. The document states: "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." Predicate accuracy: 0.3 °C for <35 °C, 0.2 °C for 35 °C to 42 °C, 0.3 °C for >42°C. |
| Measurement Range | 34.0°C to 42.2°C (93.2°F ~ 108.0°F) | Slightly narrower than predicate. Predicate: 20°C to 42.2°C (68°F to 108.0°F). Justified as meeting normal clinical use and not bringing additional risks. |
| Electrical Safety | Meets IEC 60601-1 | Same as predicate. |
| EMC (Electromagnetic Compatibility) | Meets IEC 60601-1-2 | Same as predicate. |
| Biocompatibility | Meets ISO 10993-1, ISO 10993-5, ISO 10993-10 | Same as predicate. |
| Home Use (if applicable) | Meets IEC60601-1-11 | Not explicitly stated for predicate in the table, but the subject device meets this standard. |
| Software Verification & Validation | Meets FDA Guidance "Guidance for the content of premarket submissions for software contained in Medical Devices" | Not explicitly stated for predicate in the table, but the subject device meets this guidance. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "Clinical accuracy test requirements established in the standard ASTM E1965 (Clinical part only) and ISO 80601-2-56 (Clinical accuracy validation only)". However, it does not provide details on the specific sample size used for these clinical accuracy tests, nor does it specify the country of origin of the data or whether the study was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document states that "Clinical accuracy test requirements established in the standard ASTM E1965 (Clinical part only) and ISO 80601-2-56 (Clinical accuracy validation only)" were met. For clinical thermometers, ground truth is typically established by comparing the device's readings against a highly accurate reference thermometer (e.g., rectal thermometry in controlled environments or other gold standard methods) in actual patients.
However, the document does not specify the number of experts used or their qualifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not provide any information regarding an adjudication method for establishing ground truth or evaluating the test set.
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
The device under review is an infrared ear thermometer, which is a standalone measurement device, not an AI-assisted diagnostic tool that involves human "readers." Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study focusing on human reader improvement with AI assistance is not applicable and was not performed or mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the primary performance evaluation described is for the standalone device (algorithm only, without human-in-the-loop performance beyond operating the device). The "Performance test according to ASTM E 1965 and ISO80601-2-56" and "Clinical accuracy test" directly assess the device's ability to accurately measure temperature on its own.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the clinical accuracy validation of a thermometer, the ground truth is typically established by comparison to a highly accurate reference method (e.g., a calibrated reference thermometer measuring core body temperature, often rectal or arterial temperature, in a controlled setting) as defined by the standards like ASTM E1965 and ISO 80601-2-56. The document mentions meeting these standards for clinical accuracy.
8. The sample size for the training set
The document does not provide information regarding a separate "training set" for the device. Clinical thermometers are calibrated and validated against standards; they don't typically undergo machine learning training in the same way an AI diagnostic device would.
9. How the ground truth for the training set was established
As there's no mention of a traditional machine learning "training set" in the context of this infrared ear thermometer, this question is not applicable. The device's internal algorithm is likely developed based on physics principles of infrared radiation and calibrated against known temperature sources, rather than being "trained" on a dataset with ground truth in the AI sense.
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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
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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
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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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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.RChina, 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 |
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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) | SEDiscussion |
|---|---|---|---|
| Manufacturer | JiangSu YuYue | BRAUN (Germany) | - |
| Product name | Infrared ear thermometer | ThermoScan® EarThermometer | - |
| Model | YHT101, YHT200 | PRO 6000 | - |
| Patientspopulation | People of all ages exceptpreterm babies andnewborns (1-29 days old). | People of all ages | Note No. 1 |
| Product Code | FLL | FLL | Same |
| RegulationNo. | 21 CFR 880.2910 | 21 CFR 880.2910 | Same |
| Classification | II | II | Same |
| Intended Use | The YUWELL® Infrared earthermometer is anon-sterile, reusableclinical thermometer. Thedevice is to display the | A non-sterile, re-useableclinical thermometerintended for theintermittent determinationof the human's body | Note No. 2 |
| body temperature in the earcavity by thermal radiationfor people of all agesexcept preterm babies andnewborns (1-29 days old). | temperature for people ofall ages | ||
| Productprinciple | The ear thermometer isequipped with an infraredsensor, which cantransform the infrared lightreleased by human earmembrane intocorresponding electricalsignal. The signal iscorrected by the amplifierand signal processingcircuit according to theinternal algorithm of theinstrument and the targetedemissivity, and thentransformed into thetemperature value of themeasured human body. | The ear thermometer isequipped with an infraredsensor, which cantransform the infrared lightreleased by human earmembrane intocorresponding electricalsignal. The signal iscorrected by the amplifierand signal processingcircuit according to theinternal algorithm of theinstrument and thetargeted emissivity, andthen transformed into thetemperature value of themeasured human body. | Same |
| Productstructure | Consists of shell, buttons,circuit board, and batteries | Consists of shell, buttons,circuit board, and batteries | Same |
| Operation | Hand held-Manuallyoperated | Hand held-Manuallyoperated | Same |
| Sensor | Infrared | Infrared | Same |
| MeasurementRange | 34.0°C to 42.2°C (93.2°F~108.0°F) | 20°C to 42.2°C(68°F to 108.0°F) | Note No. 3 |
| Accuracy | 34.0°C~34.9°C (93.2°F | 0.3 °C for <35 °C0.2 °C for 35 °C to42 °C0.3 °C for >42°C | Note No. 4 |
| Display | LCD | LCD | Same |
| MeasurementSite | Ear | Ear | Same |
| Dimensions | YHT101: 145mm x 37 mmx 57mmYHT200: 143mm x 39 mmx 57mm | 150mm x 60 mm x 35mm | Similar |
| Materials | YHT101: Shell: ABSmaterialButton: PC material | Common Materials-including an impactresistant casing. | Similar -validated forcytotoxicityper |
| YHT200: Shell: ABSmaterialButton: ABS material | resins. | ISO10993-5and irritationas well assensitizationper ISO10993-10 | |
| Scale | °C/°F | °C/°F | Same |
| Resolution ofdisplay | 0.1°C/0.1°F | 0.1°C/0.1°F | Same |
| OperatingMode | Adjusted mode | Adjusted mode | Same |
| EnergySource | Two (2) AAA alkalinebatteries | Two (2) AA batteries orCustom Nickel MetalHydride Battery Pack | Note No. 5 |
| Automaticpower off time | 60s±10s | 10s | Note No. 6 |
| OperatingEnvironment | 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 to95% RH ; | Note No.7 |
| StorageEnvironment | 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 |
| Controlbutton | Measure buttonMemory button | Measure buttonC/F buttonMemory buttonTimer button | Note No.9 |
| Memoryfunction | YHT101: 7 groups ofmeasured values can bememorizedYHT200: 10 groups ofmeasured values can bememorized | Memorize the lasttemperature measured. | Note No.10 |
| ElectricalSafety | 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 1965and ISO 80601-2-56 | Meets ASTM E 1965and ISO 80601-2-56 | Same |
| Biocompatibility | Meets ISO 10993-1(includesUS FDA Blue book memoG95-1-100 Title)ISO 10993-5ISO 10993-10 | Meets ISO 10993-1(includesUS FDA Blue book memoG95-1-100 Title)ISO 10993-5ISO 10993-10 | Same |
Comparison of technological characteristics
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DISCUSSION OF DIFFERENCES
| Note ID | Justification |
|---|---|
| NoteandNo.2 | According to the literature 'Temperature Control in PretermInfants-Effect of Birthweight and Gestational Agenei, pretermbabies has a lower body temperature than a normal fetus just afterbirth. Therefore, in order to reduce the risk of the product, thescope of the applicable group of people has been narrowed downto exclude: preterm babies and newborns (1-29 days old).Thesubject device has a narrow applicable population and it will notraise any new or different safety or effectiveness risks. |
| NoteandNo.4 | The measurement range of the predicate device is larger than thatof the subject device. The scale of clinical thermometer likeMercury thermometer reads temperature from 35°C to 42°C. Thesubject device measurement range is 34.0°C to 42.2°C meet thenormal clinical use. For the normal clinical measurement range of34.0°C to 42.2°C, the accuracy of the subject device and thepredicate device are the same. So the measurement range andaccuracy 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 throughthe applicable IEC standards, and the report proves that the subjectequipment powered by two AAA alkaline batteries is qualified. |
| Note No. 6 | The subject device has about 60 seconds automatic power off timeand it's longer than the 10 seconds of the predicate device. Thedesign purpose is to give the user more time to review or record thedata if needed. The difference will not raise any new safety oreffectiveness risk. |
| NoteandNo.8 | Although the operation and storage conditions of the subject deviceare slightly different from the predicate device, they meet the samestandard requirements of ISO 80601-2-56 and IEC 60601-1-11.Therefore, the operating and storage conditions will not influencethe safety and effectiveness of the product. |
| Note No.9 | The difference of button doesn't influence function of the deviceaccording to the performance test, which will not raise issues insafety and effectiveness. |
| Note No.10 | In terms of the memory function, it is to help patients remember andcheck the previous results, so this would not raise any safety andefficacy problems. |
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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.
§ 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.