(38 days)
The Non-Contact Forehead Thermometer (Model: UT30H) is a reusable, infrared thermometer intended for the intermittent measurement of human body temperature on the forehead of people of all ages. It can be used by consumers in the home environment and doctors in the clinic environment as reference.
The Non-Contact Forehead Thermometer (Model: UT30H) is a hand-held, non-sterile, reusable, batteny powered device designed to measure human body temperature wa body sites: the skin of the forehead.
The Infrared Forehead Thermometer is a battery powered, infrared Thermometer that coverts a user's forehead temperature, using the infrared energy emitted from the area around the user's forehead, to an oral equivalent temperature when placed within 1-5 cm to the subject's forehead with no contact. It uses a thermopile sensor with integrated thermistor for ambient temperature readings.
It composed by a measuring sensor, set buttons, a start button, battery compartment, Buzzer, a LCD and a ABS plastic enclosure, and measuring without probe cover.
The power supply of the thermometer are 3.0V DC, it is supplied by two A AA batteries.
The main functions of Non-Contact Forehead Thermometer are as followings:
- Forehead measure function
- Wide range of temperature readings: from 32.0℃ to 45.0℃(89.6℃ -113.0℃))
- The big LCD display showing clear measure result.
- Low battery indicator
The provided text describes the 510(k) summary for the "Non-Contact Forehead Thermometer (UT30H)" and includes information about its acceptance criteria and the study conducted.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Non-Contact Forehead Thermometer (UT30H) are primarily based on international standards for clinical thermometers. The reported device performance is stated to be compliant with these standards.
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| Accuracy | |
| $\pm$ 0.2°C /0.4°F (35.0 °C -42.0°C) | Met (implicitly, deemed substantially equivalent to predicate that also met this) |
| $\pm$ 0.3°C /0.5°F (32.0°C -34.9°C and 42.1°C -45.0°C) | Met (implicitly, deemed substantially equivalent to predicate that also met this) |
| Clinical Bias with Stated Uncertainty (ISO 80601-2-56) | Within acceptable scope specified in ISO 80601-2-56 |
| Clinical Repeatability (ISO 80601-2-56) | Met (implicitly, within acceptable scope) |
| Measurement Range | Min. 32.0℃ to Max. 45.0℃ (89.6℉ -113.0℉) (Stated as sufficient for body temperature measurement) |
| Biocompatibility (ISO 10993-5, ISO 10993-10) | All patient contacting materials compliance with ISO 10993-5 (In Vitro cytotoxicity test), ISO 10993-10 (skin irritation, skin sensitization testing) |
| Electrical Safety (IEC 60601-1) | Compliance with IEC 60601-1 |
| EMC (IEC 60601-1-2) | Compliance with IEC 60601-1-2 |
| Software Life Cycle Processes (IEC 62304) | Compliance with IEC 62304 Edition 1.1 2015-06 |
| Home Healthcare Environment Requirements (IEC 60601-1-11) | Compliance with IEC60601-1-11:2015 |
| General Specification for Infrared Thermometers (ASTM E 1965-98(R)2016) | Compliance with ASTM E 1965-98(R)2016 |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: 150 subjects.
- Data Provenance: Not explicitly stated regarding country of origin. The study was a "clinical accuracy study" and did not specify if it was retrospective or prospective, but the phrasing "were performed to determine the clinical accuracy" suggests a prospective clinical study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. For a non-contact thermometer, ground truth would typically be established by a reference thermometer (e.g., orally, rectally, or invasively) rather than expert consensus on individual readings.
4. Adjudication method for the test set
This information is not provided in the document. Given the nature of a clinical thermometer accuracy study, an adjudication method for individual readings is typically not relevant. The assessment would involve comparing the device's readings against a reference method.
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
This is not applicable as the device is a non-contact thermometer, not an AI-assisted diagnostic tool that involves human readers or interpretation of complex medical cases.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a physical thermometer measuring temperature, not an algorithm, and it always involves a human user to operate it. The "standalone" performance here refers to the device's inherent accuracy, which was indeed evaluated.
7. The type of ground truth used
The ground truth used for the clinical accuracy study was presumably a reference body temperature measurement obtained through a validated clinical method (e.g., oral, rectal, or potentially tympanic/temporal, though not specified) against which the non-contact forehead thermometer's readings were compared. The text mentions the device converts to an "oral equivalent temperature," implying a comparison to oral temperature as a ground truth or a gold standard.
8. The sample size for the training set
This information is not applicable or not provided. Clinical thermometers are typically hardware-based devices with embedded algorithms, not machine learning models that require a separate "training set" in the conventional sense. Their calibration and internal algorithms are developed during manufacturing and validated through performance testing rather than a separate training phase.
9. How the ground truth for the training set was established
This is not applicable for the reasons stated in point 8.
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January 22, 2021
Uni-Trend Technology(CHINA) CO.,LTD % Dave Yungvirt CEO Third Party Review Group, LLC 25 Independence Blvd Warren, New Jersey 07059
Re: K203656
Trade/Device Name: Non-Contact Forehead Thermometer (UT30H) Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical electronic thermometer Regulatory Class: Class II Product Code: FLL Dated: December 7, 2020 Received: December 15, 2020
Dear Dave Yungvirt:
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
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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 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,
CAPT Alan M. Stevens Director (acting) 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) K203656
Device Name
Non-Contact Forehead Thermometer, Model: UT30H
Indications for Use (Describe)
The Non-Contact Forehead Thermometer (Model: UT30H) is a reusable, infrared thermometer intended for the intermittent measurement of human body temperature on the forehead of people of all ages. It can be used by consumers in the home environment and doctors in the clinic environment as reference.
| 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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510K summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements in accordance with 21 CFR 807.92
1. Submitter Information
Sponsor Company Name: UNI-TREND TECHNOLOGY (CHINA) CO.,LTD
- Establishment Registration Number: Applying �
- � Address: No 6, Gong Ye Bei 1st Road, Songshan Lake National High-Tech Industrial Development Zone, Dongguan City, Guangdong Province, China
- � Phone: +86-769 85723888
- � Fax: +86-769 85725888
- Contact Person (including title): Mike Mao /Marketing Manager �
- � E-mail: mike@uni-trend.com.cn
Application Correspondent:
- Company Name: Guangzhou KINDA Biology Technology Co., Ltd. �
- Address: 6F, No.1 TianTai road, Science City, LuoGang District, GuangZhou City, China �
- � Contact Person: Mr. Jet Li/Regulation Manager
- � Tel: +86-18588874857
- � Email: med-jl@foxmail.com
2. Subject Device Information
| Type of 510(k) submission: | Traditional |
|---|---|
| Common Name: | Clinical Electronic Thermometer |
| Trade Name: | Non-Contact Forehead Thermometer (UT30H) |
| Classification Name: | Clinical Electronic Thermometer |
| Review Panel: | General Hospital |
| Product Code: | FLL |
| Regulation Number: | 21 CFR 880.2910 |
| Regulation Class: | 2 |
3. Predicate Device Information
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| Sponsor: | Shenzhen Calibeur Industries Co., Ltd |
|---|---|
| Common Name: | Clinical electronic thermometer |
| Trade Name: | Infrared Thermometer (DT-8836T, DT-8836P) |
| 510(k) number: | K191251 |
| Review Panel: | General Hospital |
| Product Code: | FLL |
| Regulation Number: | 21 CFR 880.2910 |
| Regulation Class: | 2 |
4. Device Description
The Non-Contact Forehead Thermometer (Model: UT30H) is a hand-held, non-sterile, reusable, batteny powered device designed to measure human body temperature wa body sites: the skin of the forehead.
The Infrared Forehead Thermometer is a battery powered, infrared Thermometer that coverts a user's forehead temperature, using the infrared energy emitted from the area around the user's forehead, to an oral equivalent temperature when placed within 1-5 cm to the subject's forehead with no contact. It uses a thermopile sensor with integrated thermistor for ambient temperature readings.
It composed by a measuring sensor, set buttons, a start button, battery compartment, Buzzer, a LCD and a ABS plastic enclosure, and measuring without probe cover.
The power supply of the thermometer are 3.0V DC, it is supplied by two A AA batteries.
The main functions of Non-Contact Forehead Thermometer are as followings:
- � Forehead measure function
- � Wide range of temperature readings: from 32.0℃ to 45.0℃(89.6℃ -113.0℃))
- � The big LCD display showing clear measure result.
- � Low battery indicator
5. Indication for use
The Non-Contact Forehead Thermometer (Model: UT30H) is a reusable, infrared thermometer intended for the intermittent measurement of human body temperature on the forehead of people of all ages. It can be used by consumers in the home environment and doctors in the clinic environment as reference.
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6. Test Summary
Infrared Thermometer conforms to applicable standards that include:
- � ASTM E 1965-98(R)2016 Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature
- � AAMI/ANSI ES 60601-1:2005/(R)2012, Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance
- � IEC 60601-1-2:2014, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- � ISO 10993-5:2009, Biological evaluation of medical devices -- Part 5: Tests for In Vitro cytotoxicity,
- � ISO 10993-10:2010, Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization
- � IEC 62304 Edition 1.1 2015-06 Medical Device Software - Software Life Cycle Processes
- � IEC60601-1-11:2015 medical electrical equipment - part 1-11: general requirements for basic safety
and essential performance - collateral standard: requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
- ISO 80601-2-56: 2017 Medical electrical equipment part 2-56: particular requirements for basic � safety and essential performance of clinical thermometers for body temperature measurement
7. Summarv of Clinical Test
The clinical accuracy study for the non-contact thermometer were performed to determine the clinical accuracy. The three groups of subjects being tested were: 1) infant under 1 year old, 2) children between 1 and 5 years old, and 3) patients over 5 years old.
The study included 150 subjects, with More than 30% febrile subjects. For each age group, the ratio of febrile subjects was more than 30%. The study excluded subjects with medical conditions such as inflammation at the measuring sites and subjects using medications known to affect body temperature. From each test site, a total of 150 data sets were collected. The clinical accuracy of the proposed device was evaluated by ISO 80601-2-56 - clinical bias with stated uncertainty and clinical repeatability. The clinical test results showed that the accuracy of the proposed device is within acceptable scope specified in ISO 81061-2-56.
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8. Comparison to Predicate Device
Compare with predicate device, the subject device is very similar in design principle, intended use, sensor, measurement mode, measuring range, accuracy and the applicable standards. The differences between subject device and predicate device do not raise and new questions of safety or effectiveness
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| Subject Device: Non-Contact Forehead Thermometer, model: UT30H | |||
|---|---|---|---|
| -- | ------------------------------------------------------------------- | -- | -- |
| Elements ofComparison | Subject Device | Predicate Device | Verdict |
|---|---|---|---|
| Manufacturer | UNI-TREND TECHNOLOGY(CHINA)CO.,LTD | Shenzhen Calibeur IndustriesCo., Ltd. | -- |
| 510 (k) Number | Pending | K191251 | -- |
| Product Name | Non-Contact Forehead Thermometer | Infrared Thermometer | -- |
| Models | UT30H | DT-8836T, DT-8836P | -- |
| Intended Use | The Non-Contact ForeheadThermometer (Model: UT30H) is areusable, infrared thermometerintended for the intermittentmeasurement of human bodytemperature on the forehead ofpeople of all ages. It can be used byconsumers in the home environmentand doctors in the clinic environmentas reference. | The Infrared thermometer is anon-contact infrared thermometerintended for the intermittentmeasurement of human bodytemperature from forehead forpeople of all ages. The device isreusable for home use andclinical use. | SE |
| Sensor | Infrared Sensor | Infrared Sensor | SE |
| MeasurementMode | Forehead measurement mode | Forehead measurement mode | SE |
| Measurementtype | Non-contact type | Non-contact type | SE |
| MeasurementDistance | 1-5cm | <3cm | Mirrordifference:Note 1 |
| MeasuringRange | $32.0°C$ to $45.0°C$ ; | Forehead mode:$32.0° C ~42.5° C$(89.6 to 108.5 ° F) | MinordifferenceNote 2 |
| Elements ofComparison | Subject Device | Predicate Device | Verdict |
| Accuracy | $\pm$ 0.2°C /0.4°F 35.0 °C -42.0°C(95.0°F-107.6°F);$\pm$ 0.3°C /0.5°F 32.0°C -34.9°C (89.6°F-94.8°F) and 42.1°C -45.0°C(107.8°F-113.0°F) | Forehead mode:$\pm$ 0.2°C (0.4°F) within35.0°C ~ 42.0°C(95.0°F ~ 107.6°F),$\pm$ 0.3°C(0.5°F) other range | SE |
| DisplayResolution | 0.1°C/0.1°F | 0.1°C/0.1°F | SE |
| Signal Outputand Display | LCD, Buzzer | LCD | SE |
| °C/°F switchable | Yes | Yes | SE |
| Memory | Last time data for measurement | 60 sets | MinordifferenceNote 3 |
| Power Supply | 3.0V DC, offered by o two AAAbatteries | Two 1.5V AAA batteries | SE |
| Low batteryindication | Yes | Not identified. | MinordifferenceNote 4 |
| OperatingConditions | Temperature: 15 °C -40 °C ; Relativehumidity: $<$ 90% R.H (non-condensation);Atmospheric pressure: 70-106KPa | 10~40°C (50°F | MinordifferenceNote 5 |
| Performance | Compliance with ASTM E 1965;ISO 80601-2-56 | Compliance with ASTM E 1965;ISO 80601-2-56 | SE |
| Elements ofComparison | Subject Device | Predicate Device | Verdict |
| Biocompatibility | All the patient contacting materials arecompliance with ISO 10993-5;ISO10993-10 (In Vitro cytotoxicity test,skin irritation, skin sensitizationtesting) | All the patient contactingmaterials are compliance withISO 10993-5; ISO10993-10 | SE |
| Electrical Safety | Compliance with IEC 60601-1 | Compliance with IEC 60601-1 | SE |
| EMC | Compliance with IEC 60601-1-2 | Compliance with IEC 60601-1-2 | SE |
| Response time | 500ms | 1s | MinordifferenceNote 6 |
| Components | It composed by a measuring sensor,set buttons, a start button, batterycompartment, Buzzer, a LCD anda ABS plastic enclosure, andmeasuring without probe cover. | It composed by a measuringsensor, set buttons, a startbutton, battery compartment,Buzzer, a LCD and a ABS plasticenclosure, and measuringwithout probe cover. | SE |
| Materials | ABS for enclosure | ABS for enclosure | SE |
| Labeling | OTC | OTC | SE |
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Subject Device: Non-Contact Forehead Thermometer, model: UT30H
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Subject Device: Non-Contact Forehead Thermometer, model: UT30H
Note 1
There is minor difference for measurement distance, but the subject device clinical accuracy and its performance comply with ISO 80601-2-56 and ASTM E 1965. Therefore, this difference does not raise the safety and effectiveness.
Note 2
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Although there is minor difference of the subject the subject device, the temperature range 32.00 to 45.00 in subject device is enough for body temperature measurement. And the subject device clinical accuracy comply with ISO 80601-2-56 and ASTM E 1965. Therefore, this difference does not raise the safety and effectiveness.
Note 3
Although the memory ralue of the subject device is differnt, both of them are compled with ASTM E 1965. This difference does not affect the safety and effectiveness.
Note 4
The subject device provided with low battery indical for operation and can remind user to replace the batter; and the subject device combied with IEC 60601-1. This difference does not affect the safety and effectiveness.
Note 5
Although Qerating environment of the predicate and subject device is different, but the instruction for use had indicate such operating condition, and the test report ASTM E1965 verifies its performance in such operating condition. The difference does not raise news s Note 6
Although there is minor difference of resolement between the predicate device and subject, but the response time do not affect the measurement accuracy and device performance. And the centing to ISO 8001-2-56. So the difference does not raise new safety and effectiveness issues.
9. Conclusion
The subject device Non-Contact Forehead Thermometer has all features of the few differences do not affect the safety and effectiveress of the subject device. Thus, the subject device is substantially equivalent to the predicate device.
10. Summary Prepared Date
25 November 2020
§ 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.