(38 days)
Not Found
No
The description details a standard infrared thermometer using a thermopile sensor and basic electronic components to convert infrared energy to a temperature reading. There is no mention of AI, ML, or complex algorithms beyond the conversion process. The performance studies focus on clinical accuracy and repeatability, not on the performance of an AI/ML model.
No.
The device is described as a thermometer intended for the measurement of human body temperature. It is a diagnostic tool, not a therapeutic one that treats or cures a condition.
No
The device is described as an infrared thermometer intended for the "intermittent measurement of human body temperature," which provides a reference for temperature readings. It does not provide a diagnosis or interpret the measured temperature for diagnostic purposes.
No
The device description explicitly states it is a hand-held, battery-powered device with physical components like a sensor, buttons, LCD, and enclosure, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device function: The Non-Contact Forehead Thermometer measures human body temperature on the forehead using infrared technology. This is a direct measurement of a physiological parameter on the body, not a test performed on a sample taken from the body.
- Intended Use: The intended use clearly states it's for "intermittent measurement of human body temperature on the forehead." This aligns with a medical device for monitoring a vital sign, not an in vitro diagnostic test.
Therefore, the Non-Contact Forehead Thermometer (Model: UT30H) is a medical device, specifically a thermometer, but it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications 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.
Product codes (comma separated list FDA assigned to the subject device)
FLL
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
forehead
Indicated Patient Age Range
all ages
Intended User / Care Setting
consumers in the home environment and doctors in the clinic environment
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 880.2910 Clinical electronic thermometer.
(a)
Identification. A clinical electronic thermometer is a device used to measure the body temperature of a patient by means of a transducer coupled with an electronic signal amplification, conditioning, and display unit. The transducer may be in a detachable probe with or without a disposable cover.(b)
Classification. Class II (performance standards). The device is exempt from the premarket notification procedures in part 807, subpart E of this chapter, subject to the limitations in § 880.9 and the following conditions for exemption:(1) Device is not a clinical thermometer with telethermographic functions;
(2) Device is not a clinical thermometer with continuous temperature measurement functions; and
(3) Appropriate analysis and testing (such as that outlined in the currently FDA-recognized editions, as appropriate, of ISO 80601-2-56, “Medical electrical equipment—Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement,” or ASTM E1965, “Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature,” or ASTM E1112, “Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature,” or ASTM E1104, “Standard Specification for Clinical Thermometer Probe Covers and Sheaths”) must validate specifications and performance of the device.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that 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.
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
1
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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3
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 of
| Comparison | Subject Device | Predicate Device | Verdict |
|---|---|---|---|
| Manufacturer | UNI-TREND TECHNOLOGY(CHINA) | ||
| CO.,LTD | Shenzhen Calibeur Industries | ||
| Co., 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 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 Infrared thermometer is a | ||
| non-contact infrared thermometer | |||
| intended for the intermittent | |||
| measurement of human body | |||
| temperature from forehead for | |||
| people of all ages. The device is | |||
| reusable for home use and | |||
| clinical use. | SE | ||
| Sensor | Infrared Sensor | Infrared Sensor | SE |
| Measurement | |||
| Mode | Forehead measurement mode | Forehead measurement mode | SE |
| Measurement | |||
| type | Non-contact type | Non-contact type | SE |
| Measurement | |||
| Distance | 1-5cm |