(34 days)
Not Found
No
The description focuses on standard infrared thermometry technology and does not mention any AI or ML components or functions.
No.
The device is described solely for the "intermittent measurement of human body temperature," not for treating or preventing any condition.
No
Explanation: The device is intended for the intermittent measurement of human body temperature. While temperature can be an indicator of health, taking a temperature measurement is not, by itself, a diagnostic act. A diagnosis would involve interpreting that temperature in the context of other symptoms or clinical findings.
No
The device description explicitly details hardware components such as a measuring sensor, set buttons, a start button, battery compartment, Buzzer, a LCD, and an ABS plastic enclosure. It is a physical, hand-held device.
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 from 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 is for "intermittent measurement of human body temperature from forehead." This aligns with a general medical device for monitoring a vital sign, not an IVD for analyzing a biological sample.
Therefore, while it is a medical device, it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Non-Contact Forehead Thermometer (Model:UT306H, UT308H) 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.
Product codes
FLL
Device Description
The Non-Contact Forehead Thermometer (Model:UT306H, UT308H) is a hand-held, nonsterile, reusable, battery 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 converts 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 is 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 AA batteries.
The main functions of Non-Contact Forehead Thermometer are as follows:
- Forehead measurement functions
- Wide range of temperature readings: from 32.0 degrees C to 45.0 degrees C (89.6 degrees F -113.0 degrees F )
- The big LCD display showing clear measurement results.
- Memory function
- 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
Home use and clinical use.
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 themometer 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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical Test
The clinical accuracy study for the non-contact themometer were performed to determine the clinical accuracy.
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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January 25, 2021
Uni-Trend Technology (China) Co., Ltd. % Dave Yungvirt CEO Third Party Review Group, LLC 25 Independence Blvd Warren, New Jersey 07059
Re: K203747
Trade/Device Name: Non-Contact Forehead Thermometer (Models UT306H & UT308H) Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: December 18, 2020 Received: December 22, 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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
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) K203747
Device Name
Non-Contact Forehead Thermometer, Model: UT306H,UT308H
Indications for Use (Describe)
The Non-Contact Forehead Thermometer (Model:UT306H, UT308H) 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.
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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510(k) 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, GuangZhouCity,China
- Contact Person: Mr. Jet Li/Regulation Manager �
- Tel: +86-18588874857 �
- � Email: med-jl@foxmail.com
Subject Device Information 2.
| Type of 510(k) submission: | Traditional |
|---|---|
| Common Name: | Clinical Electronic Thermometer |
| Trade Name: | Non-Contact Forehead Thermometer (UT306H, UT308H) |
| Classification Name: | Clinical Electronic Thermometer |
| Review Panel: | General Hospital |
| Product Code: | FLL |
| Regulation Number: | 21 CFR 880.2910 |
| Regulation Class: | 2 |
Predicate Device Information 3.
| Sponsor: | Shenzhen Calibeur Industries Co., Ltd. |
|---|---|
| ---------- | ---------------------------------------- |
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| Subject Device: | Non-Contact Forehead Thermometer, model: UT306H,UT308H |
|---|---|
| ----------------- | -------------------------------------------------------- |
| 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:UT306H, UT308H) is a hand-held, nonsterile, reusable, battery 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 converts 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.
lt is 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 AA batteries.
The main functions of Non-Contact Forehead Thermometer are as follows:
- � Forehead measurement functions
- Wide range of temperature readings: from 32.0℃ to 45.0℃ (89.6℃ -113.0℃ ) �
- � The big LCD display showing clear measurement results.
- � Memory function
- Low battery indicator �
Indication for use 5.
The Non-Contact Forehead Thermometer (Model:UT306H) 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.
6. Test Summary
Non clinical testing:
Non-Contact Forehead Thermometer conforms to applicable standards that include:
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Non-Contact Forehead Thermometer, model: UT306H,UT308H Subject Device:
- � ASTM E 1965-98(R)2016 Standard Specification for Non-Contact Forehead Thermometers for Intermittent Determination of Patient Temperature
- � AAMI/ANSIES 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
Clinical Test
The clinical accuracy study for the non-contact themometer 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.
7. Comparison to Predicate Device
Compared 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
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UNI-TREND TECHNOLOGY(CHINA) CO.,LTD Sponsor:
Subject Device:
Non-Contact Forehead Thermometer, model: UT306H,UT308H
differences between subject device and predicate device do not raise new questions of safety or effectiveness.
| 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 | UT306H,UT308H | DT-8836T, DT-8836P | -- |
| Intended Use | The Non-Contact Forehead | ||
| Thermometer (Model:UT306H, | |||
| UT308H) 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. | 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 | ≤3cm | Minor difference |
| Note 1 | |||
| Measuring | |||
| Range | 32.0°C to 45.0°C ; | Forehead mode: | |
| 32.0° C ~42.5° C | |||
| (89.6 to 108.5 ° F) | Minor difference | ||
| Note 2 | |||
| Accuracy | ±0.2℃ /0.4°F 35.0℃ -42.0℃ | ||
| (95.0°F -107.6°F); | |||
| ±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: | ||
| ±0.2°C (0.4°F) within | |||
| 35.0°C ~ 42.0°C | |||
| (95.0°F ~ 107.6°F), | |||
| ±0.3°C(0.5°F) other range | SE | ||
| Display | |||
| Resolution | 0.1°C/0.1°F | 0.1°C/0.1°F | SE |
| Signal | |||
| Output | |||
| and Display | LCD, Buzzer | LCD | SE |
| °C/°F switchable | Yes | Yes | SE |
| Memory | UT306H: 20 sets of measurements | ||
| UT308H: 32 sets of measurements | 60 sets | Minor difference | |
| Note 3 | |||
| Power Supply | 3.0V DC, offered by o two AA | ||
| batteries | Two 1.5V AAA batteries | SE | |
| Low battery | |||
| indication | Yes | Not identified. | Minor difference |
| Note 4 | |||
| Elements of | |||
| Comparison | Subject Device | Predicate Device | Verdict |
| Operating | |||
| Conditions | Temperature: 15 °C -40 °C; Relative | ||
| humidity: |