(211 days)
Not Found
No
The description details a standard infrared thermometer using a temperature sensor, AD module, and MCU for calculation and display. There is no mention of AI, ML, or complex algorithms beyond basic signal processing and calculation.
No.
The device is a non-contact thermometer used for the intermittent measurement of human body temperature and does not describe any therapeutic function.
Yes
The device is intended for the intermittent measurement of human body temperature. While it doesn't provide a diagnosis of a specific disease, measuring body temperature, especially in a clinical or home setting to identify fever, is a diagnostic step in determining a person's health status or the presence of an underlying condition. Therefore, it serves a diagnostic purpose by providing data that can be used for diagnosis.
No
The device description explicitly states it is a "hand-held, reusable, battery powered device" that includes a temperature sensor, electronic signal processing, and an LCD display screen. These are all hardware components, indicating it is not a software-only 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 described device is a non-contact infrared thermometer that measures human body temperature from the forehead. It does not analyze samples taken from the body.
- Intended Use: The intended use is for the intermittent measurement of human body temperature, not for the diagnosis of diseases or conditions based on in vitro analysis.
Therefore, while it is a medical device, it falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The Medical infrared forehead thermometer (Model: HGO1, HGO1 V1, HGO6 ) is a non-contact thermometer intended for the intermittent measurement of human body temperature from forehead for people of one year old and above. The device is reusable for home use and clinical use.
Product codes (comma separated list FDA assigned to the subject device)
FLL
Device Description
The proposed device. Medical infrared forehead thermometer, which includes model HGO1 VI, HGO6 are hand-held, reusable, battery powered device, which are intended to detect body temperature from forehead of people aged over 1 year.
The proposed devices measure temperatures of people by detecting the infrared energy radiated directly from the forehead without physical contact. The distance of the measurement is 3cm~5cm. The proposed device uses a temperature sensor, which can detect the object temperature [human body temperature], environment temperature of sensor itself; these temperatures are then transfer to electronic signal and amplified; and then it is transferred to digital signal by AD module in MCU of the proposed device. MCU will calculate the body temperature, and then transfer to screen for display.
The devices have the following features: About one-second measuring Body or Ambient temperature, 32-memory recalls, 9 and 9F unit switchable, over range message (Hi/Lo), low battery indication, auto shut-off when the device is idle for 15 seconds. When completes, the results will be displayed on the LCD display screen, and the buzzer will tell the measurement has been completed. The device will display 3 different background colors according to the result.
The power supply of Medical infrared forehead thermometer is 3.0V DC, it is powered by two AAA batteries. The package includes the following parts:
2xAAA batteries, 1xManual and 1 pcs thermometer
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
forehead
Indicated Patient Age Range
one year old and above
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical tests were conducted on representative model (HG01 V1), since the software and infrared sensor theory is the same between all the models: HG01, HG01 V1,HG06 .
The clinical tests evaluated 100 subjects which were divided into two group age ranges- children (greater than 1 to 5 years old) and adult (greater than 5 years old). Each group has 30% of subjects got temperature equalling or exceeding 37.5°C.
Based on the result, the clinical performance of the subject device complied with the requirement of ISO 80601-2-56:2017.
Clinical study for non-contact thermometer was performed to determine the clinical accuracy and to provide comparison with predicate device. The study excluded subjects with medical conditions such as inflammation at the measuring sites and subjects using medications known to affect body temperature.
The clinical tests evaluated 100 subjects which were divided into two group age ranges- children (1 to 5 years old) and adult (greater than 5 years old). 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.
Based on the result, the clinical performance of the subject device complied with the requirement of ASTM E1965-98 (2016).
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 & 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 FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 26, 2021
Hunan Honggao Electronic Technolofy Co., Ltd. % Jet Li Regulation Manager Guangzhou Kinda Biological Technology Co., Ltd 6F, No.1 TianTai road, Science City, LuoGang District, GuangZhou, Guangdong China
Re: K202111
Trade/Device Name: Medical infrared forehead thermometer Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: January 12, 2021 Received: January 25, 2021
Dear Jet Li:
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,
for 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
Indications for Use
510(k) Number (if known) K202111
Device Name
Medical infrared forehead thermometer
Indications for Use (Describe)
The Medical infrared forehead thermometer (Model: HGO1, HGO1 V1, HGO6 ) is a non-contact thermometer intended for the intermittent measurement of human body temperature from forehead for people of one year old and above. 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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3
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
Date Prepared: February 26, 2021
Submitter Information 1.
Sponsor Company Name: Hunan Honggao Electronic Technology Co., Ltd.
Address: Block 5, Comprehensive Industrial Park, Tenghui Pioneer Park, Nanxian Economic Development Zone, Yiyang, Hunan, China Phone: +86-0737-2762828 Contact Person (including title): Rongfang Hu (Manager) E-mail: hgdztechnology@126.com
Application Correspondent: Guangzhou KINDA Biological Technology Co., Ltd. Address: 6F, No.1 TianTairoad, Science City, LuoGang District, Guang Zhou City, China Contact Person: Mr. JetLi Tile: Regulation Manager Tel: +86-18588874857 Email: med-jl@foxmail.com
2. Subject DeviceInformation
Type of 510(k) submission: Traditional Common Name: Clinical Electronic Thermometer Trade Name: Medical infrared forehead thermometer 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
Sponsor: Shenzhen Jumper Medical Equipment Co., Ltd. Trade Name: Non-contact Forehead Thermometer 510(k) number: K131243 Review Panel: General Hospital Product Code: FLL Regulation Number: 21 CFR 880.2910 Regulation Class: 2
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4. Device Description
The proposed device. Medical infrared forehead thermometer, which includes model HGO1 VI, HGO6 are hand-held, reusable, battery powered device, which are intended to detect body temperature from forehead of people aged over 1 year.
The proposed devices measure temperatures of people by detecting the infrared energy radiated directly from the forehead without physical contact. The distance of the measurement is 3cm~5cm. The proposed device uses a temperature sensor, which can detect the object temperature [human body temperature], environment temperature of sensor itself; these temperatures are then transfer to electronic signal and amplified; and then it is transferred to digital signal by AD module in MCU of the proposed device. MCU will calculate the body temperature, and then transfer to screen for display.
The devices have the following features: About one-second measuring Body or Ambient temperature, 32-memory recalls, 9 and 9F unit switchable, over range message (Hi/Lo), low battery indication, auto shut-off when the device is idle for 15 seconds. When completes, the results will be displayed on the LCD display screen, and the buzzer will tell the measurement has been completed. The device will display 3 different background colors according to the result.
The power supply of Medical infrared forehead thermometer is 3.0V DC, it is powered by two AAA batteries. The package includes the following parts:
2xAAA batteries, 1xManual and 1 pcs thermometer
5. Intended Use
The The Medical infrared forehead thermometer (Model: HGO1 VI, HGO6 ) is a non-contact thermometer intended for the intermittent measurement of human body temperature from forehead for people of one year old and above. The device is reusable for home use and clinical use.
6. Material
The Medical infrared thermometer (Model: HG01, HG01 V1,HG06) are with non-contact to measurement forehead temperature at home or hospital. The device is consists of plastic enclosure, PCB circuit and Infrared sensor. There are operator or patient contacting components in the subject device as the following list.
| Operator/ Patient
contacting components | Material | Body Contact
Location | Contact Duration |
|----------------------------------------------------|---------------------------------|--------------------------|--------------------|
| Main enclosure (including
Chassis-R, Chassis-L) | PC | Intact Skin | Less than 24 hours |
| Front cover | ABS w ith blue Colorant
0.4% | Intact Skin | Less than 24 hours |
| Button | ABS w ith blue Colorant
0.4% | Intact Skin | Less than 24 hours |
| Trigger | ABS w ith blue Colorant
0.4% | Intact Skin | Less than 24 hours |
| Battery Cover | ABS w ith blue Colorant
0.4% | Intact Skin | Less than 24 hours |
| Display screen | ABS | Intact Skin | Less than 24 hours |
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7. Test Summary
Biocompatibility testing
-
� The biocompatibility evaluation for the Medical infrared forehead thermometer (Model: HG01, HG01 V1.HG06 ) was conducted in accordance with 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.
The tests included the following: -
Cytotoxicity
-
· Sensitization
-
Irritation
Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the Medical infrared forehead thermometer (Model: HG01,HG01 V1,HG06 ). The device complies with the IEC 60601-1:2012, Medical Electrical Equipment-Part 1: General Requirements for Basic Safety and Essential Performance, 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.
The device complies with the IEC 60601-1-2:2014, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility forEMC.
Software Verification and Validation Testing
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." and IEC 62304:2006+AMD1:2015 Medical Device Software - Software Life Cycle Processes.
Performance Testing
- ASTM E 1965-98 Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature test
- ISO 80601-2-56:2017/AMD 1:2018 Medical electrical equipment - part 2-56: particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement for Electrical safetytest
- Lifetime shelf life performance test
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Clinical Data:
Clinical tests were conducted on representative model (HG01 V1), since the software and infrared sensor
theory is the same between all the models: HG01, HG01 V1,HG06 .
The clinical tests evaluated 100 subjects which were divided into two group age ranges- children (greater than 1 to 5 years old) and adult (greater than5 years old). Each group has 30% of subjects got temperature equalling or exceeding37.5°C.
Based on the result, the clinical performance of the subject device complied with the requirement of
ISO 80601-2-56:2017.
8. Comparison to PredicateDevice
A comparison of key technological characteristics between the subject devices and predicate device was
listed as below:
| Elements of | Subject Device | Predicate Device | Remark |
|---|---|---|---|
| Comparison | Medical infrared forehead | ||
| thermometer (K202111) | Non-contact Forehead | ||
| Thermometer (K131243) | Remark | ||
| Manufacturer | Hunan Honggao Electronic | ||
| Technology Co., Ltd. | Shenzhen Jumper Medical | ||
| Equipment Co., Ltd | -- | ||
| Models | HG01, HG01 V1, HG06 | JPD-FR100 | -- |
| Intended Use | The The Medical infrared forehead | ||
| thermometer (Model: HGO1, | |||
| HGO1 VI, HGO6) is a non-contact | |||
| thermometer intended for the | |||
| intermittent measurement of | |||
| human body temperature from | |||
| forehead for people of one yearreusable for home use and clinical | |||
| use. | The non-contact infrared | ||
| thermometer, modelJPD- | |||
| FR100, can measure body | |||
| temperature for infants and | |||
| adults without contact to human | |||
| body. It can be used by | |||
| consumers in household | |||
| environmentand doctor in clinic | |||
| as reference | Note 1 | ||
| 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 | 3-5cm | 1-6 cm | Note 2 |
| Measuring Range | 32 | 32.2°C | Note 3 |
| Laboratory Accuracy | Forehead mode ±0.3°C | Forehead mode: ±0.2°C (0.4°F) | SE |
| Sensor type | Thermopile | Thermopile | SE |
| Fever alarm | Yes | Yes | SE |
| Buzzer | Yes | Yes | SE |
| Display type | LCD | LCD | SE |
| Auto power-off while no | |||
| operation | Yes | Yes | SE |
| °C/°F switchable | Yes | Yes | SE |
| Memory | 32 sets | 20 sets | Note 4 |
| Power Supply | DC 3V, 2xAAA Batteries | Two 1.5V AAA batteries | SE |
| Elements of | |||
| Comparison | Subject Device | ||
| Medical infrared forehead | |||
| thermometer (K202111) | Predicate Device | ||
| Non-contact Forehead | |||
| Thermometer (K131243) | Remark | ||
| Operating Conditions | Temperature : +15°C~+40°C | ||
| Humidity : ≤95% non-condensing | |||
| Atmospheric pressure : | |||
| 70kPa~106kPa | 10~40°C (50°F ~104 °F) | ||
| RH |