(195 days)
YUWELL infrared thermometer YT-1
No
The description details a standard infrared thermometer that converts infrared energy to a temperature reading using a thermopile sensor and basic signal processing. There is no mention of AI or ML algorithms for data analysis or interpretation.
No
The device is a thermometer used for measuring body temperature, not for treating or preventing diseases.
No
This device is a thermometer used for measuring body temperature, which is a physiological parameter, not for diagnosing a disease or condition. While temperature can be an indicator, the device itself doesn't provide a diagnosis.
No
The device description explicitly lists hardware components such as a thermopile sensor, printed circuit board, enclosure, button, and liquid crystal display.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- Device Function: The infrared forehead thermometer measures the human body temperature by detecting infrared energy emitted from the forehead. This is a direct measurement of a physiological parameter on the body, not an analysis of a specimen from the body.
Therefore, based on the provided information, the device is a clinical thermometer used for non-contact temperature measurement, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The infrared forehead thermometer is a nonsterile, reusable clinical thermometer intended for measuring the human body temperature in non-contact mode on the center of the forehead as the measurement site on people of all ages except the age under the 1 year.
Product codes
FLL
Device Description
The HONSUN infrared forehead thermometer is designed for measuring the body's temperature, is a handheld non-contact infrared thermometer, battery powered, detecting the infrared energy emitted in the forehead area within 0-3 cm (exclude 0 cm) that converts to a body temperature. The measurement site is center of the forehead, while reference body site is the oral.
It is intended to measure the temperature of human body in home and hospital.
It consists of thermopile sensor, printed circuit board, enclosure, button and liquid crystal display. The pressure difference generated by the sensor after receiving the infrared signal is amplified and analyzed then displayed on the LCD screen in digital form. It will be automatically power off if left idle for 20 seconds.
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 except the age under the 1 year.
Intended User / Care Setting
home and hospital
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 testing:
The LD-FT-100B infrared forehead thermometer was conducted the clinical accuracy test in Sept, 2020 according to the ISO 80601-2-56.
Two age groups were selected: older than 1 year and younger than 5 years, and older than 5 years.
In the subjects, 40 people were over one year old and less than five years old (17 with fever) and 65 people were over five years old (28 with fever).
The temperature was measured at the same measurement site (forehead) of the same subject with the reference thermometer and LD-FT-100B infrared forehead thermometer alternatively, and three values of same site were recorded.
The clinical accuracy test results of the subject infrared forehead thermometer met the requirements of ISO 80601-2-56.
Non-clinical testing:
The Infrared Forehead Thermometer is tested per the following standard, to evaluate its performance and safety. The test results demonstrated that the proposed device complies with the standards and guidance:
- IEC 60601-1:2005+AMD1:2012 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
- IEC 60601-1-11:2015 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+A1:2018 Medical electrical equipment — Particular requirements for the basic safety and essential performance of clinical thermometers for body temperature measurement
- FDA "Guidance for the content of premarket submissions for software contained in Medical Devices", 2005
- 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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy: ±0.2°C (±0.4°F) in the range of 35.0°C 42.0°C (95.0°F107.6°F); ± 0.3°C (± 0.5°F) in the range of 32.5°C 34.9°C (90.5 °F ~ 94.8°F) and 42.1°C 43.0°C (107.8°F ~109.4°F)
Predicate Device(s)
Reference Device(s)
YUWELL infrared thermometer YT-1
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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo includes the Department of Health & Human Services seal on the left. To the right of the seal is the FDA logo in blue, with the words "U.S. FOOD & DRUG ADMINISTRATION" in a sans-serif font.
December 8, 2021
Honsun (Nantong) Co., Ltd Iris Du RA Manager No.8, Tongxing Road, Nantong Economic & Technological Development Area Nantong, Jiangsu 226009 China
Re: K211629
Trade/Device Name: Infrared forehead thermometer LD-FT-100B Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: October 27, 2021 Received: November 8, 2021
Dear Iris Du:
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,
Gang Peng For Payal Patel 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 Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K211629
Device Name
Infrared forehead thermometer LD-FT-100B
Indications for Use (Describe)
The infrared forehead thermometer is a nonsterlle, reusable clinical thermometer intended for measuring the human body temperature in non-contact mode on the center of the forehead as the measurement site on people of all ages except the age under the 1 year.
| 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 K211629
1. Submitter
- Company name: HONSUN(NANTONG)Co.,Ltd
- Address:No.8, Tongxing Road, Nantong Economic & Technological development
Area,Jiangsu, 226009, China
- Postal Code:226010
- TEL:+86-513-80580127
- Contact person: Xinhua Pan (General Manager) , Iris Du(RA Manager)
- E-mail:dulh@lordmed.com/ sara-xu@lordmed.com
- Preparation Date: 11/17/2021
2. Subject Device Information
- Trade name: Infrared forehead thermometer LD-FT-100B
- Common name:Infrared forehead thermometer
- Regulation name:Clinical Electronic Thermometer
- Model:LD-FT-100B
- Regulation class: II
- Regulation number:880.2910
- Review panel:General Hospital
- Product code:FLL
3. Predicate Device
- Sponsor: Jiangsu Yuyue Medical Equipment & Supply Co.,Ltd.
- Device name: YUWELL Infrared Thermometer
- Model:YT-1, YT-lA, YT-lB, YT-lC, YT-2, YT-2A, YT-2B, YT-2C
- 510(K) number:K201864
- Product code:FLL
- Regulation class: II
- Regulation number:880.2910
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4. Device description
The HONSUN infrared forehead thermometer is designed for measuring the body's temperature, is a handheld non-contact infrared thermometer, battery powered, detecting the infrared energy emitted in the forehead area within 0-3 cm (exclude 0 cm) that converts to a body temperature. The measurement site is center of the forehead, while reference body site is the oral.
It is intended to measure the temperature of human body in home and hospital.
lt consists of thermopile sensor, printed circuit board, enclosure, button and liquid crystal display. The pressure difference generated by the sensor after receiving the infrared signal is amplified and analyzed then displayed on the LCD screen in digital form. It will be automatically power off if left idle for 20 seconds.
5. Indications for Use
The infrared forehead thermometer is a nonsterile, reusable clinical thermometer intended for measuring the human body temperature in non-contact mode on the center of the forehead as the measurement site on people of all ages except the age under the 1 year.
6. Operation principle
The device is used to measure human body temperature. Once the operator approaches the specific part of the human body (forehead) according to the use method, and presses the measurement key, the infrared radiation receiving sensor can be activated immediately, and the thermal energy generated by the arterial blood flow can be detected through the infrared sensor, and converts to a human body temperature.
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7.Substantial equivalence comparison
| Item | Subject Device | Predicate Device | Remark |
|---|---|---|---|
| Device name | infrared forehead | ||
| thermometer | Infrared thermometer | Same | |
| 510(K) | |||
| number | K211629 | K201864 | / |
| Product code | FLL | FLL | Same |
| Regulation | |||
| No. | 880.2910 | 880.2910 | Same |
| Classification | II | II | Same |
| Intended use | The infrared forehead | ||
| thermometer is a | |||
| nonsterile, reusable | |||
| clinical thermometer | |||
| intended for measuring | |||
| the human body | |||
| temperature in | |||
| non-contact mode on | |||
| the center of the | |||
| forehead as the | |||
| measurement site on | |||
| people of all ages | |||
| except the age under | |||
| the 1 year. | The YUWELL infrared | ||
| forehead thermometer | |||
| is a nonsterile, reusable | |||
| clinical thermometer | |||
| intended for measuring | |||
| the human body | |||
| temperature in | |||
| non-contact mode on | |||
| the center of the | |||
| forehead as the | |||
| measurement site on | |||
| people of all ages except | |||
| preterm babies. | Similar | ||
| Note 1 | |||
| Patient | |||
| population | People of all ages | ||
| except the age under | |||
| the 1 year. | People of all ages except | ||
| preterm babies | Similar | ||
| Note2 | |||
| Operation | Hand held-manually | ||
| operated | Hand held-manually | ||
| operated | Same | ||
| Measurement | |||
| site | Forehead | Forehead | Same |
| Design | |||
| method | Using infrared energy | ||
| conversion | Using infrared energy | ||
| conversion | Same | ||
| Display | LCD digital display | LCD digital display | Same |
| Operating | |||
| mode | Adjusted mode | Adjusted mode | Same |
| Reference | |||
| body site | Oral | Oral | Same |
| scale | °C/°F | °C/°F | Same |
| Measurement | |||
| range | 32°C to 43°C (89.6°F | ||
| to 109.4°F) | 32.5°C to 43°C (90.5°F | ||
| to 109.4°F) | Similar | ||
| Note 3 | |||
| Accuracy | ±0.2°C (±0.4°F) in the | ||
| range of 35.0°C ~42.0°C | |||
| (95.0°F~107.6°F); | |||
| ± 0.3°C (± 0.5°F) in the | |||
| range of 32.5°C ~34.9°C | |||
| (90.5 °F ~ 94.8°F) and | |||
| 42.1°C~ 43.0°C (107.8°F | |||
| ~109.4°F) | Similar | ||
| Note 4 | |||
| ±0.2°C (±0.4°F) | |||
| from 35.1°C (95.2°F) | |||
| to 42°C (107.6°F); | |||
| ±0.3°C (±0.5°F) | |||
| from 32°C (89.6°F) to | |||
| 35°C (95°F) and from | |||
| 42.1°C (107.8°F) to | |||
| 43°C (109.4°F) | |||
| Resolution of | |||
| display | 0.1°C/0.1°F | Same | |
| Operating | |||
| environment | 10°C (50°F) to 40°C (104°F), | ||
| 15%RH ~90%RH (no | |||
| condensation) | Similar | ||
| Note5 | |||
| 10°C (50°F) to 40°C (104°F) | |||
| 15%RH ~85%RH , | |||
| 700hPa~1060hPa | |||
| Storage | |||
| environment | -20°C (-4°F) to 55°C | ||
| (131°F), | |||
| 10%RH ~85%RH | Similar | ||
| Note6 | |||
| -10°C (14°F) to 50°C | |||
| (122°F), | |||
| 10%RH ~85%RH | |||
| Energy source | 2 AAA batteries | Same | |
| Measurement | |||
| distance | Within 0-5 cm | Similar | |
| Note7 | |||
| Within 0-3 cm (exclude | |||
| 0 cm) | |||
| Touch aspect | Non contact | Same | |
| Memory Size | No data stored for YT-1 | ||
| series; | |||
| Up to 10 sets of data for | |||
| YT-2 series | Similar | ||
| Note8 | |||
| 32 measurements | |||
| Performance | Meets ISO 80601-2-56 | ||
| ASTM E 1965 | Different | ||
| Note 9 | |||
| Meets ISO 80601-2-56 | |||
| Materials | |||
| contact the | |||
| patient | / | Note 10 | |
| ABS, Acrylic | |||
| Biocompatibility | Meets ISO 10993-1 | ||
| ISO 10993-5 | |||
| ISO 10993-10 | Same | ||
| Meets ISO 10993-1 | |||
| ISO 10993-5 | |||
| ISO 10993-10 | |||
| Electrical | |||
| safety | Meets IEC 60601-1 | Same | |
| Meets IEC 60601-1 | |||
| EMC | Meets IEC 60601-1-2 | Same | |
| Meets IEC 60601-1-2 |
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Discussion of difference:
| Note ID | Justification |
|---|---|
| Note1 and Note2 | The HONSUN product has been conducted the clinical |
| accuracy test in accordance of ISO 80601-2-56, and the | |
| result met the requirements. The difference does not | |
| raise new safety and effectiveness questions. | |
| Note3 | The measurement range of the subject device is slightly |
| larger (only 0.5°C) than that of the predicate device. The | |
| HONSUN product has been conducted the performance test | |
| in accordance with ISO 80601-2-56, test results met the | |
| requirements. The difference does not raise new safety and | |
| effectiveness questions. | |
| Note 4 | The accuracy of measurement range of the subject device is |
| similar with that of predicate device and complies with ISO | |
| 80601-2-56. The performance test was conducted and the | |
| test results met the requirements. The difference does not | |
| raise new safety and effectiveness questions. | |
| Note5 and Note6 | The difference of operating & storage environment of |
| subject device are different with predicate device. The | |
| performance testing shows that the subject device complies | |
| with standard ISO 80601-2-56 . The difference does not | |
| raise any new issues of safety or efficacy. | |
| Note 7 | Measurement distance of the subject device is within |
| 0-3 cm (exclude 0 cm), the predicate device's is in the range | |
| of 0-5 cm. The manufacturer had conducted performance | |
| test to verify measurement accuracy and safety for the | |
| patient population according to ISO 80601-2-56 . The test | |
| results of subject device show the accuracy met the | |
| requirements within the distance range. Therefore, this | |
| difference does not raise new safety and effectiveness | |
| questions. | |
| Note8 | The memory capacity is additional function and will not |
| influence the performance and safety of infrared forehead | |
| thermometer. Besides, the HONSUN product was conducted | |
| software verification and validation test, the IEC 60601-1 and | |
| IEC 60601-1-2 test, the test results met the requirements. | |
| Therefore, this difference does not raise new safety and | |
| effectiveness questions. | |
| Note9 | The subject device performace testing was conducted in |
| accordance with ISO 80601-2-56, IEC 60601-1 and IEC | |
| 60601-1-2. The test results met the requirements. All of these | |
| standards are applied to clinical thermometers. The | |
| difference does not raise new safety and effectiveness | |
| questions. | |
| Note10 | The parts contact with the patient are palstic enclosure, |
| plastic button and acrylic pannel, the materials are ABS, ABS | |
| and Acrylic. All these materials were conducted the | |
| biocompatibility tests, including cytotoxicity, skin irritation | |
| and skin sensitization. The test results met the requirements. | |
| The difference does not raise new safety and effectiveness | |
| questions. |
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8. Non-clinical testing
The Infrared Forehead Thermometer is tested per the following standard, to evaluate its performance and safety. The test results demonstrated that the proposed device complies with the standards and guidance.
● IEC 60601-1:2005+AMD1:2012 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
● IEC 60601-1-11:2015 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+A1:2018 Medical electrical equipment — Particular requirements for the basic safety and essential performance of clinical thermometers for body temperature measurement
● FDA "Guidance for the content of premarket submissions for software contained in Medical Devices", 2005
● 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
9. Clinical testing
The LD-FT-100B infrared forehead thermometer was conducted the clinical accuracy test in Sept, 2020 according to the ISO 80601-2-56 and following two age groups were selected: older than 1 year and younger than 5 years, and older than 5 years based
୧-୧
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on the subject device's intended target population. According to the requirement of clinical test in ISO 80601-2-56, the YUWELL infrared thermometer YT-1 was selected as the reference device. In the subjects, 40 people were over one year old and less than five years old (17 with fever) and 65 people were over five years old (28 with fever).
The temperature was measured at the same measurement site (forehead) of the same subject with the reference thermometer and LD-FT-100B infrared forehead thermometer alternatively , and three values of same site were recorded. The clinical accuracy test results of the subject infrared forehead thermometer met the requirements of ISO 80601-2-56.
10. Conclusion
The subject device HONSUN infrared forehead thermometer LD-FT-100B and predicate device YUWELL Infrared Thermometer have the same intended use and similar technological characteristics. Based on the performance testing, comparison and analysis, the infrared forehead thermometer LD-FT-100B is substantially equivalent to the predicate device (K201864).