(195 days)
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 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.
The document describes the acceptance criteria and study proving the device meets them for the HONSUN infrared forehead thermometer LD-FT-100B.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Infrared Forehead Thermometer LD-FT-100B are primarily based on the international standard ISO 80601-2-56 for clinical thermometers and ASTM E 1965. The device's performance is demonstrated through testing against these standards.
| Acceptance Criteria | Reported Device Performance (LD-FT-100B) |
|---|---|
| Measurement Range | 32°C to 43°C (89.6°F to 109.4°F) |
| Accuracy (Temperature Ranges) | ±0.2°C (±0.4°F) in the range of 35.0°C |
| ±0.3°C (±0.5°F) in the range of 32.5°C | |
| Resolution of Display | 0.1°C/0.1°F |
| Operating Environment | 10°C (50°F) to 40°C (104°F), 15%RH ~90%RH (no condensation) |
| Storage Environment | -20°C (-4°F) to 55°C (131°F), 10%RH ~85%RH |
| Measurement Distance | Within 0-3 cm (exclude 0 cm) |
| Electrical Safety | Meets IEC 60601-1 |
| EMC (Electromagnetic Compatibility) | Meets IEC 60601-1-2 |
| Biocompatibility | Meets ISO 10993-1, ISO 10993-5, ISO 10993-10 |
| Clinical Accuracy | Met the requirements of ISO 80601-2-56 based on clinical testing |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size:
- Clinical Accuracy Test Set: 105 subjects in total.
- 40 people were older than 1 year and younger than 5 years (17 with fever).
- 65 people were older than 5 years (28 with fever).
- Clinical Accuracy Test Set: 105 subjects in total.
- Data Provenance: The details of the country of origin are not explicitly stated for the clinical accuracy test. However, given that HONSUN (Nantong) Co., Ltd is located in China, it is reasonable to infer the study was conducted there. The clinical accuracy test was conducted in September 2020, implying a prospective study design for this specific test.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not specify the number or qualifications of experts used to establish ground truth for the clinical accuracy test. It states that the YUWELL infrared thermometer YT-1 (the predicate device) was used as the reference device to establish the "ground truth" for temperature measurements in the clinical accuracy study. It implies comparison with a calibrated, legally marketed device rather than human experts interpreting results.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method in the traditional sense (e.g., 2+1, 3+1). For the clinical accuracy test, the comparison was made against a reference thermometer (YUWELL infrared thermometer YT-1) by taking three measurements at the same site (forehead) alternately with the reference thermometer and the subject device. The ground truth was essentially the measurement reported by the reference device, as per the standard.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This device is a thermometer, not an AI diagnostic tool that requires human interpretation. Therefore, a study comparing human readers with and without AI assistance is not applicable.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, the primary performance evaluation for the thermometer is its standalone accuracy and compliance with relevant standards (ISO 80601-2-56, ASTM E 1965) without human interpretation being part of the measurement process itself. The clinical accuracy test directly measured the device's performance against a reference.
7. The Type of Ground Truth Used
The ground truth used for the clinical accuracy study was established by comparison against a reference thermometer (YUWELL infrared thermometer YT-1), in accordance with the requirements of ISO 80601-2-56. This is a form of device-based ground truth, where a well-characterized and established medical device serves as the standard for comparison.
8. The Sample Size for the Training Set
The document does not provide information about a "training set" as this device is a physical medical device, not a machine learning model that undergoes a training phase with data. The tests described are for validation and verification of the device's hardware and software performance.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a training set for a machine learning model, this question is not applicable to the information provided. The device's design and operating principle are based on known physics of infrared detection and conversion, rather than learned patterns from a training dataset.
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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 foreheadthermometer | Infrared thermometer | Same |
| 510(K)number | K211629 | K201864 | / |
| Product code | FLL | FLL | Same |
| RegulationNo. | 880.2910 | 880.2910 | Same |
| Classification | II | II | Same |
| Intended use | The infrared foreheadthermometer is anonsterile, reusableclinical thermometerintended for measuringthe human bodytemperature innon-contact mode onthe center of theforehead as themeasurement site onpeople of all agesexcept the age underthe 1 year. | The YUWELL infraredforehead thermometeris a nonsterile, reusableclinical thermometerintended for measuringthe human bodytemperature innon-contact mode onthe center of theforehead as themeasurement site onpeople of all ages exceptpreterm babies. | SimilarNote 1 |
| Patientpopulation | People of all agesexcept the age underthe 1 year. | People of all ages exceptpreterm babies | SimilarNote2 |
| Operation | Hand held-manuallyoperated | Hand held-manuallyoperated | Same |
| Measurementsite | Forehead | Forehead | Same |
| Designmethod | Using infrared energyconversion | Using infrared energyconversion | Same |
| Display | LCD digital display | LCD digital display | Same |
| Operatingmode | Adjusted mode | Adjusted mode | Same |
| Referencebody site | Oral | Oral | Same |
| scale | °C/°F | °C/°F | Same |
| Measurementrange | 32°C to 43°C (89.6°Fto 109.4°F) | 32.5°C to 43°C (90.5°Fto 109.4°F) | SimilarNote 3 |
| Accuracy | ±0.2°C (±0.4°F) in therange of 35.0°C | SimilarNote 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) to35°C (95°F) and from42.1°C (107.8°F) to43°C (109.4°F) | |||
| Resolution ofdisplay | 0.1°C/0.1°F | Same | |
| Operatingenvironment | 10°C (50°F) to 40°C (104°F),15%RH ~90%RH (nocondensation) | SimilarNote5 | |
| 10°C (50°F) to 40°C (104°F)15%RH | |||
| Storageenvironment | -20°C (-4°F) to 55°C(131°F),10%RH ~85%RH | SimilarNote6 | |
| -10°C (14°F) to 50°C(122°F),10%RH ~85%RH | |||
| Energy source | 2 AAA batteries | Same | |
| Measurementdistance | Within 0-5 cm | SimilarNote7 | |
| Within 0-3 cm (exclude0 cm) | |||
| Touch aspect | Non contact | Same | |
| Memory Size | No data stored for YT-1series;Up to 10 sets of data forYT-2 series | SimilarNote8 | |
| 32 measurements | |||
| Performance | Meets ISO 80601-2-56ASTM E 1965 | DifferentNote 9 | |
| Meets ISO 80601-2-56 | |||
| Materialscontact thepatient | / | Note 10 | |
| ABS, Acrylic | |||
| Biocompatibility | Meets ISO 10993-1ISO 10993-5ISO 10993-10 | Same | |
| Meets ISO 10993-1ISO 10993-5ISO 10993-10 | |||
| Electricalsafety | 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 clinicalaccuracy test in accordance of ISO 80601-2-56, and theresult met the requirements. The difference does not |
| raise new safety and effectiveness questions. | |
| Note3 | The measurement range of the subject device is slightlylarger (only 0.5°C) than that of the predicate device. TheHONSUN product has been conducted the performance testin accordance with ISO 80601-2-56, test results met therequirements. The difference does not raise new safety andeffectiveness questions. |
| Note 4 | The accuracy of measurement range of the subject device issimilar with that of predicate device and complies with ISO80601-2-56. The performance test was conducted and thetest results met the requirements. The difference does notraise new safety and effectiveness questions. |
| Note5 and Note6 | The difference of operating & storage environment ofsubject device are different with predicate device. Theperformance testing shows that the subject device complieswith standard ISO 80601-2-56 . The difference does notraise any new issues of safety or efficacy. |
| Note 7 | Measurement distance of the subject device is within0-3 cm (exclude 0 cm), the predicate device's is in the rangeof 0-5 cm. The manufacturer had conducted performancetest to verify measurement accuracy and safety for thepatient population according to ISO 80601-2-56 . The testresults of subject device show the accuracy met therequirements within the distance range. Therefore, thisdifference does not raise new safety and effectivenessquestions. |
| Note8 | The memory capacity is additional function and will notinfluence the performance and safety of infrared foreheadthermometer. Besides, the HONSUN product was conductedsoftware verification and validation test, the IEC 60601-1 andIEC 60601-1-2 test, the test results met the requirements.Therefore, this difference does not raise new safety andeffectiveness questions. |
| Note9 | The subject device performace testing was conducted inaccordance with ISO 80601-2-56, IEC 60601-1 and IEC60601-1-2. The test results met the requirements. All of thesestandards are applied to clinical thermometers. Thedifference does not raise new safety and effectivenessquestions. |
| Note10 | The parts contact with the patient are palstic enclosure,plastic button and acrylic pannel, the materials are ABS, ABSand Acrylic. All these materials were conducted thebiocompatibility tests, including cytotoxicity, skin irritationand 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).
§ 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.