(156 days)
Not Found
No
The description focuses on standard infrared thermometry principles and does not mention AI or ML.
No
The device is described as an Infrared Forehead Thermometer intended for "intermittent measurement of human body temperature," which is a diagnostic or monitoring function, not a therapeutic one.
No
The device is an infrared thermometer for measuring body temperature, which provides an indication of a physiological parameter but does not diagnose a medical condition.
No
The device description explicitly states it is a "non-contact infrared thermometer" that employs a "thermopile sensor" and displays results on an "LCD". It is also "battery powered". These are all hardware components, indicating it is not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Infrared Forehead Thermometer measures human body temperature from the forehead using infrared radiation. It does not analyze any biological samples taken from the body.
- Intended Use: The intended use is for the intermittent measurement of human body temperature, which is a direct measurement of a physiological parameter, not an analysis of a sample.
Therefore, based on the provided information, the Infrared Forehead Thermometer is a medical device, but it falls under a different category than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Infrared Forehead 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.
Product codes (comma separated list FDA assigned to the subject device)
FLL
Device Description
The subject device Infrared Forehead Thermometer has three models: LFR30B, LFR50 and LFR60. The three modes have same operation principle. A thermopile sensor is employed to detect the infrared energy emitted from the surface of the skin of the forehead which is converted into temperature measurement with the unit of °C or °F. The results can be displayed on LCD. The measurement is non-contact with the patient. The measuring distance is 0~5 cm to the forehead and the measuring time is 1s. The Infrared Forehead Thermometer is battery powered.
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
Lay user and professional / 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)
Bench test were conducted to verify that the subject device met all design specifications, as was Substantially Equivalent (SE) to the predicate device.
Biocompatibility Testing:
The Infrared Forehead Thermometer was assessed against the International Standard ISO 10993-1, "Biological evaluation of medical devices. Part 1. Guidance on selection of tests." The subject device would be classified as a Surface Medical Device in contact with the intact skin for a Limited Duration (
§ 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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February 18, 2021
Shenzhen LEPU Intelligent Medical Equipment Co., Ltd. % Arthur Goddard President FDA Regulatory and Ouality Systems Consultant 31853 Cedar Road Mayfield Heights, Ohio 44124-4445
Re: K202687
Trade/Device Name: Infrared Forehead Thermometer, Model LFR30B, LFR50, LFR60 Regulation Number: 21 CFR 21 CFR 880.2910 Regulation Name: Clinical Electrical Thermometer Regulatory Class: Class II Product Code: FLL Dated: September 3, 2020 Received: September 15, 2020
Dear Arthur Goddard:
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
1
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,
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
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Indications for Use
510(k) Number (if known) K202687
Device Name
Infrared Forehead Thermometer, Model LFR30B, LFR50, LFR60
Indications for Use (Describe)
The Infrared Forehead Thermometer is a non-contact infermometer 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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Section 5: 510(K) Summary
This summary of 510(K) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR 807.92.
The assigned 510(K) Number: K202687
ನ. 510(K) Summary
5.1. Date of Preparation: February 18, 2021
5.2. Sponsor
Shenzhen LEPU Intelligent Medical Equipment Co., Ltd. North side of floor 3, BLD 9 BaiWangxin High-Tech Industrial Park Songbai Road, Xili Street, Nanshan District 518055 Shenzhen, Guangdong, CHINA Tel: +86 0755-86952278 Fax: +86 0755-86952278
Contact Person: Aaron Lin Position: General Manager Email: aaron.lin(@lepu-medical.com
5.3. Subject Device Identification
Subject Device Name: Infrared Forehead Thermometer, Model LFR30B, LFR50, LFR60 Common name: Infrared Forehead Thermometer Regulation Name: Clinical Electronic Thermometer Product Code: FLL Regulation Number: 21 CFR 880.2910 Review Panel: General Hospital Classification: II
5.4. Predicate Device
510(k) Number: K191251 Device Name: Infrared Thermometer (DT-8836T, DT-8836P) Manufacturer: Shenzhen Calibeur Industries Co., Ltd.
5.5. Indications for use:
The Infrared Forehead 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.
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5.6. Device Description
The subject device Infrared Forehead Thermometer has three models: LFR30B, LFR50 and LFR60. The three modes have same operation principle. A thermopile sensor is employed to detect the infrared energy emitted from the surface of the skin of the forehead which is converted into temperature measurement with the unit of ℃ or ºF. The results can be displayed on LCD. The measurement is non-contact with the patient. The measuring distance is 0~5 cm to the forehead and the measuring time is 1s. The Infrared Forehead Thermometer is battery powered.
| Item | Subject Device
Infrared Forehead
Thermometer | Predicate Device
Infrared Thermometer
(DT-8836T, DT-8836P)
K191251 | Remark |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Device
Common/Usual
Name | Infrared Forehead
Thermometer | Infrared Thermometer | / |
| Device Class | Class II | Class II | SE |
| Product Code/
Regulation
Number | FLL
21 CFR 880.2910 | FLL
21 CFR 880.2910 | SE |
| Classification
Name(s) | Clinical Electronic
Thermometer | Clinical Electronic
Thermometer | SE |
| Indications for
Use | The Infrared Forehead
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. | 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 |
| Intended Users | Lay user and professional | Lay user and professional | SE |
| Measurement
Method | Infrared radiation detection | Infrared radiation detection | SE |
| Measuring Site | Forehead | Forehead | SE |
5.7. Predicate Devices and Subject Device Comparison
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| Item | Subject Device
Infrared Forehead
Thermometer | Predicate Device
Infrared Thermometer
(DT-8836T, DT-8836P)
K191251 | Remark |
|-----------------|----------------------------------------------------|-----------------------------------------------------------------------------|--------------|
| Scale Selection | °C/°F | °C/°F | SE |
| Measuring Range | 32-43°C/89.6-109.4°F | 32.0°C ~42.5°C
(89.6 to 108.5 °F) | Discussion 1 |
Discussion 1 :
The measuring range of subject device is different with predicate device. The performance testing shows that the subject device complies with performance standard IEC 80601-2-56. The difference with predicate device K191251 doesn't raise any new issues of safety or efficacy.
| Display
| Resolution | 0.1°C/0.1°F | 0.1°C/0.1°F | SE |
|---|---|---|---|
| Measuring | |||
| Accuracy | ±0.3°C (±0.5°F) within | ||
| 34.0 | |||
| ±0.4°C (±0.7°F) within | |||
| 32.0 | ±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 | Discussion 2 |
Discussion 2:
The measuring accuracy of subject device is different with predicate device. The performance testing shows that the subject device complies with performance standard IEC 80601-2-56 and ASTM E 1965. The difference with predicate device K191251 doesn't raise any new issues of safety or efficacy.
| Measure Time | 1s | 1s | SE |
|---|---|---|---|
| Measure Distance | 0~5cm | ≤3cm | Discussion 3 |
Discussion 3:
The measure distance of subject device is different with predicate device. The performance testing shows that the subject device complies with performance standard IEC 80601-2-56 and ASTM E 1965. The difference with predicate device K191251 doesn't raise any new issues of safety or efficacy.
| Sensor | Thermopile | Thermopile | SE |
|---|---|---|---|
| Audio Reminder | Buzzer | Buzzer | SE |
| Data Storage | Up to 99 sets | 60 sets | Discussion 4 |
Discussion 4:
The data storage of subject device is different with predicate device. However, the software was validation according to FDA's software guidance. The performance testing shows that the subject device complies with performance standard IEC 80601-2-56 and ASTM E 1965. The difference with predicate device K191251 doesn't raise any new issues of safety or efficacy.
| Power Supply | Batterv | Batterv | CITY |
|---|---|---|---|
| Display Screen | C | T AT | CTT |
| ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤ | UND | DI |
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| Item | Subject Device
Infrared Forehead
Thermometer | Predicate Device
Infrared Thermometer
(DT-8836T, DT-8836P)
K191251 | Remark |
|--------------------------------|----------------------------------------------------|-----------------------------------------------------------------------------|--------------|
| Operating
Condition | 5°C40°C, Relative90% | 10
Humidity 2440°C (50°F +55°C, Relative104 °F)95% | |
RH 15
| Storage/transport
Condition | -20°C
Humidity