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.

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 degree C or degree 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.

AI/ML Overview

Here's an analysis of the provided text to extract information about the acceptance criteria and the study that proves the device meets those criteria:

Device: Infrared Forehead Thermometer, Model LFR30B, LFR50, LFR60

1. Table of Acceptance Criteria and Reported Device Performance

The provided document refers to compliance with performance standards rather than explicitly listing acceptance criteria with numeric targets for all aspects. However, based on the discussions and the standards invoked, we can infer some key performance criteria.

Acceptance Criteria Category	Specific Criteria (Target/Standard)	Reported Device Performance
Measurement Accuracy	±0.3°C (±0.5°F) within 34.0~~43°C (93.2~~109.4°F), ±0.4°C (±0.7°F) within 32.0~~33.9°C (89.6~~93.0°F) (as per IEC 80601-2-56 and ASTM E1965)	The performance testing shows that the subject device complies with performance standard IEC 80601-2-56 and ASTM E 1965 for measuring accuracy.
Measuring Range	32-43°C/89.6-109.4°F (as per IEC 80601-2-56)	The performance testing shows that the subject device complies with performance standard IEC 80601-2-56.
Measurement Distance	Ability to measure accurately within 0-5 cm (as per IEC 80601-2-56 and ASTM E1965)	The performance testing shows that the subject device complies with performance standard IEC 80601-2-56 and ASTM E 1965.
Operating Condition	Functionality within 5°C~~40°C, Relative Humidity 24~~90% (as per IEC 80601-2-56 and ASTM E1965)	The performance testing shows that the subject device complies with performance standard IEC 80601-2-56 and ASTM E 1965.
Storage/Transport Condition	Functionality within -20°C~+55°C, Relative Humidity < 95% (as per IEC 80601-2-56 and ASTM E1965)	The performance testing shows that the subject device complies with performance standard IEC 80601-2-56 and ASTM E 1965.
Biocompatibility	No cytotoxicity, no sensitization, negligible irritation (as per ISO 10993-5 and ISO 10993-10)	In Vitro Cytotoxicity Study: MEM test extracts considered no cytotoxicity potential. Skin Sensitization Study: No evidence of causing delayed dermal contact sensitization. Skin Irritation Study: Irritation response classified as Negligible for polar and non-polar extracts.
Software Validation	Developed, documented, and validated in accordance with IEC 62304 and FDA guidance.	Software was validated according to FDA's software guidance.
Clinical Repeatability	Within clinical acceptability as defined in ISO 80601-2-56.	Clinical repeatability as defined in the ISO 80601-2-56 standard were within clinical acceptability.
Clinical Bias	Within clinical acceptability as defined in ISO 80601-2-56.	Clinical bias with stated uncertainty as defined in the ISO 80601-2-56 standard were within clinical acceptability.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size (Clinical Study): The clinical study involved "four age groups: 0 up to 3 months, 3 months up to 1 year, older than 1 year and younger than 5 years and older than 5 years". The exact number of subjects within each group or total subjects is not specified in this document.
Data Provenance: Not explicitly stated (e.g., country of origin). However, the sponsor is Shenzhen LEPU Intelligent Medical Equipment Co., Ltd. from Shenzhen, Guangdong, China. It is highly probable the data originates from China.
Retrospective or Prospective: Not explicitly stated, but clinical comparison studies are generally prospective. The text "A comparison study and clinical repeatability testing was performed" suggests a prospective collection of data for this study.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document states that a clinical comparison study was performed "to compare the Infrared Forehead Thermometer with Mercury thermometer." This implies the Mercury thermometer served as the reference standard (ground truth). The text does not mention human experts establishing ground truth for individual measurements, but rather the objective measurement from a validated reference device.

4. Adjudication Method for the Test Set

Not applicable/not mentioned, as the ground truth was established by comparison to a Mercury thermometer, not by expert consensus requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. The study described is a clinical comparison study of the device against a reference measurement tool (Mercury thermometer) for temperature measurement, not a study involving human readers interpreting results with and without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Yes, the studies described are standalone performance evaluations. The device's measurement accuracy, range, and other characteristics were tested directly against standards and a reference thermometer. The clinical study compares the device's output (algorithm only) to the Mercury thermometer.

7. The Type of Ground Truth Used

The primary ground truth for the clinical study was the measurement obtained from a Mercury thermometer. This serves as a widely accepted clinical standard for body temperature measurement.

8. The Sample Size for the Training Set

The document does not mention a distinct "training set" in the context of device development or performance testing for regulatory submission. It refers to a "software" and indicates it was developed, documented, and validated according to IEC 62304 and FDA guidance. This suggests the software development process involved appropriate internal testing, but no specific "training set" for an AI/ML algorithm is detailed, given this is primarily a hardware device with embedded control software.

9. How the Ground Truth for the Training Set Was Established

Not applicable/not mentioned, as no explicit training set for an AI/ML model for temperature measurement is described. The control software likely operates based on physical principles and calibration rather than a trained AI model.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The text logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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

{2}------------------------------------------------

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

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:

{4}------------------------------------------------

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 DeviceInfrared ForeheadThermometer	Predicate DeviceInfrared Thermometer(DT-8836T, DT-8836P)K191251	Remark
DeviceCommon/UsualName	Infrared ForeheadThermometer	Infrared Thermometer	/
Device Class	Class II	Class II	SE
Product Code/RegulationNumber	FLL21 CFR 880.2910	FLL21 CFR 880.2910	SE
ClassificationName(s)	Clinical ElectronicThermometer	Clinical ElectronicThermometer	SE
Indications forUse	The Infrared ForeheadThermometer is a non-contactinfrared thermometer intendedfor the intermittentmeasurement of human bodytemperature from forehead forpeople of all ages. The deviceis reusable for home use andclinical use.	The Infrared thermometer is anon-contact infraredthermometer intended for theintermittent measurement ofhuman body temperaturefrom forehead for people ofall ages. The device isreusable for home use andclinical use.	SE
Intended Users	Lay user and professional	Lay user and professional	SE
MeasurementMethod	Infrared radiation detection	Infrared radiation detection	SE
Measuring Site	Forehead	Forehead	SE

5.7. Predicate Devices and Subject Device Comparison

{5}------------------------------------------------

Item	Subject DeviceInfrared ForeheadThermometer	Predicate DeviceInfrared 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.

DisplayResolution	0.1°C/0.1°F	0.1°C/0.1°F	SE
MeasuringAccuracy	±0.3°C (±0.5°F) within34.0~~43°C (93.2~~109.4°F),±0.4°C (±0.7°F) within32.0~~33.9°C (89.6~~93.0°F)	±0.2°C (0.4°F) within35.0°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

{6}------------------------------------------------

Item	Subject DeviceInfrared ForeheadThermometer	Predicate DeviceInfrared Thermometer(DT-8836T, DT-8836P)K191251	Remark
OperatingCondition	5°C~~40°C, RelativeHumidity 24~~90%	10~40°C (50°F ~~104 °F)RH 15~~95%
Storage/transportCondition	-20°C~+55°C, RelativeHumidity < 95%	-25 ~~+55°C (-13~~+131°F)RH:15~95%	Discussion 5

Discussion 5:

The operating and storage/transport condition of subject device are 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.

Human-contactingMaterial	ABS, PC, PMMA	ABS	Discussion 6
----------------------------------	---------------	-----	--------------

Discussion 6:

The human-contacting material of subject device is different with predicate device. PC and PMMA are widely used in medical device. The biocompatibility evaluation of the subject device was conducted according to FDA Guidance for Industry and Food and Drug Administration Staff: Use of International Standard ISO 10993-1. "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". Cytotoxicity, sensitization tests are performed. The test reports addressed during the biocompatibility studies (Section 15: Biocompatibility) did not raise any new issues of biocompatible safety. The difference with predicate device K191251 doesn't raise any new issues of safety or efficacy.

BiocompatibilityInformation	ISO 10993-5ISO 10993-10	ISO 10993-5ISO 10993-10	SE
Reference BodySite	Axilla	Axilla	SE
Measuring Mode	Adjusted (Body mode)	Adjusted (Forehead mode)	SE
ConformanceStandard	ISO 80601-2-56IEC 60601-1IEC 60601-1-2ASTM E1965	ISO 80601-2-56IEC 60601-1IEC 60601-1-2ASTM E1965	SE

{7}------------------------------------------------

5.8. Performance Test Summary

Bench test were conducted to verify that the subject device met all design specifications, as was Substantially Equivalent (SE) to the predicate device.

5.8.1. 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 (<24 hours). The following test were performed for any user contacting material:

Test	Standard	Results
In Vitro CytotoxicityStudy (MTT Method)	ISO 10993-5	Under the conditions of this study, the MEMtest extracts would be considered nocytotoxicity potential. The negative controls,blank controls, and the positive controlsperformed as anticipated.
Skin Sensitization StudyGuinea Pig MaximizationTest	ISO 10993-10	Under the conditions of this study, the testarticle extracts showed no evidence ofcausing delayed dermal contact sensitizationin the guinea pig. The test article was notconsidered a sensitizer in the guinea pigmaximization test.
Skin Irritation Study	ISO 10993-10	Under the conditions of this study, theirritation response category of the test articleis classified as Negligible for polar extract andNegligible for non-polar extract.

5.8.2. Non-clinical Tests

The Infrared Forehead Thermometer is tested per the following standard, to evaluate its performance. The test results demonstrated that the proposed device comply with the standard requirements.

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

{8}------------------------------------------------

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.

ASTM E1965-98 (2016) Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature

5.8.3. Clinical Data

A comparison study and clinical repeatability testing was performed on the following four age groups: 0 up to 3 months, 3 months up to 1 year, older than 1 year and younger than 5 years and older than 5 years in accordance with ISO 80601-2-56 to compare the Infrared Forehead Thermometer with Mercury thermometer. This clinical comparison study demonstrated that the temperatures obtained with the Infrared Forehead Thermometer were highly related when compared to the Mercury thermometer, the clinical bias with stated uncertainty and clinical repeatability as defined in the ISO 80601-2-56 standard were within clinical acceptability.

5.8.4. Software

The software embedded in Infrared Forehead Thermometer has been developed, documented and validated in accordance with industry standards (IEC 62304 - Medical device software - Software life cycle processes) and FDA guidance (GUIDANCE FOR CONTENT OF PRE-MARKET SUBMISSIONS FOR SOFTWARE THE CONTAINED IN DEVICES).

5.9. Substantially Equivalent Conclusion

The subject device, Infrared Forehead Thermometer, is determined to be Substantially Equivalent (SE) to the predicate device, K191251, in respect of safety and effectiveness.

Regulation Number and Section

§ 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.