The Infrared Thermometer (model: E201) is a non-sterile, reusable, handheld device. It is intended for measuring human body temperature for people of all ages by detecting infrared heat from the forehead and auditory canal. When measuring forehead temperature, it is non-contact and the distance of measurement is 1~5cm. The device can be used by consumers in homecare environment.

Device Description

The Infrared Thermometer, model E201, is a light weight, handheld and reusable infrared thermometer that measures temperatures for people of all ages by detecting infrared energy radiated from the forehead and auditory canal in the homecare environment. It uses 3.0V alkaline batteries and can be operated continuously. To measure body temperature, the probe of the thermometer is inserted into a patient's outer ear canal or put onto the skin of a patient's forehead mode, the thermometer must keep 1-5 cm distance with the forehead of patient, a probe cover is not needed for the forehead and ear mode. The reference body site of E201 infrared thermometer is oxter (axillary). The device has the following features: 1) The device is intended to be used in the homecare environment; 2) The device is mainly composed of infrared sensor(Thermopile), signal receiving processor, buttons, buzzer, LCD display. It is powered by 2*1.5 AAA batteries; 3) Switching between °C and °F; 4) Multi-functional, can measure ear and forehead temperature; 5) The 32 sets measurement data can be stored, the user can view the previous measurement results; 6) Low battery indication, and auto shut-down within 30s.

AI/ML Overview

Here's an analysis of the provided text to extract the acceptance criteria and study information for the Infrared Thermometer (model: E201):

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily derived from the "Measuring accuracy" in the comparison table and the clinical accuracy testing based on ISO 80601-2-56.

Acceptance Criteria (from "Measuring accuracy" & ISO 80601-2-56)	Reported Device Performance (from "Measuring accuracy" & Clinical Accuracy Testing)
Measuring Accuracy (Device Output vs. Reference)
±0.3°C for temperatures between 32.0°C and 34.9°C	±0.3°C (32.0°C~34.9°C)
±0.2°C for temperatures between 35.0°C and 42.0°C	±0.2°C (35.0°C~42.0°C)
±0.3°C for temperatures between 42.1°C and 43.0°C	±0.3°C (42.1°C~43.0°C)
Clinical accuracy and repeatability within acceptable scope specified in standard ISO 80601-2-56	Clinical accuracy and repeatability met requirements per referenced standards (ISO 80601-2-56)

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

Test Set Sample Size: 150 subjects total.
- 50 subjects in the 0-1 year age group.
- 50 subjects in the 1-5 years age group.
- 50 subjects in the over 5 years age group.
Data Provenance: Not explicitly stated regarding country of origin. The study is described as a "clinical accuracy study for the E201 infrared thermometer was performed," implying a prospective clinical study. It does not mention retrospective data.

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

This information is not provided in the document. The text only states that the "reference body site of infrared thermometer is oxter (axillary)" and that clinical accuracy/repeatability testing was performed. It doesn't specify how many experts established the ground truth or their qualifications.

4. Adjudication Method for the Test Set

This information is not provided in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This is not applicable as the device is an Infrared Thermometer, not an AI-assisted diagnostic tool for human readers. No MRMC study was conducted.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This is not applicable in the context of an infrared thermometer. The device itself is the "standalone" entity that measures temperature. Its performance is evaluated directly against a reference body site.

7. The Type of Ground Truth Used

Ground Truth: The "oxter (axillary)" temperature as the reference body site.

8. The Sample Size for the Training Set

This information is not applicable as this is a traditional medical device (infrared thermometer), not an AI/ML device that requires a distinct training set. The device's algorithms are based on established physical principles of infrared radiation and temperature conversion, calibrated during manufacturing, rather than being "trained" on a dataset in the AI sense.

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

This is not applicable for the same reasons as point 8. The device's calibration and accuracy are verified against known temperature standards and clinical measurements (using oxter temperature as reference), not established through a "training set" with ground truth in the AI sense.

Summary

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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: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.

Bioland Technology Ltd Eric Tan Regulatory Engineer No. A6B7 (Block G) ShangRong Industrial Zone. No. 5 Baolong Road Shenzhen, 518116 CN

Re: K213011

Trade/Device Name: Infrared Thermometer (model: E201) Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: March 7, 2022 Received: March 7, 2022

Dear Eric Tan:

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 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

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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 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.

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 Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K213011

Device Name Infrared Thermometer (model: E201)

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary - K213011

A. Applicant

Name: Bioland Technology Ltd.

Address: No. A6B7 (Block G) Shangrong Industrial Zone, No.5 Baolong Road, Baolong Community Longgang District, 518116 Shenzhen, Guangdong PEOPLE'S REPUBLIC OF CHINA

Tel: +86 755 3690 0999 Fax: +86 755 3329 6299 Contact person: Eric Tan E-mail: regulator-b@@bioland.com.cn Date of summary prepared: 2021.12.29

B. Subject device

Trade name: Infrared Thermometer Model: E201 Classification name: Clinical Electronic Thermometer Review Panel: General Hospital Product Code: FLL Regulation number: 880.2910 Device class: Class 2 Code of Federal Regulations: 21CFR 880.2910

C. Predicate Device

Device name: Infrared Thermometer Model MD-H30 510(K) number: K191570 Manufacturer: Guangzhou Berrcom Medical Device Co., Ltd.

D. Indications for Use

The Infrared Thermometer(model: E201) is a non-sterile, reusable, handheld device. It is intended for measuring human body temperature for people of all ages by detecting infrared heat from the forehead and auditory canal. When measuring forehead temperature, it is non-contact and the distance of measurement is 1~5cm. The device can be used by consumers in homecare environment.

E. Device Description

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To measure body temperature, the probe of the thermometer is inserted into a patient's outer ear canal or put onto the skin of a patient's forehead mode, the thermometer must keep 1-5 cm distance with the forehead of patient, a probe cover is not needed for the forehead and ear mode. The reference body site of E201 infrared thermometer is oxter (axillary). The device has the following features:

The device is intended to be used in the homecare environment;
The device is mainly composed of infrared sensor(Thermopile), signal receiving processor, buttons, buzzer, LCD display. It is powered by 2*1.5 AAA batteries;

1. Switching between °C and °F;
1. Multi-functional, can measure ear and forehead temperature;

The 32 sets measurement data can be stored, the user can view the previous measurement results;

1. Low battery indication, and auto shut-down within 30s.

F. Principle Operation

The Infrared Thermometer measures temperatures of people by detecting the infrared energy radiated directly from the forehead without physical contact. All the temperature in nature above absolute zero (-273°C or -459.4°F) objects will radiate infrared, and the radiation of infrared energy and temperature is proportional to the relationship. Using this relationship, an object's temperature can be calculated by measuring its infrared intensity.

Comparison items	Subject Device	Predicate Device	Remarks
Manufacturer	Bioland Technology Ltd	Guangzhou Berrcom MedicalDevice Co., Ltd.	N/A
Model	E201	MD-H30	N/A
Classification	II	II	Same
Product code	FLL	FLL	Same
Classification name	Thermometer, electronic, clinical	Thermometer, electronic, clinical	Same
Regulation No.	880.2910	880.2910	Same
510(K) number	K213011	K191570	N/A
Intended Use	The Infrared Thermometer is anon-sterile, reusable, handheld device.It can be used by consumers inhomecare environment. It is intendedfor measuring human bodytemperature for people of all ages bydetecting infrared heat from theforehead and auditory canal	The infrared thermometer is intendedfor the intermittent measurement ofbody temperature from the auditorycanal or central forehead skin surfaceon people of all ages. It can be usedby consumers in the householdenvironment and by healthcareproviders	Same
Measurement method	Infrared radiation detection	Infrared radiation detection	Same
Comparison items	Subject Device	Predicate Device	Remarks
Measurement Site	indirect mode use : Foreheaddirect mode use: Auditory canal	indirect mode use : Foreheaddirect mode use: Auditory canal	Same
Measurement range	32.0~43.0 °C(89.6 °F ~109.4 °F)	32.0~43.0 °C(89.6 °F ~109.4 °F)	Same
Display precision	0.1 °C / °F	0.1 °C / °F	Same
°C / °F unit switchable	Yes	Yes	Same
Measuring accuracy	±0.3°C(32.0°C~~34.9°C)±0.2°C (35.0°C~~42.0°C)±0.3°C (42.1°C~43.0°C)	±0.2°C (35.0°C~42.0°C)±0.3°C for other range	Same
Power Source	AAA*2, DC 3V	AAA*2, DC 3V	Same
Low battery indication	Yes	Yes	Same
Display	LCD Display	LCD Display	Same
OperatingEnvironmentCondition	15~40°C, RH≤85% (non-condense)	10~40°C, RH≤95% (non-condense)	DifferentNote 1
Storage EnvironmentCondition	-20~55°C, RH≤93% (non-condense)	-20~55°C, RH≤95% (non-condense)	DifferentNote 1
Contact type	Contact/non contact	Contact/non contact	Same
Sensor	Thermopile	Thermopile	Same
Reference body site	Oxter	Not applicable	Same
Target population	People of all ages	People of all ages	Same
Use Environment	Homecare environment	Household environment	Same
Patient Age	People of all ages	People of all ages	Same
Measure time	1s	1s	Same
Measurementdistance (indirectmode use)	1~5cm for forehead mode	1~5cm for forehead mode	Same
Memory Set	32 sets	20 sets	DifferentNote 2
Reusable/non-resuable	Reusable	Reusable	Same
Use of probe cover	No	No	Same
Sensor	Thermopile	Thermopile	Same
Measurementtype	indirect mode use : Foreheaddirect mode use: Auditory canal	indirect mode use : Foreheaddirect mode use: Auditory canal	Same
Display type	LCD	LCD	Same
Patient contactmaterials	ABS	ABS	Same
Comparison items	Subject Device	Predicate Device	Remarks
Biocompatibility	ISO 10993-5: 2009	ISO 10993-5: 2009	Same
	ISO 10993-10: 2010	ISO 10993-10: 2010
EMC	IEC 60601-1-2: 2014	IEC 60601-1-2: 2014	Same
Electrical Safety	IEC 60601-1: 2005/A1; 2012	IEC 60601-1: 2005/A1; 2012	Same
Performance	ISO 80601-2-56	ISO 80601-2-56	Same
	ASTM E1965-98	ASTM E 1965-98

G. Substantial Equivalence table

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Note 1: The operating and storage environment condition is a little different between the subject device and predicate device, the subject device has passed the testing according to standard ASTM E1965-98 and ISO 80601-2-56, and the predicate device also conforms to the requirement of standard ISO 80601-2-56 and ASTM E1965-98. At the same time, we indicate the operating and storage environment condition on the user manual and gift-box. Therefore, the difference of declared standards has no influence on safety and effectiveness of product.

Note 2: The purpose of memory function is intended to store and view the previous measurement data. The function has been verified during software verification. The difference does not raise any issues on the device safety and effectiveness.

H. Predicate Device Comparison

The subject device and the predicate device both have same intended use, measuring range, measuring accuracy and contact materials, they both use infrared radiation detection method to detect human forehead temperature and some technical parameters are the same. Thus, it can be concluded that the subject device is substantially equivalent to the predicate devices.

Testing name	Referenced standard	Summary result	Verdict
Electric safetytesting	IEC 60601-1: 2005/A1: 2012 Medical electricalequipment Part 1: General requirements forbasic safety and essential performanceFDA Recognition number: 19-4	The subject device complieswith the applicable requirementsset forth in the referencedelectric safety standard.	Pass
EMC testing	IEC 60601-1-2:2014 Medical electricalequipment - Part 1-2: General requirements forbasic safety and essential performance -Collateral standard: Electromagneticcompatibility - Requirements and testsFDA Recognition number: 19-8	The subject device complieswith the applicable requirementsset forth in the referencedstandard.	Pass
Electric safety formedical deviceused in the home	IEC 60601-1-11:2015 Medical electricalequipment - General requirements for basicsafety and essential performance - Part 1-11:	The subject device complieswith the applicable requirementsset forth in the referenced	Pass
Testing name	Referenced standard	Summary result	Verdict
healthcareenvironment	Collateral Standard: Requirements for medicalelectrical equipment and medical electricalsystems used in the home healthcareenvironment.FDA Recognition number: 19-14	standard.
Performancetesting	ISO 80601-2-56:2017 Medical electricalequipment — Part 2-56: Particularrequirements for basic safety and essentialperformance of clinical thermometers for bodytemperature measurement.FDA Recognition number: 6-421ASTM E1965-98:2016 Standard Specificationfor Infrared Thermometers for IntermittentDetermination of Patient TemperatureFDA Recognition number: 6-125	The subject device complieswith the applicable requirementsset forth in the referencedperformance standard.	Pass
Biocompatibilitytesting	ISO 10993-1:2018 Biological evaluation ofmedical devices -- Part 1: Evaluation andtesting within a risk management processFDA Recognition number: 2-258ISO 10993-5: 2009 Biological evaluation ofmedical devices -- Part 5: Tests for In VitrocytotoxicityFDA Recognition number: 2-245ISO 10993-10: 2010 Biological evaluation ofmedical devices -- Part 10: Tests for irritationand delayed-type hypersensitivityFDA Recognition number: 2-174	The subject device complieswith the applicable requirementsset forth in the referencedbiological evaluation standard.	Pass

-Non-clinical test

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Software verification and validation

Software documentation consistent with moderate level of concern is submitted in this 510(k). All software requirement specifications are met and all software hazards have been mitigated to acceptable risk levels. The software verification and validation were conducted in accordance with the "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," dated May 11, 2005. The test results demonstrated the software function met the requirements.

J. Clinical Accuracy Testing

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The clinical accuracy study for the E201 infrared thermometer was performed to determine the clinical accuracy. The study includes 150 subjects, the three groups of subjects being tested were: 1) 0~~1 year old, 2) children between 1~~5 years old, and 3) over 5 years old. For each age group, the ratio of febrile subjects was more than 30% and less than 50%. The reference body site of infrared thermometer is oxter. 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 accuracy test results showed that the accuracy of the E201 infrared thermometer is within acceptable scope specified in standard ISO 81061-2-56.

Name ofclinicaltesting	Referenced standard	Summary oftesting	Referencebody site	Patient population(age groups,number of subjects	Verdict
Clinicalaccuracyandrepeatabilitytesting	ISO 80601-2-56:2017Medical electricalequipment — Part 2-56:Particular requirementsfor basic safety andessential performanceof clinical thermometersfor body temperaturemeasurement.FDA Recognitionnumber: 6-421	The methods andcriteria of clinicalaccuracy andrepeatability testinghad been clinicallyassessed to meetthe requirementsper the referencedstandards.	Oxter	50 subjects in eachage group: 0-1 year,1-5 years and olderthan 5 years (Total150 subjects)	Pass

The clinical accuracy test information of subject device E201 as following:

K. Conclusion

Non-clinical performance and clinical accuracy tests were conducted on the subject device and all tests met specified criteria. Base on the information provided in this submission, the subject device E201 infrared thermometer is substantially equivalent to the predicate device.

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.