Infrared thermometer is a non-sterile, reusable, handheld and non-contact device. It can be used by consumers in home care environment and doctors in clinic as reference. It is intended for measuring human body temperature of one month of age and above by detecting infrared heat from the forehead.

Device Description

The Infrared Thermometer, Model E127, is a light weight, handhold and non-contact Infrared Thermometer that measures temperatures of people ages 1 month and above by detecting the infrared energy radiated directly from the forehead without physical contact from a measurement distance of 1-5cm. . It uses 3.0V alkaline batteries. The device can measure temperature in direct and adjusted mode.

AI/ML Overview

The provided document describes the Bioland Technology Ltd. Infrared Thermometer (Model E127) and its clearance through the FDA 510(k) pathway, asserting its substantial equivalence to a predicate device. Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily derived from international and national standards, specifying performance limits for accuracy and repeatability.

Test Item	Acceptance Criteria (Standard)	Reported Device Performance
Electrical Safety	IEC 60601-1: 2005/A1: 2012	Complies with applicable requirements
EMC Testing	IEC 60601-1-2: 2014	Complies with applicable requirements
Electrical Safety (Home Use)	IEC 60601-1-11: 2015	Complies with applicable requirements
Performance (General)	ISO 80601-2-56: 2017	Complies with applicable requirements
Biocompatibility	ISO 10993-1: 2018, ISO 10993-5: 2009, ISO 10993-10: 2010	Complies with applicable requirements
Clinical Accuracy	ASTM E1965-98: 2016	Meets the requirements of clinical accuracy (Passed)
Clinical Repeatability	ISO 80601-2-56: 2017	Meets the requirements of clinical repeatability (Passed)
Measuring Accuracy	±0.3 °C (32.0 °C -34.9 °C) ±0.2 °C (35-42.0 °C) ±0.3 °C (42.1 °C -43.0 °C) (matched predicate)	Implied to meet these criteria, as it's stated as "Same" as predicate device.
Measurement Range	32.0~43.0 °C (89.6 °F ~109.4 °F) (matched predicate)	Implied to meet this range, as it's stated as "Same" as predicate device.
Display Resolution	0.1 °C / °F (matched predicate)	Implied to meet this resolution, as it's stated as "Same" as predicate device.

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

Sample Size: 150 subjects for clinical testing, divided into three age groups:
- Infants (0-1 year): 50 subjects
- Children (1-5 years): 50 subjects
- Adults (>5 years): 50 subjects
Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. It only states "clinical accuracy and repeatability testing had been clinically assessed."

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

The document does not provide information on the number of experts used or their qualifications for establishing the ground truth in the clinical accuracy and repeatability testing. Clinical trials for thermometers, especially for substantial equivalence, often compare the device's readings against established reference methods, which serve as the ground truth.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for the test set. For clinical thermometer studies, the reference method (e.g., rectal or oral thermometer readings) typically serves as the "ground truth" against which the new device's readings are compared.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study described focuses on the device's accuracy and repeatability against a reference standard, not on human reader performance with or without AI assistance. The device in question is an Infrared Thermometer, which is a standalone measurement device, not an AI-powered diagnostic tool requiring human interpretation.

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

Yes, a standalone performance assessment was done. The clinical accuracy and repeatability testing evaluated the Infrared Thermometer's ability to measure temperature directly, without human interpretation of complex data or AI assistance in a diagnostic context. The device itself is the "algorithm" in this context, directly providing a temperature reading.

7. The Type of Ground Truth Used

The ground truth for the clinical accuracy and repeatability testing would have been established by a reference method for body temperature measurement, likely an invasive or highly accurate contact thermometer (e.g., rectal temperature for infants or oral temperature for adults). The document implies this by stating the device was "clinically assessed to meet the requirements of clinical accuracy per the referenced standards" (ISO 80601-2-56 and ASTM E1965-98). These standards typically outline the methodologies for establishing such ground truth.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" or "training data" as would be relevant for machine learning algorithms. This device is an infrared thermometer, relying on physical principles of infrared radiation detection rather than a machine learning model that requires training data in the same sense. Therefore, there's no stated training set size.

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

As there is no mention of a "training set" in the context of machine learning, there is no discussion of how ground truth for a training set was established. The device measures temperature based on established physics principles and its design, which is then validated through clinical testing as described above.

Summary

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October 2, 2020

Bioland Technology Ltd. Yiging Feng R.A No. A6B7 (Block G), ShangRong Industrial Zone No. 5 Baolong Road Shenzhen, Guangdong 518116 China

Re: K201161

Trade/Device Name: Infrared Thermometer (E127) Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: September 25, 2020 Received: September 28, 2020

Dear Yiqing Feng:

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

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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 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 medical devices and radiation-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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K201161

25-84

Device Name Infrared Thermometer, E127

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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

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K201161 510(k) Summary

A. 10/2/2020

B. 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: Yiging Feng E-mail: regulator-a@bioland.com.cn

ﻥ Subject device

Trade name: Infrared Thermometer Model: E127 Classification name: Clinical Electronic Thermometer Regulation Medical Specialty: General Hospital Product Code: FLL Regulation number: 880.2910 Device class: Class 2 Code of Federal Regulations: 21CFR 880.2910

D. Predicate Device

Device name: Advocate Non-Contact Infrared Thermometer 510K number: K191004 Manufacturer: BroadMaster Biotech, Corp.

ші Indication for use

The Infrared Thermometer is a non-sterile, reusable, handheld and non-contact device. It can be used by consumers in homecare environment and doctors in clinic as reference. It is intended for measuring human body temperature of people one month of age and above by detecting infrared heat from the forehead.

Device Description ட்

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F. Principle Operation

The Infrared Thermometer measures temperatures of people by detecting the infrared energy radiated directly from the forehead without physical contact. The reference body site is the oxter (axillary). 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.

Comparisonitems	Subject Device	Predicate Device	Remarks
Manufacturer	Bioland Technology Ltd	BroadMaster Biotech, Corp	N/A
Model	E127	EF001S	N/A
Classification	II	II	Same
Product code	FLL	FLL	Same
Classificationname	Thermometer, electronic, clinical	Thermometer, electronic, clinical	Same
Regulation No.	880.2910	880.2910	Same
510(K) number	K201161	K191004	N/A
Intended Use	Infrared Thermometer is a non-sterile, reusable, handheld andnon-contact device. It can be usedby consumers in homecareenvironment and doctors in clinic asreference. It is intended formeasuring human bodytemperature of one month of ageand above by detecting infraredheat from the forehead.	Advocate Non-Contact InfraredThermometer is a non-sterile, reusable,handheld device. It can be used byconsumers in homecare environmentand doctors in clinic as reference. It isintended for measuring human bodytemperature of all ranges of people bydetecting infrared heat from theforehead.	SimilarNote 1
Intended users	Lay user and professional	Lay user and professional	Same
Measurementmethod	Infrared radiation detection	Infrared radiation detection	Same
Targetpopulation	One month of age and above	All ranges of people	SimilarNote 1
MeasurementSite	Forehead	Forehead	Same
Measurementrange	32.0~43.0 °C(89.6 °F ~109.4 °F)	32.0~43.0 °C(89.6 °F ~109.4 °F)	Same
Displayresolution	0.1 °C / °F	0.1 °C / °F	Same
°C / °F unitswitchable	Yes	Yes	Same
Measuringaccuracy	±0.3 °C (32.0 °C -34.9 °C)±0.2 °C (35-42.0 °C)±0.3 °C (42.1 °C -43.0 °C)	±0.3 °C (32.0 °C -34.9 °C)±0.2 °C (35-42.0 °C)±0.3 °C (42.1 °C -43.0 °C)	Same
Measurementdistance	1-5cm	5-10cm	DifferentNote 2
Memory	20	12	DifferentNote 3
Power Source	AAA*2, DC 3V	Two 1.5V AAA alkalinebatteries	Same
Low batteryindication	Yes	Yes	Same
Display	LCD Display	LCD Display	Same
OperatingEnvironmentCondition	15~40°C, RH≤85% (non-condense)	10 °C~40 °C, RH≤80%	SimilarNote 4
StorageEnvironmentCondition	-20~55°C, RH≤93% (non-condense)	-20~55°C, RH≤95%	SimilarNote 4
Degree ofprotection	IP22	IP20	DifferentNote 5
PCB	FR4 PCB	FR4 PCB	Same
Cleaningmethod	The thermometer outer shell andprobe can be cleaned anddisinfected by 70% alcohol	The thermometer enclosure andprobe can be cleaned anddisinfected by 70% alcohol	Same
Patient contactmaterials	ABS	ABS	Same
Biocompatibility	ISO 10993-5: 2009ISO 10993-10: 2010	ISO 10993-5: 2009ISO 10993-10: 2010	Same
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: 2017ASTM E 1965-98: 2016 (clinicalaccuracy)	ASTM E 1965-98: 2016ISO 80601-2-56: 2017	SimilarNote 6

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Note 1: Target population of subject device is one month of age and above, target population of predicate device is all ranges of people; Compared to the predicate device, the target population of subject device is a little narrower, but this difference has no effect on safety and effectiveness of product.

Note 2: Due to the difference in software algorithm and temperature sensor, so the measurement distance between subject product and predicate product; But the measurement distance of subject product has been effectively verified by the clinical repeatability and accuracy, therefore, the difference of measurement distance has no influence on safety and effectiveness of product.

Note 3: Memory function is only used to store data and is not product-critical, so it has no effect on product safety and effectiveness.

Note 4: Compared to the predicate device, the operating temperature of subject device is narrower, the operating humidity of subject device is wider, and the Storage humidity of subject device is narrower, but the operating and storage condition of subject device has passed ISO 80601-2-56 and IEC 60601-1-11 testing. Therefore, the difference of operating and storage condition has no influence on safety and effectiveness of product.

Note 5: The subject device has passed IEC 60601-1 and IEC 60601-1-11 safety test. Therefore, the difference of degree of protection has no influence on safety and effectiveness of product.

Note 6: ISO 80601-2-56: 2017 is an international standard, the subject device and the predicate device have has passed ISO 80601-2-56: 2017 performance test. The subject device was tested per the requirements in ASTM E1965-98: 2016 for clinical accuracy. Therefore, the difference of declared performance standards has no influence on safety and effectiveness of product.

Predicate Device Comparison H.

The subject device and the predicate device have the same intended use and the similar technical parameters, they both use infrared radiation detection method to detect human body forehead temperature. They have same measuring range and measuring accuracy. Thus, the subject device is substantially equivalent to the predicate devices.

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I. Non-clinical test
Testing name	Referenced standard	Summary result	Verdict
Electric safety testing	IEC 60601-1: 2005/A1: 2012 Medicalelectrical equipment Part 1: Generalrequirements for basic safety and essentialperformanceFDA Recognition number: 19-4	The subject complies with theapplicable requirements setforth in the referenced electricsafety standard.	Pass
EMC testing	IEC 60601-1-2:2014 Medical electricalequipment - Part 1-2: General requirementsfor basic safety and essential performance -Collateral standard: Electromagneticcompatibility - Requirements and testsFDA Recognition number: 19-8	The subject complies with theapplicable requirements setforth in the referenced EMC	Pass
Electric safety formedical deviceused in the homeHealthcareenvironment	IEC 60601-1-11:2015 Medical electricalequipment - General requirements for basicsafety and essential performance - Part 1-11:Collateral Standard: Requirements formedical electrical equipment and medicalelectrical systems used in the homehealthcare environment.	The subject complies with theapplicable requirements setforth in the referenced IEC60601-1-11:2015	Pass
Performancetesting	ISO 80601-2-56 Medical electrical equipment– Part 2-56: Particular requirements for basicsafety and essential performance of clinicalthermometers for body temperaturemeasurement.FDA Recognition number: 6-403	The subject complies with theapplicable requirements setforth 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 evaluationof medical devices -- Part 5: Tests for InVitro cytotoxicity.FDA Recognition number: 2-245ISO 10993-10: 2010 Biological evaluationof medical devices -- Part 10: Tests forirritation and delayed-type hypersensitivityFDA Recognition number: 2-174	The subject complies with theapplicable requirements setforth in the referencedbiological evaluation standard.	Pass

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J. Clinical Testing

Name ofclinical testing	Referenced standard	Summary of testing	Patient population(age groups, numberof subjects	Verdict
Clinicalaccuracy andrepeatabilitytesting	ISO 80601-2-56: 2017Medical electrical equipment— Part 2-56: Particularrequirements for basic safetyand essential performance ofclinical thermometers forbody temperaturemeasurement.FDA Recognition number:6-403ASTM E1965-98: 2016,Standard Specification forInfrared Thermometers forIntermittent Determination ofPatient TemperatureFDA Recognition number: 6-125	The methods and criteriaof clinical accuracy andrepeatability testing hadbeen clinically assessedto meet the requirementsof clinical accuracy perthe referencedstandards.	50 subjects in each agegroup, infants (0-1year), children(1-5years) and adults(>5 years) (Total 150subjects)	Pass

K. Conclusion

Non-clinical performance and clinical tests were conducted on the subject device and all tests met specified criteria. Base on the information provided in this submission the subject device, E127 infrared thermometer is substantially equivalent to the predicate device, EF001S.

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.