The Infrared thermometers (AOJ-20A and AOJ-20B) take human body temperature via the eardrum or forehead. They apply to all age groups except for babies under three months. Both devices apply to both professional use and home use.

Device Description

The infrared thermometers (AOJ-20A and AOJ-20B) are handheld instruments, which can measure human body's temperature either via the eardrum or the forehead for clinical or home use. The intended patient population is all age groups except for babies under three months. The thermometers are powered by AAA 1.5V×2 alkaline batteries. The results can be displayed on LCD. A thermopile sensor is employed to detect or monitor the infrared thermal energy emitted from the eardrum or the surface of the skin of the forehead, which is converted into temperature measurement with the unit of °C or °F. It is mainly composed with infrared sensor, signal receiving processor, buttons, buzzer, LCD display, battery and etc.

AI/ML Overview

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria (from ASTM E 1965-98)	Device Performance
Clinical accuracy of the subject device is at least the same as that of the reference device.	Demonstrated to be at least the same as the reference.
Accuracy is ±0.2℃ within the claimed measurement range of 32℃ - 42.9℃.	Achieved ±0.2℃ within the specified range.
No single measurement error exceeding the allowable limit.	Achieved (implied by 99% confidence and accuracy claim).

2. Sample size used for the test set and the data provenance

Sample Size: Minimum of 90 subjects.
Composition: 1/3 children (greater than one to five years), 2/3 adults (greater than five years old).
Data Provenance: Not explicitly stated, but it's a "clinical investigation" meaning prospective. The country of origin is not specified in the provided text.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the text. The study describes a "reference device" being introduced as required by the standard, implying that the ground truth is established by this reference device, not by expert consensus in the typical sense for subjective assessments.

4. Adjudication method for the test set

This information is not provided in the text. The study describes a "randomization, simple blind homologous control, pairing design of clinical investigation" but does not detail any adjudication specific to discrepancies.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is an infrared thermometer, which is a standalone measurement device, not an AI-assisted diagnostic tool that would involve human readers interpreting output.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Yes, the study described is a standalone performance study of the infrared thermometer. The thermometer directly provides a temperature reading, and its accuracy is compared against a reference device, without human interpretation of the device's output influencing the performance metrics.

7. The type of ground truth used

The ground truth for the clinical study was established by a reference device, as required by ASTM E 1965-98. The reference device's measurements serve as the comparator for the subject device's accuracy.

8. The sample size for the training set

This information is not applicable/not provided. Infrared thermometers like the AOJ-20A and AOJ-20B are typically designed and calibrated based on physics and engineering principles, not through machine learning models that require a "training set" of data in the same way an AI algorithm would.

9. How the ground truth for the training set was established

This information is not applicable/not provided for the reasons stated in point 8.

Summary

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November 20, 2018

Shenzhen AOJ Medical Technology Co., Ltd. Qihuan Zhao General Manager Room 202, HaoGu Industry Park, 2037 Guanguang Road, Guangming District, Shenzhen Guangdong, 518105 China

Re: K182133

Trade/Device Name: Infrared Thermometer, models AOJ-20A and AOJ-20B Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: October 12, 2018 Received: October 22, 2018

Dear Oihuan Zhao:

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 avare 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.

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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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Geeta K. Pamidimukkala -S

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K182133

Device Name

Infrared thermometer, models AOJ-20A and AOJ-20B

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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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

K182133

Prepared in accordance with the requirements of 21 CFR Part 807.92

1. Submitter:	Shenzhen AOJ Medical Technology Co., Ltd.
	Room 202, HaoGu industry park, 2037 Guanguang road, Guangming district,518105, Shenzhen, P.R. China
	Tel.: +86 18603031299
Contact Person:	Qihuan Zhao
Prepare date:	2018-11-15
2. Device nameand classification:	Device Name: Infrared ThermometerModels: AOJ-20A, AOJ-20B
	Regulation Number: 21 CFR 880.2910
	Regulation Name: Clinical Electronic Thermometer
	Product code: FLL
	Regulatory Class: Class II
3. PredicateDevice(s):	Shenzhen Brav Electronic Technologies Co., Ltd., EFT-165 Infrared Thermometer/K171214
4. DeviceDescription:	The infrared thermometers (AOJ-20A and AOJ-20B) are handheld instruments,which can measure human body's temperature either via the eardrum or theforehead for clinical or home use. The intended patient population is all agegroups except for babies under three months.
	The thermometers are powered by AAA 1.5V×2 alkaline batteries. The resultscan be displayed on LCD.
	A thermopile sensor is employed to detect or monitor the infrared thermal energyemitted from the eardrum or the surface of the skin of the forehead, which isconverted into temperature measurement with the unit of °C or °F.
5. Indications forUse:	The Infrared thermometers (AOJ-20Aand AOJ-20B) take human body temperaturevia the eardrum or forehead. They apply to all age groups except for babies underthree months. Both devices apply to both professional use and home use.

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6.Predicate Device Comparison

ITEM	Proposed DeviceAOJ-20A&AOJ-20B	Predicate DeviceEFT-165/K171214	ComparisonResult
Manufacture	Shenzhen AOJ MedicalTechnology Co., Ltd.	Brav Electronic TechnologiesCo., Ltd.	---
Indications forUse	The Infrared thermometers(AOJ-20Aand AOJ-20B) takehuman body temperature via theeardrum or forehead. They applyto all age groups except forbabies under three months. Bothdevices apply to bothprofessional use and home use.	The infrared thermometer isintended for the measurementand monitoring of human bodytemperature by doctor orcustomers in the hospital orhome.	Different 1
Operational Specifications
OperationalPrinciple	Infrared radiation detection	Infrared radiation detection	Same
Measuring Mode	Forehead and ear	Forehead and ear	Same
MeasurementRange	32.0°C~~42.9°C(89.6°F~~109.2°F)	32.0°C~~42.9°C(89.6°F~~109.2°F)	Same
MeasurementDistance	0 cm	0 cm	Same
Accuracy	±0.2°C(0.4°F)	±0.2°C(0.4°F)	Same
Memory DataLimit	memorize 20 measurementsautomatically	memorize 20 measurementsautomatically	Same
Productconfiguration	It is mainly composed withinfrared sensor, signal receivingprocessor, buttons, buzzer, LCDdisplay, battery and etc.	It is mainly composed withinfrared sensor, signal receivingprocessor, buttons, buzzer, LCDdisplay, battery and etc.	Same
Temperature unitand conversion	Dual temperature units “°C” and“°F” optional, and the two unitscan convert by the conversionkey automatically	Dual temperature units “°C” and“°F” optional, and the two unitscan convert by the conversionkey automatically	Same
ApplicableStandards	IEC 60601-1, IEC 60601-1-2,IEC 60601-1-11, and ASTME1965-98	AAMI ANSI ES60601-1, IEC60601-1-2, IEC 60601-1-11, andASTM E1965-98	Same
Display	0.1°C/°F, LCD	0.1°C/°F, LCD	Same
OperatingEnvironment	Temperature: 10°C~40°C(50°F-104°F)Humidity: 15%-95% RH,non-condensingAtmospheric pressure: 70–106kPa	15°C ~ 35°C (59°F to 95 °F)<85% moisture condensation	Different 2
StorageEnvironment	Ambient Temperature: -20°C to55°C (-4°F-131°F)Relative Humidity: 0-95% RH,non-condensingAtmospheric pressure: 50kPa to106kPa	-20°C~~55°C(-4°F~~131°F)≤90%moisture condensation	Same

Table 1 Comparison between main predicate EFT-165 and the subject device

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Physical Specifications
Weight	90g (battery included)	72 g (without battery)	Different 3
Dimensions	146mm 52 mm 40 mm	152mm * 44 mm *30mm
Biological Specifications
PatientContactingMaterials	PC+ABS	PC+ABS	Same
PatientContacting	Surface-contacting,Less than 24 h	Surface-contacting,Less than 24 h	Same
BiocompatibilityStandard	ISO 10993-5,ISO 10993-10	ISO 10993-5,ISO 10993-10	Same
BiocompatibilityTesting Items	In vitro CytotoxicitySkin SensitizationIrritation	In vitro CytotoxicitySkin SensitizationIrritation	Same

Justification for the differences:

1. Different Indications for Use
  As indicated in the comparison table, the subject device and the predicate device have similar indications for use, the subject device includes the patient population and areas to take temperature. The intended use is the same.
1. Different Operation&Storage&Transport Environments
  Minor difference to operation environments (including Temperature and Relative Humidity) for the subject device, but the system has demonstrated to be as safe and effective as the predicate device since the safety testing was conducted under the suggested environment; Moreover, environment testing data shows the device can work as intended under the suggested conditions. So those changes do not raise any safety and effectiveness concerns.
1. Different Physical Specifications
  The subject and the predicate are of different size but proximity. Moreover, such engineering design has been verified during development by compliance with the applicable international standards, so such minor different will not raise any new problems.

As seen in the comparison tables, the subject and predicate devices have almost the same design features and performance specifications. Moreover, as demonstrated in the non-clinical and clinical testing, AOJ-20A&AOJ-20B Infrared thermometer system can perform as intended.

7.Performance Testing

7.1 Non-Clinical Data

The following safety standards are conducted on the subject device support of the substantial equivalence determination, including performance testing and bench testing.

Performance Testing Information:

(1) ISO 10993-5 Biological evaluation for medical device Part 5 Test for In Vitro Cytotoxicity
(2) ISO 10993-10 Biological evaluation for medical device Part 10 Test for irritation and skin sensitization
(3) AAMI TIR12:2004 Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers, Approved 23 December 2004.

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Bench Testing Information:

(1) ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009((R)2012 and A2:2010/(R)2012 Medical electrical equipment Part 1: General requirements for basic safety and essential performance.
(2) IEC 60601-1-11: 2010 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.
(3) IEC 60601-1-11: 2010 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.
(4) 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.
(5) ISO 80601-2-56: 2009 Medical electrical equipment Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement for performance effectiveness.
(6) Software verification and validation testing per FDA's Guidance for Industry and FDA Staff, Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, issued on May 11, 2005.

7.2 Clinical Data

Clinical testing is conducted per ASTM E 1965-98 (Reapproved 2009) Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature.

This clinical study is a randomization, simple blind homologous control, pairing design of clinical investigation, consists of a minimum of 90 subjects, of which 1/3 are children and the rest 1/3 are adults (NOTE: Infants---newborn to one year; Children--- greater than one to five years; Adults--- greater than five years old.). with no single measurement error exceeding the allowable limit, provides a 99% confidence. A reference device is introduced as required by the standard, and the acceptance criteria is that clinical accuracy of the subject device is at least the same as that of the reference, and the accuracy is ±0.2℃ during the claimed measurement range 32℃ - 42.9℃.

8.Conclusion

Verification and validation testing was conducted on the subject device and all testing passed pre-specified criteria. This premarket notification submission demonstrates that the AOJ-20A & AOJ-20B 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.