The thermometer is intended to measure human body temperature of people over one month from surface of forehead. It is a non-sterile, reusable, non-contact and hand-held device. It is indicated to be used in homecare and healtheare environments.

Device Description

The Forehead thermometer is a handheld device, which can measure human body's temperature from the forehead for clinical or home use. The results can be displayed on LCD. The measurement is non-contact with a distance of 3-5 cm to measure the temperature. The thermometers are powered by AAA 1.5V×2 alkaline batteries, which can be used for people over one month. A thermopile sensor is employed to detect or monitor the infrared thermal energy emitted from the surface skin of the forehead, which is converted to a body temperature with the unit of °C or °F. The reference body site of the output temperature is oral. All the models share the similar design and the same critical components, and compose of a sensor, PCB, buttons, LCD display and housing. Functions include temperature measurement, memory reading recall, voice mute/unmute and unit/mode switch, low battery detection and high temperature indicator.

AI/ML Overview

The provided text describes the acceptance criteria and a study demonstrating that the device meets these criteria. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion (Subject Device)	Reported Device Performance (Subject Device)
Measurement Range: 32.0°C ~ 42.9°C	Evaluated per ISO 80601-2-56; test results met requirements.
Accuracy: ±0.2°C	Evaluated per ISO 80601-2-56; test results met requirements.
Memory Data Limit: 40 values	Verified during design and development; test results met requirements.
Operating Environments (Temperature): 15°C ~ 40°C	Performance testing conducted under suggested environment; test results met requirements.
Biocompatibility (In vitro Cytotoxicity): No potential cytotoxicity allowed	No potential cytotoxicity
Biocompatibility (Skin Sensitization): No sensitization should be observed	No sensitization observed (test sample score 0)
Biocompatibility (Skin Irritation): No irritation should be observed	Negligible (no observed primary irritation, test sample score 0)
Electrical Safety & EMC: Compliance with IEC 60601-1, IEC 60601-1-11, IEC 60601-1-2	Complies with specified standards
Performance Effectiveness: Compliance with ISO 80601-2-56	Complies with ISO 80601-2-56
Software Verification & Validation: Software functions meet requirements	Software functions met requirements
Clinical Accuracy Validation: Meet minimum number requirements for subjects in each age group (A1, A2, B, C)	Number of subjects in each age group met minimum requirements.

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

Test Set Sample Size for Clinical Accuracy Validation:
- AOJ-F101: 153 subjects
- AOJ-F102: 142 subjects
- AOJ-F103: 132 subjects
Data Provenance: The document (K221170) is a 510(k) summary submitted to the FDA by a Chinese company (Shenzhen AOJ Medical Technology Co., Ltd. in Shenzhen, China). The clinical testing was explicitly stated as "Clinical accuracy validation was carried out on people over one month indicated in the instructions for use." While not explicitly stated, clinical studies for FDA submissions typically involve prospective data collection to demonstrate performance. The country of origin for the clinical data is not specified, but usually, it aligns with the manufacturer's location or regions where clinical trials are feasible and recognized for regulatory purposes.

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 document. For a thermometer, "ground truth" for temperature is typically established using a highly accurate reference thermometer (e.g., a rectal thermometer for core body temperature, used in a clinical setting), rather than expert consensus on interpretation.

4. Adjudication method for the test set:

This information is not provided in the document. Adjudication methods like 2+1 or 3+1 are typically used for subjective assessments where multiple human readers interpret medical images or data. For a thermometer's accuracy, the ground truth is usually a precise measurement from a reference device, making such adjudication unnecessary.

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:

This is not applicable. The device is a thermometer, a measurement tool, not an AI-assisted diagnostic device that aids human readers in interpreting complex cases. Therefore, an MRMC study comparing human reader performance with and without AI assistance was not conducted.

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

The device itself is a standalone measurement device. The "Clinical data" section describes a clinical accuracy validation study to confirm its performance directly against a clinical reference for body temperature, which is a form of standalone performance evaluation for a thermometer. There is no "algorithm only" in the context of an AI device here, but rather device-only performance for a physical product.

7. The type of ground truth used:

For the clinical accuracy validation, the ground truth for body temperature measurements would have been established using a highly accurate reference clinical thermometer (e.g., an oral or rectal thermometer, depending on the standard protocol for comparison) in a controlled clinical setting. The document specifies that clinical testing was conducted "per Section 201.102 of ISO 80601-2-56," which outlines the requirements for clinical investigations of medical electrical equipment used for body temperature measurement. This standard details how to establish accurate reference temperatures.

8. The sample size for the training set:

This information is not provided in the document. The document describes premarket testing and validation for a physical medical device, not a machine learning model that requires a training set. The "software verification and validation testing" refers to traditional software engineering V&V, not AI model training.

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

This information is not applicable as there is no mention of a training set for a machine learning model. The device is a conventional electronic thermometer.

Summary

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October 7, 2022

Shenzhen AOJ Medical Technology Co., Ltd. Jack Wang Deputy Chief Room 301&4F, Blk A, Building A, Jingfa IM Park Xiaweiyuan, Gushu Community, Xixiang, Baoan Shenzhen, Guangdong 518126 China

Re: K221170

Trade/Device Name: Forehead Thermometer, models AOJ-F102, AOJ-F102, AOJ-F103, AOJ-F104 AOJ-F105, AOJ-F106, AOJ-F107 Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: September 1, 2022 Received: September 6, 2022

Dear Jack Wang:

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.

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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/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 Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K221170

Device Name

Forehead Thermometer, models AOJ-F101, AOJ-F102, AOJ-F103, AOJ-F105, AOJ-F105, AOJ-F106 and AOJ-F107

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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K221170

510(k) Summary

Prepared in accordance with the requirements of 21 CFR Part 807.92

1. Submitter:	Shenzhen AOJ Medical Technology Co., Ltd. Room 301&4F, Block A, Building A, Jingfa Intelligent Manufacturing Park, Xiaweiyuan, Gushu Community, Xixiang Street, Bao'an District, 518126, Shenzhen, China TEL: 86 755-27786026
Contact Person:	Jack Wang
Prepare date:	September 14, 2022
2. Device name and classification:	Device Name: Forehead Thermometer Models: AOJ-F101, AOJ-F102, AOJ-F103, AOJ-F104, AOJ-F105, AOJ-F106 and AOJ-F107 Classification Name: 21 CFR 880.2910 Clinical Electronic Thermometers-Temperature Monitor with Probe Product code: FLL Regulatory Class: Class II
4. Predicate Device(s):	Shenzhen Changkun Technology Co., Ltd. CK-T1503 Infrared thermometer cleared under K193253.
5. Device Description:	The Forehead thermometer is a handheld device, which can measure human body's temperature from the forehead for clinical or home use. The results can be displayed on LCD. The measurement is non-contact with a distance of 3-5 cm to measure the temperature. The thermometers are powered by AAA 1.5V×2 alkaline batteries, which can be used for people over one month. A thermopile sensor is employed to detect or monitor the infrared thermal energy emitted from the surface skin of the forehead, which is converted to a body temperature with the unit of °C or °F. The reference body site of the output temperature is oral. All the models share the similar design and the same critical components, and compose of a sensor, PCB, buttons, LCD display and housing. Functions include temperature measurement, memory reading recall, voice mute/unmute and unit/mode switch, low battery detection and high temperature indicator.
6. Indications for Use:	The thermometer is intended to measure human body temperature of people over one month from surface of forehead. It is a non-sterile, reusable, non-contact and hand-held device. It is indicated to be used in homecare and healthcare environments.

7. Predicate Device Comparison

Comparison to the predicate devices, the subject device has same intended use, similar product design, same performance effectiveness, performance safety as the predicate device.

Please refer to following table to find differences between the subject device and predicate device. All the differences do not affect the basic design principle, usage, effectiveness and safety of the subject

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device. And no question is raised regarding to effectiveness and safety.

ITEM	Proposed Device K221170AOJ-F101/AOJ-F102/AOJ-F103/AOJ-F104/AOJ-F105/AOJ-F106/AOJ-F107	Predicate DeviceCK-T1503/K193253	ComparisonResult
Manufacture	Shenzhen AOJ MedicalTechnology Co., Ltd.	Shenzhen Changkun TechnologyCo., Ltd.	---
Indications forUse	The thermometer is intended tomeasure human bodytemperature of people over onemonth from surface of forehead.It is a non-sterile, reusable,non-contact and hand-helddevice. It is indicated to be usedin homecare and healthcareenvironments.	Infrared Thermometer (model:CK-T1501, CK-T1502,CK-T1503) is a non-sterile,reusable, non-contact andhandheld device. It can be usedby consumers in homecareenvironment and doctors inclinic as reference. It is intendedfor measuring human bodytemperature of people over onemonth old by detecting infraredheat from the forehead.	Different 1
Operational Specifications
OperationalPrinciple	Infrared radiation detection	Infrared radiation detection	Same
Measuring Mode	Forehead	Forehead	Same
MeasurementDistance	3~5 cm for forehead mode	3~5 cm for forehead mode	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
MeasurementRange	32.0°C~42.9°C	32.0°C~42.5°C	Different 2
Accuracy	±0.2°C	32°C~~34.9°C: ± 0.3°C35°C~~42°C: ±0.2°C42.1°C~42.5°C: ±0.3°C	Different 3
Memory DataLimit	40 values	32 values	Different 3
Temperature unitand conversion	YES, °C/°F switchable	YES, °C/°F switchable	Same
ApplicableStandards	IEC 60601-1, IEC 60601-1-2,IEC 60601-1-11, and ISO80601-2-56	IEC 60601-1, IEC 60601-1-2,IEC 60601-1-11, and ISO80601-2-56	Same
Display	0.1°C/°F, LCD	0.1°C/°F, LCD	Same
OperatingEnvironments	Temperature: 15°C~ 40°CHumidity: 10% - 85%(Non-Condensing)Atmospheric pressure: 70–106kPa	Temperature: 10°C~ 40°CHumidity: 15%-85%(Non-Condensing)Atmospheric pressure: 80-106kPa	Different 4
Transport andStorageEnvironments	Temperature: 0°C~ 40°CHumidity: no more than 90%(Non-Condensing)	Temperature: 0°C~ 50°CHumidity: ≤90%(Non-Condensing)	Same
	Atmospheric pressure: 70-106 kPa	Atmospheric pressure: 80-106 kPa
Power supply	2 X 1.5V AAA Alkaline battery	2 X 1.5V AAA Alkaline battery	Same
Physical Specifications
Weight	AOJ-F101: 100 g (W/O battery)AOJ-F102: 100 g (W/O battery)AOJ-F103: 102 g (W/O battery)AOJ-F104/AOJ-F105/AOJ-F106 /AOJ-F107: 100 g(W/O battery)	172 g (battery included)	Different 5
Dimensions(mm×mm×mm)	AOJ-F101: 158×102×41AOJ-F102: 158×83×45AOJ-F103: 158×95×43AOJ-F104/AOJ-F105/AOJ-F106 /AOJ-F107:158×83×45	149×77×43
Biological Specifications
PatientContactingMaterials	ABS, PC	ABS	Different 6
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

Table 1 Comparison between the predicate CK-T1503 and the subject devices

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Justification for the differences:

1. Different Indications for Use
  As indicated in the comparison table, the application scenario of the subject device and the predicate device can be used both in hospital and home, they have same intended use, they are just some language description differences. The difference does not raise new safety and effectiveness issues.
1. Different measurement range and accuracy
  The measurement range and accuracy of subject device have minor difference from that of the predicate device, which are software-controlled function, and the measurement range and accuracy has been evaluated per the internal standards ISO 80601-2-56. The test results met the requirements.

The differences do not raise new safety and effectiveness issues.

1. Different memory capacity
  The predicate device can store up to 32 values, while the subject device has the capacity to store 40 memories, this memory function has been verified during the design and development process. The test results met the requirements.

The differences do not raise new safety and effectiveness issues.

1. Different Operation Environments
  Minor difference to operation environments between the subject device and the predicate device, but the system has been proved to be safe and effective since the performance testing was conducted under the suggested environment and the results met the requirements. The difference does not raise

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new safety and effectiveness issues.

1. Different Physical Specifications
  The weight and size of the subject device and predicate are different. The performance testing was conducted in accordance with standards. The test results met requirements. The differences do not raise new safety and effectiveness issues.
1. Different Patient Contacting Materials
  Different materials used in the subject device and the predicate.

Biocompatibility testing was conducted for the subject device. The test results demonstrate the subject device comply with standard ISO 10993-5 and ISO 10993-10. The difference does not raise any new safety and effective issues.

8. Performance Testing:

Performance data includes "Non-Clinical Data" and "Clinical Data", brief description of which are shown as below.

Non-Clinical Data:

Biocompatibility testing

The biocompatibility evaluation for the thermometer were conducted in accordance with the International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The worst case of the whole system is considered surface-contacting, limited exposure (-less than 24 hours). And the evaluation of testing is summarized as below.

Test name	Test standard	Evaluation endpoint	Summary results
In vitroCytotoxicity	ISO 10993-5	No potentialcytotoxicity is allowed	No potential cytotoxicity
Skin Sensitization	ISO 10993-10	No sensitizationshould be observed	No sensitization observed (test samplescore 0)
Skin Irritation	ISO 10993-10	No irritation shouldbe observed	Negligible (no observed primaryirritation, test sample score 0).

Electrical safety and electromagnetic compatibility (EMC)

Electrical safety and EMC testing were conducted on the thermometer device complies with the IEC 60601-1 Medical electrical equipment Part 1: General requirements for basic safety and essential performance for safety, IEC 60601-1-11 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, and the IEC 60601-1-2 Medical electrical equipment-Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests standard for EMC.

Bench Testing

Bench testing was conducted on the thermometer device, consisting of all the accessories in the system. The system complies with the 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 for performance effectiveness.

Software Verification and Validation Testing

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Software verification and validation testing were conducted and the test results demonstrated the software function met the requirements. The documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern.

Clinical data:

The clinical testing was conducted per Section 201.102 of ISO 80601-2-56 on the subject device. Clinical accuracy validation was carried out on people over one month indicated in the instructions for use. The number of subjects in each age group met the minimum number requirements. The specific number of tested subjects, age groups and test results are described as below.

Item	Age group	Subject numberin total
Model
AOJ-F101	A1, A2, B, C	153
AOJ-F102	A1, A2, B, C	142
AOJ-F103	A1, A2, B, C	132

Age group is defined as below:

A1 1 month up to 3 months l
-A2 3 months up to one year
-B older than one and younger than five years
C older than five years -

9. Conclusion:

Verification and validation testing was conducted on the subject device and all testing passed pre-specified criteria. Based on the performance testing, comparison and analysis above, the subject AOJ Forehead 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.