The Infrared No-Touch Forehead Thermometer is intermittent measurement of body temperature from the forehead on people of all ages. It can be used by consumers in the household environment and by healthcare providers.

Device Description

The iHealth PT3 Infrared No-Touch Forehead Thermometer is hand-held, reusable, battery operated device, which can measure human body forehead temperature without touching patient's skin. Its operation is based on measuring the natural thermal radiation from the central forehead. Put the probe of the thermometer at a measurement distance less than or equal to 1.18 inch (3cm) without touching the skin at the center of the patient's forehead. lt uses a thermopile sensor to measure the patient's forehead temperature and convert it to the oral equivalent. Pressing the activation button to start the measurement of proposed infrared radiation. The time from start of measurement to display of temperature reading is about 1 second. The electrical signal read out from the detector is fed to the circuit for amplification and calculation. The final measured temperature will be appeared on a LED display.

AI/ML Overview

The provided document describes the clearance of an iHealth Infrared No-Touch Forehead Thermometer (Model: PT3) and includes information about its performance testing. However, it does not describe an AI/ML medical device where the performance is measured by metrics like sensitivity, specificity, or AUC, nor does it detail a study involving human readers or expert panels for ground truth establishment.

Instead, this document details the substantial equivalence of a clinical electronic thermometer to a predicate device. The performance criteria are related to the accuracy of temperature measurement and compliance with established standards (like ASTM E1965-98) for such devices.

Therefore, many of the requested categories related to AI/ML device evaluation (like sample size for test set, number of experts for ground truth, adjudication methods, MRMC study, standalone performance) are not applicable to this type of device and the information provided.

I will fill in the relevant available information, and mark non-applicable sections clearly.

Acceptance Criteria and Device Performance for iHealth Infrared No-Touch Forehead Thermometer (Model: PT3)

The device is an iHealth Infrared No-Touch Forehead Thermometer (Model: PT3) and its performance is assessed against the requirements for a clinical electronic thermometer, primarily focusing on temperature measurement accuracy.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Standard / Parameter)	Performance Standard	Reported Device Performance (iHealth PT3)
Accuracy	±0.4°F (0.2°C) within 95~~107.6°F (35~~42°C)	±0.4°F (0.2°C) within 95~~107.6°F (35~~42°C)
	±0.5°F (0.3°C) for other ranges	±0.5°F (0.3°C) for other ranges
Compliance Standard	ASTM E1965-98 (2016)	Complies with ASTM E1965-98 (2016)
Electrical Safety	IEC 60601-1:2005/(R)2012 And A1:2012,C1:2009/(R)2012 And A2:2010/(R)2012	Test performed and device meets standard
Electromagnetic Compatibility (EMC)	IEC 60601-1-2:2014	Test performed and device meets standard
Performance (Specific to Thermometers)	ISO 80601-2-56 (incl. Amendment 1 (2018))	Test performed and device meets standard
Software Verification and Validation	FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (May 11, 2005)	Conducted and demonstrates no new performance questions
Biocompatibility (for skin-contacting components)	ISO 10993-1, ISO 10993-5, ISO 10993-10	Complies; no new risk for proposed device
Reprocessing: Cleaning and Disinfection	According to Instructions for Use	Validation performed

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

This is not an AI/ML device, so there isn't a "test set" in the typical machine learning sense. The performance was evaluated through clinical accuracy testing and laboratory testing.

Clinical Accuracy Test Sample Size:
- Infants (0-1 year): 40 subjects
- Children (1-5 years): 40 subjects
- Adults (>5 years): 50 subjects
- Total: 130 subjects
Data Provenance: Not explicitly stated, but the submission is from a Chinese company (Andon Health Co., Ltd., Tianjin, China). It is reasonable to assume the clinical testing was conducted in a region accessible to the manufacturer, but specific country/site is not detailed. The study type is prospective clinical investigation as implied by "Clinical investigation and data analysis have performed according to ASTM E1965-98. The test report shows result of 40 subjects..."

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

Not applicable in the context of an AI/ML device where experts establish ground truth. For a thermometer, "ground truth" is typically established by comparing the device's readings to highly accurate reference thermometers or established clinical methods (e.g., rectal temperature). The clinical accuracy test was conducted according to ASTM E1965-98, which outlines the methodology for such evaluations, often involving a comparison to a precise primary standard. The document does not specify human experts adjudicating temperature readings.

4. Adjudication Method for the Test Set

Not applicable. There is no "adjudication" in the sense of reconciling differences between multiple human readers or expert opinions for this type of medical device. The accuracy is determined by direct comparison of the device's temperature readings to a reference standard as per the ASTM E1965-98 protocol.

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

Not applicable. This device is a standalone thermometer, not an AI-assisted diagnostic tool that aids human readers.

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

Yes, in essence. The "standalone performance" refers to the device's direct measurement capabilities. The clinical accuracy test and laboratory tests (electrical safety, EMC, performance per ISO 80601-2-56) demonstrate the performance of the device itself, independent of human interpretation or assistance beyond its proper operation. The temperature reading is directly generated by the device's thermopile sensor and internal algorithms converting infrared radiation to a temperature display.

7. The Type of Ground Truth Used

Reference Temperature Standard: The ground truth for temperature measurement accuracy in this context is established by a reference thermometer or method that conforms to the accuracy requirements of relevant standards (e.g., ASTM E1965-98), often involving core body temperature measurements (e.g., rectal temperature) as a comparator. The document states "Clinical investigation and data analysis have performed according to ASTM E1965-98," which specifies the methods for establishing true body temperature for comparative accuracy testing.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device; therefore, there is no "training set" in the machine learning context. The device's internal algorithms are based on physics and engineering principles of infrared thermometry, not on machine learning from a large dataset.

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

Not applicable. As there is no training set for an AI/ML model, this question is not relevant. The device's calibration and internal functioning are based on established physical laws and engineering design that relate detected infrared radiation to temperature values.

Summary

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July 15, 2020

Andon Health Co., Ltd. Mr. Liu Yi President No. 3 Jinping Street, Ya An Road, Nankai District Tianjin, 300190 China

Re: K200531

Trade/Device Name: iHealth Infrared No-Touch Forehead Thermometer, Model: PT3 Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: June 10, 2020 Received: June 15, 2020

Dear Mr. Liu Yi:

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 Actinclude 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

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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-devices/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 (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, Sapana Patel -S

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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Indications for Use

510(k) Number (if known) K200531

Device Name

iHealth Infrared No-Touch Forehead Thermometer (Model: PT3)

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

K200531

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.

1.0 Submitter's information

Name:	Andon Health Co., Ltd.
Address:	No 3, Jinping Street Ya An Road, Nankai District, Tianji n,P.R. China
Phone number:	86-22-87611660
Fax number:	86-22-6052 6162
Contact:	Liu Yi
Date of Preparation:	7/14/2020

2.0 Device information

Trade name: iHealth Infrared No-Touch Forehead Thermometer (model: PT3) Infrared forehead thermometer Common name: Classification name: Clinical Electronic Thermometer

3.0 Classification

Production code: FLL Regulation number: 880.2910 Classification: II Panel: General Hospital

4.0 Predicate device information

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

5.0 Indications for Use

The Infrared No-Touch Forehead Thermometer is intended for the intermittent measurement of body temperature from the forehead on people of all ages. It can be used by consumers in the household environment and by healthcare providers.

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6.0 Device description

		7.0 Summary comparing technological characteristics with predicate
device

Item	Subject Device(K200531)	Predicate Device(K191570)	Comparison
Models	PT3	MD-H30	Different
Product code	FLL	FLL	Same
Regulationnumber	21 CFR 880.2910	21 CFR 880.2910	Same
Manufacturer	Andon Health Co., Ltd	Guangzhou BerrcomMedical Device Co., Ltd.	Different
Indications forUse	The Infrared No-TouchForehead Thermometer isintended for the intermittentmeasurement of bodytemperature from theforehead on people of allages. It can be used byconsumers in the householdenvironment and byhealthcare providers.	The infrared thermometer isintended for the intermittentmeasurement of bodytemperature from theauditory canal or centralforehead skin surface onpeople of all ages. It can beused by consumers in thehousehold environment andby healthcare providers.	Different
Probe contacttype	Non-contact;measurement distance: $\leq$1.18 in(3 cm)	Skin contacting	Different
Sensor	Thermopile	Thermopile	Same
Measurementmethod	Infrared radiation detection	Infrared radiation detection	Same
Display type	LED	LCD	Different

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Other feature	Vibration when getmeasurement	Beep when getmeasurementProbe cover provided	Different
Measuring range	32- 42.9° C (89.6- 109.2°F)	32- 43° C (89.6- 109.4° F)	different
Accuracy	±0.4°F (0.2°C) within95~~107.6°F (35~~42°C),±0.5°F (0.3°C) for otherrange.	±0.4°F (0.2°C) within95~~107.6°F (35~~42°C),±0.5°F (0.3°C) for otherrange.	Same
Temperature unit	°C or °F	°C or °F	Same
Display resolution	0.1 °F (0.1 °C )	0.1°F (0.1 °C )	Same
Powerrequirements	2X1.5V AAA battery	2X1.5V AAA battery	Same
Operationenvironment	15-40° C, 15%-95% RH,70-106kPa	10°C~40°C; ≤95% RH	Different,
Storageenvironment	-20-55° C, 10%-95% RH,70-106kPa	-20~55°C; ≤95%RH
Materials ofskin-contactingcomponents	ABS and PMMA	ABS	Different.
biocompatibility	Comply with ISO 10993-1	Comply with ISO 10993-1	Same

The manufacturer of the subject device is different from the predicate device, so the model is also different, there is slightly difference in the indications for use because the subject device only takes measurement from the forehead while the predicate device takes measurement from both forehead skin and auditory canal. Moreover, the predicate device is skin contacting when taking forehead temperature measurement while the subject device is non-contact device. Both subject and predicate devices detect the infrared radiation from forehead. The software validation, laboratory accuracy test and clinical accuracy test demonstrated the difference does not raise any new performance questions.

The display component of the new device PT3 is changed from LCD to LED, the software validation and performance test demonstrated the difference does not raise any new performance questions.

When measurement completed, the device with results displayed on LED, while the predicate will beep when completed measurement. This feature is different, but the software validation demonstrated the difference does not raise any new performance questions.

The subject device is non-contact when taking measurement, which is different from the predicate device, the performance study and clinical accuracy test

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demonstrated the difference does not raise any new performance questions.

The Measuring range is different from the predicate device, the performance test and the clinical accuracy test demonstrated the difference does not raise any new performance questions.

The operation temperature range of the proposed device PT3 is narrow than the predicate device, and the storage humidity range of the proposed device PT3 is also narrow than the predicate device, but the performance test demonstrated the difference does not raise any new performance questions.

The material of skin-contacting components is different, the biocompatibility report conforms that there is no new risk for the proposed device.

8.0 Discussion of non-clinical and clinical test performed

Non-clinical tests were conducted to verify that the proposed device meet all design specifications in order to demonstrate that it is Substantially Equivalent to the predicate device.

Non-clinical Tests

Electrical Safety test was performed according to IEC 60601-1:2005/(R)2012 And A1:2012,C1:2009/(R)2012 And A2:2010/(R)2012 (Consolidated Text) Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance

EMC test was performed according to 60601-1-2:2014, Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility requirements and tests

Performance test was performed according to 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. [Including: Amendment 1 (2018)]. is the applicable standards for this device.

The software verification and validation were conducted according to FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices", dated May 11, 2005.

Biocompatibility test (including cytotoxicity, sensitization, irritation) was performed according to (1) ISO 10993-1 Fifth edition 2018-08 Biological

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evaluation of medical devices - Part 1: Evaluation and testing within a risk management process, (2)ISO 10993-5 Third edition 2009-06-01 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity and (3) ISO 10993-10 Third Edition 2010-08-01 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization.

Reprocessing: Cleaning and Disinfection

The subject device is a non-sterile device. The cleaning validation was performed according to the Instructions for Use.

Clinical Data Accuracy Validation Test

Clinical investigation and data analysis have performed according to ASTM E1965-98. The test report shows result of 40 subjects in infants group (0-1 year), 40 subjects in children group (1-5 years) and 50 subjects in adults group (>5 years) (Total 130 subjects) are within acceptable range. Based on the test results, it demonstrates the clinical accuracy of ±0.4°F (0.2°C) within 95~~107.6°F (35~~42°C), and ±0.5°F (0.3°C) for other range. The iHealth PT3 Infrared No-Touch Forehead Thermometer complies with the requirement of ASTM E1965-98 (2016).

9.0 Conclusion

Basing on the performance testing, comparison and analysis above, the subject device i Health PT3 Infrared No-Touch 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.