The Infrared Ear thermometer is intended for the intermittent measurement of body temperature from the ear canal on people of all ages except for babies under 3 months. It is suitable for home use and healthcare facilities use.

Device Description

The iHealth PT5 Infrared Ear Thermometer is a hand-held, reusable, battery operated device, which can measure human body temperature on one's ear canal. Its operation is based on measuring the natural thermal radiation from the ear canal with a built-in correction algorithm to compensate the influence of ambient temperature using a heated tip. Put the probe of the thermometer into a patient's ear canal, after a self-check, pressing the activation button to start the measurement of proposed infrared radiation. 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. It is recommended that adult take the measurement instead when infants and children cannot use the ear thermometer themselves.

AI/ML Overview

The iHealth PT5 Infrared Ear Thermometer measures body temperature from the ear canal. The device's performance was evaluated through non-clinical and clinical tests to demonstrate substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

Item	Acceptance Criteria (from ASTM E1965-98 & ISO 80601-2-56)	Reported Device Performance (iHealth PT5)
Accuracy for body temperature measurement	±0.2°C (0.4°F) within 35.5°C~~42°C (95.9-107.6°F) and ±0.3°C (0.5°F) for other ranges based on predicate's accuracy. More stringent requirements for subject device: ±0.4°F (0.2°C) within 93.2~~107.6°F (34~42°C), ±0.5°F (0.3°C) for other range.	Meets ASTM E1965-98 and ISO 80601-2-56 requirements. Specifically: ±0.4°F (0.2°C) within 93.2~~107.6°F (34~~42°C), ±0.5°F (0.3°C) for other range.
Repeatability	<0.3°C (as per predicate device and implied by standards)	<0.3°C
Electrical Safety	Meets IEC 60601-1:2005/(R)2012 And A1:2012,C1:2009/(R)2012 And A2:2010/(R)2012	Meets IEC 60601-1:2005/(R)2012 And A1:2012,C1:2009/(R)2012 And A2:2010/(R)2012 (Consolidated Text)
EMC	Meets 60601-1-2:2014	Meets 60601-1-2:2014
Biocompatibility	Meets ISO 10993-1, ISO 10993-5, and ISO 10993-10	Validated for cytotoxicity per ISO 10993-5 and irritation as well as sensitization per ISO 10993-10.
Operating Temperature	Tested within 10°C-40°C (50°F-104°F) and ≤95%RH, non-condensing	Test performed to ISO 80601-2-56 and ASTM E1965-98 within this range.

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

The clinical accuracy validation test included temperature readings from 129 subjects. The subjects were divided into three age groups:

Infant group (3 months up to 1 year)
Children group (1-5 years)
Over 5 years old ( > 5 years)

The document does not explicitly state the country of origin for the clinical data or whether it was retrospective or prospective. However, based on the testing being conducted to international standards (ASTM and ISO), it is likely to be a prospective clinical study specifically designed for regulatory submission.

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

This information is not explicitly provided in the document. The document states "Clinical accuracy validation test report included temperature readings," implying that a reference standard temperature measurement (often oral or rectal temperature by trained clinicians) was used as the ground truth, but the number or qualifications of experts involved in establishing this ground truth are not detailed.

4. Adjudication Method for the Test Set:

This information is not explicitly provided in the document.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:

This type of study is not applicable here as the device is an infrared ear thermometer, which measures a physical parameter (temperature) and does not involve human readers interpreting images or data to make a diagnosis that would be assisted by AI. The device operates in a standalone manner.

6. Standalone Performance:

Yes, a standalone performance study was done. The "Clinical Accuracy Validation Test" performed according to ASTM E1965-98 directly evaluated the iHealth PT5 Infrared Ear Thermometer's performance in measuring body temperature in a clinical setting without human interpretation or intervention in the temperature measurement itself. The non-clinical tests also evaluated the device's technical standalone performance.

7. Type of Ground Truth Used:

Based on the nature of a clinical accuracy validation test for thermometers, the ground truth would most likely be established by a reference standard temperature measurement (e.g., core body temperature measurements from oral or rectal thermometers) taken by trained medical personnel. This is implied by the reference to ASTM E1965-98, which outlines methods for clinical performance evaluation of intermittent thermometers.

8. Sample Size for the Training Set:

The document does not mention a training set in the context of this device. Thermometers typically rely on established physical principles and calibration, not machine learning algorithms that require a "training set" in the conventional sense. The "correction algorithm to compensate the influence of ambient temperature using a heated tip" mentioned in the device description refers to a predefined algorithm, not one trained on a dataset.

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

As there is no mention of a training set for a machine learning algorithm, this question is not applicable based on the provided text.

Summary

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January 28, 2022

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

Re: K212598

Trade/Device Name: iHealth infrared Ear thermometer Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: December 17, 2021 Received: December 29, 2021

Dear 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 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

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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 Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K212598

Device Name iHealth Infrared Ear Thermometer (PT5)

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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K212598 510(K) SUMMARY

(In accordance with 21 CFR 807.92)

1.0 Submitter's Information

Name:	Andon Health Co., Ltd.
Address:	No 3, Jinping Street, Ya An Road, Nankai District, Tianjin,300190, P.R. China
Phone Number:	86-22-87611660
Fax Number:	86-22-87612379
Contact:	Mr. Liu Yi
Date of Preparation:	November 15, 2021

2.0 Device Information

Device Name:	iHealth PT5 Infrared Ear Thermometer
Common Name:	Infrared Ear Thermometer
Classification Name:	Clinical Electronic Thermometer

3.0 Classification

Product Code:	FLL
Regulation Number:	21 CFR880.2910
Classification:	II
Review Panel:	General Hospital

4.0 Predicate Device Information

Manufacturer:	Kaz USA, Inc.
Device:	Braun Thermoscan® IRT 4000 series and BraunThermoscan® PRO 4000 series Clinical Infrared EarThermometer
510(k) Number:	K103800
Classification	II
Product Code	FLL

5.0 Intended Use

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6.0 Device Descrintion

7.0 Comparison of Technological Characteristics with Predicate Device

Item	Subject Device	Predicate Device(K103800)Braun Thermoscan®PRO 4000)	Comparison Result
Device name	Infrared Ear Thermometer	Infrared Ear Thermometer	--------
Models	PT5	Braun Thermoscan® IRT4000 series and BraunThermoscan® PRO 4000series Clinical InfraredEar Thermometer	--------
Product code	FLL	FLL	Same
Regulationnumber	21 CFR 880.2910	21 CFR 880.2910	Same
Manufacturer(legal)	Andon Health Co., Ltd	Kaz, USA Inc	--------
Indications forUse	The Infrared Earthermometer is intended forthe intermittentmeasurement of bodytemperature from the earcanal on people of all agesexcept for babies under 3months. It is suitable forhome use and healthcarefacilities use.	The Braun Thermoscan®IRT 4000 series and BraunThermoscan®PRO 4000series Clinical Infrared EarThermometers is indicatedfor the intermittentmeasurement andmonitoring of human bodytemperature by consumersof all ages in a homeuse/professional useenvironment respectively.The probe cover is used as a	See Note 1.
		sanitary barrier between theinfrared thermometer, andthe ear canal.
Sensor	Infrared	Infrared	Same
Measurementmethod	Infrared radiation detection	Infrared radiation detection	Same
Dimensions	About138mm×34mm×27mm(5.43in x 1.34in x 2.24in)	150mm x 45 mm x 30 mm	See Note 2
Measurementrange	34- 42.9°C (93.2- 109.2°F)	20- 42.2°C	See Note 3
Accuracy forbodytemperaturemeasurement	±0.4°F (0.2°C) within93.2~~107.6°F (34~~42°C),±0.5°F (0.3°C) for otherrange.	±0.2°C within 35.5°C~42°C±0.3°C for other range	See Note 4
Repeatability	<0.3 deg C	<0.3 deg C	Same
Displayresolution	0.1°F (0.1°C)	0.1°F (0.1°C)	Same
Operatingtemperature	Temperature:10°C-40°C (50°F-104°F)Humidity: ≤95%RH,non-condensing	10- 42°C ambient and up to95% RH	See Note 5
Display	LED	LCD	See Note 6
ResponseTime	<3s	2-3 sec	See Note 7
Signal input	Button, NTC and Thethermopile sensor	Button, NTC and Thethermopile sensor	Same
Signal output	LED Display, buzzer andprobe heating signal	LCD Display, buzzer andprobe heating signal	Similar, see note 6
Presence ofheating feature	Yes, probe heat function	Yes, probe heat function	Same
Mode ofoperation	Adjusted mode	Adjusted mode	Same
Referencebody Site	Oral	Oral	Same
Powerrequirements	2X1.5V AAA battery	2X1.5V AA battery orcustom rechargeable NickelMetal Hydride Battery Pack	See Note 8
Materials ofconstructionfor patientcontactingcomponent	Shell: ABSKey/button: PMMAProtective cover: PPProbe: TPU	Common Materialsincluding an impactresistant casing.Biocompatible metals andresins.	Similar - validated forcytotoxicity perISO10993-5 and irritationas well as sensitization perISO 10993-10, See Note 9
Temperatureunit	°C or °F	°C or °F	Same
Accessory	Probe cover	Probe cover	Same
Performance	Meets ASTM E 1965, andISO80601-2-56	Meets ASTM E 1965	All standards verified andvalidated for test deviceand met acceptancecriteria.
ElectricalSafety	Meets IEC 60601-1	Meets IEC 60601-1	Same
EMC	Meets IEC 60601-1-2	Meets IEC 60601-1-2	Same

The following table is the summary of the technological characteristics of the proposed subject device and predicate device.

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DISCUSSION OF DIFFERENCES:

Note No	Difference	Justification
1	Indications for Use	The scope of the applicable group of people has been narrowed down toexclude babies under 3 months. The subject device has a narrowerintendedpopulation and it will not raise any new or different safety oreffectiveness risks.
2	Dimensions	The software validation and clinical accuracy test demonstrated thedifference does not raise any new performance questions.
3	Measurement range	The measurement range of the predicate device is different from that of thesubject device. The subject device measurement range is 34°C to 42.9°C.Regarding the predicate's clinical measurement range of 34°C to 42.2°C, theaccuracy of the subject device and the predicate device are same or evenstricter than the predicate device. And the performance test and clinicalaccuracy test showed that the subject device do not raise any new questions.
4	Accuracy for bodytemperaturemeasurement	The accuracy of subject device is same or even stricter than that of predicatedevice.For measurement range of 35.5°C~42°C, the accuracy of the subject deviceand the predicate device are same, and for 34°C-35.5°C, the accuracy of thesubject device is stricter than that of predicate device, and the accuracy ofother ranges are same for subject device and predicate device.And based on the testing, the subject device meets ASTM E1965-98, and ISO80601-2-56 requirements.
5	Operatingtemperature	Our operating temperature and relative humidity are different from predicatedevice, but we performed test according to ISO 80601-2-56 and ASTME1965-98, and it is demonstrated that it is substantially equivalent onperformance.
6	Display	Different, the display component of the new device PT5 is changed fromLCD to LED, the software validation and performance test demonstrated thedifference does not raise any new performance questions.
7	Response Time	Both subject device and the predicate device can get measurement within 3s,
		the software validation showed that the difference does not raise any new
		performance questions.
8	Power requirements	Power supply of the subject device is different from the predicate device, theelectrical safety and EMC test demonstrated the difference does not raise anynew performance questions.
9	Materials ofconstruction forpatient contactingcomponent	The materials used for subject device and predicate device are similar, and itis validated for cytotoxicity per ISO10993-5 and irritation as well assensitization per ISO 10993-10, and it is demonstrated that the subjectdevice does not raise any new questions.

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8.0 Discussion of Non-Clinical & Clinical Testing

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 tests were 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)].

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 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.

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9.0 Clinical Accuracy Validation Test

Clinical testing have performed according to ASTM F1965-98. The clinical accuracy validation test report included temperature readings of 129 subjects divided into three group age ranges- Infant group (3 months up to 1 year), Children group (1-5 years) and Over 5 years old ( > 5 years). Based on the result, it is demonstrated the the clinical performance of iHealth PT5 Infrared Ear Thermometer complies with the requirement of ASTM E1965-98 (2016).

10. Comparison to the Predicate Device and Conclusion

The conclusion drawn from the nonclinical tests and clinical test demonstrate that the subject device Infrared Ear Thermometer is very similar with its predicate device in the intended use, design principle, performance and applicable standards. And the tests in this submission demonstrate that the differences compared to the predicate device do not raise any new questions of safety and effectiveness. Therefore, the subject device is substantially equivalent to the legally marketed predicate device (K103800).

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.