The Clinical Digital Thermometer is intended to measure the body temperature oral or axillaries (under the arm) and to be used by consumers in household environments. It is intended for use on adults and children ages 4 and up.

Device Description

The iHealth PT1 Clinical Digital Thermometer is hand-held, predictive, thermistor-based, stick thermometer capable of measuring temperature in about 30 seconds. The thermometer uses a negative temperature coefficient thermistor embedded in a measurement tip that is in contact with the measurement site. As the thermistor changes temperature, the resistance of the thermistor also changes, which is measured by the thermometer and converted to a measurement of the temperature of the tip of the thermometer. This temperature, following the use of the predictive algorithm, is then displayed to the end user. Because the thermometer displays the measurement for the physiological site at which it is used, it does not need to convert this temperature via clinical offset.

AI/ML Overview

The provided text is for a Clinical Digital Thermometer (iHealth PT1). Here's a breakdown of the acceptance criteria and the study that proves the device meets those criteria:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Standard)	Reported Device Performance
Accuracy (ISO 80601-2-56:2017)
89.6°F~102.2°F (32°C-39°C)	±0.2°F
102.3°F~109.4°F (39.1°C-43°C)	±0.3°F
Clinical Bias	≤ 0.03
Repeatability	≤ 0.07
Electrical Safety (IEC 60601-1)	Meets the standard
EMC (IEC 60601-1-2)	Meets the standard
Performance (ISO 80601-2-56)	Meets the standard
Software Validation	Conducted per FDA guidance
Biocompatibility (ISO 10993 Series)	Meets the standards

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

Sample Size: 110 subjects
- 40 subjects in the children's group (4-5 years old)
- 70 subjects in the adults' group (> 5 years old)
Data Provenance: Not explicitly stated (e.g., country of origin, retrospective or prospective), but the study is described as a "Clinical investigation," which typically implies a prospective design.

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

The document does not specify the number or qualifications of experts used to establish ground truth for the clinical accuracy validation test. It only mentions that the "Clinical investigation and data analysis have performed according to ISO 80601-2-56." This standard outlines requirements for clinical accuracy, which would involve comparison to a reference thermometer reading.

4. Adjudication method for the test set

The document does not explicitly state the adjudication method (e.g., 2+1, 3+1). The clinical accuracy test was conducted according to ISO 80601-2-56, which specifies protocols for such measurements, likely involving a skilled operator taking readings against a reference.

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 as the device is a clinical digital thermometer, not an AI-assisted diagnostic tool involving human readers.

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

This is a standalone device in the sense that it provides a temperature reading directly to the user. The "predictive algorithm" mentioned in the device description is integral to its function of displaying a rapid temperature measurement, so its performance (as part of the device) was evaluated.

7. The type of ground truth used

For the clinical accuracy validation test, the ground truth was established by comparison to a reference temperature measurement, as dictated by the ISO 80601-2-56 standard for clinical thermometers.

8. The sample size for the training set

The document does not explicitly mention a separate "training set" in the context of machine learning model training. The predictive algorithm used by the thermometer would likely have been developed and validated during the device's design phase, prior to this specific submission. The listed clinical accuracy validation test dataset (110 subjects) is for the evaluation of the device's performance, not necessarily for training the predictive algorithm itself.

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

As there's no explicit mention of a training set for an AI model in the context of this submission, the method for establishing its ground truth is not described. The predictive algorithm's development would likely have used a robust set of physiological temperature data paired with reference measurements, conforming to relevant scientific and engineering best practices for medical device software.

Summary

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January 5, 2021

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

Re: K202791

Trade/Device Name: iHealth Clinical Digital Thermometer (PT1) Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: December 4, 2020 Received: December 8, 2020

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,

CAPT Alan M. Stevens Acting 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) K202791

Device Name

iHealth Clinical Digital Thermometer (PT1)

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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510(k) Summary

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, Tianjin,P.R. China
Phone number:	86-22-87611660
Fax number:	86-22-87612379
Contact:	Liu Yi
Date of Preparation:	9/18/2020

2.0 Device information

iHealth Clinical Digital Thermometer (PT1) Trade name: Common name: Clinical Digital Thermometer 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

Kaz USA, Inc., A Helen of Troy Company Manufacturer: Vicks RapidRead Digital Thermometer Device: 510(k) number: K180131

5.0 Intended use

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6.0 Device description

Item	Subject Device	Predicate Device (K180131)	Comparison
Device name	iHealth PT1 Clinical DigitalThermometer	Vicks® VDT972RapidRead™ DigitalThermometer	N/A
Manufacturer(legal)	Andon Health Co., Ltd	Kaz USA, Inc., a Helen ofTroy Company	N/A
Contractmanufacturer	Andon Medical Co., Ltd	Microlife Corporation	N/A
ThermometerType	Axillary / Oral, PredictiveDigital Thermometer	Axillary / Oral / Rectal,Predictive DigitalThermometer	Different note 1
Models	PT1	Vicks® VDT972RapidRead™Digital Thermometer	N/A
510K number	K202791	K180131	N/A
Indications forUse	The Clinical DigitalThermometer is intended tomeasure the bodytemperature oral or axillaries(under the arm) and to beused by consumers inhousehold environments. Itis intended for use on adultsand children ages 4 and up.	The Vicks® VDT972RapidRead™ DigitalThermometer is a handheld,battery-powered, predictive,digital stick thermometerintended for the intermittentdetermination of human bodytemperature orally, rectally, orunder the arm, in a home-useenvironment for people of allages (infants, children, andadults). It is intended to be	Similar note 2

		used with a single use,disposable probe cover for allmeasurements.
User population	Children (ages 4 and up) andadults	Infants, children, and adults	Different note 3
Labeling	Instructions for use, package/ box, and rating label	Instructions for use, package/ box, and rating label	Similar note 4
Components	On / Off Button, sensor head,microcontroller, & LCD	On / Off Button, SiteSelection Button, sensorhead, protective cover,microcontroller, & LCD	Different note 5
Sensor	Thermistor	Thermistor	Same
Principles ofoperation	The thermometer uses anegative temperaturecoefficient thermistorembedded in ameasurement tip that is incontact with themeasurement site. As thethermistor changestemperature, the resistanceof the thermistor alsochanges, which is measuredby the thermometer andconverted to a measurementof the temperature of the tipof the thermometer. Thistemperature, following theuse of the predictivealgorithm, is then displayedto the end user. Because thethermometer displays themeasurement for thephysiological site at which itis used, it does not need toconvert this temperature viaclinical offset.	The thermometer uses anegative temperaturecoefficient thermistorembedded in a measurementtip that is in contact with themeasurement site. As thethermistor changestemperature, the resistanceof the thermistor alsochanges, which is measuredby the thermometer andconverted to a measurementof the temperature of the tipof the thermometer. Thistemperature, following theuse of the predictivealgorithm, is then displayed tothe end user. Because thethermometer displays themeasurement for thephysiological site at which itis used, it does not need toconvert this temperature viaclinical offset.	Same
Measurementrange	$89.6°F-109.4°F (32°C-43°C)$	$34- 43° C (93.2- 109.4° F)$	Different note 6
Accuracy	$89.6°F~~102.2°F (32°C-39°C) ±0.2°F102.3°F~~109.4°F (39.1°C-43°C) ±0.3°F$	$± 0.1°C / 0.2°F$ withinmeasurement range ( $34.0°C$to $43.0°C /93.2°F$ to $109.4°F$ )at room temperature of $71°F$	Different note 7
Display resolution	$0.1°F (0.1°C)$	$0.1°F (0.1°C)$	Same
Response time	Predictive mode: 30 secondsMonitor mode: 3 minutes	2 to 8 seconds	Different note 8
Signal output anddisplay	LCD, Buzzer	LCD, Buzzer	Same
OperatingEnvironment	temperature: +41°F~+104°F(5°C-40°C )humidity: ≤85% RH	15.0°C to 40.0°C /59.0°F to 104.0°F;≤ 95% Relative Humidity	Different note 9
StorageEnvironment	temperature: -4°F~+131°F(-20°C-55°C )Humidity: ≤95% RH	-25.0°C to 60.0°C /-13.0°F to 140.0°F;≤ 95% Relative Humidity	Different note 10
Power supply	One 3V CR1632 button	One 3V CR2032 button	Different note 11
Battery life	Approx 1000 measurementfor predictive modeAbout 200 times for othermode	More than 400measurements orapproximately 2 years if usedevery other day.	Different note 12
Materials	User contacting materialsinclude ABS (shell, batterydoor and On / Off Button),PET(LCD lens and protectivefilm), PP(probe protectivecover and SUS(sensor tip)	User contacting materialsinclude ABS (sensor head,battery door and On / OffButton), TPR (probe and SiteSelection Button), PMMA(LCD lens and protectivecover), and stainless steel(sensor tip)	Different note 13
Performance	Meets ASTM E1112-00:2011and ISO 80601-2-56:2017	Meets ASTM E1112-00:2011and ISO 80601-2-56:2017	Same
Biocompatibility	Meets ISO 10993 and FDAbluebook memo G95-1	Meets ISO 10993 and FDAbluebook memo G95-1	Same
Electrical Safety	Meets IEC 60601-1	Meets IEC 60601-1	Same
EMC	Meets IEC 60601-1-2	Meets IEC 60601-1-2	Same

7.0 Summary comparing technological characteristics with predicate device

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Note 1: The subject device is not labeled for rectal use. This technological difference does not raise new questions of safety or efficacy.

Note 2: There is a difference in the indication for use because the subject device only takes intermittent measurement of body temperature on children and adults, and no disposable probe cover is provided for all measurements. Testing was not conducted with a probe cover. The software validation and clinical accuracy test demonstrated the difference does not raise any new performance questions.

Note 3: While the user population is different, the clinical accuracy test demonstrated the difference does not raise any new performance questions because it performs effectively in the labeled population of use.

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Note 4: The labeling is similar and both of them comply with consensus standards.

Note 5: There is no separate Site Selection Button on the subject device and the on/off button is used as site and mode selection button, which is different from the predicate device. The performance test and software validation demonstrated the difference does not raise any new performance questions.

Note 6: The Measuring range of the subject device is different from the predicate device. The performance test and the clinical accuracy test demonstrated the difference does not raise any new performance questions.

Note 7: The accuracy of the subject device is different from the predicate device. The performance test and the clinical accuracy test demonstrated the difference does not raise any new performance questions, and it is consistent with ISO 80601-2-56.

Note 8: Response time of the subject is different from the predicate device, the clinical accuracy test demonstrated the difference does not raise any new performance questions.

Note 9: The operating environment of the new device PT1 is changed, the performance test demonstrated the difference does not raise any new performance questions.

Note 10: The storage environment of the new device PT1 is changed, the performance test demonstrated the difference does not raise any new performance questions.

Note 11: Power supply and lens filter function of the subject device is different from the predicate device. The electrical safety and EMC test demonstrated the difference does not raise any new performance questions.

Note 12: Battery life of the new device is different from the predicate device, the electrical safety test, EMC test and performance test demonstrated the difference does not raise any new performance questions.

Note 13: The material contacted is different. The biocompatibility test demonstrated the difference does not raise any new performance questions.

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8.0 Discussion of non-clinical and clinical test performed

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

Non-clinical Tests

Electrical Safety testing 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 testing 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 testing 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)]. This is the applicable standard 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 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.

Clinical Accuracy Validation Test

Clinical investigation and data analysis have performed according to ISO 80601-2-56. The test report shows result of 40 subjects in children group (4-5 year) and 70 subjects in adults group (>5 years) (Total 110 subjects) are within acceptable range. Based on the test results, the clinical bias is ≤ 0.03 and the repeatability is ≤ 0.07, which is equivalent to the predicate device.

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9.0 Conclusion

Basing on the performance testing, comparison and analysis above, the subject device iHealth PT1 Clinical Digital 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.