iHealth Clinical Digital Thermometer

• K Number: K202791
• Device Name: iHealth Clinical Digital Thermometer
• Manufacturer: Andon Health Co., Ltd.
• Date Cleared: 2021-01-05 ( 105 days)
• Product Code: FLL
• Regulation Number: 880.2910

Intended Use

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.

Predicate Devices

K180131

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description mentions a "predictive algorithm" but provides no details suggesting it uses AI/ML. The performance studies focus on standard clinical accuracy metrics and do not mention AI/ML-specific validation. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".

Therapeutic

No
A therapeutic device is used to treat a condition or disease. This device is a thermometer, which is used for measurement and diagnosis, not treatment.

Diagnostic

No
The device measures body temperature, which is a physiological parameter, but the "Intended Use" states it is for measuring body temperature and does not indicate it is used to diagnose a disease or condition. While temperature can be a symptom, the device itself reports the temperature value and not a diagnosis.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "hand-held, predictive, thermistor-based, stick thermometer" and describes the physical components and how they measure temperature, indicating it is a hardware device with embedded software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to examine these samples outside of the body.
• Device Function: The Clinical Digital Thermometer measures body temperature directly from the body (oral or axillary). It does not analyze samples taken from the body.
• Intended Use: The intended use is to measure body temperature, which is a physiological measurement taken directly from the patient.

Therefore, this device falls under the category of a medical device, but not specifically an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes

FLL

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

oral or axillaries (under the arm)

Indicated Patient Age Range

adults and children ages 4 and up

Intended User / Care Setting

consumers in household environments.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

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.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-clinical tests: Electrical Safety testing (IEC 60601-1:2005/(R)2012 And A1:2012,C1:2009/(R)2012 And A2:2010/(R)2012), EMC testing (60601-1-2:2014), Performance testing (ISO 80601-2-56), 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", dated May 11, 2005), Biocompatibility test (ISO 10993-1, ISO 10993-5, ISO 10993-10).

Clinical Accuracy Validation Test: Clinical investigation and data analysis performed according to ISO 80601-2-56. Sample size was 40 subjects in children group (4-5 year) and 70 subjects in adults group (>5 years) (Total 110 subjects). Key results: clinical bias is ≤ 0.03 and the repeatability is ≤ 0.07, which is equivalent to the predicate device.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Clinical bias: ≤ 0.03
Repeatability: ≤ 0.07

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K180131

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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 ([e-mail]) or phone [phone] 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)

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.

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

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.

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6.0 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.

Item	Subject Device	Predicate Device (K180131)	Comparison
Device name	iHealth PT1 Clinical Digital
Thermometer	Vicks® VDT972
RapidRead™ Digital
Thermometer	N/A
Manufacturer
(legal)	Andon Health Co., Ltd	Kaz USA, Inc., a Helen of
Troy Company	N/A
Contract
manufacturer	Andon Medical Co., Ltd	Microlife Corporation	N/A
Thermometer
Type	Axillary / Oral, Predictive
Digital Thermometer	Axillary / Oral / Rectal,
Predictive Digital
Thermometer	Different note 1
Models	PT1	Vicks® VDT972
RapidRead™
Digital Thermometer	N/A
510K number	K202791	K180131	N/A
Indications for
Use	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.	The Vicks® VDT972
RapidRead™ Digital
Thermometer is a handheld,
battery-powered, predictive,
digital stick thermometer
intended for the intermittent
determination of human body
temperature orally, rectally, or
under the arm, in a home-use
environment for people of all
ages (infants, children, and
adults). It is intended to be	Similar note 2
		used with a single use,
disposable probe cover for all
measurements.
User population	Children (ages 4 and up) and
adults	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, Site
Selection Button, sensor
head, protective cover,
microcontroller, & LCD	Different note 5
Sensor	Thermistor	Thermistor	Same
Principles of
operation	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.	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.	Same
Measurement
range	$89.6°F-109.4°F (32°C-43°C)$	$34- 43° C (93.2- 109.4° F)$	Different note 6
Accuracy	$89.6°F102.2°F (32°C-39°C) ±0.2°F102.3°F109.4°F (39.1°C-43°C) ±0.3°F$	$± 0.1°C / 0.2°F$ within
measurement 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 seconds
Monitor mode: 3 minutes	2 to 8 seconds	Different note 8
Signal output and
display	LCD, Buzzer	LCD, Buzzer	Same
Operating
Environment	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
Storage
Environment	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 measurement
for predictive mode
About 200 times for other
mode	More than 400
measurements or
approximately 2 years if used
every other day.	Different note 12
Materials	User contacting materials
include ABS (shell, battery
door and On / Off Button),
PET(LCD lens and protective
film), PP(probe protective
cover and SUS(sensor tip)	User contacting materials
include ABS (sensor head,
battery door and On / Off
Button), TPR (probe and Site
Selection Button), PMMA
(LCD lens and protective
cover), and stainless steel
(sensor tip)	Different note 13
Performance	Meets ASTM E1112-00:2011
and ISO 80601-2-56:2017	Meets ASTM E1112-00:2011
and ISO 80601-2-56:2017	Same
Biocompatibility	Meets ISO 10993 and FDA
bluebook memo G95-1	Meets ISO 10993 and FDA
bluebook 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.