The Infrared Digital No-Touch 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.

Device Description

The iHealth PT2L Infrared Digital No-Touch Thermometer is hand-held, reusable, battery operated device, which can measure human body forehead skin 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. It 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 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 LCD display.

AI/ML Overview

The document is a 510(k) summary for the iHealth PT2L Infrared Digital No-Touch Thermometer. It details the device's characteristics, indications for use, comparison to a predicate device, and the non-clinical and clinical tests performed to support its substantial equivalence.

Here's a breakdown of the requested information regarding acceptance criteria and the study proving the device meets them:

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

The primary acceptance criterion mentioned, specifically for clinical accuracy, is conformance to ASTM E1965-98 (2016). This standard outlines requirements for "Standard Test Method for Infrared Thermometers for Intermittent Determination of Patient Temperature." The document states that the device complies with this requirement.

Acceptance Criteria (Standard)	Performance Met Acknowledged
ASTM E1965-98 (2016)	Complies

Note: While not explicitly presented as a table in the document, the "Accuracy" row in the comparison table on page 5 provides specific numerical criteria that the device's performance is intended to meet. The clinical accuracy study confirms that the device meets the ASTM standard, which encompasses these accuracy specifications.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Sample Size for Test Set (Clinical Accuracy): 130 subjects
- Infants (0-1 year): 40 subjects
- Children (1-5 years): 40 subjects
- Adults (>5 years): 50 subjects
Data Provenance: The document does not specify the country of origin of the data. It implies a prospective clinical investigation ("Clinical investigation and data analysis have performed according to ASTM F1965-98").

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This is not applicable as the device is a thermometer measuring body temperature, not an AI diagnostic device requiring expert interpretation of images or other data for ground truth. The ground truth for temperature measurement would be established by a reference standard thermometer as per the ASTM F1965-98 protocol. The document does not specify details of the reference thermometer or its calibration.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. The clinical accuracy study for a thermometer involves direct comparison of the device's readings against a reference standard, not a subjective interpretation requiring adjudication among multiple experts.

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 is a standalone medical device (thermometer), not an AI-assisted diagnostic tool.

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

Yes, the clinical accuracy validation test described is a standalone performance test of the device. The device itself (the thermometer) performs the measurement, and its accuracy is assessed against a reference standard. There is no human interaction for 'interpretation' of results in the way an AI diagnostic algorithm might have.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the clinical accuracy study would be the temperature measurements obtained from a reference standard thermometer (e.g., a highly accurate rectus or oral thermometer) as described in ASTM F1965-98. The document does not specify the type of reference standard used.

8. The sample size for the training set

Not applicable. This is a traditional medical device (thermometer) that does not use machine learning, and therefore does not have a "training set" in the context of AI/ML models.

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

Not applicable, as there is no training set for this type of device.

Summary

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October 1, 2020

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

Re: K200710

Trade/Device Name: Infrared PT2L Digital No-Touch Thermometer Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical electronic thermometer Regulatory Class: Class II Product Code: FLL Dated: August 24, 2020 Received: September 1, 2020

Dear Liu Yi:

We have reviewed vour 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

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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-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,

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 Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K200710

Device Name

iHealth PT2L Infrared Digital No-Touch Thermometer

Indications for Use (Describe)

The Infrared Digital No-Touch Thermometer is intennittent 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.

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-K200710

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

1.0 submitter's information

Name:	Andon Health Co., Ltd.
Address:	No 3, Jinping Street Ya An Road, Nankai District, TianjinP.R. China
Phone number:	86-22-87611660
Fax number:	86-22-6052 6162
Contact:	Liu Yi
Date of Preparation:	8/21/2020

2.0 Device information

Trade name: iHealth PT2L Infrared Digital No-Touch Thermometer Infrared forehead thermometer Common name: Regulation name: Clinical Electronic Thermometer

3.0 Classification

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

4.0 Predicate device information

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

5.0 Indications for Use

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6.0 Device description

Item	Subject Device(K200710)	Predicate Device(K191570)	Comparison
Models	PT2L	MD-H30	Different
Product code	FLL	FLL	Same
Regulation number	21 CFR 880.2910	21 CFR 880.2910	Same
Manufacturer	Andon Health Co., Ltd	Guangzhou BerrcomMedical Device Co., Ltd.	Different
Indications for Use	The Infrared Digital No-TouchThermometer is intended forthe intermittent measurementof body temperature from theforehead on people of all ages.It can be used by consumersin the household environmentand by healthcare 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 contact type	Non-contact;measurement distance: ≤ 1.18in(3 cm)	Skin contacting	Different
Sensor	Thermopile	Thermopile	Same
Measurement method	Infrared radiation detection	Infrared radiation detection	Same
Measurement Site	Forehead	Forehead or Ear	Different
Reference site	Oral	Oral	Same

7.0 Summary comparing technological characteristics with predicate device

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Display type	LCD	LCD	Same
Dimension	141mm×32mm×48mm	Not known	different
Other feature	Beep when get measurementcolored screen indicates thetemperature is outside of'normal' or 'high' temperatureranges	Beep when getmeasurementProbe cover provided	different
Measuring range	34-43° C (93.2-109.4° F)	32- 43° C (89.6- 109.4° F)	different
Accuracy	±0.5°F (±0.3°C) for 34-43° C (93.2- 109.4° F)	±0.4° F (±0.2° C) within95~~107.6°F (35~~42° C),±0.5°F (±0.3° C) forother range.	Different
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, ≤95%RH,70-106kPa	10°C~40°C; ≤95% RH	Different,
Storageenvironment	-25-55°C, ≤95%RH,70-106kPa	-20~55°C; ≤95%RH	Different,
Materials ofskin-contactingcomponents	ABS and PMMA	ABS	Different
biocompatibility	Comply with ISO 10993-1	Comply with ISO 10993-1	Same
electrical safety	Comply with IEC 60601-1	Comply with IEC 60601-1	Same
EMC	Comply with IEC 60601-1-2	Comply with IEC 60601-1-2	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 indication for use because the subject device only take measurement from the forehead skin while the predicate device take measurement from both forehead skin and auditory canal. Moreover, the predicate device is skin contacting when taking measurement while the subject device is non-contact device. The software validation and clinical accuracy test demonstrated the difference does not raise any new performance questions.

Dimension of the subject device is different from the predicate device, but the electrical safety and EMC test and the performance test demonstrated the difference does not raise any new performance questions.

The subject device has no probe cover provided, while the predicate device will provide probe cover, and the subject device has function of flashing/colored screen that indicates the temperature is outside of 'normal' or

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'high' temperature ranges, but the performance test of the subject device demonstrated the difference does not raise any new performance questions.

The Measuring range and accuracy 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 measuring range and accuracy is within the ASTM 1965-98 standard for Skin IR thermometers.

The operation temperature range of the proposed device PT2L is narrow than the predicate device, and the storage humidity range of the proposed device PT2L is also wide 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 confirms 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.

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Biocompatibility test (including cytotoxicity, sensitization, irritation) was leveraged from their own reference device K 2 0 0 5 3 1 . The tests performed on the reference device 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.

Reprocessing: Cleaning and Disinfection

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

Clinical Accuracy Validation Test

Clinical investigation and data analysis have performed according to ASTM F1965-98. 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 group (>5 years) (Total 130 subjects) are within acceptable range. Based on the test results, it demonstrates the iHealth PT2L Infrared Digital No-Touch Thermometer complies with the requirement of ASTM E1965-98 (2016).

9.0 Comparison to the predicate device and the conclusion

Basing on the performance testing, comparison and analysis above, the subject device iHealth PT2L Infrared Digital No-Touch 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.