This device is a non-sterile reusable, contact thermometer, intermittent determination of human body temperature through on the ear canal or forehead as the measurement site on people of all age. The ThermArt (Model IR-EFT) can be used in clinical and home environment.

Device Description

The ThermArt (Model IR-EFT) is a hand-held, battery powered device designed to measure human body temperature. This Thermometer takes the body temperature the infrared energy emitted from the forehead skin or the ear canal. The Thermometer adopts gentle-touch, user friendly and non-invasive measurement design. It instantly displays the accurate reading of the body temperature with just a gentle touch.

AI/ML Overview

The provided document is a 510(k) summary for the ThermArt (Model IR-EFT) clinical electronic thermometer, outlining its substantial equivalence to a predicate device (K190873). It details the device's characteristics, indications for use, and a comparison with the predicate device.

Regarding the acceptance criteria and the study that proves the device meets them, the document states that the evaluation was based on non-clinical data and adherence to voluntary standards. This suggests that performance was assessed through laboratory testing rather than a clinical study involving human patients in a Multi-Reader Multi-Case (MRMC) comparative effectiveness study, or a standalone AI algorithm performance study.

Here's an attempt to extract and synthesize the information based on the provided text, addressing your points. Note that the document is focused on demonstrating substantial equivalence through non-clinical testing and adherence to standards, rather than proving a novel AI device's performance against human readers or a detailed statistical analysis of a clinical test set.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily defined by adherence to established international and national standards for clinical electronic thermometers and general medical electrical equipment safety. The "reported device performance" is essentially that the device met the requirements of these standards.

Acceptance Criteria (Defined by Standards)	Reported Device Performance
Accuracy (ASTM E1965):	- $\pm0.4°F/\pm0.2°C$ (95°F - 107.6 °F/35.0°C - 42°C)
- $\pm0.2°C$ (0.4°F) during 35.5°C ~42.0°C (95.9°F ~107.6°F) at 15°C ~35°C (59.0°F ~95.0°F) operating temperature range	- $\pm0.5°F/\pm0.3°C$ (outside this temperature range)
- $\pm0.3°C$ (0.5°F) for other measuring and operating temperature range (per predicate)	- Performed accuracy test according to ASTM E1965 and ISO 80601-2-56 and met the requirements.
Biocompatibility (ISO 10993-1, -5, -10):	- Performed Cytotoxicity, Skin irritation, Skin sensitization tests according to ISO 10993-1, -5, -10 and met the requirements.
- Evaluation and testing within a risk management process, in vitro cytotoxicity, irritation, and skin sensitization.	- The device's different materials (PC enclosure, glass & ABS probe for subject; ABS enclosure, Stainless steel & ABS probe for predicate) were found to be substantially equivalent in biocompatibility risk after testing.
Cleaning Validation:	- Performed cleaning validation according to the method in the instruction for use, and the validation result shows that the method of cleaning meets the cleaning requirements.
Medical Electrical Safety (ANSI/AAMI ES60601-1, IEC 60601-1-2, IEC 60601-1-11):	- Performed medical electrical safety tests according to these standards (including for home healthcare environment) and met the requirements. The different screen display types were addressed by these tests.
- General requirements for basic safety and essential performance, electromagnetic disturbances, and requirements for use in the home healthcare environment.
Operating Environment (ISO 80601-2-56, ASTM E1965):	- Performed accuracy test according to the ISO 80601-2-56 and ASTM E1965, and met the requirements, despite differences in specified operating temperature and humidity ranges.
- Performance within specified temperature and humidity ranges.
Transportation and Storage Conditions (ISO 80601-2-56, ASTM E1965):	- Performed accuracy test according to the ISO 80601-2-56 and ASTM E1965, and met the requirements, despite differences in specified transportation and storage conditions.
- Performance after transportation and storage within specified conditions.

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

The document does not specify a "test set" in the context of human patient data. The performance studies cited (e.g., ASTM E1965, ISO 80601-2-56) are non-clinical performance tests conducted to verify the device's technical specifications and accuracy under controlled conditions. This implies laboratory testing rather than a patient-based study.

Sample Size: Not applicable in the context of a clinical test set. The testing was done according to the methodologies prescribed by the relevant standards (e.g., how many measurements, temperature points, etc., are required for accuracy testing).
Data Provenance: Not applicable in the context of a clinical test set. The data originates from laboratory performance testing.

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

Not applicable. This device is a clinical electronic thermometer, and "ground truth" for temperature measurement is typically established by reference temperature standards and precise measurement instruments in a laboratory setting, not by human expert consensus or interpretation of images.

4. Adjudication Method for the Test Set

Not applicable, as "ground truth" was not established by human readers or experts requiring adjudication.

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

No, an MRMC comparative effectiveness study was not performed, nor is it relevant for this type of device. This medical device is a thermometer, not an AI-powered diagnostic imaging tool that assists human readers.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done

This question is not applicable to a clinical electronic thermometer. The device itself is the "algorithm" for temperature measurement, and its performance was evaluated through non-clinical testing against standards. There isn't a separate AI algorithm being assessed.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by reference temperature standards and precise measurement equipment used in laboratory settings as per the methodologies defined in standards like ASTM E1965 and ISO 80601-2-56. This is not based on expert consensus, pathology, or outcomes data in the way an AI diagnostic tool would be.

8. The Sample Size for the Training Set

Not applicable. This is a traditional medical device (thermometer) and does not rely on machine learning or AI models that require a "training set" of data.

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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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left side of the image 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 FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

September 28, 2021

Comper Chuangxiang (Beijing) technology Co., Ltd. Han Du Manager Building 1, Unit 4, Room 102, 103 1st Floor, No.1 Kangding Street, Beijing Economic Technological Development Area Beijing, 100176 China

Re: K202481

Trade/Device Name: ThermArt (Model IR-EFT) Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: August 17, 2021 Received: August 27, 2021

Dear Han Du:

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

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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,

For 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 Ouality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known) K202481

Device Name ThermArt (Model IR-EFT)

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

_ Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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K202481 510(K) Summary

Prepared in accordance with the requirements of 21 CFR Part 807.92

Prepared Date: 28 September, 2021

1. Submitter's Information

The submitter of this pre-market notification is:

Name:	Comper Chuangxiang (Beijing) technology Co., Ltd. Address: Room 102-103 1st Floor, Building 4 No.1 Kangding Street, Daxing District Beijing, CHINA 100176
Contact person:	Han Du
Title:	Manager
E-mail:	registration@comper.com
Tel:	+86-10-57480968

2. Device Identification

Trade/Device Name:	ThermArt
Models:	IR-EFT
Common Name:	Clinical Electronic Thermometer
Regulation Number:	21 CFR 880.2910
Regulation Name:	Clinical electronic thermometer
Regulation Class:	Class II
Product Code:	FLL

3. Predicate Device

510(K) number:	K190873
Device Name:	Infrared Ear/Forehead Thermometer
Manufacturer:	Joytech Healthcare Co., Ltd.
Regulation Number:	21 CFR 880.2910
Regulation Name:	Clinical electronic thermometer
Regulation Class:	Class II
Product Code:	FLL

4. Device Description

510(k) Summary

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5. Indications for use

This device is a non-sterile reusable, contact thermometer, intended for intermittent determination of human body temperature through on the ear canal or forehead as the measurement site on people of all age. The ThermArt (Model IR-EFT) can be used in clinical and home environment.

6. Substantial Equivalence Discussion

Comparison to the predicate devices, the subject device has same indications for use, similarproduct design,

same performance effectiveness, performance safety as the predicate device as summarized in the following table

Feature	Subject device	Predicate device	Discussion
510(k) Number	K202481	K190873	/
Regulationnumber	21 CFR 880.2910	21 CFR 880.2910	Same
Product Code	FLL	FLL	Same
Indications forUse	This device is a non-sterilereusable, contactthermometer, intended forintermittent determination ofhuman body temperaturethrough on the ear canal orforehead as the measurementsite on people of all age. TheThermArt (Model IR-EFT)can be used in clinical andhome environment.	Infrared Ear/ForeheadThermometer DET-218 isintended for the intermittentmeasurement of human bodytemperature by people of all ages.The devices are reusable forhome use only.	Our indications for use isdifferent from thedescription of the predicatedevice, but the means isessentially the same.
Patient population	people of all ages	people of all ages	Same
Measure Method	Infrared radiation detection	Infrared radiation detection	Same
Key TemperatureSensor	Thermopile Sensor	Thermopile Sensor	Same
Materials	Enclosure: PC;Probe: glass & ABS	Enclosure: ABS;Probe: Stainless steel & ABS;	Different, but both of ourdevice and predicate devicehave performed theBiocompatibility testaccording to the ISO 10993-1, both two devices meet therequirements of ISO 10993.therefore it is substantiallyequivalent onBiocompatibility risk.
Temperaturerange	32.0°C ~43.0°C (89.6°F -109.4°F)	34.0°C to 43.0°C(93.2°F to 109.4°F)	Our measurement range isgreater than predicatedevice, but we performedaccuracy test according to
Accuracy	$\pm0.4°F/\pm0.2°C$ (95°F107.6 °F/35.0°C -42°C)$\pm0.5°F/\pm0.3°C$ (outside thistemperature range)	Ear/Forehead mode:$\pm0.2°C$ (0.4°F) during 35.5°C~42.0°C (95.9°F ~107.6°F ) at 15°C~35°C (59.0°F ~95.0°F ) operatingtemperature range $\pm0.3°C$ (0.5°F )for other measuring and operatingtemperature range.	the ASTM E1965,therefore it is substantiallyequivalent on performance.Our accuracy is greater thanpredicate device, but weperformed accuracy testaccording to the ASTME1965, therefore it issubstantially equivalent onperformance.
Operatingenvironment	Temperature: 15°C -40°C (59°F -104°F)relative humidity: ≤ 95%;atmospheric pressure: 70kPa~106 kPa	Temperature:10°C~~40°C(50°F~~104°F),relative humidity: 15%~85%RHnon-condensingAtmospheric Pressure : 700hPa ~1060hPa	Our operating temperatureand relative humidity aredifferent from predicatedevice, but we performedaccuracy test according tothe ISO 80601-2-56 andASTM E1965, therefore it issubstantially equivalent onperformance.
Transportation andstorage conditions	Temperature: -20°C~+ 55°C(-4°F -131°F); relative humidity:95%;atmospheric pressure: 70kPa~106 kPa	-25°C~ 55°C (-13°F~131°F),≤15%~95%RH, non-condensingAtmospheric Pressure : 700hPa ~1060hPa	Our operating temperatureand relative humidity aredifferent from predicatedevice, but we performedaccuracy test according to theISO 80601-2-56 and ASTME1965, therefore it issubstantially equivalent onperformance.
Thecontact/noncontactuse of the device	ContactEar: the ear probe covercontacts with skin;Forehead: the forehead probecover contacts with skin	Contact	Same
The use of aprobe cover	Ear: use the ear probe coverForehead: use the foreheadprobe cover	Ear: use the ear probe coverForehead: use the forehead cap	Same
Measuring time	1s	1s	Same
Resolution ofdisplay	0.1°C / 0.1°F	0.1°C / 0.1°F	Same
MeasurementPlace	ForeheadEar	ForeheadEar	Same
Scale Selection	°C /°F	°C /°F	Same
Signal output anddisplay	LEDTransfer transmit data tomobile device for secondarydisplay	-Internal firmware and local LCDdisplay-Also able to transfer transmitdata to mobile device for	Different type of screendisplay, but both of ourdevice and predicate devicehave performed the
		secondary display	Medical electrical safety testaccording to the IEC60601-1 and IEC 60601-1-2both two devices meet therequirements. therefore it issubstantially equivalent onElectrical risk.
Wireless Interface	Not applicable	Bluetooth Low Energy (BLE)	Different , Do not affect theuse and precisionmeasurement
Signaltransmission	Not applicable	Bluetooth 4.0	Different , Do not affect theuse and precisionmeasurement
Receiver (mobileterminal)	Not applicable	iOS9.0 or above mobile deviceAndroid5.0 or above mobiledevice	Different, Do not affect theuse and precisionmeasurement
Auto power-offwhile nooperation	Yes	Yes	Same
Power Source	DC3V(2×AAA battery)	DC3V(2×AAA battery)	Same
Biocompatibility	Cytotoxicity, Skin irritation,Skin sensitization	Cytotoxicity, Skin irritation,Skin sensitization	Same
Voluntarystandards forClinicalElectronicThermometers,	ASTM E1965ISO 80601-2-56	ASTM E 1965 andISO 80601-2-56	Same
Medical ElectricalSafety andEMC	IEC 60601-1, IEC 60601-1-2	IEC 60601-1, IEC 60601-1-2	Same

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Comper Chuangxiang (Beijing) Technology Co., Ltd

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Comper Chuangxiang (Beijing) Technology Co., Ltd

Discussion

Here is a summary of the difference and the tests performed on these differences to address the safety and effectiveness of the subject device.

No.	Difference	Tests performed
1.	Materials	Biocompatibility test according to the ISO 10993-1, ISO10993-5 and ISO 10993-10.
2.	temperature range	Accuracy test according to the ASTM E1965.
3.	accuracy
4.	operating environment	Accuracy test according to the ISO 80601-2-56 andASTM E1965.
5.	transportation and storageconditions
6.	signal output and display	Medical electrical safety test according to the IEC60601-1 and IEC 60601-1-2.

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7.	wireless interface	No test performed because the subject device does not contain these functions.
8.	signal transmission
9.	receiver (mobile terminal)

Comper Chuangxiang (Beijing) Technology Co., Ltd

The required testing demonstrated that different do not raise new questions of safety and effectiveness between the subject and the predicate device.

8. Performance Data

Non-clinical data

Cleaning validation:

We performed the cleaning validation according to the method if instruction for use, the validation result shows that the method of cleaning meets the cleaning requirements.

Safety:

1. ANSI/AAMI ES60601-1:(R) 2012 AND A1:2012 Medical electrical equipment Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD)
1. AAMI/ANSI ES60601-1-2:2014 Medical electrical equipment -- Part 1-2: General requirements for basic safety and essential performance -- Collateral Standard: Electromagnetic disturbances -- Requirements and tests
1. IEC 60601-1-11:2015 Medical electrical equipment Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment

Performance:

ISO 80601-2-56:2017 Medical electrical equipment Part 2-56: Particular requirements for basic safety and 4. essential performance of clinical thermometers for body temperature measurement.
1. ASTM E1965 (2016) Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature

Biocompatibility:

1. ISO 10993-1:2018 Biological evaluation of medical devices Part 1: Evaluation and testing within arisk management process
1. ISO 10993-5:2009 Biological evaluation of medical devices Part 5: Tests for in vitrocytotoxicity
1. ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation andskin sensitization

The tests were selected to show substantial equivalence between the subject device and the predicate.

9. Conclusion

The differences between the predicate and the subject device do not raise any new or different questions of safety or effectiveness. Based on the safety and performance testing and compliance with performance

510(k) Summary

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Comper Chuangxiang (Beijing) Technology Co., Ltd
standards, the ThermArt (Model IR-EFT) is substantially equivalent to the Infrared Ear/Forehead Thermometer cleared under K190873 with respect to the indications for use, target populations, treatment method, and technological characteristics.

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.