The Infrared thermometer is non-contact infrared thermometer intended for the intermittent measurement of human body temperature from forehead for people of all age. The device is reusable for home use and clinical use

Device Description

The proposed device, infrared thermometer, is hand-held, battery powered device, which is intended to measure human body temperature by measuring forehead. The distance of the measurement is 1~5cm. The device is non-contacting infrared thermometer and intended for people of all age.

AI/ML Overview

The provided document describes the FDA 510(k) clearance for an Infrared Thermometer (K202368). The study conducted focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical and a single clinical study verifying accuracy and repeatability against a standard.

Here's an analysis based on your request, understanding that this is a medical device clearance, not an AI/ML product often associated with complex MRMC studies:

Acceptance Criteria and Reported Device Performance

The core acceptance criterion for the Infrared Thermometer is its accuracy. The study aims to show that the device meets the accuracy requirements specified in the standard ISO 80601-2-56 and ASTM E1965-98 (2016).

Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criterion (Standard / Specified)	Reported Device Performance
Accuracy (ISO 80601-2-56 / ASTM E1965-98):	Demonstrated to meet acceptance criteria through a controlled human clinical study.
±0.2°C (0.4°F) at 35.0°C ~ 42.0°C (95.0°F ~ 107.6°F)	Confirmed to meet this range.
Others ±0.3°C (0.5°F)	Confirmed to meet this range.
Repeatability (ASTM E1965-98):	Demonstrated to meet acceptance criteria through a controlled human clinical study.
Biocompatibility (ISO 10993-5, ISO 10993-10):	No adverse effects (No Cytotoxicity, No Sensitization, No Irritation)
Electrical Safety (IEC 60601-1):	Operates normally, no performance degradation or safety issue.
EMC (IEC 60601-1-2):	Operates normally, no performance degradation or safety issue.
Software Functionality:	Software achieves its performance.
Service Life (3 years):	Maintains function as intended at the end of the proposed service life.

Study Details:

Sample Size and Data Provenance:
- Test Set Sample Size: The document states that a "controlled human clinical study was conducted." However, it does not specify the sample size (number of subjects/measurements) used in this clinical study.
- Data Provenance: The location of the clinical study is not explicitly stated, but the company is based in China. The study is described as a "controlled human clinical study," which generally implies a prospective data collection for the purpose of the study.
Number of Experts and Qualifications (for Ground Truth Establishment):
- This document describes the clearance of an infrared thermometer, not an AI/ML diagnostic device that typically relies on expert interpretation of complex medical images. The "ground truth" for temperature measurement is typically established using a reference thermometer (e.g., a rectal thermometer) adhering to an established clinical standard.
- Therefore, the concept of "experts establishing ground truth" in the sense of radiologists reviewing images does not apply to this type of device. The ground truth for temperature is based on established metrological traceability and standard reference measurements.
Adjudication Method:
- Not applicable as this is not a study involving expert adjudication of diagnostic findings. The clinical study for a thermometer compares its readings against a gold standard reference thermometer.
Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:
- No, a MRMC study was not performed. This type of study is relevant for AI/ML diagnostic tools where human readers (e.g., radiologists) interpret images with and without AI assistance. This device is a direct measurement tool, not an AI diagnostic aid.
Standalone (Algorithm Only) Performance:
- Yes, the clinical study essentially evaluates the standalone performance of the device by comparing its temperature readings against a reference method (the "predicate device" also serves as a comparison point, and the study was done "in accordance with ASTM E1965-98 (2016)," which sets standards for clinical thermometer performance). The device itself is an algorithm (software) translating sensor data into a temperature reading.
Type of Ground Truth Used:
- For the clinical study, the ground truth for body temperature was established by comparing the proposed device's measurements against a reference method or established clinical standard as per ASTM E1965-98 (2016). This standard outlines procedures for determining the accuracy of clinical thermometers, typically involving comparisons to highly accurate reference thermometers in a controlled clinical setting. It is not based on expert consensus, pathology, or outcomes data in the typical sense used for diagnostic imaging AI.
Sample Size for Training Set:
- This document describes the regulatory clearance of a finished medical device (an infrared thermometer). While it contains software, it is not described as an adaptable AI/ML model that undergoes a separate "training" phase with a large dataset in the way a deep learning model would.
- Therefore, the concept of a separate "training set" with a specified sample size for an AI/ML algorithm is not directly applicable or described in this 510(k) summary for this device. The software verification and validation are more about traditional software engineering principles.
How Ground Truth for Training Set Was Established:
- As there's no mention of a traditional "training set" for an AI/ML algorithm, this question is not applicable in the context of this 510(k) submission. The "ground truth" for the device's functionality and performance is based on its design specifications, adherence to standards, and the results of the clinical and non-clinical tests.

Summary

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February 12, 2021

Shandong Bittel Intelligent Technology Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co.,Ltd Contact AddressP.O. Box 120-119 Shanghai. 200120 China

Re: K202368

Trade/Device Name: Infrared Thermometer Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: January 14, 2021 Received: January 15, 2021

Dear Diana Hong:

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 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,

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 Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K202368

Device Name Infrared thermometer

Indications for Use (Describe)

The Infrared thermometer is non-contact infered thermometer intent measurement of human body temperature from forehead for people of all age. The device is reusable for home use and clinical use

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)

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Exhibit # 2 510(k) Summary

This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.

The assigned 510(k) Number: K202368

1. Date of Preparation: 02/12/2021
1. Sponsor Identification

Shandong Bittel Intelligent Technology Co., Ltd. No.1 Rizhao North Road, Rizhao, Shandong China 276800

Establishment Registration Number: Not Registered yet

Contact Person: Cui Shi Position: Management Director Tel: +86-633-2212103 Fax: +86-633- 2212186 Email: sc@bittelgroup.com

Designated Submission Correspondent 3.
Ms. Diana Hong (Primary Contact Person) Ms. Ying Xu (Alternative Contact Person)

Mid-Link Consulting Co., Ltd. P.O. Box 120-119, Shanghai, 200120, China

Tel: +86-21-22815850, Fax: 360-925-3199 Email: info@mid-link.net

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4. Identification of Proposed Device

Trade Name: Infrared thermometer Common Name: Clinical electronic thermometer

Regulatory Information

Classification Name: Clinical electronic thermometer; Classification: II; Product Code: FLL; Regulation Number: 21CFR 880.2910 Review Panel: General Hospital;

Indication for Use Statement:

Device Description

ર. Identification of Predicate Device

510(k) Number: K191251 Device Name: Infrared Thermometer Product Code: FLL; Regulation Number: 21CFR 880.2910

Non-Clinical Test Conclusion 6.
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test performed on the proposed device include

Biocompatibility testing

The biocompatibility test for the proposed device was conducted in accordance with the FDA guidance "Use of International Standard ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". The biocompatibility testing items include cytotoxicity, Sensitization and Irritation test, the test result demonstrated that there was no adverse

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effects, thereby, it can be determined that the device can comply with the following standards

ISO 10993-5: 2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
ISO 10993-10: 2010 Biological evaluation of medical devices Part 10: Tests for irritation and skin A sensitization

Electrical safety and EMC

Electrical safety and EMC testing were conducted on the proposed device and the test result demonstrated that the device can operate normally and did not raise any performance degradation and safety issue, thereby, it can be determined that the device can comply with the following standards

A IEC 60601-1: 2005+CORR.1(2006)+CORR.2(2007)+AMI(2012) Medical electrical equipment-Part 1: general requirement for basic safety and essential performance
IEC 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.
A ISO 80601-2-56: 2017+A1: 2018 Medical Electrical Equipment- Part 1-2: Particular Requirements for Basic Safety And Essential Performance of Clinical thermometers for body temperature measurement

Software Verification and Validation Testing

Software verification and validation testing were conducted on the Infrared thermometer and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The test result demonstrated that the software can achieve its performance.

Clinical Test Conclusion 7.
A controlled human clinical study was conducted on proposed device by comparing against with predicate device in accordance with ASTM E1965-98 (2016). The test result demonstrated that accuracy and repeatability can meet the acceptance criteria. Therefore, it can be considered that the device conforms with ASTM E1965-98 (2016).

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Substantially Equivalent (SE) Comparison 8.

ITEM	Proposed Device	Predicate Device	Remark
	K202368	K191251
Product Code	FLL	FLL	Same
Regulation Number	21 CFR 880.2910	21 CFR 880.2910	Same
Indication for Use	The Infrared thermometer isnon-contact infraredthermometer intended for theintermittent measurement ofhuman body temperature fromforehead for people of all age.The device is reusable forhome use and clinical use	The Infrared thermometer isnon-contact infraredthermometer intended for theintermittent measurement ofhuman body temperature fromforehead for people of all age.The device is reusable forhome use and clinical use	Same
Measurement Method	Infrared radiation detection	Infrared radiation detection	Same
Components	Side button and main buttonLeft/Right shellSpear shellDisplay screen caseBattery cover	ButtonShellLCD display caseBattery cover	Different 1
Measurement Range	32.5°C ~ 42.5°C(90.5 ~ 108.5 °F)	32.0°C ~ 42.5°C(89.6 ~ 108.5 °F)	Different 2
Accuracy	±0.2°C (0.4°F) at 35.0°C ~42.0°C (95.0°F ~ 107.6 °F)Others ±0.3°C (0.5 °F)	±0.2°C (0.4°F) at 35.0°C ~42.0°C (95.0°F ~ 107.6 °F)Others ±0.3°C (0.5 °F)	Same
Display	0.1°C(0.1°F)	0.1°C(0.1°F)	Same
Memory	NA	60 sets	Different 3
Measurement mode	Direct mode	Direct mode	Same
Display type	LCD	LCD	Same
Measurement Place	Forehead	Forehead	Same
Measurementdistance	1~5cm	≤3cm	Different 4
Response time	1s	1s	Same
Sensor type	Thermopile	Thermopile	Same
Scale Selection	°C/°F	°C/°F	Same
Auto power-off whileno operation	Yes	Yes	Same
Operation	15°C ~ 40°C (59 ~ 104 °F)	10°C ~ 40°C (50°F ~ 104 °F)	Different 5
environment	15%~85% RH	15%~95% RH
Storage environment	-25°C~+50°C (-13 ~ +122°F)15%~90% RH	-25°C~+55°C (-13~+131°F)15%~95% RH
Power requirements	Two pieces of 1.5V AAA batteries	Two pieces of 1.5V AAA batteries	Same
Safety	Complied with IEC 60601-1	Complied with IEC 60601-1	Same
EMC	Complied with IEC 60601-1-2	Complied with IEC 60601-1-2	Same
Performance	Complied with ISO 80601-2-56	Complied with ISO 80601-2-56	Same
Service life	3 years	Unknown	Different 6
Patient-contact Materials	ABSPCSilicone rubber	ABS	Different 7
Biocompatibility	No CytotoxicityNo SensitizationNo Irritation	No CytotoxicityNo SensitizationNo Irritation	Same

Table 1 Comparison of Technology Characteristics

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Different 1 - Components

The components of the proposed device is different with the predicate device. However, the components don't affect the intended use. Therefore, the different will not affect the substantially equivalency.

Different 2 - Measurement Range

The measurement range of the proposed device is different with the predicate device, but the measurement range of the proposed device is within the measurement range of predicate device and the measurement range can meet the requirement of ISO 80601-2-56. In addition, the clinical investigation has been conducted on the proposed device and the test result demonstrated that the accuracy can meet the requirement. Therefore, this difference is not considered to affect the substantially equivalency.

Different 3 - Memory

The proposed device does not have the memory function. However, this function does not affect the intended use. Therefore, the different will not affect the substantially equivalency.

Different 4 - Measurement distance

The measurement distance of the proposed device is different from the predicate device. However, the clinical investigation has been conducted on the proposed device within the intended measurement range (1~5cm) and the test result demonstrated that the accuracy can meet the requirement. Therefore, this difference is not considered to affect the substantially equivalency.

Different 5 - Operation environment & Storage environment

The operation environment and storage environment of the proposed device is different with the

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predicate device. However, the operation environment and storage environment is similar with predicate device. Therefore, this difference is not considered to affect the substantially equivalency.

Different 6 - Service life

The service life for the predicate device is unknown. However, the service life test has been conducted on the proposed device and the results show that the proposed device can still maintain its function as intended at the end of the proposed service life. Therefore, this difference is not considered to affect the substantially equivalency.

Different 7 - Materials

The material of the proposed device is different with the predicate device, however, the biocompatibility test has been conducted on the proposed device and the test result does not show any adverse effects. Therefore, this difference is not considered to affect the substantially equivalency.

Substantially Equivalent (SE) Conclusion 9.

From the bench test conducted on the proposed device provided in above, the test result showed that the proposed device can meet the requirements of related standards. Therefore, it can be determined that the proposed devices are Substantially Equivalent (SE) to the predicate device, K191251.

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.