Infrared Thermometer (model: ZST-A) is a non-sterile, reusable, non-contact and handheld device. It can be used by consumers in homecare environment and doctors in clinic as reference. It is intended for measuring human body temperature of people over one month old by detecting infrared heat from the forehead.

Device Description

The Infrared Thermometer, Model ZST-A is a non-contact long-distance infrared thermometer which is specialized in measuring human body temperature. It contains buzzer prompt, memory reading, backlight reminder, temperature offset setting, alarm threshold setting, automatic shutdown and common functions of equipment. The Infrared Thermometer measures the temperature by using the principle of receiving infrared. The product is composed of built-in infrared detector and related hardware and software, which can receive, analyze and record the measured object and ambient temperature. Therefore, once the user approaches the specific part of the human body (forehead) and presses the measurement key, the infrared sensor can be activated immediately, and the thermal energy generated by the arterial blood flow can be detected quickly through the passive infrared sensor, so as to accurately measure the body temperature of the human body. The measurement distance of the subject device is 1~5 cm from the middle of the forehead.

AI/ML Overview

The provided document is a 510(k) summary for an Infrared Thermometer (Model: ZST-A). It details the device's technical specifications, intended use, and comparison to a predicate device, along with non-clinical and clinical test conclusions.

Here's an analysis of the acceptance criteria and study proving the device meets them, based on the provided text:

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

The primary acceptance criteria for the infrared thermometer are related to its accuracy in measuring human body temperature. The standard referenced is ASTM E1965-98.

Acceptance Criteria (Standard: ASTM E1965-98)	Reported Device Performance (Model: ZST-A)
Accuracy	±0.2°C (0.4°F) within 33.0°C ~ 39.0°C (91.4°F ~ 102.2°F)
	±0.3°C (0.5°F) other range
Measurement Range	Forehead mode: 32.0°C ~ 43.0°C (89.6 to 109.4 °F)
Clinical Performance	Complied with the requirement of ASTM E1965-98 (2016)
Measurement Distance	1~5 cm from the middle of the forehead (demonstrated to meet clinical accuracy within this range)

2. Sample size used for the test set and the data provenance:

Sample Size: A minimum of 105 subjects were used for the clinical study. These subjects were divided into three age groups, with at least 35 subjects per group.
Data Provenance: The document does not explicitly state the country of origin where the clinical study was conducted. It mentions "Shandong Zhushi Pharmaceutical Group Co., Ltd." in China as the submitter, which implies the study could have been performed in China, but this is not definitively stated for the clinical trial location. The study is described as a "clinical investigation," which generally implies prospective data collection, but the document does not explicitly specify "retrospective" or "prospective." However, clinical trials are typically prospective.

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

The document does not provide details on the number or qualifications of experts used to establish the ground truth for the clinical test set. For temperature measurement, the ground truth is typically established using a reference thermometer (e.g., a rectal thermometer for core body temperature, as per ASTM standards for clinical thermometry studies) rather than expert consensus.

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

The document does not describe any adjudication method. This is typically not relevant for a temperature measurement device where a reference standard device provides the "ground truth" rather than human interpretation.

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 to an infrared thermometer. An MRMC study is typically performed for AI-powered diagnostic imaging devices where human readers (e.g., radiologists) interpret images with or without AI assistance. The Infrared Thermometer is a direct measurement device and does not involve human interpretation of complex data that AI would assist with.

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

The device itself, the "Infrared Thermometer," operates as a standalone device. Its performance is measured directly (algorithm only, as it's an embedded system) without continuous human interaction in the measurement process other than positioning and activating the device. The clinical study assessed the device's accuracy against a recognized standard (ASTM E1965-98), which inherently evaluates its standalone performance.

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

The ground truth for the clinical study would have been established by a reference clinical thermometer (e.g., a rectal or oral thermometer depending on the specific ASTM E1965-98 protocol used), which is considered the gold standard for core body temperature measurement in such studies. The document states that the clinical study was conducted "per ASTM E1965-98." This standard details the methodology for clinical accuracy assessment for infrared thermometers, which involves comparing measurements from the test device to core body temperatures obtained from a highly accurate reference thermometer.

8. The sample size for the training set:

The document does not mention a training set or any machine learning/AI training process in the conventional sense. This device is a traditional infrared thermometer, not an AI/ML-based diagnostic tool that would typically have a separate training phase. Its operation is based on established physical principles of infrared radiation detection and calibrated algorithms, not learned patterns from a large training dataset.

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

As no training set is mentioned or implied for this type of device, this point is not applicable.

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.

Shandong Zhushi Pharmaceutical Group Co., Ltd. % Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. RM. 608, No. 738, Shangcheng Rd., Pudong Shanghai, Shanghai 200120 China

Re: K203454

Trade/Device Name: Infrared Thermometer Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: March 26, 2021 Received: March 30, 2021

Dear Boyle Wang:

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 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 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) K203454

Device Name Infrared Thermometer

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)

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510(k) Summary (K203454)

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

1.0 submitter's Information

Name: Shandong Zhushi Pharmaceutical Group Co., Ltd. Address: No.6 Shande Road,Shan County, Heze City, Shandong, China Tel: 86-15764021131 Fax: 86-530-4265777 Contact: Junhui Zhu Date of Preparation: Mar.26,2021

Designated Submission Correspondent

Mr. Boyle Wang Shanghai Truthful Information Technology Co., Ltd. Room 608, No. 738 Shangcheng Rd., Pudong Shanghai, 200120 China Tel: +86-21-50313932 Email: Info@truthful.com.cn

2.0 Device Information

Trade name: Infrared Thermometer Common name: Infrared Thermometer Classification name: Clinical electronic thermometer Model(s): ZST-A

3.0 Classification

Production code: FLL Regulation number: 21CFR 880.2910 Classification: Class II Panel: General Hospital

4.0 Predicate Device Information

Manufacturer: Shenzhen Changkun Technology Co., Ltd. Infrared Thermometer (Models: CK-T1501, CK-T1502, CK-T1503) Device: 510(k) number: K193253

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5.0 Device Description

The Infrared Thermometer measures the temperature by using the principle of receiving infrared.

♦ All objects radiate energy to their surroundings.

◆The temperature of an object is directly proportional to the intensity of radiation energy, that is, the higher the temperature, the greater the radiation energy.

♦ The energy radiated from human body is mainly infrared radiation. Therefore, human body temperature can be calculated by measuring the intensity of infrared energy radiated from human body to its surroundings.

♦Through the accurate measurement of the weak infrared radiation energy released by the human body, the non-contact infrared thermometer can accurately obtain the human body temperature after complex calculation processing and various compensation correction. The product is composed of built-in infrared detector and related hardware and software, which can receive, analyze and record the measured object and ambient temperature. Therefore, once the user approaches the specific part of the human body (forehead) and presses the measurement key, the infrared sensor can be activated immediately, and the thermal energy generated by the arterial blood flow can be detected quickly through the passive infrared sensor, so as to accurately measure the body temperature of the human body.

The measurement distance of the subject device is 1~5 cm from the middle of the forehead.

6.0 Indication for Use Statement

7.0 Comparison to the Predicate Device

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Item	Subject Device K203454	Predicate Device K193253	Remark
Type ofThermometer	Infrared ThermometerZST-A	Infrared thermometerCK-T1501,CK-T1502,CK-T1503	--
Product Code	FLL	FLL	Same
Regulation No.	21 CFR 880.2910	21 CFR 880.2910	Same
Class	II	II	Same
Intended Use&Indications foruse	Infrared Thermometer(model: ZST-A) is anon-sterile, reusable,non-contact and handhelddevice. It can be used byconsumers in homecareenvironment and doctors inclinic as reference. It isintended for measuringhuman body temperature ofpeople over one month old bydetecting infrared heat fromthe forehead.	Infrared Thermometer(model:CK-T1501,CK-T1502,CK-T1503) isa non-sterile, reusable,non-contact andhandheld device. It canbe used by consumersin homecareenvironment anddoctors in clinic asreference. It is intendedfor measuring humanbody temperature ofpeople over one monthold by detecting infraredheat from the forehead.	Same
Prescription/over-the-counteruse	over-the-counter use	over-the-counter use	Same
Measurementtechnology	Infrared radiation detectionthat converts a user'sforehead temperature usingthe infrared energy emitted inthe area around the user'sforehead to a reference siteequivalent temperature	Infrared radiationdetection	Same
Measurementplace	Forehead	Forehead	Same
MeasurementRange	Forehead mode:32.0°C ~43.0°C(89.6 to 109.4 ° F)	32.0°C ~42.5°C(89.6 to 108.5 ° F)
Accuracy	±0.2°C (0.4°F) within33.0°C ~ 39.0°C(91.4°F ~ 102.2°F),±0.3°C(0.5°F) other range	±0.2°C (0.4°F) within35.0°C ~ 42.0°C(95.0°F ~ 107.6°F),±0.3°C(0.5°F) otherrange	Different1

Displayresolution	0.1°C(0.1°F)	0.1°C(0.1°F)	Same
C/F switchable	Yes	Yes	Same
Measurementdistance	1~5 cm	3~5 cm	Different2
Response time	1s	1s	Same
Sensor type	Thermopile	Thermopile	Same
Memory	32 sets	32 sets	Same
Buzzer	Yes	Yes	Same
Auto power-offwhile nooperation	Yes	Yes	Same
Power supply	2*1.5V AA battery	DC 3V (2 of AA alkalinebatteries)	Same
Display screen	LCD	LCD	Same
OperationEnvironment	15.0°C~~40.0°C(59.0°F~~104°F)RH≤90%70.0kPa-106.0kPa	10°C ~ 40°C;15% ~ 85%RH;80kPa~106kPa	Different3
StorageEnvironment	-20.0℃~~55.0°F(-4.0°F~~131.0°F)RH≤90%70.0kPa-106.0kPa	Not Publicly available	--
Dimension	1594cm	Not Publicly available	--
Weight	≤93g	Not Publicly available	--
Materials	User contacting materials areABS (Device Plastic Case,Button & Battery Cover)	ABS	Same
Conformancestandard	ISO80601-2-56,IEC60601-1,IEC60601-1-2,IEC 60601-1-11ASTM E1965-98	ISO80601-2-56,IEC60601-1,IEC60601-1-2,IEC 60601-1-11ASTM E1965-98	Same
Biocompatibility	ISO 10993-5ISO 10993-10	ISO 10993-5ISO 10993-10	Same

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Analysis:

From the comparison table, the subject devices and predicate device have the same Intended use & Indications for Use, Measurement place, Display resolution, Display screen, Auto power-off while no operation and

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Conformance standard. There are slightly differences between the devices and predicate device as follows:

Different 1: Both devices have different measurement range, but they have the same accuracy and the measurement range of subject devices meet the requirements of ASTME1965-98. The different does not raise new performance questions.

Different 2: Measurement distance of the subject devices is 1-5cm, the predicate device's is 3-5cm. Although the "measurement distance" of subject device is a little different from the predicate devices. The clinical trial report of the subject device demonstrates the device meets the clinical accuracy requirements of the standards ISO 80601-2-56 and ASTM E1965-98 within the distance range, the differences between the predicate device and subject device will not affect the safety and effectiveness of the subject device.

Different 3: Both devices have slightly different Operation &Storage Environment, but the subject devices meet the requirements of IEC60601-1.In conclusion, these differences do not raise any new safety or performance questions.

8.0 Non-Clinical Test Conclusion

Non-Clinical Performance Testing:

Non clinical tests were conducted to verify that the subject devices met all design specifications as were Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

IEC 60601-1: 2012 Medical Electrical Equipment Part 1: General
Requirements 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
ISO 80601-2-56: 2017+A1:2018 Medical electrical equipment Particular
requirements for the basic safety and essential performance of clinical thermometers for body temperature measurement.
●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

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Biocompatibility Testing:

The biocompatibility evaluation for the ZST-A Infrared Thermometer were conducted in accordance with International Standards ISO 10993-1:2018, Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process, ISO 10993-5:2009, Biological evaluation of medical devices -- Part 5: Tests for In Vitro cytotoxicity, and ISO 10993-10:2010, Biological evaluation of medical devices -- Part 10: Tests for irritation and sensitization, as recognized by FDA, and per FDA guidance document entitled Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process,dated on September 4, 2020. The testing conducted included the following:

· Cytotoxicity
Irritation
Sensitization

Software Information:

Software validation was conducted in accordance with a moderate level of concern designation in accordance with the FDA November 2005 document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices"

9.0 Clinical Test Conclusion

Clinical tests were conducted per ASTM E1965-98(Reapproved 2016) Specification for Infrared Thermometers for for Intermittent Standard Determination of Patient Temperature. This clinical study is a randomization, simple blind homologous control, pairing design of clinical investigation, consists of a minimum of 105 subjects which were divided into three group age

ranges- A Infant group (Group A1- 0 up to 3 months; Group A2- 3 months up to 1 year), B Child group (greater than 1 to 5 years old) and C Over 5 years old (Above 5 years old). Each group at least has 35 subjects.

Based on the result, it is demonstrated the clinical performance of the subject device complied with the requirement of ASTM E1965-98 (2016).

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10.0 Conclusion

Performance testing contained in this submission demonstrates the minor differences in technological characteristics between the subject device and the predicate do not raise different questions of safety and effectiveness. And based on the performance testing and compliance with acceptable voluntary standards, we believe the Infrared Thermometer ZST-A are substantially equivalent to its predicate device in K193253.

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.