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

Device Description

The Infrared thermometers are hand-held, battery powered devices designed to measure human body temperature from the forehead for clinical or home use.
The thermometers are powered by AAA 1.5V×2 alkaline batteries. The results can be displayed on LCD. A thermopile sensor is employed to detect or monitor the infrared thermal energy emitted from the surface of the skin of the forehead, which is converted into temperature measurement with the unit of ℃ or ºF. The measurement distance of the subject device is no more than 3cm.
The Infrared thermometer included DT-8836T, DT-8836P. These two models are identical on hardware and software except the physical dimensions and appearance.

AI/ML Overview

The Infrared Thermometer (Model DT-8836T, DT-8836P) has undergone testing to demonstrate its performance against established acceptance criteria.

1. Table of Acceptance Criteria and Reported Device Performance

Feature/Standard	Acceptance Criteria (Predicate)	Reported Device Performance (Subject Device)
Accuracy	±0.2°C (0.4°F) within 36.0°C ~39.0°C (96.8°F ~102.2°F), ±0.3°C (0.5°F) other range (per ASTM E1965-98 and ISO 80601-2-56)	±0.2°C (0.4°F) within 35.0°C ~ 42.0°C (95.0°F ~ 107.6°F), ±0.3°C (0.5°F) other range (demonstrated compliance with IEC 80601-2-56 and ASTM E 1965-98 Reapproved 2009)
Measurement Range	32.0°C ~42.9°C (89.6 to 109.22°F)	32.0°C ~42.5°C (89.6 to 108.5°F) (demonstrated compliance with IEC 80601-2-56)
Biocompatibility	Compliance with ISO 10993-5 and ISO 10993-10	Passed Cytotoxicity, Sensitization, and Irritation tests based on ISO 10993-1 guidance
Electrical Safety	Compliance with IEC 60601-1 (General requirements for basic safety and essential performance)	Demonstrated compliance with IEC 60601-1
EMC	Compliance with IEC 60601-1-2 (Electromagnetic compatibility)	Demonstrated compliance with IEC 60601-1-2
Home Healthcare Environment	Compliance with IEC 60601-1-11 (Requirements for medical electrical equipment and systems used in home healthcare)	Demonstrated compliance with IEC 60601-1-11
Software Validation	Compliance with FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," dated May 11, 2005	Software validation and verification conducted according to FDA guidance
Clinical Performance	Compliance with ASTM E 1965-98 (Reapproved 2009) for clinical accuracy	Clinical study demonstrated compliance with ASTM E 1965-98 (Reapproved 2009)

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

The clinical study was a randomization, simple blind homologous control, pairing design of clinical investigation.

Sample Size: Minimum of 150 subjects.
- 1/3 Infants (newborn to one year)
- 1/3 Children (greater than one to five years)
- 1/3 Adults (greater than five years old)
Data Provenance: The document does not explicitly state the country of origin for the clinical data. It also does not specify if the data was retrospective or prospective, but the description of a "clinical investigation" strongly suggests a prospective study.

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

The document does not specify the number of experts used or their qualifications for establishing ground truth in the clinical study. It refers to the "clinical performance of the subject device [having] complied with the requirement of standard ASTM E 1965-98 (Reapproved 2009)," which dictates methods for determining accuracy against a reference thermometer, but does not detail the roles of experts in this process.

4. Adjudication Method for the Test Set

The document describes the clinical study as a "randomization, simple blind homologous control, pairing design of clinical investigation." It does not provide details on an adjudication method involving multiple readers. The accuracy is assessed by comparing the device's readings to a reference thermometer as per ASTM E 1965-98.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done. This device is an infrared thermometer, and its performance is evaluated against a reference standard for temperature measurement, not through human reader interpretation of images or data.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Performance

Yes, a standalone performance evaluation was conducted. The non-clinical data and the clinical data sections describe tests performed on the device itself against established standards:

Non-clinical data: Testing to IEC 60601-1, IEC 60601-1-2, ISO 80601-2-56, and IEC 60601-1-11, and software validation. These are tests of the device's technical specifications and performance without human interpretation in the loop.
Clinical data: Evaluation against ASTM E 1965-98 for accuracy. This standard defines how a clinical thermometer's readings are compared to a reference standard thermometer (e.g., a rectal thermometer for core body temperature), essentially assessing the device's standalone accuracy in a clinical setting.

7. Type of Ground Truth Used

The ground truth for the clinical performance evaluation was established by a reference standard thermometer (as per ASTM E 1965-98 requirements) which defines the true body temperature against which the infrared thermometer's readings are compared. This is a form of outcomes data or reference standard comparison.

8. Sample Size for the Training Set

The document does not explicitly mention a separate "training set" for the device. The device is an Infrared Thermometer, which typically relies on pre-calibrated sensors and algorithms based on physical principles, rather than machine learning models that require extensive training data. Therefore, the concept of a training set as used in AI/ML is not directly applicable here. The development and calibration of the device would involve engineering and physical testing, not a "training set" in the common sense of data-driven models.

9. How Ground Truth for the Training Set Was Established

As noted above, a distinct "training set" in the context of AI/ML is not applicable to this device as described. The "ground truth" for the device's inherent accuracy and performance characteristics would have been established through laboratory calibration against highly accurate reference thermometers and physical standards during its design and manufacturing process, in accordance with standards like ISO 80601-2-56 and ASTM E 1965-98 for the initial development and calibration.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains 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.

October 15, 2019

Shenzhen Calibeur Industries Co., Ltd. % Kevin Wang Consultant Chonconn Medical Device Consulting Co., Ltd. No. A415, Block A, NanShan Medical Devices Industrial Park Nanshan District Shenzhen, Guangdong 518067 China

Re: K191251

Trade/Device Name: Infrared Thermometer, Model DT-8836T, DT-8836P Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: September 16, 2019 Received: September 16, 2019

Dear Mr. Kevin 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.

{1}------------------------------------------------

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 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 Geeta Pamidimukkala 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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K191251

Device Name

Infrared Thermometer (Model DT-8836T, DT-8836P)

Indications for Use (Describe)

The Infrared thermometer is a non-contact infermometer intended for the intermittent measurement of human body temperature from forehead for people of all ages. 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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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

{3}------------------------------------------------

510(K) Summary

Prepared in accordance with the requirements of 21 CFR Part 807.92 K191251

Prepared Date: 2019/10/14

1. Submission sponsor

Name: Shenzhen Calibeur Industries Co., Ltd.

Address: No. 11 Bldg., Shiguan Industrial Park, Gongming New District, Shenzhen, P.R China.

Contact person: Weibin He

Title: Quality Manager

E-mail: qc@calibeur.com

Tel: +86-755-26010950

2. Submission correspondent

Name: Chonconn Medical Device Consulting Co., Ltd.

Address: No. A415, Block A, NanShan Medical devices Industrial Park Nanshan District, Shenzhen,

Guangdong, P.R. China 518067

Contact person: Kevin Wang

E-mail: kevin(@chonconn.com

Tel: +86-755 33941160

3. Subject Device Information
Trade/Device Name	Infrared Thermometer
Model	DT-8836T, DT-8836P
Common Name	Infrared Thermometer
Regulatory Class	Class II
Classification	21CFR 880.2910 / Clinical electronic thermometer /
Submission type	Traditional 510(K)
Product Code	FLL

ನ Subiect Device Information

4. Predicate Device

510(k) Number: K171578 Manufacturer: Shenzhen Aeon Technology Co., Ltd. Device name/ Model: Infrared thermometer/ A200

5. Device Description

The Infrared thermometers are hand-held, battery powered devices designed to measure human body temperature from the forehead for clinical or home use.

The thermometers are powered by AAA 1.5V×2 alkaline batteries. The results can be displayed on LCD. A thermopile sensor is employed to detect or monitor the infrared thermal energy emitted from the surface of

{4}------------------------------------------------

the skin of the forehead, which is converted into temperature measurement with the unit of ℃ or ºF. The measurement distance of the subject device is no more than 3cm.

The Infrared thermometer included DT-8836T, DT-8836P. These two models are identical on hardware and software except the physical dimensions and appearance.

Intended use & Indication for use 6.

Features	Subject device K191251Infrared thermometer DT-8836T, DT-8836P	Predicate device K171578Infrared thermometer A200	Note
Regulation number	21 CFR 880.2910	21 CFR 880.2910	Same
Product code	FLL	FLL	Same
Intended Use&Indications for use	The Infrared thermometer is a non-contact infrared thermometer intended for the intermittent measurement of human body temperature from forehead for people of all ages. The device is reusable for home use and clinical use.	The Infrared thermometer model A200 is a non-contact infrared thermometer intended for the intermittent measurement of human body temperature by Forehead mode for people of all ages.	Different 1)
MeasurementMethod	Infrared radiation detection	Infrared radiation detection	Same
MeasurementRange	Forehead mode:$32.0°C ~42.5°C$(89.6 to 108.5 ° F)	Forehead mode:$32.0°C ~42.9°C$(89.6 to 109.22 ° F)	Different 2)
Accuracy	Forehead mode:$\pm0.2°C (0.4°F)$ within$35.0°C ~ 42.0°C$(95.0°F ~ 107.6°F),$\pm0.3°C(0.5°F)$ other range	Forehead mode:$\pm0.2°C (0.4°F)$ within$36.0°C ~39.0°C$(96.8°F ~102.2°F),$\pm0.3°C(0.5°F)$ other range	Same
Display	$0.1°C(0.1°F)$	$0.1°C(0.1°F)$	Same
Measurementdistance	<3cm	<3cm	Same
Measurementplace	Forehead	Forehead	Same

Comparison to the Predicate Device 7.

{5}------------------------------------------------

Features	Subject device K191251Infrared thermometer DT-8836T, DT-8836P	Predicate device K171578Infrared thermometer A200	Note
Response time	1 s	1s	Same
Sensor type	Thermopile	Thermopile	Same
Scale Selection	°C /°F	°C /°F	Same
Memory	60 sets	25 sets	Different 3)
Buzzer	Yes	Yes	Same
Autopower-offwhile no operation	Yes	Yes	Same
Power supply	2 * 1.5V AAA	2 * 1.5V AAA	Same
Display screen	LCD	LCD	Same
Contact materials	ABS	ABS	Same
Operation	10~40°C (50°F ~104 °F)	10~40°C (50°F ~104 °F)	Same
Environment	RH 15~95%	RH 15~95%
Storage	-25 ~~+55°C (-13~~+131°F)	-25 ~~+55°C (-13~~+131°F)	Same
Environment	RH:15~95%	RH:15~95%
Dimension	153.862.462.4 mm	1704753mm	---
Weight	96g	75g	---
Conformancestandard	ISO80601-2-56(performance),IEC60601-1(Safety),IEC60601-1-2(EMC)ASTM E1965-98	ISO80601-2-56(performance),IEC60601-1(Safety),IEC60601-1-2(EMC)ASTM E1965-98	Same
	Patientcontactmaterials	ABS	ABS	Same
	Biocompatibility	ISO 10993-5ISO 10993-10	ISO 10993-5ISO 10993-10	Same

Justification of difference:

Different 1): Both subject and predicate devices are non-contact infrared thermometer. They are over-thecounter reusable devices for home and clinical use. The wording change in the statement. They are both intended for intermittent measurement of human body temperature from forehead. Thus, this different does not raise any new safety or performance questions.

Different 2): The measurement range of subject device is different from predicate device. The performance testing shows that the subject device complies with performance standard IEC 80601-2-56. Thus, this difference does not raise any new safety or performance questions.

Different 3): The memory of subject device is different from predicate device. However, the software was validation according to FDA's software guidance. The performance testing shows that the subject device complies with performance standard IEC 80601-2-56. Thus, this difference does not raise any new safety or performance questions.

{6}------------------------------------------------

8. Performance Data

The following performance data were provided in support of the substantial equivalence determination.

Biocompatibility testing

The biocompatibility evaluation for the Infrared thermometer was conducted in accordance with the FDA Guidance for Industry and Food and Drug Administration Staff: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". The battery of testing included the following tests:

. Cytotoxicity
Sensitization .
. Irritation

Non-clinical data

The Infrared thermometer has been tested according to the following standards:

IEC 60601-1: Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and essential performance
IEC 60601-1-2: 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: Medical electrical equipment - Particular requirements for the basic safety and essential performance of clinical thermometers for body temperature measurement.
IEC 60601-1-11: 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
The software validation and verification were conducted in accordance with FDA's guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," dated May 11, 2005.

Clinical data

Clinical testing is conducted per ASTM E 1965-98 (Reapproved 2009) Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature.

This clinical study is a randomization, simple blind homologous control, pairing design of clinical investigation, consists of a minimum of 150 subjects, of which 1/3 are infants, 1/3 are children and the rest 1/3 are adults (NOTE: Infants---newborn to one year; Children--- greater than one to five years; Adults---greater than five years old.). The test result demonstrated the clinical performance of the subject device complied with the requirement of standard ASTM E 1965-98 (Reapproved 2009).

9. Conclusion

Performance testing and compliance with voluntary standards demonstrate that the proposed devices are substantially equivalent to the relevant aspects of the predicate device in terms of design, components, materials, principals of operation, biocompatibility, performance characteristics, and intended use.

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.