The Belter Infra-red Ear thermometer is an electronic thermometer using an infrared sensor to detect human body temperature from the ear canal on people of all ages for home and professional use.

Device Description

The Belter Infra-red Ear Thermometer is characterized by measuring human body temperature from the ear canal. It utilizes infrared technology to measure infrared energy emitted from eardrum tissue when making a temperature measurement.

AI/ML Overview

This document describes the acceptance criteria and study results for the Belter Infra-red Ear Thermometer.

1. Table of Acceptance Criteria and Reported Device Performance

Criteria	Acceptance Value (ISO80601-2-56)	Reported Device Performance
Laboratory Accuracy (bench)	≤ 0.2 ℃	0.01 ~ 0.19 ℃
Clinical Repeatability	≤ 0.3 ℃	0.07 ~ 0.11 ℃
Structural Integrity	Meets requirements	Meets requirements

2. Sample Size and Data Provenance

The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions "bench test report" and "clinical repeatability."

3. Number of Experts and Qualifications

This information is not provided in the document.

4. Adjudication Method

This information is not provided in the document.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted as this device is a thermometer, not an AI-assisted diagnostic tool.

6. Standalone Performance

Yes, a standalone performance assessment was done, evaluating the device's accuracy and repeatability without human intervention. The reported values for laboratory accuracy and clinical repeatability are standalone metrics.

7. Type of Ground Truth Used

The ground truth for accuracy was established against a reference standard in laboratory settings (bench tests) and through clinical repeatability measurements in a clinical setting. The specific method for determining the "true" temperature for comparison during clinical repeatability is not detailed, but it typically involves comparison to another validated thermometer or a set protocol.

8. Sample Size for Training Set

This information is not applicable as this is not an AI/ML device requiring a training set.

9. How Ground Truth for Training Set Was Established

This information is not applicable as this is not an AI/ML device requiring a training set.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 21, 2014

Shenzhen Belter Health Measurement and Analysis Technology Company, Limited Pang Ming RA Manager 702, 704, Block C, Tsinghua Unis Science Park, Langshan Rd, Hi-Tech Industrial Park (north), Nanshan District, Shenzhen, Gangdong CHINA 518057

Re: K140681 Trade/Device Name: Belter Infra-red Ear Thermometer, Models TE-66, TE-68, TE-79, TE-90, and TE-91 Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical electronic thermometer Product Code: FLL Regulatory Class: II Dated: July 15, 2014 Received: July 21, 2014

Dear Mr. Ming:

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. 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.

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Page 2 - Mr. Ming

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mary S. Runner -S

Erin Keith, M.S. Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K140681

Device Name Belter Infra-red Ear Thermometer Model: TE-66,TE-68, TE-79, TE-90, TE-91

Indications for Use (Describe)

The Belter Infra-red Ear thermometer is an electronic thermometer using an infrared sensor to detect human body temperature from the ear canal on people of all ages for home and professional use.

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

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Image /page/3/Picture/0 description: The image shows the logo for eBelter. The logo consists of the letter 'e' in orange, followed by the word 'BELTER' in blue. The 'e' is stylized with a circular shape, and the word 'BELTER' is in a bold, sans-serif font.

Section 5 510 (K) Summary

Date: 2014,1,15 Submitter Information

Name : Shenzhen Belter Health Measurement and Analysis Technology Co.,Itd Address: 702、704,block C ,Tsinghua Unis science park,No.13 Langshan Rd,Hi-Tech Industrial park(north),Nanshan District,518057 shenzhen. People's Republic of China Tel: +86-755-61869839 Fax: +86-755-61869122 Contact person: pang minq E-mail: panqm@ebelter.com

Name of device

Trade name: Belter Infra-red Ear Thermometer Model: TE-66,TE-68, TE-79, TE-90, TE-91 Common name: Belter Infra-red Ear Thermometer Classification name: Thermometer, Electronic, Clinical Production regulation: 21 CFR 880.2910 Product code: FLL

Predicate Device

Infrared Ear Thermometer THP Series (Radiant Innovation Inc,FLL,K111637)

Description

Intended use

The Belter Infra-red Ear Thermometer is an electronic thermometer using an infrared sensor to detect human body temperature from the ear canal on people of all ages for home and professional use.

Summary of technological characteristics of device compared to the predicate devices (K111637), see the table1

Table 1
SE	Subject device	Predicate device	comment
Comparisons	Present application	K111637	nt

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Image /page/4/Picture/0 description: The image shows the word "BELTER" in blue font with an orange "e" symbol to the left of the word. The "e" symbol is a stylized letter "e" inside of a circle. The word "BELTER" is in all capital letters and has a slightly rounded font. The image is likely a logo or brand name.

Intended Use&Indication for use	The Belter Infra-red EarThermometer is anelectronic thermometerusing an infrared sensorto detect human bodytemperature from theear canal on people ofall ages for home andprofessional use.	The device is an electronic clinicalthermometer using an infraredsensor to detect bodytemperature from the auditorycanal in the neonatal, pediatricand adult population used in thehome setting.	Similar
MeasurementRange	32.0 °C -42.2℃ (89.6 °F-108.0°F)	34.0°C ~42.2°C(93.2°F ~108.0°F)	Similar
Accuracy	±0.2℃ (36℃≤t<39) ;±0.3°Cother range	±0.2°C (0.4°F) within35.5~~42°C (95.9~~107.6°F),±0.3°C(0.5°F) other range	Similar
Response time	1 sec.	1 sec.	same
Measurementplace	ear	ear	same
Scale selection	°C /°F	C /°F	same
Display screen	LCD	LCD	same
Memory	10 sets	25 sets	Similar
Fever alarm	Yes	Yes	same
Disposableprobe cover	No	MOLD RING W/PE FILMCOVER	----
Backlight	optional	optional	Same
Buzzer	Yes	Yes	same
Auto power-offwhileoperation	no Yes	Yes	Same
Power supply	2 x AAA	CR2032 *1pcs	---
Conformancestandard	ISO80601-2-56(performance),EN60601-1(Safety),IEC60601-1-2(EMC)ISO10993-1,5,10(Biocompatibility)	ISO80601-2-56(performance),EN60601-1(Safety),IEC60601-1-2(EMC)ISO10993-1,5,10(Biocompatibility)	Same

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Performance Data

Compliance to applicable standards includes ISO80601-2-56,as well as IEC 60601-1 , IEC 60601-1-2 and IEC60601-1-11 requirements.

The bench test report of this submission shows the laboratory accuracy is 0.01~0.19℃, which is not greater than 0.2 ℃, and the clinical repeatability is 0.07 ~ 0.11℃,which is less than 0.3℃,so the accuracy of the device ,both bench and clinical, meets the requirements of ISO80601-2-56.

About the structural integrity of device item, the device has be done shock tests and broad-band random vibration test ,the result in bench test of this submission showed the device meets the requirement.

Conclusion

The Belter Infra-red Ear Thermometer, has the similar intended use and characteristics as the cleared device in K111637. Moreover, bench testing contained in this submission supplied demonstrate that the modification of Belter units, do not raise any new questions of safety or effectiveness. Thus, the subject device is substantially equivalent to the predicate device.

Regulation Number and Section

§ 880.2910 Clinical electronic thermometer.

(a)
Identification. A clinical electronic thermometer is a device used to measure the body temperature of a patient by means of a transducer coupled with an electronic signal amplification, conditioning, and display unit. The transducer may be in a detachable probe with or without a disposable cover.(b)
Classification. Class II (performance standards). The device is exempt from the premarket notification procedures in part 807, subpart E of this chapter, subject to the limitations in § 880.9 and the following conditions for exemption:(1) Device is not a clinical thermometer with telethermographic functions;
(2) Device is not a clinical thermometer with continuous temperature measurement functions; and
(3) Appropriate analysis and testing (such as that outlined in the currently FDA-recognized editions, as appropriate, of ISO 80601-2-56, “Medical electrical equipment—Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement,” or ASTM E1965, “Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature,” or ASTM E1112, “Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature,” or ASTM E1104, “Standard Specification for Clinical Thermometer Probe Covers and Sheaths”) must validate specifications and performance of the device.