Digital Thermometers comprises a thermistor for getting temperature signal, a reference resistor for comparing the resistance of the thermistor, a buzzer for sounding effect, an ASIC for processing the target temperature digitally, and a LCD for displaying the temperature result. The design principle of thermometer is based on thermos sensor and ASIC technology. A thermistor is used as thermos sensor. The ASIC gets the sensor's signal from human body, then processes the signal and calculates the result, after that displays the temperature result by a LCD.

AI/ML Overview

The application describes a Digital Thermometer (Models: BT-301, BT-302, BT-303, BT-305, BT-306, BT-308, BT-311, BT-318) intended for measuring and monitoring human body temperature.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the "Measurement Accuracy" and "Response Time" listed and are identical to the predicate device. The performance is reported as meeting these criteria, asserting substantial equivalence.

Acceptance Criteria (Implied)	Reported Device Performance
Measurement Accuracy:
35.0 ~ 39.0°C	+/- 0.1°C
The rest (outside 35.0-39.0°C)	+/- 0.2°C
Response Time:	60s

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

The document states, "The whole product and manufacturing used for the Digital thermometer are identical to those of the predicate device... All hardware and software of the subject device are based on that of the predicate device (K172508), since no new testing is presented in the submission."

This indicates that no new test set or data provenance information is provided for the subject device (K193621). The substantial equivalence argument relies on the predicate device's prior testing and the assertion of identical components and manufacturing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

This information is not provided in the document as no new testing data for the subject device is presented.

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

This information is not provided in the document as no new testing data for the subject device is presented.

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 as the device is a digital thermometer, not an AI-assisted diagnostic tool requiring human interpretation.

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

The device itself is a standalone thermometer. The performance criteria (accuracy and response time) inherently describe its standalone performance. However, there's no dedicated study for the subject device's standalone performance described as separate from the predicate's established performance.

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

For a digital thermometer, the ground truth for performance testing is typically established using calibrated reference thermometers or environmental conditions to provide a known, accurate temperature for comparison. This document relies on the testing performed for the predicate device, which would have used such ground truth. Specific details on the ground truth for the predicate are not provided in this summary, but the listed standards (IEC 80601-2-56, ASTM E1112-00) dictate how such ground truth is established for clinical thermometers.

8. The sample size for the training set:

This information is not applicable/not provided as the device is not an AI/ML device that requires a training set.

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

This information is not applicable/not provided as the device is not an AI/ML device that requires a training set.

Summary

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November 23, 2020

Dongguan E-Test Technology Co., Ltd % Cassie Lee Manager Guangzhou GLOMED Biological Technology Co., Ltd. Suite 306, Kecheng Mansion, No.121 Science Road, Guangzhou Science Park Guangzhou, 510000 China

Re: K193621

Trade/Device Name: Digital Thermometer (Model BT-301, BT-302, BT-303, BT-305, BT-306, BT-308. BT-311. BT-318) Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: October 21, 2020 Received: October 28, 2020

Dear Cassie Lee:

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.

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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 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) K193621

Device Name

Digital Thermometer (Model: BT-301, BT-302, BT-305, BT-306, BT-308, BT-311, BT-318)

Indications for Use (Describe)

Digital Thermometers are intended for the measurement and monitoring of human body temperature by doctor or consumers in the hospital or home.

It can be used for axillary measurement, oral measurement and rectal measurement.

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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510(k) Summary -K193621

This summary of 510(K) information is being submitted in accordance with the requirements of

SMDA and 21 CFR 807.92.

Date: 11/20/2020

1. Submitter's Information

510(k) Owner's Name: DONGGUAN E-TEST TECHNOLOGY CO., LTD

Establishment Registration Number: Applying

Address: Room 201,301, Building 1, Changping Section No.1, Dongshen Road, Changping Town, Dongguan City, Guangdong, China.

Tel: +86-0769-81158038

Contact Person (including title): Victor Wan (Vice-president)

E-mail: victor@agelh.com

Application Correspondent:

Contact Person: Ms. Cassie Lee

DONGGUAN E-TEST TECHNOLOGY CO., LTD

Address: Room 201,301, Building 1, Changping Section No.1, Dongshen Road, Changping Town, Dongguan City, Guangdong, China

Tel: +86-0769-81158038 Email: regulatory@glomed-info.com

2. Subject Device Information

Type of 510(k):	Traditional
Common Name:	Thermometer, electronic
Trade Name:	Digital Thermometer -(Model BT-301, BT-302, BT-303, BT-305, BT-306, BT-308, BT-311, BT-318)
Classification Name:	Thermometer, electronic, clinical
510(K) Number:	K193621
Review Panel:	General Hospital

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Sponsor:	DONGGUAN E-TEST TECHNOLOGY CO., LTD
Subject Device:	Digital Thermometer, model: BT-301, BT-302, BT-303, BT-305, BT-306, BT-308, BT-311, BT-318
File No.:	510(k) Summary

Product Code: FLL Regulation Number: 880.2910 Requlation Class: 2

3. Predicate Device Information

510(K) Number: K172508
Sponsor: Dongguan Ageless Health Industrial Co., Ltd.

Common Name: Thermometer, electronic

Trade Name: Ageless Health Medical Digital Thermometer

Classification Name: Thermometer, electronic, clinical

Review Panel: General Hospital

Product Code: FLL

Regulation Number: 880.2910

Regulation Class: 2

Device Description 4.

5. Intended Use

Digital Thermometers are intended for the measurement and monitoring of human body temperature by doctor or consumers in the hospital or home.

It can be used for axillary measurement, oral measurement and rectal measurement.

Test Summary 6.

The whole product and manufacturing used for the Digital thermometer are identical to those of the predicate device, which were demonstrated to conform with the following standards:

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Sponsor:	DONGGUAN E-TEST TECHNOLOGY CO., LTD
Subject Device:	Digital Thermometer, model: BT-301, BT-302, BT-303, BT-305, BT-306, BT-308, BT-311, BT-318
File No.:	510(k) Summary

. IEC 60601-1 (2005/(R)2012 and A1:2012) Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance
IEC 80601-2-56 (2018) Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement.
I IEC 60601-1-2 (2014) Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
I 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
. ASTM E1112-00 (2011) Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature
" 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 sensitization

7. Comparison to Predicate Device

Compare with predicate device, the subject device is very similar in design principle, intended use, indications for use, functions, material and the applicable standards.

Elements ofComparison	Subject Device	Predicate Device	Remark
Company	DONGGUAN E-TESTTECHNOLOGY CO., LTD	Ageless Health Industrial Co.,Ltd.	--
Name andModel	Digital Thermometer, models:BT-301, BT-302, BT-303,BT-305, BT-306, BT-308,BT-311, BT-318	Ageless Health Medical DigitalThermometer, models: BT-301,BT-302, BT-303, BT-305,BT-306, BT-308, BT-311, BT-318	--
510(k)Number	K193621	K172508	--
ThermometerType	Digital Thermometer	Digital Thermometer	SE
Intended Use/ Indication forUse	Digital Thermometers areintended for the measurementand monitoring of human body	Ageless Health Medical DigitalThermometers are intended forthe measurement and monitoring	SE

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Sponsor:

DONGGUAN E-TEST TECHNOLOGY CO., LTD Digital Thermometer, model: BT-301, BT-302, BT-305, BT-306, BT-308, BT-311, Subject Device: BT-318 ary

File No.:	510(k) Summary
-----------	----------------

Elements ofComparison	Subject Device	Predicate Device	Remark
	temperature by doctor orconsumers in the hospital orhome.It can be used for axillarymeasurement, oral measurementand rectal measurement.	of human body temperature bydoctor or consumers in thehospital or home.It can be used for axillarymeasurement, oral measurementand rectal measurement.
Sensor	Thermistor	Thermistor	SE
SignalProcessingand Display	Using the resistance change ofthermal resistor to detect bodytemperature and displayedthrough the LCD.	Using the resistance change ofthermal resistor to detect bodytemperature and displayedthrough the LCD.	SE
PowerRequirement	1.5V button battery	1.5V button battery	SE
MeasurementTemperatureRange	32.0°C ~ 42.9°C	32.0°C ~ 42.9°C	SE
MeasurementAccuracy	35.0 ~ 39.0°C : +/- 0.1°CThe rest: +/- 0.2°C	35.0 ~ 39.0°C : +/- 0.1°CThe rest: +/- 0.2°C	SE
AmbientTemperature	10~35°C	10~35°C	SE
ResponseTime	60s	60s	SE
CompliedStandard	IEC 60601-1, IEC 80601-2-56,IEC 60601-1-2, IEC 60601-1-11,ASTM E1112, ISO 10993-5, ISO10993-10	IEC 60601-1, IEC 80601-2-56,IEC 60601-1-2, IEC 60601-1-11,ASTM E1112, ISO 10993-5, ISO10993-10	SE

Conclusion

The subject device Digital Thermometer has all features of the predicate devices. No differences will affect the safety and effectiveness of the subject device. Thus, the subject device is substantially equivalent to the predicate device. All hardware and software of the subject device are based on that of the predicate device (K172508), since no new testing is presented in the submission.

8. Summary Prepared Date

20 November 2020

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.