Digital Thermometer (models TM-2011, TM-3002, TM-3102) intended for the measurement and monitoring of human body temperature by users for home use. It can be used for axillary measurement and oral measurement.

Device Description

Digital Thermometers comprises a thermistor for getting temperature signal, a reference resistor for comparing the resistance of the thermistor, an ASIC for processing the target temperature digitally, and a LCD for displaying the temperature. The design principle of thermometer is based on thermosensor and ASIC technology. A thermistor is used as thermosensor. 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. There is buzzing noise occurs when the device turns on and when the measurement is completed (for model TM-3002 and TM-3102 only.

AI/ML Overview

The provided document describes the 510(k) premarket notification for a Digital Thermometer. It includes a summary of tests performed to demonstrate safety and performance.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document refers to adherence to specific standards rather than explicitly listing acceptance criteria with numerical targets in a table against which the device performance is reported. However, the "Remark" column in the comparison table indirectly indicates that the device meets the criteria by stating "SE" (Substantially Equivalent) or by providing explanations if there are differences.

Acceptance Criteria (Standard Reference)	Reported Device Performance (Compliance)
Electrical safety (IEC 60601-1)	Complied
Electromagnetic compatibility (IEC 60601-1-2)	Complied
Biocompatibility (ISO 10993-1, -5, -10)	Complied
Usability (IEC 62366)	Complied
Particular Requirements for Basic Safety and Essential Performance of Clinical Thermometers for Body Temperature Measurement (ASTM E1112-00)	Complied
Basic Safety and Essential Performance of Clinical Thermometers for Body Temperature Measurement (ISO 80601-2-56)	Complied
Software verification and validation (FDA Guidance for Content of Premarket Submissions for Software Contained in Medical Devices)	Complied
Measurement Accuracy	±0.1°C, 37.0°C ~ 39.0°C ±0.2°C, 35.0°C ~ 36.9°C, 39.1°C ~ 42.0°C ±0.3°C, 32.0°C ~ 34.9°C, 42.1°C ~ 43.0°C (At 25°C)
Measurement Speed	45s

Note 1: The document states that "Although there is a little difference between the 'measurement accuracy' and 'Measurement Speed', the subject device accuracy is compliance with ISO 80601-2-56 and ASTM E 1112 requirements. So, the difference of accuracy will not raise any safety of effectiveness issue." This implies that the specific performance values meet the acceptance criteria defined by these standards.

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

Sample Size for Clinical Tests: 240 subjects were evaluated for the clinical tests performed on Model TM-3102.
Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It only mentions that the clinical performance test protocol and data analysis were conducted "in accordance with the requirement of ISO 80601-2-56."

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

Not applicable. This device is a digital thermometer, and the ground truth for temperature measurement is typically obtained directly from the device's reading or a reference standard, not through expert interpretation of images or other subjective data. No experts were used to establish ground truth in the context of diagnostic interpretation.

4. Adjudication method for the test set

Not applicable, as this is a digital thermometer and not an AI/imaging device requiring expert adjudication for ground truth. The performance is assessed against physical standards and clinical measurements.

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

Not applicable. This is a standalone medical device (digital thermometer), not an AI-assisted diagnostic tool that would involve human readers.

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

Yes, a standalone performance evaluation was done. The "Test Summary" and "Discussion of Clinical Tests Performed" sections describe various lab bench tests and clinical tests to evaluate the safety and performance of the device itself (Models TM-2011, TM-3002, TM-3102) against established standards (e.g., IEC 60601-1, ISO 80601-2-56, ASTM E1112-00). This indicates the algorithm (or the device's internal processing) only performance was assessed.

7. The type of ground truth used

The ground truth for the clinical performance tests (temperature measurements) would primarily be the actual body temperature measurements obtained through a reference standard or the device's readings compared against such standards, as required by ISO 80601-2-56 and ASTM E1112-00 for clinical electronic thermometers.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set. Its functionality is based on established thermistor and ASIC technology.

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

Not applicable, as there is no training set for this type of device.

Summary

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December 31, 2019

Xiamen Ants Bro Technology Co., Ltd. % Cassie Lee Manager Guangzhou GLOMED Biological Technology Co., Ltd. 2231, Building 1, Rui Feng Center, Kaichuang Road Huangpu District Guangzhou, 510000 China

Re: K190990

Trade/Device Name: Digital Thermometer (Models: TM-2011, TM-3002, TM-3102) Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: November 26, 2019 Received: December 2, 2019

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.

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

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Indications for Use

510(k) Number (if known) K190990

Device Name

Digital Thermometer (Models: TM-2011, TM-3002, TM-3102)

Indications for Use (Describe)

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 K190990

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

1. Submitter's Information

510(k) Owner's Name: Xiamen Ants Bro Technology Co., Ltd. Establishment Registration Number: Applying Address: 4th and 5th floor, No. 5 Building, Tech.&Innovation center, No. 289 Wengjiao Road, Haicang District, Xiamen, Fujian, China Tel: 86-592-6537633 Fax: 0592-6537633 Contact Person: Jane Xu (Manger) Email: Sales1@asxd.com.cn

Application Correspondent:

Contact Person: Cassie Lee Guangzhou GLOMED Biological Technology Co., Ltd. Address: 2231, Building 1, Rui Feng Center, Kaichuang Road, Huangpu District, Guangzhou, Guangdong, China Tel: +86 20 8266 2446 Email: regulatory@glomed-info.com

2. Subject Device Information

Type of 510(k): Traditional Common Name: Clinical electronic thermometer Classification Name: Thermometer, electronic, clinical Trade Name: Digital Thermometer Model Name: TM-2011, TM-3002, TM-3102 Review Panel: General Hospital Product Code: FLL Regulation Number: 880.2910 Regulatory Class: 2

3. Predicate Device Information

Sponsor: Fudakang Industrial Co., Ltd. Trade Name: Digital Thermometer Common Name: Clinical electronic thermometer Classification Name: Thermometer, Electronic, Clinical 510(K) Number: K101387 Review Panel: General Hospital Product Code: FLL Regulation Number: 880.2910 Regulation Class: 2

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4. Device Description

5. Intended Use / Indications for Use

6. Test Summary

6.1 Digital Thermometer has been evaluated the safety and performance by lab bench testing as following:

Electrical safety test according to IEC 60601-1 standards �
� Electromagnetic compatibility test according to IEC 60601-1-2 standard
� Biocompatibility test according to ISO 10993-1, ISO 10993-5 and ISO 10993-10 standards
� Usability test according to IEC 62366 standard
� Particular Requirements for Basic Safety and Essential Performance of Clinical Thermometers for Body Temperature Measurement according to ASTM E1112-00 Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature
� 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.
� Software verification and validation test according to the requirements of the FDA "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".

6.2 Discussion of Clinical Tests Performed

Clinical tests were conducted on the Model TM-3102. The clinical tests evaluated 240 of subjects. and the thermometer was evaluated in four groups A1 - 0 up to three months to one year; B1 older than one years and younger than five years; and C - older than five years old. The clinical performance test protocol and data analysis were conducted in accordance with the requirement of ISO 80601-2-56. The test report showed the clinical performance of the subject devices complied with the requirement of ISO 80601-2-56.

6.3 Discussion of Cleaning Validation

Cleaning verification was performed on TM-2011, TM-3002, TM-3102. Each model took 15 samples and 45 samples each. The test report showed the cleaning instructions are appropriate for cleaning and reuse.

7. Comparison to predicate device and conclusion

The subject device Digital Thermometers (Model : TM-2011, TM-3002, TM-3102) have all features of the predicate devices K101387. The few differences do not affect the safety and effectiveness of the subject device. Thus, the subject device is substantially equivalent to the predicate devices.

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Elements ofComparison	Subject Device	Predicate Device	Remark
Company	Xiamen Ants Bro Technology Co.,Ltd.	Fudakang Industrial Co., Ltd.	--
Name andModel	Digital Thermometer, models: TM-2011, TM-3002, TM-3102	Digital Thermometer, Model: BT-A11CN, BT-A21CN, BT-A41 CN	--
510(k) Number	K190990	K101387	--
Product Code	FLL	FLL	SE
ThermometerType	Digital Thermometer	Digital Thermometer	SE
Intended Use /Indication forUse	Digital Thermometer (models TM-2011, TM-3002, TM-3102) intendedfor the measurement andmonitoring of human bodytemperature by users for home use.It can be used for axillarymeasurement and oralmeasurement.	Fudakang Digital Thermometersare intended for the measurementand monitoring of human bodytemperature by doctor orconsumers in the hospital or home.BT-A11CN, BT-A21CN, BT-A41CNcan be used for axillarymeasurement, oral measurementand rectal measurement.	SE
Sensor	Thermistor	Thermistor	SE
SignalProcessing andDisplay	Using the resistance change ofthermal resistor to detect bodytemperature and displayed throughthe LCD.	Using the resistance change ofthermal resistor to detect bodytemperature and displayed throughthe LCD.	SE
PowerRequirement	1.5V button battery	1.5V button battery	SE
Battery type	One 1.5 V DC. button battery (sizeLR41or SR41, UCC 392)	One 1.5 V DC. button battery (sizeLR41or SR41, UCC 392)DMT-4726,DMT-4735:One 3.0V CR2032 battery	SE
MeasurementTemperatureRange	32.0°C ~ 43°C	32.0°C ~ 43°C	SE
Voice function	For model TM-3002, TM-3102: Yes;(There is buzzing noise occur whenthe device turning on and when themeasurement is completed.)For model TM-2011: None	Yes	SENote 1
Patient contactmaterial	Enclosure and Key: ABS plasticProbe: Stainless steel	Enclosure and Key: ABS plasticProbe: Stainless steel	SE
MeasurementAccuracy	$±0.1°C, 37.0°C ~ 39.0°C$$±0.2°C ,35.0°C ~ 36.9°C, 39.1°C ~ 42.0°C$$±0.3°C, 32.0°C ~ 34.9°C, 42.1°C ~ 43.0°C$At Standard room temperature of25°C (77.0°F)	35.0°C ~ 39.0°C: ±0.1°C95.0 ~ 102.0 °F: ±0.1°Fthe rest: ±0.2°CAt Standard room temperature of25°C (77.0°F)	SENote 2
MeasurementSpeed	45s	60s	SENote 2
Elements of Comparison	Subject Device	Predicate Device	Remark
	Measurement site	Orally, axillary	DMT series (except DMT-455):orally, rectally or under the armDMT-455:orally
Power ON/OFF	Switch the thermometer ON and OFF by shaking it orSwitch the thermometer ON and OFF by press the power button	Switch the thermometer ON and OFF by press the power button	SENote 1
Describe and compare features	For model TM-3002 and TM-3102:Voice featureFor model TM-2011: No voice featureOther functions are the same	--	SENote 1
Probe cover use?	No	For rectal measurement only	SE
Complied Standard	IEC 60601-1,ISO 80601-2-56,IEC 60601-1-2,IEC 60601-1-11,ASTM E1112,ISO 10993-1,ISO 10993-5,ISO 10993-10	IEC 60601-1,IEC 80601-2-56,IEC 60601-1-2,IEC 60601-1-11,ASTM E1112,ISO 10993-1,ISO 10993-5,ISO 10993-10	SE

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Note 1:

Although the "Voice function", "Measurement site", "Describe and compare features" and "Power ON/OFF" of subject device is a little different with predicate device, but they are just for indication and operation only, and the whole product are all compliance with safety standard and performance standards, these differences will not raise any safety or effectiveness issue.

Note 2:

Although there is a little difference between the "measurement accuracy" and "Measurement Speed", the subject device accuracy is compliance with ISO 80601-2-56 and ASTM E 1112 requirements. So, the difference of accuracy will not raise any safety of effectiveness issue.

Final Conclusion:

The subject device Digital Thermometers (Model: TM-2011, TM-3002, TM-3102) have all features of the predicate devices K101387. Thus, the subject device is substantially equivalent to the predicate devices

8. Date of the summary prepared: December 31, 2019

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.