The Digital Thermometer is intended to measure the human body temperature in regular mode orally, rectally or under the arm. And the devices are reusable for clinical or home use on people of all ages.

Device Description

The digital thermometer DMT-4735b is hand held instruments which can measure human body's temperature orally, axillary (under the arm), and rectally The results can be displayed on LCD. And, the results measured by DMT-4735b can be transmitted to mobile device (i.e. iPhone) with Bluetooth and the application APP installed on a mobile device using the iOS system or the Android system. The thermometer is reusable for clinical or home use on people of all ages with adult supervision. The device can be used with as a stand-alone device or in conjunction with the App on a compatible BLE enabled smartphone.

AI/ML Overview

The provided text describes a 510(k) submission for a Digital Thermometer (Model: DMT-4735b). The document asserts substantial equivalence to a predicate device (K163518, Model: DMT-4735). The acceptance criteria for this device are largely derived from international standards and performance specifications rather than a comparative effectiveness study with human readers or clinical trials.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally framed as compliance with international standards and specific performance ranges. The table below summarizes the key performance aspects where criteria are implied by the predicate device comparison and reported performance is stated.

Acceptance Criteria (Implied from predicate comparison or stated standards)	Reported Device Performance (DMT-4735b)
Intended Use / Indication for Use: Measure human body temperature orally, rectally, or under the arm; reusable for clinical or home use on people of all ages.	Intended to measure the human body temperature in regular mode orally, rectally or under the arm. And the devices are reusable for clinical or home use on people of all ages.
Fundamental Technology & Operating Principle: Thermistor resistance changes with temperature, measured by MCU, displayed on LCD/APP.	A change of thermistor resistance, caused by changes of temperature. The resistance is measured by MCU, so changes of temperature will correspond to changes of resistance. Then display the measured temperature on the LCD or APP through BLE.
Measurement Range: Typically around 32.0°C-42.9°C (89.6°F-109.2°F) as per predicate. (Note 1 refers to meeting ISO80601-2-56 requirements)	32.00°C-43.99°C (89.60°F-111.18°F). (Note 1 states "The measurement range and accuracy of subject devices meet the requirements of ISO80601-2-56.")
Accuracy: Typically ± 0.2°F (± 0.1°C) during 95.9°F ~107.6°F (35.5°C ~42.0°C) as per predicate. (Note 1 refers to meeting ISO80601-2-56 requirements)	± 0.05 °C ( ± 0.1 °F) during 35.00 °C ~38.00 °C (95.00 °F ~100.40°F); ± 0.1 °C ( ± 0.2 °F) during T<35.00°C(95.00°F) or T>38.00°C(100.40°F). (Note 1 states "The measurement range and accuracy of subject devices meet the requirements of ISO80601-2-56.")
Response Time: ≤45s as per predicate. (Note 1 refers to meeting ISO80601-2-56 requirements)	≤60s. (Note 1 states "The measurement range and accuracy of subject devices meet the requirements of ISO80601-2-56.")
Resolution of Display: 0.1 °C / 0.1 °F as per predicate. (Note 1 refers to meeting ISO80601-2-56 requirements)	0.01 °C / 0.01°F. (Note 1 states "The measurement range and accuracy of subject devices meet the requirements of ISO80601-2-56.")
Electrical Safety: Compliance with AAMI / ANSI ES60601-1:2005/(R)2012 and A1:2012,C1:2009/(R)2012 and A2:2010/(R)2012 Medical Electrical Equipment, and ISO 80601-2-56:2017.	Complied with IEC 60601-1 (stated in comparison table). Performance data section lists compliance with AAMI / ANSI ES60601-1:2005/(R)2012, A1:2012,C1:2009/(R)2012, A2:2010/(R)2012, and ISO 80601-2-56:2017.
Electromagnetic Compatibility (EMC): Compliance with IEC 60601-1-2:2014.	Complied with IEC 60601-1-2 (stated in comparison table). Performance data section lists compliance with IEC 60601-1-2:2014, EN300328, ETSI EN 301489-1, ETSI EN 301489-17. Also, Note 2 states "FCC, EN301489-1, EN301489-17, EN 300328 and wireless coexistence test passed."
Biocompatibility: Compliance with ISO 10993-5 and ISO 10993-10.	Comply with ISO 10993-5 and ISO 10993-10 (stated in comparison table). Performance data section lists compliance with ISO 10993-5:2009 and ISO10993-10:2010.
Software/Firmware Validation: In accordance with "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," dated May 11, 2005.	Software/firmware verification and validation was provided in accordance with the "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," dated May 11, 2005.
Wireless Interface (BLE): Performance of Bluetooth Low Energy, compliance with wireless standards. (Implied by differences from predicate)	Bluetooth Low Energy (BLE). Note 2 states "FCC, EN301489-1, EN301489-17, EN 300328 and wireless coexistence test passed."
Home Healthcare Environment Requirements: Compliance with IEC 60601-1-11:2015.	Performance data section lists compliance with IEC 60601-1-11:2015.

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

The document states: "Clinical testing was not required to establish equivalency of the device." This implies that no specific test set involving human subjects with associated sample sizes was used for demonstrating the performance of the device against a clinical ground truth. The acceptance is based on compliance with international standards and comparison to a predicate device.

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

Since "Clinical testing was not required," there would be no experts establishing ground truth for a clinical test set in the context of this 510(k) submission.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set requiring expert adjudication was described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. The document explicitly states "Clinical testing was not required." Therefore, no MRMC study, or any study involving human readers, was conducted or reported.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The device is a digital thermometer, not an AI/algorithm-based diagnostic tool that would typically undergo "standalone" algorithm performance testing in the sense of image recognition or diagnostic algorithms. Its "performance" refers to its accuracy, response time, and compliance with technical standards, which were evaluated through bench testing and compliance with various engineering and safety standards (e.g., electrical safety, EMC, biocompatibility) rather than a standalone algorithm performance independent of a human operator interpreting its output. While the device does have software/firmware and can connect to a mobile app, its primary function as a thermometer relies on its sensor and internal processing, which is verified through the listed engineering standards.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by physical standards and measurement traceability in laboratories and testing facilities that verify compliance with standards like ISO 80601-2-56 for clinical thermometers. For accuracy, this would involve comparing the device's readings against calibrated reference thermometers under controlled environmental conditions. For other aspects like electrical safety, EMC, and biocompatibility, the ground truth is defined by the specific test methods and limits outlined in the relevant IEC/ISO standards.

8. The Sample Size for the Training Set

Not applicable. This device is a digital thermometer, not a machine learning model that requires a training set of data.

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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February 28, 2019

Joytech Healthcare Co., Ltd. Ren Yunhua General manager No.365, Wuzhou Road, Yuhang Economic Development Zone Hangzhou City Hangzhou, 311100 China

Re: K182629 Trade/Device Name: Digital Thermometer Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical electronic thermometer Regulatory Class: Class II Product Code: FLL Dated: January 26, 2019 Received: January 30, 2019

Dear Ren Yunhua:

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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

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for Tina Kiang, Ph.D. Acting 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)

Device Name Digital Thermometer DMT-4735b

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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Prescription Use (Part 21 CFR 801 Subpart D)

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

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JOYTECH HEALTHCARE CO., LTD.

510(k) Summary

The assigned 510(k) number is:

1. Date Prepared: 2019.01.26

2. Submitter's Identification:

Name: JOYTECH HEALTHCARE CO., LTD.

Add.:No.365, Wuzhou Road, Yuhang Economic Development Zone,

Hangzhou city, 311100 Zhejiang,China

Contact Person: Yunhua Ren

Phone: +86-571-81957767

Fax: +86-571-81957750

Email: RENYH@SEJOY.COM

3. Name of the Device:

Trade Name: Digital Thermometer Model: DMT-4735b Common Name: Digital Thermometer Classification name: Clinical Electronic Thermometer

4. Classification Information:

Product Code: FLL- Clinical Electronic Thermometer Device Class: II Panel: 80 Regulation number:880-2910

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5. Predicate Device Information:

The Digital Thermometer DMT-4735b is substantially equivalent to the following devices:

510k number	model	Product code	manufacturer
K163518	DMT-4735	FLL	JOYTECH HEALTHCARE CO., LTD.

Intended use / Indication for Use: 6.

7. Device Description:

8. Substantial Equivalence Comparison:

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JOYTECH HEALTHCARE CO., LTD.

Comparisons	Subject device Present application	Predicate device K163518 (Model:DMT-4735)	Comparison Result
Intended Use /Indication for use	Intended to measure the human body temperature in regular mode orally, rectally or under the arm. And the devices are reusable for clinical or home use on people of all ages.	Intended to measure the human body temperature in regular mode orally, rectally or under the arm. And the devices are reusable for clinical or home use on people of all ages.	Similar
Fundamental technology &Operating principle	A change of thermistor resistance, caused by changes of temperature. The resistance is measured by MCU, so changes of temperature will correspond to changes of resistance. Then display the measured temperature on the LCD or APP through BLE.	A change of thermistor resistance, caused by changes of temperature. The resistance is measured by MCU, so changes of temperature will correspond to changes of resistance.	Similar
Operation	Handheld device containing user facing button, sensor head, microcontroller, display	Handheld device containing user facing button, sensor head, microcontroller, display	Same
Sensor	Thermistor	Thermistor	Same
Signal processing and display	-Internal firmware and local LCD display-Also able to transfer transmit data to an auxiliary device for secondary display	Internal firmware and local LCD display	Different (Note 2)
Wireless Interface	Bluetooth Low Energy (BLE)	None	Different (Note 2)
Power requirements	Battery powered CR2032 (3V)	Battery powered CR2032 (3V)	Same
Material	Biocompatible Stainless Steel and ABS	Biocompatible Stainless Steel and ABS	Same
Scale	Switchable	Switchable	Same
Measurement locations	Oral, Axillary and Rectal	Oral, Axillary and Rectal	Same
Measurement Range	$32.00°C-43.99°C$$(89.60°F-111.18°F)$	$32.0°C-42.9°C$$(89.6°F-109.2°F)$	Different (Note 1)
Operating Environment	Temperature: $5°C~~40°C$$(41°F~~104°F)$	Temperature: $5°C~~40°C$$(41°F~~104°F)$	Same
	Relative humidity:15%~95%RHAtmospheric Pressure :700hPa ~ 1060hPa	Relative humidity:15%~95%RHAtmospheric Pressure :700hPa ~ 1060hPa
Accuracy	$\pm$ 0.05 °C ( $\pm$ 0.1 °F) during35.00 °C ~38.00 °C (95.00 °F~100.40°F)$\pm$ 0.1 °C ( $\pm$ 0.2 °F) duringT<35.00°C(95.00°F)or T>38.00°C(100.40°F)	$\pm$ 0.2°F( $\pm$ 0.1°C) during 95.9°F~107.6 °F (35.5 °C ~42.0°C) at64.4 °F ~~82.4 °F (18°C~~28 °C )ambient operating range$\pm$ 0.4 °F ( $\pm$ 0.2 °C) for othermeasuring and ambientoperating range	Different(Note 1)
Response Time	≤60s	≤45s	Different(Note 1)
Resolution ofDisplay	0.01 °C / 0.01°F	0.1 °C / 0.1 °F	Different(Note 1)
Low powerindication	Yes	Yes	Same
Memory	Last memory	Last memory	Same
Reuse	Yes	Yes	Same
Display unitspecification	IOS or Android device display	/	Different(Note 2)
Signal transmission	Bluetooth 4.0	/	Different(Note 2)
Receiver (mobileterminal)	iOS8.0 or above smartphoneor tablet;Android 4.3 or abovesmartphone or tablet	/	Different(Note 2)
Biocompatibility	Comply with ISO 10993-5 and ISO 10993-10		Same
Electrical Safety	Complied with IEC 60601-1		Same
EMC	Complied with IEC 60601-1-2		Same

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Image /page/6/Picture/0 description: The image shows the logo for JOYTEC. The logo is blue, except for the dash between JOYTEC and the Chinese characters, which is red. The Chinese characters are also blue.

JOYTECH HEALTHCARE CO., LTD.

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Analysis

From the comparison table, the subject devices and predicate devices have the similar Intended use & Indications for Use, Measurement place, Scale selection, Display screen, Auto power-off while no operation & Conformance standard. There are slightly differences between the devices and predicate devices as follows.

Note1	The measurement range and accuracy of subject devicesmeet the requirements of ISO80601-2-56.
Note2	FCC, EN301489-1, EN301489-17, EN 300328 and wirelesscoexistence test passed.

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9. Performance data

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

Performance testing was conducted to validate and verify that Digital Thermometers, DMT series met all requirements of related international standards, including electrical safety, EMC, biocompatibility, software validation and product specifications. Results of these tests demonstrate compliance to the requirements of the below consensus standards.

Electrical Safety and performance requirements:

AAMI / ANSI ES60601-1:2005/(R)2012 And A1:2012,C1:2009/(R)2012 And A2:2010/(R)2012 Medical Electrical Equipment
ISO 80601-2-56:2017 Medical electrical equipment Part 2-56 Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement

Home-used medical equipment requirements and environmental test:

· IEC 60601-1-11:2015 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

Electromagnetic compatibility requirements:

. 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
EN300328:Electromagnetic compatibility and Radio spectrum Matters (ERM); . Wideband transmission systems; Data transmission equipment operating in the 2,4 GHz ISM band and using wide band modulation techniques;
ETSI EN 301489-1: Electromagnetic compatibilityand Radio spectrum Matters(ERM); . ElectroMagnetic Compatibility (EMC)standard for radio equipment and services;Part 1:Common technical requirements;
ETSI EN 301489-17: Electromagnetic compatibility and Radio spectrum Matters . (ERM);ElectroMagnetic Compatibility (EMC) standard for radio equipment; Part 17: Specific conditions or Broadband Data Transmission Systems;

Biocompatibility Evaluation for patient contacting components:

· ISO 10993-5:2009 Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity
· ISO10993-10:2010 Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization

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Guidance Document:

• Guidance on the content of Premarket Notifications [510(k)] Submissions for clinical electronic thermometers

The software/firmware verification and validation was provided in accordance with the "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," dated May 11, 2005.

10. Discussion of Clinical Tests Performed:

Clinical testing was not required to establish equivalency of the device.

Conclusions: 11.

Based on the information provided in this submission, the submit Digital thermometer DMT-4735b is substantially equivalent to the predicate Thermometers

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.