Digital Pacifier Thermometer TM-03 is a non-sterile, reusable & battery-operated clinical electronic thermometer for use by medical professional or at home. The TM-03 is intended to measure the oral temperature of infant to children up to 5 years old.

Device Description

Digital Pacifier Thermometer TM-03 is a reusable, battery-operated clinical electronic thermometer, with which a thermistor installed inside the nipple, for use by medical professional or at home. Different from the traditional electronic thermometer, our TM-03 is designed specifically for the measuring the oral temperature of baby or little child. Therefore, our TM-03 is molded as a pacifier. The patient contact portion is the thermometer's nipple which is made of medical silicon rubber. The body of TM-03 is then manufactured by ABS hard plastic. TM-03 utilizes the phenomenon of thermal conductivity changes of our selected NTC thermistor when there are changes of external environment temperature. Whenever the external temperature changed, the resistance of our thermistor changed uniformly. Then, the changes in resistance are converted to the changes of frequency of R-C oscillator circuit. This means TM-03 keep monitoring the frequency of the oscillator and the temperature can be measured accurately.

AI/ML Overview

Here's a summary of the acceptance criteria and the study details for the Digital Pacifier Thermometer (Model No.: TM-03), based on the provided text:

Acceptance Criteria and Device Performance

Acceptance Criteria (Performance)	Reported Device Performance (TM-03)
Accuracy: +/-0.2°F for 95°F – 107.6°F	Meets the requirement of +/-0.2°F for 95°F – 107.6°F
Not Specified	Biological evaluation of medical devices (ISO10993 sets): No evidence of delayed dermal contact sensitization, classified as non-irritant, not cytotoxic potential.
Not Specified	Nitrosamine content (CPG Sec. 500.450 Volatile N-Nitrosamines in Rubber Baby Bottle Nipples reference): Safe and within acceptance limit (10ppb).
Not Specified	Not made with BPA in accessible parts.
Not Specified	Electrical safety (EN60601-1, FCC Part 15, IEC60601-1-2): Complies with requirements, classified as Class B device, meets acceptance limit (40dB (uV/m)).

Study Details

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

Sample Size: Not explicitly stated for the clinical test. For the independent laboratory test based on ASTME1112, the sample size is not specified.
Data Provenance: The general nature of the studies (clinical test and independent laboratory test) suggests prospective testing of the device. The country of origin for the data is not specified, but the applicant is Cotronic Technology Limited from Hong Kong/China.

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

This information is not provided in the document. The studies focus on device accuracy against established standards rather than expert-derived ground truth for diagnostic interpretation.

3. Adjudication method for the test set:

Not applicable as the studies relate to temperature measurement accuracy and safety, not diagnostic interpretation requiring adjudication.

4. 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:

No, an MRMC comparative effectiveness study was not done. This device is a clinical electronic thermometer, not an AI-powered diagnostic tool that assists human readers.

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

Yes, the performance tests conducted were standalone, evaluating the device's accuracy and safety specifications directly. The "clinical test" and independent laboratory test assessed the thermometer's ability to measure temperature accurately.

6. The type of ground truth used:

The ground truth for the accuracy tests was comparison against established temperature references or standards, as implied by the ASTME1112 standard and the statement "meets the requirement of +/-0.2°F". For safety tests, the ground truth was adherence to international and national standards (e.g., ISO10993, EN60601-1, FCC Part 15, IEC60601-1-2, CPG Sec. 500.450).

7. The sample size for the training set:

Not applicable. This device is a traditional electronic thermometer; it does not involve machine learning or AI models that require specific training sets.

8. 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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Section IV: 510k Summary

Applicant's Identification

Applicant	Cotronic Technology Limited
Phone Number	+852-2602-2021 / +86-755-8145-3681
Fax Number	+852-2609-4485 / +86-755-8145-3080
Contact Person	Ms. Tani Mok
Date of Application ·	1st March, 2012
Date of Summary	13th March, 2013

Device's Identification

Digital Pacifier Thermometer (Model No.: TM-03) Device Proprietary Name Clinical Electronic Thermometer Common Name Thermometer, Electronic, Clinical Classification Name (Class II per 21 CFR 880.2910)

Marketed Devices to which Equivalence is Claimed

DEVICE	MANUFACTURER	510(k) Number
Microlife Digital Pacifier Thermometer,	Microlife Intellectual	K051100
Model MT1751Q	Property GmbH, Switzerland

Device Description

TM-03 utilizes the phenomenon of thermal conductivity changes of our selected NTC thermistor when there are changes of external environment temperature. Whenever the external temperature changed, the resistance of our thermistor changed uniformly. Then, the changes in resistance are converted to the changes of frequency of R-C oscillator circuit. This means TM-03 keep monitoring the frequency of the oscillator and the temperature can be measured accurately.

MAY 1 7 2013

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Intended Use (Indication for Use)

Comparison of Technological Characteristics between New Device and Predicate Devices

Our Digital Pacifier Thermometer TM-03 is non-sterile, reusable & battery-operated clinical electronic thermometer and utilizes the phenomenon of thermal conductivity changes of NTC thermistor to measure the oral temperature reading of infant/children. The key components of device are a NTC thermistor, silicon nipple & a ABS hard plastic The predicate device adopts exactly same methodology and key components for bodv. measuring the infant's oral temperature.

Item	Predicate Device(Microlife MT1751QDigital PacifierThermometer)	TM-03
Product Design	Dummy-like Shape	Equivalent
Temperature MeasurementTechnology	NTC ThermistorResistance Technique	Equivalent
Key Temperature Sensor	NTC Thermistor	Equivalent
Material	Resistances, capacitances,transistors, buzzer, MCU, athermistor, button key,PCB, silicon, ABS plasticcabinet, battery	Equivalent
Energy Source	1 x SR 41battery	1 x LR41 battery
Measurement Time	Around 5 minutes	3 — 5mins

A comparison table between New Device and Predicate Device is listed as below:

Clinical & Non-clinical Tests

A systematic & independent clinical test was conducted to validate the performance of the Digital Pacifier Thermometer (Model No. TM-03). The results demonstrated that our device (Model No. TM-03) meets the requirement of +/-0.2°F for 95°F – 107.6°F. Also, we have asked an independent laboratory to test the accuracy of our device (Model No. TM-03) based on the ASTME1112 and the results further verified our device meets the requirement of +/-0.2°F for 95°F - 107.6°F.

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For the electrical safety of our device, comprehensive testings were carried out according various international standards. Firstly, our devices are tested and compiled with the EN60601-1 (Standard Title: Medical Equipment Part 1: General requirements for safety), which includes a collective of safety tests. Then, the electrical safety of our devices is further verified via conducting the electromagnetic compatibility test according to FCC Part 15 and IEC60601-1-2. The results classified and demonstrated our devices as Class B device and are compiled with the acceptance limit (40dB (uV/m)).

Furthermore, we have conducted various tests on the safety of material to verify our device (Model No. TM-03) was made by safe material. Firstly, we applied the ISO10993 sets to test the biocompatibility of our device. The results showed no evidence of causing delayed dermal contact sensitization. And our device is classified as a non-irritant and not a cytotoxic potential. Secondly, we tested the silicon nipple of our device with US Compliance Policy Guide Part 7117.11 for nitrosamine content in rubber baby bottle nipples. We notice that the testing scope of Policy Guide Part 7117.11 was not applicable to our product category. However, we still would like to have a reference on the safety towards nitrosamine content in our device (Model No. TM-03). The results demonstrated our device is safe and within the corresponding acceptance limit (10ppb). Thirdly, our device/device components not made with BPA. BPA is not used in the manufacture of the accessible parts of the device (TM-03).

Comprehensive safety and EMC tests were performed and compiled to demonstrate (Model No.TM-03) is safe for use. Tests include

Biological evaluation of medical devices --- Part10: Tests for irritation and skin sensitization
Biological evaluation of medical devices --- Part12: Sample preparation and reference materials
Biological evaluation of medical devices --- Part 5: Tests for In Vitro Cytotoxicity
Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature
CFR Title 16 Part 1511 - Requirement for pacifiers
CPG Sec. 500.450 Volatile N-Nitrosamines in Rubber Baby Bottle Nipples
Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Requirement
Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance

Conclusion

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Additional information of K120671

K120671

Our Digital Pacifier Thermometer TM-03 has the same intended use and similar technological characteristics as predicate device (K051100). Moreover, bench testing contained in this submission and clinical testing supplied demonstrated that no differences in the technological characteristics and questioning on safety or effectiveness to be raised. Thus, the Digital Pacifier Thermometer TM-03 is substantially equivalent to the predicate device.

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Public Health Service

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

May 17, 2013

Ms. Tani Mok Cotronic Technology, Limited Floor 4-6, Block 7, West of Zhoushi Road Xixiang Street Baoan Zone, Shenzhen, Guang Dong Province. China 518126

Re: K120671

Trade/Device Name: Digital Pacifier Thermometer (Model No .: TM-03) Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: April 24, 2013 Received: May 16, 2013

Dear Ms. Mok:

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 - Ms. Mok

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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

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

Sincerely yours,

DAGRID

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director

FOR Anthony D. Watson, B.S., M.S., M.B.A. 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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Section V: Statement of Indications for Use

1120071 510(k) Number (if known):

Device Name:

Digital Pacifier Thermometer (Model No.: TM-03)

Indications For Use:

Digital Pacifier Thermometer TM-03 is a non-sterile, reusable & battery-operated clinical electronic thermometer for use by medical professional or at home. The TM-03 is intended to measure the oral thermometer of infant to children up to 5.years old.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Richard C. Chapman 2013.05.17 09:50:15 -04'00'

(Division Sign-Off) Tivision of Anesthesiology, General Hospital ection Control, Dental Devices

K12667) 510(k) Number: ___

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.