The Wireless Thermometer is a battery-operated electronic device with intended use of measuring and monitoring human armpit temperature continuously via wireless signal transmission of the measuring result. The system is intended for armpit temperature monitoring for persons with all ages.

The products can be used in hospital and at home.

Device Description

The MCU chip in the wireless electronic thermometer collects the voltage value of the NTC thermal resistor, a thermo-sensitivity resistance, whose resistance will change according to temperature. After collecting and filtering algorithm, a resistance value data is obtained. After that, the Bluetooth chip performs a table lookup operation to find the Celsius temperature value corresponding to the resistance value. The temperature data is transmitted through the Bluetooth transmission to the compatible smart phone, in order to achieve the function of temperature measurement.

The wireless thermometer is composed of a Patch and a Mobile App.

Patch: One side of Patch is medical adhesive which is used to fix the patch on the armpit of patients. The other side is foam. There is a circuit board inside the patch. The patch is used for detecting of human body temperature and then transferred to Mobile App for display and further management. There is no display function on the patch, except for a indicator to indicating power on/off status.
Patches are single use only, and available in different configuration. The models ECH-b1-S, ECH-b1-M and ECH-b1-L all share the same design principles, materials, mechanism of actions. However they are different in size and intended patient.

Mobile APP: The APP is intended for display and management of obtained human body temperature data.

AI/ML Overview

The provided text is a 510(k) Summary for a Wireless Thermometer. It outlines the device description, intended use, and comparison to a predicate device to establish substantial equivalence.

Based on the provided document, here's a breakdown of the acceptance criteria and the study that proves the device meets them:

Important Note: The device described is a clinical electronic thermometer, not an AI-powered diagnostic device. Therefore, many of the typical criteria for AI/ML medical devices (such as MRMC studies, ground truth establishment by experts, and sample sizes for training/test sets for algorithm performance) do not apply to this submission. The "study" here refers to non-clinical testing and benchmarking against established standards and a predicate device.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria/Standard	Reported Device Performance	Study Type/Evidence
Safety	ISO 10993-5:2009 (Cytotoxicity)	Complied	Non-clinical test
	ISO 10993-10:2010 (Irritation & Skin Sensitization)	Complied	Non-clinical test
	IEC 60601-1:2012 (General Requirements for Basic Safety and Essential Performance)	Complied	Non-clinical test
	IEC 60601-1-11:2010 (Home Healthcare Environment Safety)	Complied	Non-clinical test
Electromagnetic Compatibility (EMC)	IEC 60601-1-2:2014	Complied	Non-clinical test
Performance (Accuracy & Measurement Range)	ISO 80601-2-56 First Edition 2009-10-01 (Particular Requirements for Clinical Thermometers)	Complied (Accuracy: ±0.2 °C for 25-45 °C)	Non-clinical test
Substantial Equivalence	Comparison to predicate device (TempTraq, Model TT-100, K143267) across key characteristics (Intended Use, Measurement Site, Features, Components, Working Voltage, Measurement Range, Accuracy, Signal Transmission, Receiver, Unit, Biocompatibility, Electrical Safety, EMC).	Found to be "Similar" for all compared items, with noted differences in exact measurement range and accuracy being within acceptable limits as both comply with ISO 80601-2-56.	Comparison table, non-clinical tests

Study Details (Focusing on the type of device)

A table of acceptance criteria and the reported device performance: See table above.
Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable in the context of an AI/ML test set. For non-clinical tests (e.g., biocompatibility, electrical safety, EMC, accuracy testing), the sample sizes are determined by the specific standards (e.g., number of units tested, number of in vitro samples). These details are not provided in the 510(k) summary but would be in the full test reports.
- Data Provenance: Non-clinical test data generated at the manufacturer's or contracted testing facilities (not specified in detail, but standard for medical device testing). No direct patient data provenance (country, retrospective/prospective) is relevant as no clinical study was performed.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is not an AI/ML device relying on human expert annotation for ground truth. Ground truth for thermometer accuracy is established by reference measurement instruments following metrological standards. For other tests (e.g., biocompatibility), results are determined by laboratory analysis.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This concept applies to human expert review for AI/ML ground truth, not device performance testing.
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 device is a standalone thermometer, not an AI-assisted diagnostic tool that supports human readers. The submission explicitly states: "No clinical study is included in this submission."
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Yes, in essence, the device's accuracy and safety were evaluated as a standalone product through non-clinical testing against standards. The "algorithm" here is the embedded firmware that converts sensor readings to temperature, and its performance (accuracy) was assessed.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For temperature accuracy: The ground truth is established by traceable reference temperature measurement apparatus and methods, as per ISO 80601-2-56. This is a metrological standard, not expert consensus or pathology.
- For safety (biocompatibility, electrical safety): Ground truth/acceptance is based on compliance with the quantitative and qualitative acceptance criteria specified in the relevant international standards (ISO 10993, IEC 60601 series).
The sample size for the training set: Not applicable. This is not an AI/ML device that requires a training set in the typical sense. The device's internal algorithm is designed and calibrated based on engineering principles and sensor characteristics, not machine learning from a large dataset.
How the ground truth for the training set was established: Not applicable. As above, there is no "training set" for an AI/ML algorithm. The calibration and design of the thermometer are based on established physical laws and engineering practices for NTC thermistors.

Summary

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Tab #2 510(k) Summary

This 510(k) Summary is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.

The assigned 510(k) Number: K170769

1. Date of Preparation: 07/24/2017
1. Sponsor Identification

ECH (ChangZhou) Medical Instrument Co., Ltd.

No.65 Huilin west road, zhouqu town, zhong lou District Changzhou city , Jiangsu Province ,213144

Establishment Registration Number: Not yet registered

Contact Person: Mr. Yuan Hu Position: deputy general manager Tel: +86-0519-88161606 Fax: +86-0519-83635058 Email: huyuan@ech-med.com

1. Designated Submission Correspondent
  Ms. Diana Hong (Primary Contact Person) Ms. Cindy Wang (Alternative Contact Person)

Mid-Link Consulting Co., Ltd

P.O. Box 120-119, Shanghai, 200120, China

Tel: +86-21-22815850, Fax: 240-238-7587 Email: info@mid-link.net

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1. Identification of Proposed Device
  Trade Name: Wireless Thermometer, Model(s): ECH-b1-L, ECH-b1-M, and ECH-b1-S

Common Name: Clinical electronic thermometer Model(s): ECH-b1-L, ECH-b1-M, ECH-b1-S

Regulatory Information

Classification Name: Clinical electronic thermometer Classification: Class II Product Code: FLL Regulation Number: 21 CFR 880.2910 Review Panel: General Hospital

1. Intended Use Statement:
  The Wireless Thermometer is a battery-operated electronic device with intended use of measuring and monitoring human armpit temperature continuously via wireless signal transmission of the measuring result. The system is intended for armpit temperature monitoring for persons with all ages.

The products can be used in hospital and at home.

1. Device Description
  The MCU chip in the wireless electronic thermometer collects the voltage value of the NTC thermal resistor, a thermo-sensitivity resistance, whose resistance will change according to temperature. After collecting and filtering algorithm, a resistance value data is obtained. After that, the Bluetooth chip performs a table lookup operation to find the Celsius temperature value corresponding to the resistance value. The temperature data is transmitted through the Bluetooth transmission to the compatible smart phone, in order to achieve the function of temperature measurement.

The wireless thermometer is composed of a Patch and a Mobile App.

Patch: One side of Patch is medical adhesive which is used to fix the patch on the armpit of patients. The other side is foam. There is a circuit board inside the patch. The patch is used for detecting of human body temperature and then transferred to Mobile App for display and further management. There is no display function on the patch, except for a indicator to indicating power on/off status.
Patches are single use only, and available in different configuration. The models ECH-b1-S, ECH-b1-M and ECH-b1-L all share the same design principles, materials, mechanism of actions. However they are different in size and intended patient.
Mobile APP: The APP is intended for display and management of obtained human body temperature data.

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The mobile APP is intended to be run on compatible smart phones with iOS operating system or Android operating system, including:

iPhone 5, iPhone 5s, iphone 5C, iPhone 6, iPhone 6 Plus, iPhone 6s, iPhone 6s Plus, Iphone SE, iPhone 7, iPhone 7 Plus smart phone run on IOS 7.1 or advanced operation system or
Nexus 5, Sumsang Galaxy S6, Huawei Mate 8 smart phone run on Android 4.4 or advanced operation system.

Its function includes:

Patient management;
Communication with Patch;
Simultaneous display of temperature;
Indication of low battery content of patch.

There is no alarming and interpretation feature.

1. Identification of Predicate Device(s)
  510(k) Number: K143267 Product Name: TempTraq, Model TT-100
Non-Clinical Test Conclusion 8.
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
♪ ISO 10993-5:2009 Biological evaluation of medical devices- Part 5: Tests for in vitro cvtotoxicitv
ISO 10993-10:2010 Biological evaluation of medical devices- Part 10: Tests for irritation and skin sensitization
IEC 60601-1:2012, Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance.
IEC 60601-1-2:2014, Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements And Tests.
ISO 80601-2-56 First Edition 2009-10-01, Medical Electrical Equipment - Part 2-56: Particular Requirements For Basic Safety And Essential Performance Of Clinical Thermometers For Body Temperature Measurement.
IEC 60601-1-11:2010 Medical electrical equipment- Part 1-11:General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical system used in the home healthcare environment

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9. Clinical Test Conclusion

No clinical study is included in this submission.

10. Substantially Equivalent (SE) Comparison

Item	Proposed Device	Predicate Device	Remark
Product Code	FLL	FLL	Similar
Regulation Number	21 CFR 880.2910	21 CFR 880.2910	Similar
Class	Clinical electronic thermometers	Clinical electronic thermometers	Similar
Intended Use	The Wireless Thermometer is a battery-operated electronic device with intended use of measuring and monitoring human armpit temperature continuously via wireless signal transmission of the measuring result. This system is intended for armpit temperature monitoring for persons with all ages. The products can be used in hospital and at home.	The wireless thermometer, model TT-100, is a battery-operated electronic device with intended use of measuring human body temperature precisely. This device is a single-use and intended for armpit temperature measurement of persons of all age.	Similar
Measurement Site	Under the armpit	Under the armpit	Similar
Features	Compatible with iOS or Android Mobile Device via Bluetooth connectionDisplay in mobile application, no display on device	Compatible with iOS or Android Mobile Device via wireless connectionDisplay in mobile application, no display on device	Similar
Component	Temperature Sensitive SensorCircuit BoardNo CableBattery (button cell)	Temperature Sensitive SensorCircuit BoardNo cableBattery(button cell)	Similar
Working voltage	3.0Vdc	3.0 Vdc	Similar
Measurement range	25.0~45.0 ℃	30~42.4 ℃	Similar
Accuracy	$\pm$ 0.2 °C for 25-45 °C,	$\pm$ 0.1 °C for 30-42.4 °C,	Similar
Signaltransmission	Bluetooth Version 4.0	Bluetooth Version 4.0	Similar
Receiver	IOS 7.1 or later/ Android 4.4or later based smart phoneswith Bluetooth® 4.0interface.	IOS 7.1 through 8.1 orAndroid operating 4.3through 4.4 operatingsystem supportable smartphones	Similar
Unit	°C or °F	°C or °F	Similar
Biocompatibility	CytotoxicitySensitizationIrritation	No CytotoxicityNo sensitizationNegligible	Comply with ISO 10993-5and ISO 10993-10Similar
Electrical Safety	Complied with IEC 60601-1	Complied with IEC60601-1	Similar
EMC	Complied with IEC60601-1-2	Complied with IEC60601-1-2	Similar

Table 1 Comparison of Technology Characteristics

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The intended use, measurement range and accuracy of proposed device and predicate device are different. Intended use of the proposed device and predicate device are the same. The difference is only expression difference. The measurement range and accuracy of proposed device is different from that of the predicated device, but both the proposed device and predicated device comply with IEC 80601-2-56. Therefore, these differences will not affect the substantially equivalency concerning safety and effectiveness.

1. Substantially Equivalent (SE) Conclusion
  Based on the comparison and analysis above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate devices

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

July 26, 2017

ECH (Changzhou) Medical Instrument Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co., Ltd Room 405, Ziguang Mansion No.341 Shangcheng Road Shanghai. 200120 CHINA

Re: K170769

Trade/Device Name: Wireless Thermometer, Models: ECH-b1-L, ECH-b1-M, and ECH-b1-S Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: June 26, 2017 Received: June 27, 2017

Dear Diana Hong:

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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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 devicerelated 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/ResourcesforYou/Industry/default.htm. 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 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/Resourcesfor You/Industry/default.htm.

Sincerely,

for Michael Ryan 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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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.