The Cloud Smart Thermometer is a battery-operated electronic device with intended use of measuring and monitoring human axillary temperature continuously via wireless signal transmission of the measuring result. Meanwhile, the device is reusable and is intended for axillary temperature monitoring for persons over two years old, and it is used for household and medical institutions.

Device Description

The Cloud Smart Thermometer (WT001-1) which is a combination device of thermometer and Bluetooth communication unit is to be worn in the axillary temperature continuously for household and medical institutions.

To start the monitoring operation, switch the thermometer on and place it on the plaster (which is a waterproof medical dressing), and then paste the plaster in the user's axilla. The thermometer will make a Bluetooth connection between the thermometer and the receiver automatically (User should setup Bluetooth properly on receiver). Then the thermometer starts to measure the body temperature by means of testing the thermistor's resistance value and calculates the body temperature every four seconds continuously and sends the temperature data to the receiver through Bluetooth connection.

The thermometer uses a CR2025 battery for operation. When the battery capacity is below 90% rated voltage, internal circuit will detect the low battery condition automatically and send "low battery" signal through Bluetooth communication unit to receiver, then the receiver will send out a warning. Meanwhile, the thermometer is capable of monitoring the axillary temperature continuously for 24 hours and it can also save measured data in the Cloud for remote real-time monitoring.

AI/ML Overview

The extracted text is a premarket notification 510(k) summary for a medical device, the "Cloud Smart Thermometer." This document is focused on demonstrating substantial equivalence to a predicate device, not on proving the device meets specific performance acceptance criteria through a clinical study. Therefore, most of the requested information regarding an acceptance criteria table, sample sizes, expert involvement, ground truth establishment, MRMC studies, or standalone performance studies is not present in the provided text.

The document primarily addresses the device's technical specifications, non-clinical testing for safety and electromagnetic compatibility, and a comparison to a predicate device to argue for substantial equivalence.

Here's a breakdown of the information that can and cannot be extracted from the provided text based on your request:

Information NOT present in the document:

1. A table of acceptance criteria and the reported device performance: While there is a table comparing specifications between the targeted device and the predicate (Table 1 Comparison), it doesn't present "acceptance criteria" in the sense of predefined thresholds for a study to pass, nor does it present "reported device performance" from a clinical study. It shows comparative specifications.
2. Sample sizes used for the test set and the data provenance: No clinical test set or sample size for human subjects is mentioned. The document refers to non-clinical testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no human-based ground truth establishment is described for a clinical study.
4. Adjudication method for the test set: Not applicable as no clinical study with adjudication is described.
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 device is a thermometer, not an AI-assisted diagnostic imaging device that would typically undergo MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The document describes the device's inherent function, but not a "standalone performance" study in the context of an algorithm's diagnostic performance. Its "performance" refers to its accuracy in temperature measurement, which is verified through non-clinical standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth, in the context of a clinical study for diagnostic accuracy, is not discussed. The device's accuracy is presumably verified against a reference standard in non-clinical tests (e.g., a calibrated temperature source), but this isn't detailed as "ground truth" for a clinical performance study.
8. The sample size for the training set: The document does not describe any machine learning/AI training, so no training set is mentioned.
9. How the ground truth for the training set was established: Not applicable.

Information that can be extracted, though not directly in the format requested for a clinical study:

While the document doesn't describe a clinical study to prove the device met acceptance criteria, it does state that the device underwent non-clinical tests to verify it met design specifications. The acceptance criteria for a thermometer typically relate to its accuracy, repeatability, and adherence to specific temperature range tolerances.

Based on Table 1: Comparison on pages 4-5, we can infer some "performance" characteristics and their comparison to the predicate device, which implicitly serve as a proxy for meeting expected performance.

Inferred "Acceptance Criteria" and "Reported Device Performance" (based on Table 1 for the targeted device):

Parameter	Acceptance/Targeted Performance (Cloud Smart Thermometer)	Predicate Performance (Wireless Thermometer, K132761)	Notes
Measuring range	25°C ~ 45°C	25°C ~ 45°C	Both devices have the same measuring range. Implicit acceptance is to match or exceed predicate.
Accuracy	±0.1°C (at 36.0~40.0°C) ±0.2°C (at other temperature range)	±0.05°C (35°C~~38.5°C) ±0.1°C (25°C~~34.99°C and 38.51°C~45°C)	Difference: The targeted device has slightly lower accuracy specified than the predicate in the core temperature range (±0.1°C vs ±0.05°C). The document states: "Although some specifications are slightly different from the predicate device, the thermometer quality has been verified and validated as a part of performance testing..."
Repeatability error	≤0.2°C	N/A	Specific to the targeted device; predicate does not report this. Implicit acceptance is meeting this specified value.
Response time	10 minutes at least required for the device to obtain a steady state reading	8 minutes at least required for the device to obtain a steady state reading	Difference: The targeted device has a longer response time. The document implies this is acceptable through the general statement about verified quality.
Measuring frequency/time	Every 4 seconds	Every 4 seconds	Same. Implicit acceptance is to match predicate.

Details from the document explaining the "proof":

Type of Study / Proof: The document states "Non-clinical tests were conducted to verify that the targeted device meet all design specifications in order to demonstrate that it is Substantially Equivalent to the predicate device." These tests focus on meeting safety and performance standards.
Standards Met (Non-Clinical):
- IEC 60601-1 (Basic safety and essential performance)
- IEC 60601-1-2 (Electromagnetic compatibility)
- IEC 60601-1-11 (Home healthcare environment)
- ISO 80601-2-56 (Particular Requirements For Basic Safety And Essential Performance Of Clinical Thermometers For Body Temperature Measurement)
- ASTM E1112-00 (Reapproved 2011) (Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature)
- CFR 47 FCC PART 15 Subpart C: 2014 section 15.247 (Wireless communication)
- Software verification and validation (for "moderate level of concern")
- Biocompatibility testing for skin-contacting components (ISO 10993-1, ISO 10993-5, ISO 10993-10).

Summary regarding "proof":
The "Cloud Smart Thermometer" demonstrated its performance and safety not through a clinical study with human subjects, but through adherence to a comprehensive set of recognized non-clinical standards for electronic thermometers, electrical safety, electromagnetic compatibility, and biocompatibility. The comparison table highlights its technical specifications against a predicate device, and the slight differences in accuracy and response time are deemed acceptable because the device's "quality has been verified and validated as a part of performance testing and safety /EMC testing." The FDA's 510(k) clearance signifies that the device is "substantially equivalent" to a legally marketed predicate, meaning it is as safe and effective as the predicate device.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure, composed of three stylized human profiles facing to the right.

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

December 13, 2016

Guangzhou Bosma Technology Co Ltd. Guoxing Dai Quality Manager 2nd Floor, Building A5, No.11 Kaiyuan Avenue, Science Park, Guangzhou Hi-tech Industrial Development Zone Guangzhou City, Guangdong Province, P.R China 510530

Re: K160306

Trade/Device Name: Cloud Smart Thermometer Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: November 3, 2016 Received: November 9, 2016

Dear Guoxing Dai:

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.

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

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the quality systems (OS) 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Michael J. Ryan -S

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) K160306

Device Name Cloud Smart Thermometer (WT001-1)

Indications for Use (Describe)

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

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

(1) Applicant information:

Applicant:	GUANGZHOU BOSMA TECHNOLOGY CO LTD2ndFloor, Building A5, No.11, Kaiyuan Avenue, Science Park,Guangzhou Hi-tech Industrial Development Zone, Guangzhou City,Guangdong Province, P.R.China
Contact person:	XingguoDai
Phone number:	+86 1372 603 7760
Fax number:	+86 020 3220 3099
Email:	daixg@bosma.com.cn
Application date:	November 9, 2016

(2) Proprietary name of the device

Trade name/Model:	Cloud Smart Thermometer/WT001-1
Regulation number:	21 CFR 880.2910, Clinical electronic thermometer
Product code:	FLL
Review panel:	General Hospital
Regulation class:	Class II

(3) Predicate device:

K132761 Wireless Thermometer, cleared Jul.8, 2014

(4) Description of device:

The thermometer uses a CR2025 battery for operation. When the battery capacity is below 90% rated voltage, internal circuit will detect the low battery condition automatically and send

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"low battery" signal through Bluetooth communication unit to receiver, then the receiver will send out a warning. Meanwhile, the thermometer is capable of monitoring the axillary temperature continuously for 24 hours and it can also save measured data in the Cloud for remote real-time monitoring.

(5) Indications for Use:

(6) Technological characteristics and substantial equivalence:

The following table compares the device to the predicate device(Wireless Thermometer, K132761, cleared Jul.08, 2014) with respect to intended use, technological characteristics, principles of operation, etc.

Device	Targeted device	Predicate device 1		year
Trade name	Cloud Smart Thermometer	Wireless Thermometer	Measuring range	25°C ~45°C	25°C~45°C
510(k) number	K160306	K132761	Accuracy	±0.1°C (at 36.0~40.0°C);±0.2°C (at other temperaturerange);	±0.05°C (35°C~~38.5°C)±0.1°C (25°C~~34.99°C) and(38.51°C~45°C)
Regulationnumber	21CFR 880.2910	21CFR 880.2910	Repeatability error	≤0.2°C	N/A
Regulationdescription	Clinical electronic thermometer	Clinical electronic thermometer	Temperature unit	°C or °F (settable in App)	°C or °F
Classificationname	Thermometer, Electronic, Clinical	Thermometer, Electronic, Clinical	Display unitspecification	iOS or Android device display	iOS device Display
Product code	FLL	FLL	Signaltransmission	Wireless 2.4G Bluetooth 4.0	Wireless 2.4G Bluetooth BLE
Device class	II	II	Receiver (mobileterminal)	iOS7.0 or above smartphone ortablet:Android 4.3 or above smartphone,tablet or television	iPhone 4S, iPhone 5, iPad(3rd generation), iPad (4thgeneration), iPad mini, iPod touch(5th generation)
Working voltage	DC3V	DC3V	Valid transmissiondistance	Up to 15 meters (under barrier-freeenvironment)	Up to 5 meters
Batteryspecification	MAXELL CR2025 Buttonbattery(3.0V, 170mAh)	The button battery 3.0V, 210mAh	Response time	10 minutes at least required for thedevice to obtain a steady statereading	8 minutes at least required for thedevice to obtain a steady statereading
Battery life	--Continuous measurement:120hours Note: you will get a lowbattery indication when the batterycapacity is below 90% rated voltage--Standby time: no less than half a	120 days at 8 hours per dayNote: frequent synchronization ofdata may deplete power morequickly	Measuringfrequency/time	Every 4 seconds	Every 4 seconds
Storage time(Bluetoothsendingfrequency)	Three modes:--Accuracy mode, data saved every4 seconds--Power mode, data saved every 60seconds, a default mode--Ultra Power Saving mode, datasaved every 120 seconds	N/A
Operatingtemperature	0°C ~+40°C	5°C~40°C
Operatinghumidity	15%~85% (non-condensing)	15~85%

Table 1 Comparison

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Indications for use/Intended use	The Cloud Smart Thermometer is a battery-operated electronic device with intended use of measuring and monitoring human axillary temperature continuously via wireless signal transmission of the measuring result. Meanwhile, the device is reusable and is intended for axillary temperature monitoring for persons over two years old, and it is used for household and medical institutions.	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 reusable and intended for armpit temperature monitoring for persons over two years old.
Location for use	OTC	OTC
Thermometer type	Axilla	Armpit
Shelf life	3 years	5 years
Skin-contacting components	Plastic shell, temperature sensor, medical plasters	Plastic shell, temperature probe, medical patches
Materials of skin-contacting components	Plastic shell: ABSTemperature Sensor: Stainless steel 304Medical plaster: medical waterproof dressing	Plastic shell: ABSTemperature probe: N/AMedical patches: medical dressing
Materials	ISO 10993-1:2009ISO 10993-5:2009/(R) 2014	GB/T16886.1-2011GB/T16886.5-2003

Discussion of feature comparison:

The Cloud Smart Thermometer, Model WT001-1 has similar indications for use and technological characteristics as the predicate device:

A WT001-1 has the same intended use as the predicate device: to measure axillary temperature.
A The same and/or similar technologies and parameters are used in WT001-1 thermometers as the predicate device.
A The identified differences in technological characteristics do not raise new or different questions of safety and effectiveness.
A Although some specifications are slightly different from the predicate device, the thermometer quality has been verified and validated as a part of performance testing and safety /EMC testing and the results are included as a part of this submission. Performance information and evidence of compliance to recognized standards demonstrate the device is

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substantially equivalent to the predicate device.

A The targeted device may connect to iOS device and Android device through wireless method, but the predicate device can only connect to iOS device. Risk analysis and associated verification (include cybersecurity test, FCC test and wireless verification) have been performed that the wireless feature is acceptable.
Both devices use similar materials for construction and have direct skin surface contact.

Based upon the same intended use, similar materials for device construction, product specification and operation, as well as performance testing, it could be concluded that the Cloud Smart Thermometer, Model WT001-1 device is substantially equivalent to the predicate device.

(7) Non-clinical studies and tests performed:

Non-clinical tests were conducted to verify that the targeted device meet all design specifications in order to demonstrate that it is Substantially Equivalent to the predicate device. The test results demonstrate that the targeted device complies with the following standards:

A IEC 60601-1Medical electrical equipment –Part 1: General requirements for basic safety and essential performance
IEC 60601-1-2 Medical electrical equipment -Part 1-2: General requirements for basic safety and essential performance -Collateral standard: electromagnetic compatibility
A IEC 60601-1-11 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
A 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
A ASTM E1112-00 (Reapproved 2011) Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature
CFR 47 FCC PART 15 Subpart C: 2014 section 15.247 under the operating frequency of 2400~2483.5MHz

Software verification and validation: Software documentation consistent with moderate level of concern is submitted in this 510(k). System validation testing presented in this 510(k) demonstrate that all software requirement specifications are met and all software hazards have been mitigated to acceptable risk levels. And Cybersecurity test is performed in accordance with "Content of Premarket Submission for Management of Cybersecurity in Medical Devices".

The body-contacting components of this device (plastic shell, temperature sensor, and medical plaster) were tested according to ISO 10993-1 for skin-contacting biocompatibility:

A ISO 10993-5:2009/(R) 2014, 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.

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(8) Conclusion

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

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.