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.

Device Description

The wireless thermometer, WT701, which is the combination device of thermometer and Bluetooth communication unit intended to be worn at axilla to monitor the armpit temperature continuously. For the monitoring operation, switch the thermometer on and stick the thermometer 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 measures the body temperature by means of testing the NTC resistance value and calculates the body temperature every 4 seconds continuously and sends the temperature data to the receiver through Bluetooth connection. The wireless thermometer uses a CR2032 battery for operation. When the battery is low, internal circuit will detect the low battery condition automatically and send "low battery" signal through Bluetooth communication unit to receiver.

AI/ML Overview

Here's the analysis of the provided text, focusing on acceptance criteria and supporting study details:

Acceptance Criteria and Device Performance Study for Wireless Thermometer (K132761)

The provided document describes the 510(k) submission for the Raiing Medical Company Wireless Thermometer, Model WT701. The core of the information regarding acceptance criteria and device performance is found in the "Comparison of Technology Characteristics" table and the "Non-Clinical Test Conclusion" section.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Wireless Thermometer WT701 are primarily outlined by its specifications, which are compared to a predicate device. The performance is reported as meeting these specifications and complying with relevant standards.

Acceptance Criteria (Specification / Standard)	Reported Device Performance
Measurement Range	25 °C ~ 45 °C
Accuracy	±0.05℃ (35℃-38.5℃)
	±0.1℃ (25℃-34.99℃ and 38.51°C-45°C)
Operating Temperature	5℃~40℃
Operating Humidity	15-85%
Signal Transmission (Valid distance)	Up to 5 meters
IEC60601-1:2005 (Basic safety & essential performance)	Complies
IEC 60601-1-2:2007 (EMC)	Complies
FCC Part 15 Subpart C & 15.247 (Wireless)	Complies
ASTM E1112-00: 2006 (Intermittent Temp)	Complies
EN 12470-4: 2000+A1:2009 (Continuous Temp)	Complies
Performance Test (Dimension, Weight, Accuracy transmission)	Conducted and met specifications

2. Sample Size and Data Provenance

The document does not specify the sample size used for any of the tests, nor does it explicitly state the data provenance (e.g., country of origin, retrospective or prospective nature). The tests are categorized as "non-clinical tests" and "performance tests," suggesting laboratory-based assessments rather than patient-based clinical trials for establishing accuracy.

3. Number and Qualifications of Experts for Ground Truth

The document does not mention the involvement of experts to establish ground truth for testing. Given the type of device (thermometer) and the standards cited (e.g., ASTM E1112, EN 12470-4), the "ground truth" for temperature measurements would typically be established by calibrated reference thermometers or environmental chambers, not human experts.

4. Adjudication Method

The document does not mention any adjudication method, as it does not describe a study involving human interpretation or subjective measurements that would require adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

There is no mention of an MRMC comparative effectiveness study involving human readers. This device is a measurement tool, not an interpretive diagnostic aid, so such a study would not be applicable.

6. Standalone Performance Study

Yes, a standalone performance assessment was conducted. The "Non-Clinical Test Conclusion" section states that "Non-clinical tests were conducted to verify that the proposed device met all design specifications" and complied with various standards (IEC, FCC, ASTM, EN). These tests assess the algorithm's and hardware's ability to accurately measure temperature independently. Specific performance tests mentioned include:

Dimension Test
Weight Test
Accuracy transmission test under a complex electromagnetic environment
Compliance with accuracy specifications: ±0.05℃ (35℃-38.5℃) and ±0.1℃ (25℃-34.99℃ and 38.51°C-45°C).

7. Type of Ground Truth Used for Standalone Performance

The type of ground truth used for the standalone performance testing would have been calibrated reference standards and physical measurements. For temperature accuracy, this implies using highly accurate, traceable reference thermometers and controlled environments (e.g., temperature-controlled baths or chambers) to simulate body temperatures across the specified range. For other tests like dimension, weight, and signal transmission, physical measurement tools and electromagnetic compatibility testing equipment would serve as the ground truth.

8. Sample Size for the Training Set

The document does not provide any information regarding a training set sample size. This is expected as the device appears to be a hardware-based electronic thermometer, not a device employing machine learning or AI that typically requires training data.

9. How Ground Truth for the Training Set Was Established

As there is no mention of a training set or machine learning/AI components, this information is not applicable and is not provided in the document. The device's functionality is based on direct physical measurement of NTC resistance and conversion to temperature.

Summary

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JUL 08 2014

Section 3 510(k) Summary

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

The assigned 510(k) Number: K132761

Prepared Date: Aug. 26, 2013
Sponsor Identification

イ

Raiing Medical Company 21 Huoju St, Beijing, China

Establishment Registration Number: 3010052175

Mr. Wu Wei

Title: General Engineer Email: tjww@raiing.com Tel: 86-10-64118658

Fax: 86-10-80115555 ext. 776445 Raiing Medical Company 21 Huoju St, Beijing, China

Submission Correspondent

Mr. Wu Wei
Title: General Engineer Email: tjww@raiing.com Tel: 86-10-64118658 Fax: 86-10-80115555 ext. 776445 Raiing Medical Company

21 Huoju St, Beijing, China

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4. Proposed Device Identification

Proposed Device Name: Wireless Thermometer Proposed Device Common Name: Thermometer

Regulatory Information: Classification Name: Clinical Electronic Thermometer; Classification: II; Product Code: FLL; Regulation Number: 21 CFR 880.2910; Review Panel: General Hospital;

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. This system is reusable and intended for armpit temperature monitoring for persons over two years old.

Predicate Device Identification

510(k) Number: K121696 Predicate Device Name: Wireless Thermometer WTM-BT30-I Manufacturer: Raiing Medical Company

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Device Description 6.

The wireless thermometer, WT701, which is the combination device of thermometer and Bluetooth communication unit intended to be worn at axilla to monitor the armpit temperature continuously.

For the monitoring operation, switch the thermometer on and stick the thermometer 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 measures the body temperature by means of testing the NTC resistance value and calculates the body temperature every 4 seconds continuously and sends the temperature data to the receiver through

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Bluetooth connection.

The wireless thermometer uses a CR2032 battery for operation. When the battery is low, internal circuit will detect the low battery condition automatically and send "low battery" signal through Bluetooth communication unit to receiver.

7. Non-Clinical Test Conclusion

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:
IEC60601-1:2005 Medical electrical equipment Part 1: General requirements for basic safety and essential performance

IEC 60601-1-2:2007 Medical electrical equipment- Part 1-2: General requirements for basic safety and essential performance- Collateral standard: Electromagnetic compatibility- Requirements and tests

FCC Part 15 Subpart C test FCC Part 15.247

ASTM E1112-00: 2006 Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature.

EN 12470-4: 2000+A1:2009 Clinical thermometers Part-4: performance of electrical thermometers for continuous measurement.

And the proposed device also conducted the performance test, which include Dimension Test, Weight Test, and accuracy transmission test under a complex electromagnetic environment.

8. Substantially Equivalent (SE) Conclusion

The following table compares the DEVICE to the predicate device with respect to intended use, technological characteristics and principles of operation, etc.

ITEM	Proposed Device	Predicate Device
	WT701	K121696
Product Code	FLL	FLL
Regulation No.	880.2910	880.2910
Class	Class II	Class II

Table 3-1 Comparison of Technology Characteristics

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	ThermometerTheWirelessisa	Wireless Thermometer, modelThe
	electronicbattery-operateddevice	WTM-B530-1, is a battery-operated
	with intended use of measuring and	electronicdeviceelectedwith
	monitoring human armpit temperature	measuringintendeduse ofand
	continuouslyvia wirelesssignal	monitoring human armpit temperature
Intended Use	transmission of the measuring result.	wirelesscontinuouslyviasignal
	This system is reusable and intended	transmission of the measuring result.
	for armpit temperature monitoring for	systemis reusable and isThis
	persons over two years old.	armpit temperatureintendedfor
		monitoring for persons over two years
		old.
Display Unit Specification	iOS device Display	LED and iOS device Display
Working voltage	DC3V	DC3.7V
Battery	The button battery 3.0 V, 210mAh	Internal 3.7V, 100mAh Li Battery
Measurement range	25 °C ~ 45 °C	:25 ℃~45 ℃
Accuracy	+0.05℃(35℃-38.5℃)	+0.1°C
	±0.1℃(25℃-34.99℃ and
	38.51°C-45°C)
Temperature unit	°C or °F	°C or °F
Signal transmission	Wireless 2.4G Bluetooth BLE	Wireless 2.4G Bluetooth 3.0
Receiver	iPhone 4S, iPhone 5, iPad(3rd	iPod touch 4, iPhone 4, iPhone 4S,
	generation), iPad(4th	iPad, iPad 2, The new iPad
	generation), iPad mini, iPod
	touch(5th generation)
Valid transmission distance	Up to 5 meters	Up to 5 meters
Operating Temperature	5℃~40℃	5°C-40 °C
Operating Humidity	15-85%	15-85%

Based on the comparison and analysis above, the proposed device is determined to be Substantially Equivalent (SE) 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

July 8, 2014

Raiing Medical Company Mr. Wei Wu General Engineer No.11 Huatong Rd Beijing CHINA

Re: K132761

Trade/Device Name: Wireless Thermometer, Model W7701 Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical electronic thermometer Regulatory Class: Class II Product Code: FLL Dated: June 3, 2014 Received; June 6, 2014

Dear Mr. Wu:

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 - Mr. Wu

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); 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" (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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.goy/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mary S. Runner -S

Erin I. Keith, M.S. 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) K132761

Device Name Wireless Thermometer, Model WT701

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)

PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Digitally signed by Richard C. Chapman -S Date: 2014.07.08 11:26:01 -04'00'

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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.