WIRELESS THERMOMETER

K121696 · Raling Medical Company · FLL · Oct 11, 2012 · General Hospital

Device Facts

• Record ID: K121696
• Device Name: WIRELESS THERMOMETER
• Applicant: Raling Medical Company
• Product Code: FLL · General Hospital
• Decision Date: Oct 11, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2910
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Wireless Thermometer, model WTM-BT30-I, 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 is intended for armpit temperature monitoring for persons over two years old.

Device Story

Battery-operated electronic thermometer; measures human armpit temperature continuously; transmits data via Bluetooth to receiver for real-time display. Reusable device; intended for use in persons over two years old. Provides continuous monitoring; enables healthcare providers or users to track temperature trends; facilitates clinical decision-making regarding fever management or patient status. Operates via wireless signal transmission.

Clinical Evidence

Bench testing only. Conformance to IEC 60601-1 (electrical safety), IEC 60601-1-2 (electromagnetic compatibility), and ASTM E1112-00 (performance) demonstrated. Biocompatibility testing conducted per ISO 10993-1, -5, -10, and -12.

Technological Characteristics

Battery-operated electronic thermometer; wireless (Bluetooth) data transmission. Materials meeting skin-contact biocompatibility requirements (ISO 10993). Performance standards: ASTM E1112. Electrical safety: IEC 60601-1. Electromagnetic compatibility: IEC 60601-1-2 and FCC Part 15.

Indications for Use

Indicated for continuous armpit temperature monitoring in persons over two years of age.

Regulatory Classification

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.

Special Controls

(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.

Predicate Devices

• K100226/RIO FLEXON TECHNOLOGY CO., LTD.

Submission Summary (Full Text)

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# Section 1 510(k) Summary

#### As required by 807.92

## The assigned 510(k) Number is 12 1696

Sponsor

Raiing Medical Company No. 11, Huatong Rd., Beijing, China 102200 Mr. Wu Wei, General Engineer Tel:[phone] Fax: [phone] ext. 776445 Email: [e-mail]

Submission Correspondent Mr. Wu Wei Raiing Medical Company No. 11, Huatong Rd., Beijing, China 102200 Tel: [phone] Fax: [phone] ext. 776445 Email: [e-mail]

Wireless Thermometer

WTM-BT30-I

21 CFR 880.2910

FLL

Class II

New Device

Proposed Product

Trade Name Model Product Code: Regulation Number: Device Class:

Submission Purpose:

Predicate Device:

K100226/RIO FLEXON TECHNOLOGY CO., LTD.

The proposed device is use to measure, monitor and record Device Description the body temperature in armpit, and transmits the data recorded to receiver for display by wireless (blue tooth) way in real time.

Test Conclusion IEC 60601-1 IEC 60601-1-2 ASTM E1112-00

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FCC Part 15 Performance Test

The proposed device is Substantially Equivalent (SE) to the SE Determination predicate device which is US legally market device. Therefore, the subject device is determined as safe and effectiveness. Please refer to the brief SE Comparison Table as following.

#### Intended Use/Indication for Use

The Wireless Thermometer, model WTM-BT30-I, 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 is intended for armpit temperature monitoring for persons over two years old.

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| Comparison Elements | Proposed Device | Predicate Device (K100226) | |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------|
| Intended Use | The Wireless Thermometer, model WTM-B530-I, 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 is intended for armpit temperature monitoring for persons over two years old. | The Wireless body temperature monitor, model BTM-D1x series are the battery-operated electronic devices with intended use of measuring human ear temperature precisely and continuously monitors armpit temperature via wireless signal transmission of measuring result. This device is reusable and intended for ear temperature measurements as well as the armpit temperature monitor for the person above two years old. | |
| Device Specifications | The proposed device has the similar device specification with the predicate device without new risk of safety and effectiveness. | | |
| Material Specification | All materials used for skin-connecting are meet the requirements of FDA and the biocompatibility test has been conducted. | | |
| Safety and Performance | Biocompatibility | Conformed to ISO 10993-1, ISO 10993-5, ISO10993-10, ISO10993-12. | Conformed to ISO 10993-1, ISO 10993-5, ISO10993-10, ISO10993-12. |
| | Electrical Safety | Conformed to IEC 60601-1 | Conformed to IEC 60601-1 |
| | Electromagnetic Compatibility | Conformed to IEC 60601-1-2 and FCC | Conformed to IEC 60601-1-2 and FCC |
| | Performance | Conformed to ASTM E1112 | Conformed to ASTM E1112 |

:

Brief SE Comparison Table between the Proposed Device and Predicate Device

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Image /page/3/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, a symbol often associated with medicine and healthcare.

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

Raiing Medical Company
Mr. Wu Wei
General Engineer
No. 11, Huatong Road
Beijing, China 102200

OCT 1 1 2012

Re: K121696

Trade/Device Name: Wireless Thermometer WTM-BT30-I Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: September 10, 2012 Received: September 10, 2012

Dear Mr. Wei:

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. Wei

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 go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

For S. Shultz

Anthony D. Watson, B.S., M.S., M.S., M.B.A. Director

Division of Anesthesiology, General Hospital, 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): _ k121696

Device Name: Wireless Themometer /Model: WTM-BT30-I

Indications For Use:

The Wireless Thermometer, model WTM-B530-I, is a battery-operated elected 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 is intended for armpit temperature monitoring for persons over two years old.

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

Over-The-Counter Use (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)

Rill Chaye 9/21/12

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

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**510(k) Number:** K121696