MONITORING EAR THERMOMETER, MODEL BTM-D1A

K062445 · Rio Flexon Technology Co., Ltd. · FLL · Feb 16, 2007 · General Hospital

Device Facts

• Record ID: K062445
• Device Name: MONITORING EAR THERMOMETER, MODEL BTM-D1A
• Applicant: Rio Flexon Technology Co., Ltd.
• Product Code: FLL · General Hospital
• Decision Date: Feb 16, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2910
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Monitoring Ear Thermometer, model BTM-D1A is the battery-operated electronic devices with intended use of measuring human ear temperature precisely and continuously monitor armpit temperature via wireless signal transmission of measuring result. This device is reusable and intended for ear temperature measurement as well as the armpit temperature monitor for the person above two years olds.

Device Story

BTM-D1A is a combination device consisting of a receiver unit and a wearable armband. The armband contains a thermo sensor and wireless transmitter to monitor armpit temperature continuously; the receiver unit features an ear thermometer, LCD display, and operation keys. Upon activation, the armband transmits temperature data wirelessly to the receiver every 12 seconds. Users can manually trigger ear temperature measurements using the receiver's functional key, which temporarily interrupts the armpit monitoring display. The device is battery-operated and includes an ASIC circuit for low-battery detection. It is intended for use by patients or caregivers to track temperature trends, aiding in clinical decision-making regarding fever management.

Clinical Evidence

Bench testing only. The submission relies on performance data from the predicate devices (Taidoc TD-1107) for the ear thermometry function. No new clinical data was generated for this submission. Compliance with ASTM E1112-00 and ASTM E1965-02 standards was verified.

Technological Characteristics

Battery-operated (3.0V DC) electronic thermometer. Features wireless signal transmission (armband to receiver). Includes thermo sensor, ASIC circuit for low-battery detection, and LCD display. Designed to ASTM E1112-00 and ASTM E1965-02 standards. Complies with EN 60601-1-1 and EN 60601-1-2.

Indications for Use

Indicated for human ear temperature measurement and continuous armpit temperature monitoring in patients above 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

• Taidoc Ear/skin/surface IR thermometer, model clever TD-1107 (K050463)
• Funai Wireless thermometer, model RT-901 (K003326)

Submission Summary (Full Text)

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Rio Flexon Technology Co., Ltd.

## FEB 1 6 2007

## 510(K) SUMMARY

02445

Page 1

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is: Submitter's Identifications: Rio Flexon Technology Co., Ltd. 15F., No. 868-2, Jhong Jheng Rd., Jhonghe City, Taipei County 235, Taiwan, R.O.C.

Contact: Jeff Liao Date of Summary Preparation: August 20, 2006

- 1. Name of the Device: Monitoring Ear Thermometer, model BTM-D1A.
- 2. Information of the 510(k) Cleared Device (Predicate Device): Taidoc Ear/skin/surface IR thermometer, model clever TD-1107 (K050463). Funai Wireless thermometer, model RT-901 (K003326).
- 3. Device Description:

The Monitoring Ear Thermometer/model BTM-D1A is the combination device of ear thermometer and wireless temperature monitor intended to be worn at left arm to monitor the armpit temperature continuously.

BTM-D1A is composed of two operational parts, the receiver and armband. The receiver is the main operation unit on which the ear thermometer, the measuring circuit, LCD display control circuit and the main operation keys are included. And the armband was designed and constructed with the thermo sensor and the signal communication unit and is to be worn at left arm for the continuous armpit temperature monitor.

For the monitoring operation, both receiver and armband shall be switched on. Sooner after these two parts are switched on, the wireless signal communication will be set up between receiver and armband. The temperature monitoring signal measured at armpit will be continuously indicated on the LCD of receiver every 12 sec.

In addition to the continuous armpit temperature monitoring, the user can also operate the functional key on receiver to take temperature measurement on ear any time he needs. The LCD will be returned to armpit temperature monitor as soon as the ear temperature measurement operation is completed.

This system uses a 3.0V DC battery for operation of complete system. Whenever the battery is low, the ASIC circuit will detect the low battery condition automatically, and displays 'Low battery' in LCD display. Regarding the performance of BTM-D1A, it was designed and verified according to the US standard AŠTM E1112-00 and ASTM E1965-02.

## Intended Use:

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The Monitoring Ear Thermometer, model BTM-D1A is the battery-operated electronic devices with intended use of measuring his the Datery-operature precisely and continuously monitor armpit temperature via wireless signal transmission of measuring result. This device is reusable and intended for ear temperature measuring result. This aevice is reusers is reuseded and
above two vears olds above two years olds.

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Rio Flexon Technology Co., Ltd.

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- 5. Comparison to the 510(k) Cleared Device (Predicate Device):
- mparison to the 510(K) Cleared Dowled (1 realisation at ampit is to be compared to the Funai wireless thermometer model RT-9101 (K003326).
- thermometer model R1-9101 (K00520).
The ear thermometer function is to be compared to the Taidoc Ear/Skin/Surface IR thermometer model TD-107 (K050463).
- Discussion of Non-Clinical Tests Performed Determination of Substantial Eguivalence are as follows 6. Discussion of Non-Cliffical Tests Fenomed Decoludes ASTM E1112: 2000, ASTM E1965: 2002, as 2002, as 2002, as 1 Compliance to applicable voluntaly standalus norm. 11.2. 2011.
well as EN 60601-1-1, and EN 60601-1-1, and EN 60601-1-2 requirement. All of the required conformity well as were included on the 510(k) submission documents.
- 7. Discussion of clinical report for measurement accuracy:

Discussion of clinical report for measurement assured in of the chosen 510(k)
Since the ear temperature measuring function of BTM-D1A submission (K0504) Since the ear temperature the administration of the Don't and on Taidors on (KO50463)
clear model: Taidoc/TD-1107, the clinical report as included on Taidors for RTM-D1A clear model: Taldoc/TD-1107, the cimical report as model on is still available for BTM-D1A.

No additional clinical report is included on this 510(k) submission.

- Conclusions 8.
Conclusions
The Rio Flexon / Monitoring Ear Thermometer, model BTM-D1A has the same intended use and Tairling The Rio Hexon / Montoning Ear Themionece, in our Drive of France (KRT-910) (K003326) and Taide technological characteristics as the cleared using on I alidation tests contained in this submission model TD-1107 (KU504G5). Moreover, Vennounce and the difference in the submitted
demonstrate that the difference in the submitted demonstrate that the difference in the submi demonstrate that the ullierence in the babmitted combins as that of cleared device.

In the other words, those engineering difference do not: (1) affect the intended use or (2) alter the in the other words, those engineening alliorenos us not (-) it is reasonable to conclude that fundamental scientific technology of the chosen predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Jeff Liao Official Correspondent RIO Flexon Technology Company, Limited 15F, 868-2, Jhong Jheng Road Jhonghe City Taipei County Taiwan 235

FEB 1 6 2007

Re: K062445

Trade/Device Name: Monitoring Ear Thermometer / Model: BTM-D1A Regulation Number: 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: January 26, 2007 Received: January 29, 2007

Dear Mr. Liao:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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. Liao

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/industry/support/index.html.

Sincerely yours.

Chiu Lin, Ph.D.

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):

Device Name: Monitoring Ear Thermometer / Model: BTM-D1A.

Indications For Use:

The Monitoring Ear Thermometer, model BTM-D1A is the battery-operated electronic devices with intended use of measuring human ear temperature precisely and continuously monitor armpit temperature via wireless signal transmission of measuring result. This device is reusable and intended for ear temperature measurement as well as the armpit temperature monitor for the person above two years olds.

Prescription Use (Part 21 CFR 801 Subpart D)

OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Chm

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