Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard electronic thermometer with wireless transmission and display of temperature readings. There is no mention of AI, ML, or any complex data processing beyond basic measurement and display.

Therapeutic

No
The device is solely for measuring and monitoring body temperature, not for treatment or diagnosis of a disease.

Diagnostic

Yes.
The device measures human ear and armpit temperature, which is used to monitor an individual's health status. Temperature measurement can be a key indicator in diagnosing various medical conditions.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a battery-operated electronic device composed of a receiver and an armband, both containing hardware components like sensors, circuits, and a display.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an In Vitro Diagnostic (IVD).

Here's why:

IVDs are used to examine specimens derived from the human body. The intended use and device description clearly state that this device measures human ear and armpit temperature directly from the body. It does not analyze blood, urine, tissue, or any other bodily fluid or substance.
The device's function is temperature measurement and monitoring. This is a physiological measurement taken directly from the patient, not an analysis of a biological sample.

Therefore, the Wireless Body temperature monitor, model BTM-D1x series, falls under the category of a medical device but not specifically an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Wireless Body temperature monitor, model BTM-D1x series (model BTM-D1C, D, E, F, G and H) is 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 measurement as well as the armpit temperature monitor for the person above two years old. In which, model BTM-D1C is with two functions of ear temperature measurement and armpit temperature monitor; the rest of models, BTM-D1D, E, F, G and H are only with the function of armpit temperature monitor.

Product codes

FLL

Device Description

The Wireless body temperature monitor, BTM-D1X series include the BTM-D1C, D, E, F, G and H, which are the battery-operated electronic devices with intended to be worn at left arm to monitor the armpit temperature continuously. In addition, BTM-D1C has additional function of ear thermometer.

The device 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. 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 if needed. The LCD will be returned to armpit temperature monitor after 30 sec.

This system uses a 3.0V DC battery for operation of complete system. Whenever the battery is low, the MCU circuit will detect the low battery condition automatically, and displays "Low battery" in LCD display. Regarding the performance of BTM-D1X series, it was designed and verified according to the US standard ASTM E1112-00 and ASTM E1965-02.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Ear, armpit

Indicated Patient Age Range

The person above two years old.

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-Clinical Tests Performed:

Compliance to applicable voluntary standards including ASTM E1112:2000, ASTM E1965:2002, as well as EN 60601-1 and EN 60601-1-2 requirement.
All required conformity reports were included on the 510(k) submission documents.

Clinical Report for Measurement Accuracy:

The ear temperature measuring function of BTM-D1x series (only for BTM-D1C) is an integration of the chosen 510(k) cleared model: Taidoc/TD-1107.
The clinical report for measurement accuracy, as required by ASTM E1965:2002, included in Taidoc's 510(k) submission (K050463) is considered available for BTM-D1x series.
No additional clinical report is included in this 510(k) submission.

Performance Tests conducted:

EN 60601-1: Performed by Electronics Testing Center, Taiwan
EN 60601-1-2/ EN 300 440-2/ EN 3011489-1/-3: Performed by Electronics Testing Center, Taiwan
ASTM/ E 1112-00: Performed by Rio Flexon Technology Co., Ltd
ASTM/ E 1965-02: Performed by Taidoc Technology Corporation
Biocompatibility (ISO 10993): Performed by Taiwan National Chung-Hsing University Lab.
FCC: Performed by Electronics Testing Center, Taiwan

Key Results:

The tests performed demonstrate that the difference in the submitted models could maintain the same safety and effectiveness as the predicate device.
The technological characteristics do not raise any new questions of safety and effectiveness.
The major function and software are the same, except for the product appearance differences, which do not affect the intended use or alter the fundamental scientific technology of the device.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Accuracy for armpit temperature: +- 0.1C
Accuracy for ear temperature: +- 0.2C for 36C ~ 39C ; +- 0.3C for the others

Predicate Device(s)

K062445

Reference Device(s)

K050463

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

0

( P. 1366)

1.3 510(k) SUMMARY

MAY 2 7 2008

510(K) SUMMARY

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

The assigned 510(k) number is: _ KØ8/256

Manufacturer:

RIO FLEXON TECHNOLOGY CO., LTD 15F, No 868-2, Jhongjheng Road, Jhonghe City Taipei County, 235, Taiwan

Official Correspondent:

Mr. Chi-Hung, Liao / General Manager 15F, No 868-2, Jhongjheng Road, Jhonghe City Taipei County, 235, Taiwan Tel: 886-2-8221 8199 Fax: 886-2-8221 8198 E-amil: Jeff-Liao@rio-flexon.com.tw

US agent and correspondent:

Mr. Jeff Chen / Manager APEX computer technology 18467 Railroad Street, City of Industry CA 91789, USA Tel: 1-626-912 1894 Fax: 1-626-912 3694 E-mail: jeff@apextechusa.com

Date of Submission:

8/Oct/2007

Classification name:

Clinical Electronic Thermometer / Class II

1

K 431256 (1220F6)

Proprietary Name:

Wireless Body Temperature Monitor/ BTM-D1X series (BTM-D1C, D, E, F, G & H)

Common name:

Wireless Body Temperature Monitor

Regulatory Reference:

21 CFR 880.2910

Predicate Device:

Rio Flexon Technology Co., Ltd BTM-D1A/ Monitor Ear Thermometer, K062445

Intended Use:

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 measurement as well as the armpit temperature monitor for the person above two years old.

Device Descrintion:

The Wireless body temperature monitor, BTM-D1X series include the BTM-D1C, D, E, F, G and H, which are the battery-operated electronic devices with intended to be worn at left arm to monitor the armpit temperature continuously. In addition, BTM-D1C has additional function of ear thermometer.

The device 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. 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 if needed. The LCD will be returned to armpit temperature monitor after 30 sec.

2

(43/256 (93000)

This system uses a 3.0V DC battery for operation of complete system. Whenever the battery is low, the MCU circuit will detect the low battery condition automatically, and displays "Low battery" in LCD display. Regarding the performance of BTM-D1X series, it was designed and verified according to the US standard ASTM E1112-00 and ASTM E1965-02.

Comparison to Predicated Devices:

Here the predicated device is BTM-D1A/ Monitoring Ear Thermometer, K062445 which BTM-D1x series is completely expanding from the predicated device, BTM-D1A has ear thermometer function and armpit temperature monitoring function. And BTM-D1x series include 6 models, BTM-D1C/D/E/F/G &H; BTM-D1C has ear thermometer function and armpit temperature monitoring function which is the same as the predicated device; the rest of models, BTM-D1D~H, only has armpit temperature monitoring function. The main difference between BTM-D1x series with the predicated device BTM-D1A is the appearance different only. The function and the software are substantially equivalent in safety and effectiveness to the K062445 Monitoring Ear Thermometer, BTM-D1A. The table below has comparison between predicated device, BTM-D1A, and the BTM-D1X series.

| Element of comparison | BTM-D1A
(Predicated Device) | BTM-D1C (BTM-D1X series) | BTM-D1D ~ H
(BTM-D1X series) |
|----------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Ear Thermometer type | Infrared tympanic
thermometer | Infrared tympanic
thermometer | N/A |
| Intended use | 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 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 | This device is
intended to
continuously
monitor
armpit
temperature
via wireless
signal
transmission
of measuring
result. The
device is |
| | intended for ear
temperature
measurement as
well as the armpit
temperature
monitor for the
person above two
years old. | measurement as well as
the armpit temperature
monitor for the person
above two years old. | intended to be
used for two
years old
above. |
| Brand Name | Rio Flexon | Rio Flexon | Rio Flexon |
| Signal processing and
display | Wireless 2.4G
transmission & display
on LCD screen of
monitor | Wireless 2.4G
transmission & display
on LCD screen of
monitor | Wireless 2.4G
transmission &
display on LCD
screen of monitor |
| Power requirements of
Armband | 3V / CR2032 Lithium | 3V / CR2032 Lithium | 3V / CR2032
Lithium |
| Power requirement of
Receiver | AAA battery x 2pcs | AAA battery x 2pcs | AAA battery x
2pcs |
| Temperature range | $25℃ ~ 43℃$ | $25℃ ~ 43℃$ | $25℃ ~ 43℃$ |
| Ambient temperature | $15℃ ~ 42℃$ (with
95% RH humidity) | $15℃ ~ 42℃$ (with
95% RH humidity) | $15℃ ~ 42℃$
(with 95% RH
humidity) |
| Storage condition | $-20℃ ~ 50℃$ (with
95% RH humidity) | $-20℃ ~ 50℃$ (with
95% RH humidity) | $-20℃ ~ 50℃$
(with 95% RH
humidity) |
| Accuracy for armpit
temperature | $\pm 0.1℃$ | $\pm 0.1℃$ | $\pm 0.1℃$ |
| Accuracy for ear
temperature | $\pm 0.2℃$ for $36℃ ~$
$39℃$ ; $\pm 0.3℃$ for the
others | $\pm 0.2℃$ for $36℃ ~$
$39℃$ ; $\pm 0.3℃$ for the
others | N/A |
| Monitoring time | 24 hours | 24 hours | 24 hours |
| components | 1. Receiver IC#:
HT-49R50
2. Armband IC#:
HT-46R52
3. Ear temperature
measuring module | 1. Receiver IC#:
HT-49R50
2. Armband IC#:
HT-46R52
3. Ear temperature
measuring module | 1. Receiver IC#:
HT-49R50
2. Armband IC#:
HT-46R52
3. RF
transmission |
| | 4. RF transmission module (2.4GH) | 4. RF transmission module (2.4GHz) | module (2.4GHz) |
| Sensor | SENTECH sensor | SENTECH sensor | SENTECH sensor |
| Electrical safety standard | EN 60601-1 | EN 60601-1 | EN 60601-1 |
| EMC conformity | EN 60601-1-2 & FCC | EN 60601-1-2 & FCC | EN 60601-1-2 & FCC |
| Conformity of
Bio-compatibility for
the skin contact material
(Armband) | ISO 10993
Cytotoxicity / Negative
Sensitization / Negative
Primary skin irritation /
Negative | ISO 10993
Cytotoxicity / Negative
Sensitization / Negative
Primary skin irritation /
Negative | ISO 10993
Cytotoxicity /
Negative
Sensitization /
Negative
Primary skin
irritation / Negative |
| Measuring location | Ear & armpit | Ear & armpit | Armpit |

1-12

3

K431256 (P. 40F6)

:

4

(481256 (P. 55F6)

Discussion of Non-Clinical Tests Performed Determination of Substantial Equivalence

Compliance to applicable voluntary standards includes ASTM E1112:2000, ASTM E1965:2002, as we as EN 60601-1 and EN 60601-1-2 requirement. All of the required conformity reports were included on the 510(k) submission documents.

Discussion of clinical report for measurement accuracy

Since the ear temperature measuring function of BTM-D1x series (only for BTM-D1C) is the integration of the chosen 510(k) clear model: Taidoc/TD-1107, the clinical report as included on Taidoc 510(k) submission (K050463) for measurement accuracy as required by ASTM E1965:2002 is still available for BTM-D1x series.

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

Performance Tests:
Test Performed	Laboratory
1. EN 60601-1	Electronics Testing Center, Taiwan
2. EN 60601-1-2/ EN 300 440-2/ EN 3011489-1/-3	Electronics Testing Center, Taiwan
3. ASTM/ E 1112-00	Rio Flexon Technology Co., Ltd

5

K431256 (P.6 of 6)

1. ASTM/ E 1965-02
1. Biocompatibility (ISO 10993)
1. FCC

Taidoc Technology Corporation Taiwan National Chung-Hsing University Lab.

Electronics Testing Center, Taiwan

Conclusions:

Regarding to above comparison table, BTM-D1x series has the same intended use as the predicated device K062445/ BTM-D1A-Monitoring Ear Thermometer. In fact, BTM-D1x series is completely expanding from the predicated device, BTM-D1A, which the function, the software and the intended use is the same as predicated device. BTM-D1x series include BTM-D1C, D, E, F, G and H. In which the BTM-D1C is with both function of ear thermometer and armpit temperature monitor as predicated device, BTM-D1A, and the rest of models of BTM-D, E, F, G and H are only with the function of armpit temperature monitor. According to the tests performed in this submission demonstrates that the difference in the submitted models could maintain the same safety and effectiveness as predicated device. In addition, the technological characteristics do not raise any new questions of safety and effectiveness. In general, the BTM-D1x series is expanded from BTM-D1A, the major function and software are the same except the product appearance. In other words, those appearance differences do not affect the intended use or alter the fundamental scientific technology of the device. In conclusion, BTM-D1x series is substantially equivalent to the predicated device approved as BTM-D1A/K062445.

6

Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and tail. The eagle faces right and is positioned to the right of the text. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 7 2008

Rio Flexon Technology Company, Limited C/O Mr. Jeffrey D. Rongero Responsible Third Party Official Underwriters Laboratories, Incorporated 12 Laboratory Drive Research Triangle Park, North Carolina 27709

Re: K081256

Trade/Device Name: Wireless Body temperature Monitor / Model: BTM-D1C, D, E, F. G and H Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: May 15, 2008 Received: May 16, 2008

Dear Mr. Rongero:

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.

7

Page 2 - Mr. Rongero

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 (240) 276-0120. 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 (800) 638-2041 or (301) 443-6597 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

8

Kø81256

4.4 Indication for Use

Indication for Use

510(k) Number (If know):

Device Name: Wireless Body Temperature Monitor / Model: BTM-D1C, D, E, F, G and H.

Indication for Use:

The Wireless Body temperature monitor, model BTM-D1x series (model BTM-D1C, D, E, F, G and H) is 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 measurement as well as the armpit temperature monitor for the person above two years old. In which, model BTM-D1C is with two functions of ear temperature measurement and armpit temperature monitor; the rest of models, BTM-D1D, E, F, G and H are only with the function of armpit temperature monitor.

Prescription Use

OR

Over-The-Counter Use V

(Part 21 CFR 801 Subpart D)

(21CFR 807 Subpart C)

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

(Division Sign-Off)	Concurrence of CDRH, office of Device Evaluation (ODE)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices

510(k) Number: -081356