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.

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.

AI/ML Overview

Here's a summary of the acceptance criteria and the study that proves the device meets the acceptance criteria, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Parameter	Acceptance Criteria (Standard)	Reported Device Performance (BTM-D1x Series)
Armpit Temperature Accuracy	$\pm 0.1℃$ (implied by predicate device and substantial equivalence claim)	$\pm 0.1℃$
Ear Temperature Accuracy	$\pm 0.2℃$ for $36℃ ~ 39℃$; $\pm 0.3℃$ for others (ASTM E1965:2002)	$\pm 0.2℃$ for $36℃ ~ 39℃$; $\pm 0.3℃$ for others (BTM-D1C only)
Electrical Safety	EN 60601-1	Compliance to EN 60601-1
EMC Conformity	EN 60601-1-2 & FCC	Compliance to EN 60601-1-2 & FCC
Bio-compatibility (Skin Contact)	ISO 10993 (Cytotoxicity, Sensitization, Primary skin irritation – all negative)	Compliance to ISO 10993 (Cytotoxicity, Sensitization, Primary skin irritation – all negative)
Device Performance (General)	ASTM E1112-00 and ASTM E1965-02	Designed and verified according to ASTM E1112-00 and ASTM E1965-02

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size used for the test set of the BTM-D1x series. It refers to a clinical report for ear temperature measurement accuracy (required by ASTM E1965:2002) that was included in the Taidoc 510(k) submission (K050463) for the chosen clear model Taidoc/TD-1107. However, no details about the sample size or data provenance (country of origin, retrospective/prospective) of that clinical report are provided in this document.

For the armpit temperature accuracy, the document implies that the BTM-D1x series meets the same accuracy as the predicate device (BTM-D1A) due to substantial equivalence, but no specific test set data is provided.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. The document refers to compliance with standards like ASTM E1965:2002 for ear temperature accuracy, which typically involves clinical studies with reference thermometers. However, details about the experts involved in establishing ground truth (e.g., medical professionals, lab technicians) are missing.

4. Adjudication Method for the Test Set

This information is not provided in the document.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted for this device as it is a medical device for temperature measurement, not a diagnostic imaging or interpretation system where human readers are directly involved in interpretation with or without AI assistance. The context of an "effect size of how much human readers improve with AI vs without AI assistance" does not apply here.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The studies mentioned are for the performance of the device itself (accuracy, safety, EMC, biocompatibility), which can be considered "standalone" in the sense that they assess the device's inherent performance without direct human interpretation in a diagnostic sense. The device measures and displays temperature, and its accuracy is tested against reference standards.

7. Type of Ground Truth Used

For Ear Temperature Accuracy: The ground truth would have been established through a clinical study as required by ASTM E1965:2002. This typically involves comparison against a highly accurate reference thermometer (e.g., rectal thermometer or specialized aural thermometer) measurements taken by trained personnel. The document references the clinical report from a predicate device (Taidoc/TD-1107, K050463) for this, implying the ground truth methodology followed the standard.
For Armpit Temperature Accuracy: The ground truth would similarly be established by comparing the device's readings against a highly accurate reference thermometer, though specific details of such a study for the BTM-D1x series are not provided beyond the claim of substantial equivalence to the predicate.
Other tests (Electrical Safety, EMC, Biocompatibility): Ground truth for these is established by adherence to the specified international standards (EN 60601-1, EN 60601-1-2, FCC, ISO 10993) through laboratory testing, where established protocols and reference measurements define the "ground truth" for compliance.

8. Sample Size for the Training Set

The document does not provide information on a "training set" for this device. This device measures temperature based on physical principles (infrared for ear, thermistor for armpit) and signal processing, not a machine learning or AI algorithm that typically requires a distinct training set. The "software" mentioned in the comparison table refers to the operational program, not a learned model.

9. How the Ground Truth for the Training Set Was Established

Since there is no mention of a training set, this information is not applicable.

Summary

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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

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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:

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(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 tympanicthermometer	Infrared tympanicthermometer	N/A
Intended use	Intended use ofmeasuring humanear temperatureprecisely andcontinuouslymonitors armpittemperature viawireless signaltransmission ofmeasuring result.This device isreusable and	Intended use ofmeasuring human eartemperature preciselyand continuouslymonitors armpittemperature viawireless signaltransmission ofmeasuring result. Thisdevice is reusable andintended for eartemperature	This device isintended tocontinuouslymonitorarmpittemperaturevia wirelesssignaltransmissionof measuringresult. Thedevice is
	intended for eartemperaturemeasurement aswell as the armpittemperaturemonitor for theperson above twoyears old.	measurement as well asthe armpit temperaturemonitor for the personabove two years old.	intended to beused for twoyears oldabove.
Brand Name	Rio Flexon	Rio Flexon	Rio Flexon
Signal processing anddisplay	Wireless 2.4Gtransmission & displayon LCD screen ofmonitor	Wireless 2.4Gtransmission & displayon LCD screen ofmonitor	Wireless 2.4Gtransmission &display on LCDscreen of monitor
Power requirements ofArmband	3V / CR2032 Lithium	3V / CR2032 Lithium	3V / CR2032Lithium
Power requirement ofReceiver	AAA battery x 2pcs	AAA battery x 2pcs	AAA battery x2pcs
Temperature range	$25℃ ~ 43℃$	$25℃ ~ 43℃$	$25℃ ~ 43℃$
Ambient temperature	$15℃ ~ 42℃$ (with95% RH humidity)	$15℃ ~ 42℃$ (with95% RH humidity)	$15℃ ~ 42℃$(with 95% RHhumidity)
Storage condition	$-20℃ ~ 50℃$ (with95% RH humidity)	$-20℃ ~ 50℃$ (with95% RH humidity)	$-20℃ ~ 50℃$(with 95% RHhumidity)
Accuracy for armpittemperature	$\pm 0.1℃$	$\pm 0.1℃$	$\pm 0.1℃$
Accuracy for eartemperature	$\pm 0.2℃$ for $36℃ ~$$39℃$ ; $\pm 0.3℃$ for theothers	$\pm 0.2℃$ for $36℃ ~$$39℃$ ; $\pm 0.3℃$ for theothers	N/A
Monitoring time	24 hours	24 hours	24 hours
components	1. Receiver IC#:HT-49R502. Armband IC#:HT-46R523. Ear temperaturemeasuring module	1. Receiver IC#:HT-49R502. Armband IC#:HT-46R523. Ear temperaturemeasuring module	1. Receiver IC#:HT-49R502. Armband IC#:HT-46R523. RFtransmission
	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 ofBio-compatibility forthe skin contact material(Armband)	ISO 10993Cytotoxicity / NegativeSensitization / NegativePrimary skin irritation /Negative	ISO 10993Cytotoxicity / NegativeSensitization / NegativePrimary skin irritation /Negative	ISO 10993Cytotoxicity /NegativeSensitization /NegativePrimary skinirritation / Negative
Measuring location	Ear & armpit	Ear & armpit	Armpit

1-12

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K431256 (P. 40F6)

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(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

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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.

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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.

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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

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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:

Prescription Use

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

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.