The Wireless Body Temperature Monitor, model BTM-D1X series (model BTM-D1C, D, E, F, G and H), is a battery-operated electronic device with intended use of measuring human ear temperature precisely and continuously monitoring armpit temperature via wireless signal transmission of the measuring result. This device is reusable and is intended for ear temperature measurement as well as armpit temperature monitoring for persons over two years old. Model BTM-D1C has two functions, both ear temperature measurement and armpit temperature monitoring. The rest of models, BTM-D1D, E, F, G and H, have only the function of ampit temperature monitoring.

Device Description

The Wireless Body Temperature Monitor BTM-D1X series includes models BTM-DIC, D, E, F, G and H. This device is a battery-operated electronic device that is intended to be worn at left arm to monitor the armpit temperature continuously. In addition, BTM-D1C has the additional function of an ear thermometer.

The device is composed of two operational parts, the receiver and armband. An optional accessory may be included to assist in affixing the sensor of the armband more tightly. 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. The armband was designed and constructed with a thermo sensor and signal communication unit. For the monitoring operation, both the receiver and armband must be switched on. Soon after these two parts are switched on, the wireless signal communication will set up between the receiver and the armband. The temperature monitoring signal measured at armpit will be continuously indicated on the LCD of the receiver and will update every 12 seconds.

The device also has a high/low audible alarm, which will sound if the body temperature goes above the high alarm temperature or below the low alarm temperature set by the user.

In addition to the continuous armpit temperature monitoring, the user can also operate the functional key on the receiver to take an ear temperature measurement at any time if needed. The reading on the LCD screen will return to the armpit temperature after 30 seconds.

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

AI/ML Overview

The provided text describes a 510(k) premarket notification for a Wireless Body Temperature Monitor (BTM-D1X series) and references studies conducted for its predicate device (K081256) and an integrated component (K050463). The core of the submission revolves around demonstrating substantial equivalence, particularly concerning the addition of a high/low alarm function.

Here's an analysis based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Performance Metric	Acceptance Criteria (Predicate/Claimed)	Reported Device Performance (Modified Device)
Armpit Temperature Accuracy	$\pm$ 0.1 °C	Claimed to be the same as the predicate device, which met this criterion. No new studies were performed for armpit temperature accuracy for the modified device, implying it still meets $\pm$ 0.1 °C.
Ear Temperature Accuracy	$\pm$ 0.2 °C for 36 °C - 39 °C; $\pm$ 0.3 °C for others (for BTM-D1C only)	Ear temperature measuring function of the modified BTM-D1X series (BTM-D1C model only) is stated as "the same as the predicate BTM-D1X series (BTM-D1C model only) from K081256". This predicate device integrated a 510(k) cleared model (Taidoc/TD-1107, K050463) which itself met these accuracy specifications per ASTM E1965:2002. Therefore, the modified device is assumed to meet these same accuracy specs.
High Alarm Temperature Range	36°C - 40°C (Manual setting)	The modified device adds this function with the specified range. Implicitly, the alarm will function correctly within this range, as this is a new feature for which direct performance against the range is the acceptance.
Low Alarm Temperature Range	32°C - 35.5°C (Manual setting)	The modified device adds this function with the specified range. Implicitly, the alarm will function correctly within this range.
Electrical Safety	Compliance with EN 60601-1	Compliance report included from Electronics Testing Center, Taiwan.
EMC/Wireless Performance	Compliance with EN 60601-1-2 / EN 300 440-2 / EN 3011489-17-3	Compliance report included from Electronics Testing Center, Taiwan.
Biocompatibility	Cytotoxicity / Negative, Sensitization / Negative, Primary skin irritation / Negative (per ISO 10993)	Compliance report included from Taiwan National Chung-Hsing University Lab.
Continuous Monitoring Time	24 hours	Stated as 24 hours for both predicate and modified devices, implying continued performance.
Temperature Range (Measurement)	25 °C - 43 °C	Stated as 25 °C - 43 °C for both predicate and modified devices, implying continued performance.
Ambient Temperature (Operation)	15 °C - 42 °C (with 95% RH humidity)	Stated as 15 °C - 42 °C (with 95% RH humidity) for both predicate and modified devices, implying continued performance.
Storage Condition	-20 °C - 50 °C (with 95% RH humidity)	Stated as -20 °C - 50 °C (with 95% RH humidity) for both predicate and modified devices, implying continued performance.

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

Armpit Temperature (ASTM E1112-00): The K100226 submission references the predicate K081256 for armpit temperature accuracy. K081256 would have conducted the ASTM E1112-00 test. The text does not specify the sample size for this test, nor the country of origin or whether it was retrospective or prospective. However, ASTM E1112-00 (Standard Specification for Electronic Thermometers for Intermittent Determination of Patient Temperature) outlines specific requirements for clinical testing, usually involving a defined number of subjects for accuracy verification.
Ear Temperature (ASTM E1965-02): The K100226 submission specifically states that the ear temperature accuracy data comes from the 510(k) submission for Taidoc/TD-1107 (K050463) and was referenced in K081256.
- Sample Size: The text does not explicitly state the sample size for the ASTM E1965-02 clinical report from K050463. ASTM E1965-02 (Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature) also mandates a specific number of subjects and measurements for clinical accuracy determination.
- Data Provenance: The original K050463 submission would contain this information. The current text does not specify the country of origin of the data or if it was retrospective or prospective. Given it's a clinical report for a device, it would typically be prospective clinical study data.

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

The document does not provide information on the number of experts used or their qualifications for establishing ground truth for either the armpit or ear temperature accuracy studies. These details would typically be found in the original clinical study reports referenced (from K081256 and K050463). Clinical accuracy studies for thermometers generally rely on highly accurate reference thermometers (e.g., specific probe types, calibrated against NIST standards) and trained clinical personnel for proper measurement, rather than "experts" in the context of image interpretation.

4. Adjudication Method for the Test Set

The document does not provide information on an adjudication method. This concept is typically relevant for studies involving ambiguous interpretations (e.g., medical image diagnosis) where multiple readers review cases and disagreements need to be resolved. For thermometer accuracy studies, the ground truth is established by a reference measurement, not typically through adjudication of different interpretations.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. MRMC studies are employed to evaluate the effectiveness of an AI system when used in conjunction with human readers, often for diagnostic tasks. This device is a measurement tool, and its evaluation focuses on accuracy compared to a reference standard, not its impact on human reader performance in a diagnostic workflow.

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone performance study was done for accuracy. The "performance tests" listed, specifically "ASTM/ E 1112-00" for armpit temperature and "ASTM/ E 1965-02" for ear temperature, are standalone accuracy evaluations of the device itself against established reference measurement standards. The device's ability to measure temperature accurately is assessed independently of a diagnostic human-in-the-loop scenario. The primary modification in K100226, the high/low alarm, would also be tested standalone for its functionality (e.g., alarm triggers correctly at set temperatures).
The device is a direct measurement device; therefore, its performance is its standalone accuracy.

7. Type of Ground Truth Used

Armpit Temperature: The ground truth for armpit temperature accuracy (evaluated by ASTM E1112-00) would be established using reference temperature measurements from highly accurate, calibrated thermometers, often in a controlled clinical setting, or by comparison to standard clinical methods (e.g., rectal temperature).
Ear Temperature: The ground truth for ear temperature accuracy (evaluated by ASTM E1965-02, from K050463) would be established using reference temperature measurements from highly accurate, calibrated thermometers, typically tympanic temperature probes, or by comparison to standard clinical methods (e.g., rectal temperature).
Other performance tests (electrical safety, EMC, biocompatibility): Ground truth for these is established by adherence to the respective international standards (e.g., EN 60601-1, ISO 10993) through laboratory testing.

8. Sample Size for the Training Set

This submission describes a medical device (thermometer), not an AI/ML algorithm that requires a "training set" in the context of machine learning. The device's operation is based on fundamental principles of thermometry and wireless communication, not on learning from a dataset. Therefore, the concept of a "training set" as typically used for AI does not apply here.

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

As stated above, this device does not involve a "training set" in the AI/ML sense. Its operational parameters and calibration are established through engineering design, component specifications, and adherence to established performance standards.

Summary

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K100226

1.4 510(K) SUMMARY

510(K) SUMMARY

MAR 1 8 2010

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:

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:

Alan Schwartz/Executive VP mdi Consultants, Inc. 55 Northern Blvd. Great Neck, NY 11021.U.S.A Tel: 516 482 9001 Fax: 516 482 0186 Alan P. Schwartz [Alan@mdiconsultants.com]

Date of Submission:

January 25, 2010

Classification name:

Clinical Electronic Thermometer / Class II

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

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Predicate Device:

Rio Flexon Technology Co., Ltd Wireless Body Temperature Monitor, BTM-D1X series (K081256)

Intended Use:

The Wireless Body Temperature Monitor, model BTM-D1X series (model BTM-D1C, D, E, F. G and H), is a battery-operated electronic device with intended use of measuring human ear temperature precisely and continuously monitoring armpit temperature via wireless signal transmission of the measuring result. This device is reusable and is intended for ear temperature measurement as well as armpit temperature monitoring for persons over two vears old. Model BTM-D1C has two functions, both ear temperature measurement and armpit temperature monitoring. The rest of models, BTM-D1D, E, F, G and H, have only the function of armpit temperature monitoring.

Device Description:

The device also has a high/low audible alarm, which will sound if the body temperature goes above the high alarm temperature or below the low alarm temperature set by the user.

Comparison to Predicate Devices:

The new BTM-D1X series is the same as the predicate BTM-D1X series under K081256, except for the addition of the high/low alarm function.

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Element ofcomparison	Prior BTM-D1C modelfrom K081256	Prior BTM-D1D/E/F/G/Hmodels fromK081256	Modified BTM-D1C model	Modified BTM-D1D/E/F/G/Hmodels
EarThermometertype	Infraredtympanicthermometer	N/A	Infraredtympanicthermometer	N/A
Intended use	Intended use ofmeasuringhuman eartemperatureprecisely andcontinuouslymonitoringarmpittemperature viawireless signaltransmission ofthe measuringresult. Thisdevice isreusable andintended for eartemperaturemeasurement aswell as armpittemperaturemonitoring forpersons overtwo years old	This device isintended tocontinuouslymonitor armpittemperature viawireless signaltransmission ofmeasuringresult. Thedevice isintended to beused for personsover two yearsold.	Intended use ofmeasuringhuman eartemperatureprecisely andcontinuouslymonitoringarmpittemperature viawireless signaltransmission ofthe measuringresult. Thisdevice isreusable andintended for eartemperaturemeasurement aswell as armpittemperaturemonitoring forpersons overtwo years old	This device isintended tocontinuouslymonitor armpittemperature viawireless signaltransmission ofmeasuringresult. Thedevice isintended to beused for personsover two yearsold.
Brand Name	Rio Flexon	Rio Flexon	Rio Flexon	Rio Flexon
Signalprocessing anddisplay	Wireless 2.4Gtransmission &display on LCDscreen ofmonitor	Wireless 2.4Gtransmission &display on LCDscreen ofmonitor	Wireless 2.4Gtransmission &display on LCDscreen ofmonitor	Wireless 2.4Gtransmission &display on LCDscreen ofmonitor
Powerrequirements ofArmband	3V / CR2032Lithium	3V / CR2032Lithium	3V / CR2032Lithium	3V / CR2032Lithium
Powerrequirement ofReceiver	AAA battery x2pcs	AAA battery x2pcs	AAA battery x2pcs	AAA battery x2pcs
Temperaturerange	25 °C - 43 °C	25 °C - 43 °C	25 °C - 43 °C	25 °C - 43 °C
High/low alarm	N/A	N/A	Manual	Manual
Element ofcomparison	Prior BTM-D1C modelfrom K081256	Prior BTM-D1D/E/F/G/Hmodels fromK081256	Modified BTM-D1C model	Modified BTM-D1D/E/F/G/Hmodels
High alarmtemperaturerange	N/A	N/A	36°C - 40°C	36°C - 40°C
Low alarmtemperaturerange	N/A	N/A	32°C - 35.5°C	32°C - 35.5°C
Ambienttemperature	15 °C - 42 °C(with 95% RHhumidity)	15 °C - 42 °C(with 95% RHhumidity)	15 °C - 42 °C(with 95% RHhumidity)	15 °C - 42 °C(with 95% RHhumidity)
Storagecondition	-20 °C - 50 °C(with 95% RHhumidity)	-20 °C - 50 °C(with 95% RHhumidity)	-20 °C - 50 °C(with 95% RHhumidity)	-20 °C - 50 °C(with 95% RHhumidity)
Accuracy forarmpittemperature	$\pm$ 0.1 °C	$\pm$ 0.1 °C	$\pm$ 0.1 °C	$\pm$ 0.1 °C
Accuracy for eartemperature	$\pm$ 0.2 °C for 36°C - 39 °C; $\pm$ 0.3°C for the others	N/A	$\pm$ 0.2 °C for 36°C - 39 °C; $\pm$ 0.3°C for the others	N/A
Monitoring time	24 hours	24 hours	24 hours	24 hours
Components	1. ReceiverIC#: HT-49R50	1. ReceiverIC#: HT-49R50	1. ReceiverIC#: HT-49R50.	1. ReceiverIC#: HT-49R50
	2. ArmbandIC#: HT-46R52	2. ArmbandIC#: HT-46R52	2. ArmbandIC#: HT-46R52	2. ArmbandIC#: HT-46R52
	3. Eartemperaturemeasuringmodule	3. RFtransmissionmodule(2.4GHz)	3. Eartemperature.measuringmodule (forBTM-D1Cmodels only)	3. RFtransmissionmodule(2.4GHz)
	4. RFtransmissionmodule(2.4GHz)		4. RFtransmissionmodule(2.4GHz)
Sensor	SENTECHsensor	SENTECHsensor	SENTECHsensor	SENTECHsensor
Electrical safety	EN 60601-1	EN 60601-1	EN 60601-1	EN 60601-1
Element ofcomparison	Prior BTM-D1C modelfrom K081256	Prior BTM-D1D/E/F/G/Hmodels fromK081256	Modified BTM-D1C model	Modified BTM-D1D/E/F/G/Hmodels
Bio-compatibility forthe skin contactmaterial(Armband)	Cytotoxicity /NegativeSensitization /NegativePrimary skinirritation /Negative	Cytotoxicity /NegativeSensitization /NegativePrimary skinirritation /Negative	Cytotoxicity /NegativeSensitization /NegativePrimary skinirritation /Negative	Cytotoxicity /NegativeSensitization /NegativePrimary skinirritation /Negative
Measuringlocation	Armpit and ear(for BTM-D1Cmodels only)	Armpit and ear(for BTM-D1Cmodels only)	Armpit and ear(for BTM-D1Cmodels only)	Armpit and ear(for BTM-D1Cmodels only)

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Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence

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

Discussion of clinical report for measurement accuracy

The ear temperature measuring function of the modified BTM-D1X series (BTM-D1C model only) is the same as the predicate BTM-D1X series (BTM-D1C model only) from K081256, which involved the integration of the 510(k) cleared model, Taidoc/TD-1107 (K050463). Therefore, the clinical report for measurement accuracy (per ASTM E1965:2002), which was included in the 510(k) submission for Taidoc/TD-1107 (K050463) and referenced in K081256, is still applicable for the modified BTM-D1X series.

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

Performance Tests:

Test Performed

1. EN 60601-1
1. EN 60601-1-2/ EN 300 440-2 / EN · 3011489-17-3
1. ASTM/ E 1112-00
1. ASTM/ E 1965-02
- 1. Biocompatibility (ISO 10993)
- 1. FCC

Laboratory

Electronics Testing Center, Taiwan Electronics Testing Center, Taiwan

Rio Flexon Technology Co., Ltd Taidoc Technology Corporation Taiwan National Chung-Hsing University Lab Electronics Testing Center, Taiwan

Conclusions:

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The modified device has the same fundamental scientific technology and intended use as the predicate device. The only difference between the modified BTM-DIX series and the predicate device (K081256/BTM-D1X series) is the addition of the high/low alarm function.

、

. .

September 19.

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Image /page/6/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or a stylized human figure. The symbol is composed of three curved lines that converge at the top and then separate into three wavy lines at the bottom.

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

MAR ] & 2010

Mr. Chi-Hung Liao General Manager RIO Flexon Technology Company, Limited 15F, 868-2, JhongJheng Road Jhonghe City, Taipei County China (TAIWAN) 235

Re: K100226

Trade/Device Name: Wireless Body Temperature Monitor/Model: BTM-D1C.D.E.F.G and H. Regulation Number: 21CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: March 4, 2010 Received: March 5, 2010

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. 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. 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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/ ucm 1 15809.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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Susan Danner

Anthony D. Watson, B.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:

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

Indication for Use:

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

1-10

Charles R. Hoppe

(Division Sign-Off) (7/vision of Anesthesiology, General Hospital Intection Control, Dental Devices

Page 1 of 1.

510(k) Number: K100226

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.