(52 days)
No
The description focuses on standard electronic components, temperature sensing, wireless communication, and basic alarm functions. There is no mention of AI, ML, or any complex data processing that would suggest the use of such technologies.
No.
Explanation: This device is a body temperature monitor, intended for measuring and monitoring temperature, not for treating any condition or disease.
No.
Explanation: The device is described as a "Wireless Body Temperature Monitor" intended for "measuring human ear temperature precisely and continuously monitoring armpit temperature". While it provides temperature data, which can be useful in diagnosis, its primary function as described is measurement and monitoring, not the interpretation of data to identify a disease or condition, which is characteristic of a diagnostic device. It provides raw data (temperature readings) that a user or healthcare professional would then interpret.
No
The device description explicitly states it is a "battery-operated electronic device" composed of hardware components like a receiver, armband with a thermo sensor, LCD display, and operational keys. It also mentions wireless signal transmission and battery operation, all indicative of a physical hardware device.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the living body.
- Device Function: The Wireless Body Temperature Monitor measures and monitors body temperature directly from the ear and armpit. This is a measurement taken from the living body, not a test performed on a sample taken from the body.
- Intended Use: The intended use is to measure and monitor human body temperature, which is a physiological parameter, not to perform a diagnostic test on a biological sample.
Therefore, while it is a medical device, it falls under the category of devices that measure physiological parameters directly from the body, not IVDs.
N/A
Intended Use / Indications for 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 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.
Product codes (comma separated list FDA assigned to the subject device)
FLL
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.
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
persons over 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 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:
Tests Performed:
- EN 60601-1
- EN 60601-1-2/ EN 300 440-2 / EN 3011489-17-3
- ASTM/ E 1112-00
- ASTM/ E 1965-02
- Biocompatibility (ISO 10993)
- FCC
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy for armpit temperature: ± 0.1 °C
Accuracy for ear temperature: ± 0.2 °C for 36 °C - 39 °C; ± 0.3 °C for the others
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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
1
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 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.
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.
2
| Element of
comparison | Prior BTM-
D1C model
from K081256 | Prior BTM-
D1D/E/F/G/H
models from
K081256 | Modified BTM-
D1C model | Modified BTM-
D1D/E/F/G/H
models |
|------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Ear
Thermometer
type | Infrared
tympanic
thermometer | N/A | Infrared
tympanic
thermometer | N/A |
| Intended use | 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
intended for ear
temperature
measurement as
well as armpit
temperature
monitoring for
persons over
two years old | This device is
intended to
continuously
monitor armpit
temperature via
wireless signal
transmission of
measuring
result. The
device is
intended to be
used for persons
over two years
old. | 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
intended for ear
temperature
measurement as
well as armpit
temperature
monitoring for
persons over
two years old | This device is
intended to
continuously
monitor armpit
temperature via
wireless signal
transmission of
measuring
result. The
device is
intended to be
used for persons
over two years
old. |
| Brand Name | Rio Flexon | 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 | Wireless 2.4G
transmission &
display on LCD
screen of
monitor |
| Power
requirements of
Armband | 3V / CR2032
Lithium | 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 | AAA battery x
2pcs |
| Temperature
range | 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 of
comparison | Prior BTM-
D1C model
from K081256 | Prior BTM-
D1D/E/F/G/H
models from
K081256 | Modified BTM-
D1C model | Modified BTM-
D1D/E/F/G/H
models |
| High alarm
temperature
range | N/A | N/A | 36°C - 40°C | 36°C - 40°C |
| Low alarm
temperature
range | N/A | N/A | 32°C - 35.5°C | 32°C - 35.5°C |
| Ambient
temperature | 15 °C - 42 °C
(with 95% RH
humidity) | 15 °C - 42 °C
(with 95% RH
humidity) | 15 °C - 42 °C
(with 95% RH
humidity) | 15 °C - 42 °C
(with 95% RH
humidity) |
| Storage
condition | -20 °C - 50 °C
(with 95% RH
humidity) | -20 °C - 50 °C
(with 95% RH
humidity) | -20 °C - 50 °C
(with 95% RH
humidity) | -20 °C - 50 °C
(with 95% RH
humidity) |
| Accuracy for
armpit
temperature | $\pm$ 0.1 °C | $\pm$ 0.1 °C | $\pm$ 0.1 °C | $\pm$ 0.1 °C |
| Accuracy for ear
temperature | $\pm$ 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. Receiver
IC#: HT-
49R50 | 1. Receiver
IC#: HT-
49R50 | 1. Receiver
IC#: HT-
49R50. | 1. Receiver
IC#: HT-
49R50 |
| | 2. Armband
IC#: HT-
46R52 | 2. Armband
IC#: HT-
46R52 | 2. Armband
IC#: HT-
46R52 | 2. Armband
IC#: HT-
46R52 |
| | 3. Ear
temperature
measuring
module | 3. RF
transmission
module
(2.4GHz) | 3. Ear
temperature.
measuring
module (for
BTM-D1C
models only) | 3. RF
transmission
module
(2.4GHz) |
| | 4. RF
transmission
module
(2.4GHz) | | 4. RF
transmission
module
(2.4GHz) | |
| Sensor | SENTECH
sensor | SENTECH
sensor | SENTECH
sensor | SENTECH
sensor |
| Electrical safety | EN 60601-1 | EN 60601-1 | EN 60601-1 | EN 60601-1 |
| Element of
comparison | Prior BTM-
D1C model
from K081256 | Prior BTM-
D1D/E/F/G/H
models from
K081256 | Modified BTM-
D1C model | Modified BTM-
D1D/E/F/G/H
models |
| Bio-
compatibility for
the skin contact
material
(Armband) | Cytotoxicity /
Negative
Sensitization /
Negative
Primary skin
irritation /
Negative | Cytotoxicity /
Negative
Sensitization /
Negative
Primary skin
irritation /
Negative | Cytotoxicity /
Negative
Sensitization /
Negative
Primary skin
irritation /
Negative | Cytotoxicity /
Negative
Sensitization /
Negative
Primary skin
irritation /
Negative |
| Measuring
location | Armpit and ear
(for BTM-D1C
models only) | Armpit and ear
(for BTM-D1C
models only) | Armpit and ear
(for BTM-D1C
models only) | Armpit and ear
(for BTM-D1C
models only) |
:
3
.
4
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
-
- EN 60601-1
-
- EN 60601-1-2/ EN 300 440-2 / EN · 3011489-17-3
-
- ASTM/ E 1112-00
-
- ASTM/ E 1965-02
-
- Biocompatibility (ISO 10993)
-
- 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:
5
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.
·
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1
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- September 19.
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6
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.
7
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
8
Indications for Use
510(k) Number:
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 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.
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