(307 days)
No
The description focuses on basic temperature sensing, calculation, and wireless transmission, with no mention of AI or ML algorithms for data analysis, prediction, or interpretation.
No.
The device's intended use is solely for monitoring temperature, not for treating or providing therapy for a medical condition.
No
The device is described as a thermometer for measuring and monitoring temperature, which is a measurement function. While the data might be used in a diagnostic process, the device itself performs a measurement, not a diagnosis.
No
The device description explicitly states it is a "combination device of thermometer and Bluetooth communication unit" and is a "battery-operated electronic device," indicating it includes hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Wireless Thermometer measures and monitors human armpit temperature. This is a direct measurement of a physiological parameter on the body, not a test performed on a sample taken from the body.
- Intended Use: The intended use is "measuring and monitoring human armpit temperature continuously." This aligns with a medical device for physiological monitoring, not an IVD.
- Device Description: The description details how the device measures temperature using an NTC resistance value and transmits the data wirelessly. This process does not involve analyzing a biological sample.
Therefore, the Wireless Thermometer described is a medical device for physiological monitoring, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Wireless Thermometer is/a battery-operated electronic device with intended use of measuring and monitoring human armpit temperature continuously via wireless signal transmission of the measuring result. This system is reusable and intended for armpit temperature monitoring for persons over two years old.
Product codes
FLL
Device Description
The wireless thermometer, WT701, which is the combination device of thermometer and Bluetooth communication unit intended to be worn at axilla to monitor the armpit temperature continuously.
For the monitoring operation, switch the thermometer on and stick the thermometer in the user's axilla. The thermometer will make a Bluetooth connection between the thermometer and the receiver automatically (User should setup Bluetooth properly on receiver). Then the thermometer starts to measures the body temperature by means of testing the NTC resistance value and calculates the body temperature every 4 seconds continuously and sends the temperature data to the receiver through Bluetooth connection.
The wireless thermometer uses a CR2032 battery for operation. When the battery is low, internal circuit will detect the low battery condition automatically and send "low battery" signal through Bluetooth communication unit to receiver.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human 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 were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
IEC60601-1:2005 Medical electrical equipment Part 1: General requirements for basic safety and essential performance
IEC 60601-1-2:2007 Medical electrical equipment- Part 1-2: General requirements for basic safety and essential performance- Collateral standard: Electromagnetic compatibility- Requirements and tests
FCC Part 15 Subpart C test FCC Part 15.247
ASTM E1112-00: 2006 Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature.
EN 12470-4: 2000+A1:2009 Clinical thermometers Part-4: performance of electrical thermometers for continuous measurement.
And the proposed device also conducted the performance test, which include Dimension Test, Weight Test, and accuracy transmission test under a complex electromagnetic environment.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy: +0.05℃(35℃-38.5℃), ±0.1℃(25℃-34.99℃ and 38.51°C-45°C)
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
JUL 08 2014
Section 3 510(k) Summary
This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR-Section 807.92.
The assigned 510(k) Number: K132761
-
Prepared Date: Aug. 26, 2013
-
Sponsor Identification
i
イ
Raiing Medical Company 21 Huoju St, Beijing, China
Establishment Registration Number: 3010052175
Mr. Wu Wei
Title: General Engineer Email: tjww@raiing.com Tel: 86-10-64118658
Fax: 86-10-80115555 ext. 776445 Raiing Medical Company 21 Huoju St, Beijing, China
- Submission Correspondent
- Mr. Wu Wei
Title: General Engineer Email: tjww@raiing.com Tel: 86-10-64118658 Fax: 86-10-80115555 ext. 776445 Raiing Medical Company
21 Huoju St, Beijing, China
1
4. Proposed Device Identification
Proposed Device Name: Wireless Thermometer Proposed Device Common Name: Thermometer
Regulatory Information: Classification Name: Clinical Electronic Thermometer; Classification: II; Product Code: FLL; Regulation Number: 21 CFR 880.2910; Review Panel: General Hospital;
Intended Use Statement:
The Wireless Thermometer is/a battery-operated electronic device with intended use of measuring and monitoring human armpit temperature continuously via wireless signal transmission of the measuring result. This system is reusable and intended for armpit temperature monitoring for persons over two years old.
- Predicate Device Identification
510(k) Number: K121696 Predicate Device Name: Wireless Thermometer WTM-BT30-I Manufacturer: Raiing Medical Company
í
Device Description 6.
The wireless thermometer, WT701, which is the combination device of thermometer and Bluetooth communication unit intended to be worn at axilla to monitor the armpit temperature continuously.
For the monitoring operation, switch the thermometer on and stick the thermometer in the user's axilla. The thermometer will make a Bluetooth connection between the thermometer and the receiver automatically (User should setup Bluetooth properly on receiver). Then the thermometer starts to measures the body temperature by means of testing the NTC resistance value and calculates the body temperature every 4 seconds continuously and sends the temperature data to the receiver through
3-2
2
Bluetooth connection.
The wireless thermometer uses a CR2032 battery for operation. When the battery is low, internal circuit will detect the low battery condition automatically and send "low battery" signal through Bluetooth communication unit to receiver.
7. Non-Clinical Test Conclusion
- Non-clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
IEC60601-1:2005 Medical electrical equipment Part 1: General requirements for basic safety and essential performance
IEC 60601-1-2:2007 Medical electrical equipment- Part 1-2: General requirements for basic safety and essential performance- Collateral standard: Electromagnetic compatibility- Requirements and tests
FCC Part 15 Subpart C test FCC Part 15.247
ASTM E1112-00: 2006 Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature.
EN 12470-4: 2000+A1:2009 Clinical thermometers Part-4: performance of electrical thermometers for continuous measurement.
And the proposed device also conducted the performance test, which include Dimension Test, Weight Test, and accuracy transmission test under a complex electromagnetic environment.
8. Substantially Equivalent (SE) Conclusion
The following table compares the DEVICE to the predicate device with respect to intended use, technological characteristics and principles of operation, etc.
| ITEM | Proposed Device | Predicate Device |
|---|---|---|
| WT701 | K121696 | |
| Product Code | FLL | FLL |
| Regulation No. | 880.2910 | 880.2910 |
| Class | Class II | Class II |
Table 3-1 Comparison of Technology Characteristics
3-3
3
| | Thermometer
The
Wireless
is
a | Wireless Thermometer, model
The |
|-----------------------------|-------------------------------------------|-------------------------------------------|
| | electronic
battery-operated
device | WTM-B530-1, is a battery-operated |
| | with intended use of measuring and | electronic
device
elected
with |
| | monitoring human armpit temperature | measuring
intended
use of
and |
| | continuously
via wireless
signal | monitoring human armpit temperature |
| Intended Use | transmission of the measuring result. | wireless
continuously
via
signal |
| | This system is reusable and intended | transmission of the measuring result. |
| | for armpit temperature monitoring for | system
is reusable and is
This |
| | persons over two years old. | armpit temperature
intended
for |
| | | monitoring for persons over two years |
| | | old. |
| Display Unit Specification | iOS device Display | LED and iOS device Display |
| Working voltage | DC3V | DC3.7V |
| Battery | The button battery 3.0 V, 210mAh | Internal 3.7V, 100mAh Li Battery |
| Measurement range | 25 °C ~ 45 °C | :25 ℃~45 ℃ |
| Accuracy | +0.05℃(35℃-38.5℃) | +0.1°C |
| | ±0.1℃(25℃-34.99℃ and | |
| | 38.51°C-45°C) | |
| Temperature unit | °C or °F | °C or °F |
| Signal transmission | Wireless 2.4G Bluetooth BLE | Wireless 2.4G Bluetooth 3.0 |
| Receiver | iPhone 4S, iPhone 5, iPad(3rd | iPod touch 4, iPhone 4, iPhone 4S, |
| | generation), iPad(4th | iPad, iPad 2, The new iPad |
| | generation), iPad mini, iPod | |
| | touch(5th generation) | |
| Valid transmission distance | Up to 5 meters | Up to 5 meters |
| Operating Temperature | 5℃~40℃ | 5°C-40 °C |
| Operating Humidity | 15-85% | 15-85% |
Based on the comparison and analysis above, the proposed device is determined to be Substantially Equivalent (SE) to the predicate device.
3-4
.
4
Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white and appears to be a scanned image.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 8, 2014
Raiing Medical Company Mr. Wei Wu General Engineer No.11 Huatong Rd Beijing CHINA
Re: K132761
Trade/Device Name: Wireless Thermometer, Model W7701 Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical electronic thermometer Regulatory Class: Class II Product Code: FLL Dated: June 3, 2014 Received; June 6, 2014
Dear Mr. Wu:
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.
5
Page 2 - Mr. Wu
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 of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.goy/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mary S. Runner -S
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number (if known) K132761
Device Name Wireless Thermometer, Model WT701
The Wireless Thermometer is a battery-operated electronic device with intended use of measuring and monitoring human armpit temperature continuously via wireless signal transmission of the measuring result. This system is reusable and intended for armpit temperature monitoring for persons over two years old.
Type of Use (Select one or both, as applicable)
- Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Digitally signed by Richard C. Chapman -S Date: 2014.07.08 11:26:01 -04'00'
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