(323 days)
Not Found
No
The description details a standard electronic thermometer that converts temperature to a digital display, with no mention of AI or ML algorithms for processing or interpretation.
No
The device is intended for measuring temperature, which is a diagnostic function, not a therapeutic one. It does not treat or alleviate any medical condition.
Yes
Explanation: The device measures temperature in the human body, which is a diagnostic indicator. While it doesn't diagnose a specific disease, the measurement it provides is used as part of a diagnostic process to detect fever, a symptom of many conditions.
No
The device description explicitly mentions a "temperature sensor" and "LCD digital display," indicating hardware components are integral to its function. The performance studies also mention testing for "electrical safety, EMC, biocompatibility," which are typically associated with hardware devices.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to measure temperature in the human body (Armpit or Oral). This is a direct measurement of a physiological parameter within the body, not an analysis of a sample taken from the body (like blood, urine, or tissue).
- Device Description: The description details how the device converts body temperature into an electronic signal for display. This aligns with a standard medical device for measuring a physical property, not an IVD which analyzes biological samples.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, reagents, or any processes typically associated with in vitro diagnostics.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This thermometer does not fit that definition.
N/A
Intended Use / Indications for Use
It is intended for use in measuring temperature in the human body (Armpit or Oral).
Product codes (comma separated list FDA assigned to the subject device)
FLL
Device Description
The body temperature is converted into electronic signal by the temperature sensor, and then the electronic signal is converted into LCD digital display.
The Electronic Thermometers TF3100, TF3101 and TF3102 have the same basic principles, main function, performance and intended use, and they are consistent in product structure and material.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Armpit or Oral
Indicated Patient Age Range
Not Found
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)
Laboratory testing was conducted to validate and verify that Electronic Thermometer met all requirements of related international standards, including electrical safety, EMC, biocompatibility, specification. Results of these tests demonstrate compliance to the requirements of the bellow consensus standards.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Not Found
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
K131210
510(k) Summary
1. Applicant
| Applicant Name: | SHENZHEN PUMP MEDICAL SYSTEM CO., LTD. |
|---|---|
| Address: | 2/F West, M-7 Sinosteel Building, Maqueling Estate, |
| Hi-Tech Industrial Park, Nanshan District, | |
| Shenzhen 518057, China |
Contact person:
| Name: | Xie Qiongyu |
|---|---|
| Phone numbers: | 86-0755-26710795 |
| Fax numbers: | 86-0755-26012025 |
| E-mail: | xieqy@bpump.com.cn |
| Date Prepared: | 2013-04-20 |
2. Device information
- Trade name: Electronic Thermometer .
- Model No.: TF3100, TF3101, TF3102 .
- Classification name: Thermometer, electronic, clinical (per CER 880.2910) .
- . Class: 2
- . Requlation Medical Specialty : General Hospital
- . Review Panel: General Hospital
- Product code: FLL- Clinical Electronic Thermometer .
- Regulation Description: Clinical electronic thermometer .
- Regulation Number: 880.2910
Indications for Use: It is intended for use in measuring temperature in the human body (Armpit or Oral).
Predicates
Digital thermometer Model MT Series K-number: K062784 Product Code: FLL
Indications for Use:
The devices Model MT series (MT-201, MT-301, MT-402, and MT-403) are intended to measure the human body temperature in regular mode orally, rectally or under the arm, and the devices are reusable for clinical or home use on people of all ages.
Manufacture: SEJOY ELECTRONICS & INSTRUMENTS CO., LTD.
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4. Description of the device
The body temperature is converted into electronic signal by the temperature sensor, and then the electronic signal is converted into LCD digital display.
The Electronic Thermometers TF3100, TF3101 and TF3102 have the same basic principles, main function, performance and intended use, and they are consistent in product structure and material.
| ELEMENT OF
COMPARISON | Electronic Thermometer
Model No.: TF3100, TF3101,
TF3102
Manufacture: SHENZHEN PUMP
MEDICAL SYSTEM CO., LTD. | Digital thermometer MT Series
(K062784)
Manufacture: SEJOY ELECTRONICS
& INSTRUMENTS CO., LTD. |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| thermometer type | TF3100, TF3101, TF3102 | MT-301 |
| intended use(s) | It is intended for use in measuring
temperature in the human body
(Armpit or Oral). | The devices Model MT series
(MT-201, MT-301, MT-402, and
MT-403) are intended to measure the
human body temperature in regular
mode orally, rectally or under the
arm, and the devices are reusable for
clinical or home use on people of all
ages. |
| components | Temperature sensor, liquid crystal display, battery and circuit of motherboard | |
| sensor | Thermistor | |
| signal processing and
display | Using the resistance change of thermal resistor to detect body temperature,
and displayed through the LCD. | |
| power requirements | DC3.7V Rechargeable Lithium
Battery | One 1.5 V Button Battery model LR 41 |
| Materials | ABS plastic and stainless steel | |
| temperature range | $32.00°C ~ 42.00°C$ | $32.00°C - 42.90°C$ |
| ambient temperature
environment | $+5°C~+40°C$ | $10°C ~ 35°C$ |
| accuracy | $0.05°C(35.30°C ~ 39.00°C)$
$0.1°C( 39.00°C )$ | $±0.1°C,35.5°C - 42.0°C$
$±0.2°C under 35.5°C or over 42.0°C$ |
| precision and
repeatability | 4 numerical digits, display in 0.01
degree increments | 4 numerical digits, display in 0.01
degree increments |
| Response time | 5 minutes | 5 minutes |
| Water-proof | IP22 | IP22 |
5. Comparison to Predicate Devices
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Comparing to the predicate, the subject devices used same the Measuring Principle, same electrical measurement technologic and same measurement site (Measuring on Armpit or Oral). The subject devices do not constitute a new intended use.
As a result, the subject device is Substantially Equivalent (SE) to the predicate which is US legally market device.
6. Discussion of Non-Clinical Tests Performed for Determination of Substantial
Equivalence
Laboratory testing was conducted to validate and verify that Electronic Thermometer met all requirements of related international standards, including electrical safety, EMC, biocompatibility, specification. Results of these tests demonstrate compliance to the requirements of the bellow consensus standards.
| Standard: |
|---|
| Electrical Safety and performance requirements: |
| IEC 60601-1 |
| ASTM E1112-00 |
| Home-used medical equipment requirements and Environmental test: |
| IEC 60601-1-11 |
| Electromagnetic Compatibility Requirements: |
| EN 60601-1-2 |
| Biocompatibility Evaluation for the part contacted to patient |
| ISO 10993-5, ISO 10993-10 |
7. Clinical Evaluation
Clinical evaluation of Electronic Thermometers has been conducted by SHENZHEN PUMP MEDICAL SYSTEM CO., LTD.
8. Conclusion
As stated above, the Electronic Thermometer (Models: TF3100, TF3101 and TF3102) have the same intended use and similar technological characteristics as the cleared devices of the digital thermometer MT series (K062784).
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Moreover, the Electronic Thermometer (Models: TF3100, TF3101 and TF3102) comply with the appropriate medical device standards. Verification and validation test reports contained in this submission demonstrate that any differences in their characteristics do not raise any new questions of safety or effectiveness.
Furthermore, those engineering differences do not affect the intended use or alter the fundamental scientific technology of the cleared devices of the digital thermometer MT series (K062784).
As a result, Electronic Thermometers (Models: TF3101 and TF3102) are safety and effective, and substantially equivalent to the earlier identified predicate devices.
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Public Health Service
Food and Drug Administration 0903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 18, 2014
SHENZHEN PUMP MEDICAL SYSTEM Company, Limited C/O Ivy Chen Shenzhen Huatongwei International Inspection Co., Ltd. Keji Nan No.12 Road, Hi-tech Park Shenzhen, Guangdong 518057 CHINA
Re: K131210
Trade/Device Name: Electronic Thermometer, Models TF3100, TF3101, TF3102 Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: November 27, 2013 Received: March 13, 2014
Dear Ms. Chen:
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 - Ms. Chen
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 Small Manufacturers, International and Consumer Assistance at its tollfree 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/Medical/Devices/Safety/Reportal?roblem/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 vours.
Mary S. Runner -S
Erin 1. Keith. M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K131210
Device Name
Electronic Thermometer, Models TF3100, TF3101, TF3102
Indications for Use (Describe)
(Armpit or Oral) . It is intended for use in measuring human body temperature
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.
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