(260 days)
Not Found
No
The device description details a simple digital thermometer based on a thermistor and ASIC, with no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No.
A therapeutic device is used for treatment or therapy. This device is a digital thermometer, which is used for measurement and monitoring of body temperature, not for treatment.
No
The intended use of the device is for the measurement and monitoring of human body temperature, not for diagnosing a disease or condition. While temperature measurement can be an indicator, the device itself doesn't provide a diagnosis.
No
The device description explicitly lists hardware components such as a thermistor, reference resistor, ASIC, and LCD, indicating it is a physical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- Device Function: This digital thermometer measures human body temperature directly, externally, and non-invasively. It does not analyze any specimens taken from the body.
- Intended Use: The intended use is for "measurement and monitoring of human body temperature," which is a direct physiological measurement, not an in vitro analysis.
Therefore, based on the provided information, this digital thermometer falls under the category of a general medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Digital Thermometer (models TM-2011, TM-3002, TM-3102) intended for the measurement and monitoring of human body temperature by users for home use. It can be used for axillary measurement and oral measurement.
Product codes
FLL
Device Description
Digital Thermometers comprises a thermistor for getting temperature signal, a reference resistor for comparing the resistance of the thermistor, an ASIC for processing the target temperature digitally, and a LCD for displaying the temperature. The design principle of thermometer is based on thermosensor and ASIC technology. A thermistor is used as thermosensor. The ASIC gets the sensor's signal from human body, then processes the signal and calculates the result, after that displays the temperature result by a LCD. There is buzzing noise occurs when the device turns on and when the measurement is completed (for model TM-3002 and TM-3102 only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
axillary, oral
Indicated Patient Age Range
The clinical tests evaluated 240 of subjects. and the thermometer was evaluated in four groups A1 - 0 up to three months to one year; B1 older than one years and younger than five years; and C - older than five years old.
Intended User / Care Setting
users for home use.
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
Clinical tests were conducted on the Model TM-3102. The clinical tests evaluated 240 of subjects. and the thermometer was evaluated in four groups A1 - 0 up to three months to one year; B1 older than one years and younger than five years; and C - older than five years old. The clinical performance test protocol and data analysis were conducted in accordance with the requirement of ISO 80601-2-56.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Digital Thermometer has been evaluated the safety and performance by lab bench testing as following:
- Electrical safety test according to IEC 60601-1 standards
- Electromagnetic compatibility test according to IEC 60601-1-2 standard
- Biocompatibility test according to ISO 10993-1, ISO 10993-5 and ISO 10993-10 standards
- Usability test according to IEC 62366 standard
- Particular Requirements for Basic Safety and Essential Performance of Clinical Thermometers for Body Temperature Measurement according to ASTM E1112-00 Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature
- 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.
- Software verification and validation test according to the requirements of the FDA "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".
Clinical tests: Clinical tests were conducted on the Model TM-3102. The clinical tests evaluated 240 of subjects. and the thermometer was evaluated in four groups A1 - 0 up to three months to one year; B1 older than one years and younger than five years; and C - older than five years old. The clinical performance test protocol and data analysis were conducted in accordance with the requirement of ISO 80601-2-56. The test report showed the clinical performance of the subject devices complied with the requirement of ISO 80601-2-56.
Cleaning verification: Cleaning verification was performed on TM-2011, TM-3002, TM-3102. Each model took 15 samples and 45 samples each. The test report showed the cleaning instructions are appropriate for cleaning and reuse.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Measurement Accuracy: +/- 0.1 deg C, 37.0 deg C ~ 39.0 deg C; +/- 0.2 deg C, 35.0 deg C ~ 36.9 deg C, 39.1 deg C ~ 42.0 deg C; +/- 0.3 deg C, 32.0 deg C ~ 34.9 deg C, 42.1 deg C ~ 43.0 deg C. At Standard room temperature of 25 deg C (77.0 deg F)
Measurement Speed: 45s
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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 31, 2019
Xiamen Ants Bro Technology Co., Ltd. % Cassie Lee Manager Guangzhou GLOMED Biological Technology Co., Ltd. 2231, Building 1, Rui Feng Center, Kaichuang Road Huangpu District Guangzhou, 510000 China
Re: K190990
Trade/Device Name: Digital Thermometer (Models: TM-2011, TM-3002, TM-3102) Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: November 26, 2019 Received: December 2, 2019
Dear Cassie Lee:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Geeta Pamidimukkala Acting Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K190990
Device Name
Digital Thermometer (Models: TM-2011, TM-3002, TM-3102)
Indications for Use (Describe)
Digital Thermometer (models TM-2011, TM-3002, TM-3102) intended for the measurement and monitoring of human body temperature by users for home use. It can be used for axillary measurement and oral measurement.
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary K190990
This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.
1. Submitter's Information
510(k) Owner's Name: Xiamen Ants Bro Technology Co., Ltd. Establishment Registration Number: Applying Address: 4th and 5th floor, No. 5 Building, Tech.&Innovation center, No. 289 Wengjiao Road, Haicang District, Xiamen, Fujian, China Tel: 86-592-6537633 Fax: 0592-6537633 Contact Person: Jane Xu (Manger) Email: Sales1@asxd.com.cn
Application Correspondent:
Contact Person: Cassie Lee Guangzhou GLOMED Biological Technology Co., Ltd. Address: 2231, Building 1, Rui Feng Center, Kaichuang Road, Huangpu District, Guangzhou, Guangdong, China Tel: +86 20 8266 2446 Email: regulatory@glomed-info.com
2. Subject Device Information
Type of 510(k): Traditional Common Name: Clinical electronic thermometer Classification Name: Thermometer, electronic, clinical Trade Name: Digital Thermometer Model Name: TM-2011, TM-3002, TM-3102 Review Panel: General Hospital Product Code: FLL Regulation Number: 880.2910 Regulatory Class: 2
3. Predicate Device Information
Sponsor: Fudakang Industrial Co., Ltd. Trade Name: Digital Thermometer Common Name: Clinical electronic thermometer Classification Name: Thermometer, Electronic, Clinical 510(K) Number: K101387 Review Panel: General Hospital Product Code: FLL Regulation Number: 880.2910 Regulation Class: 2
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4. Device Description
Digital Thermometers comprises a thermistor for getting temperature signal, a reference resistor for comparing the resistance of the thermistor, an ASIC for processing the target temperature digitally, and a LCD for displaying the temperature. The design principle of thermometer is based on thermosensor and ASIC technology. A thermistor is used as thermosensor. The ASIC gets the sensor's signal from human body, then processes the signal and calculates the result, after that displays the temperature result by a LCD. There is buzzing noise occurs when the device turns on and when the measurement is completed (for model TM-3002 and TM-3102 only.
5. Intended Use / Indications for Use
Digital Thermometer (models TM-2011, TM-3002, TM-3102) intended for the measurement and monitoring of human body temperature by users for home use. It can be used for axillary measurement and oral measurement.
6. Test Summary
6.1 Digital Thermometer has been evaluated the safety and performance by lab bench testing as following:
- Electrical safety test according to IEC 60601-1 standards �
- � Electromagnetic compatibility test according to IEC 60601-1-2 standard
- � Biocompatibility test according to ISO 10993-1, ISO 10993-5 and ISO 10993-10 standards
- � Usability test according to IEC 62366 standard
- � Particular Requirements for Basic Safety and Essential Performance of Clinical Thermometers for Body Temperature Measurement according to ASTM E1112-00 Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature
- � 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.
- � Software verification and validation test according to the requirements of the FDA "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".
6.2 Discussion of Clinical Tests Performed
Clinical tests were conducted on the Model TM-3102. The clinical tests evaluated 240 of subjects. and the thermometer was evaluated in four groups A1 - 0 up to three months to one year; B1 older than one years and younger than five years; and C - older than five years old. The clinical performance test protocol and data analysis were conducted in accordance with the requirement of ISO 80601-2-56. The test report showed the clinical performance of the subject devices complied with the requirement of ISO 80601-2-56.
6.3 Discussion of Cleaning Validation
Cleaning verification was performed on TM-2011, TM-3002, TM-3102. Each model took 15 samples and 45 samples each. The test report showed the cleaning instructions are appropriate for cleaning and reuse.
7. Comparison to predicate device and conclusion
The subject device Digital Thermometers (Model : TM-2011, TM-3002, TM-3102) have all features of the predicate devices K101387. The few differences do not affect the safety and effectiveness of the subject device. Thus, the subject device is substantially equivalent to the predicate devices.
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| Elements of
Comparison | Subject Device | Predicate Device | Remar
k |
|-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| Company | Xiamen Ants Bro Technology Co.,
Ltd. | Fudakang Industrial Co., Ltd. | -- |
| Name and
Model | Digital Thermometer, models: TM-
2011, TM-3002, TM-3102 | Digital Thermometer, Model: BT-
A11CN, BT-A21CN, BT-A41 CN | -- |
| 510(k) Number | K190990 | K101387 | -- |
| Product Code | FLL | FLL | SE |
| Thermometer
Type | Digital Thermometer | Digital Thermometer | SE |
| Intended Use /
Indication for
Use | Digital Thermometer (models TM-
2011, TM-3002, TM-3102) intended
for the measurement and
monitoring of human body
temperature by users for home use.
It can be used for axillary
measurement and oral
measurement. | Fudakang Digital Thermometers
are intended for the measurement
and monitoring of human body
temperature by doctor or
consumers in the hospital or home.
BT-A11CN, BT-A21CN, BT-A41CN
can be used for axillary
measurement, oral measurement
and rectal measurement. | SE |
| Sensor | Thermistor | Thermistor | SE |
| Signal
Processing and
Display | Using the resistance change of
thermal resistor to detect body
temperature and displayed through
the LCD. | Using the resistance change of
thermal resistor to detect body
temperature and displayed through
the LCD. | SE |
| Power
Requirement | 1.5V button battery | 1.5V button battery | SE |
| Battery type | One 1.5 V DC. button battery (size
LR41or SR41, UCC 392) | One 1.5 V DC. button battery (size
LR41or SR41, UCC 392)
DMT-4726,DMT-4735:
One 3.0V CR2032 battery | SE |
| Measurement
Temperature
Range | 32.0°C ~ 43°C | 32.0°C ~ 43°C | SE |
| Voice function | For model TM-3002, TM-3102: Yes;
(There is buzzing noise occur when
the device turning on and when the
measurement is completed.)
For model TM-2011: None | Yes | SE
Note 1 |
| Patient contact
material | Enclosure and Key: ABS plastic
Probe: Stainless steel | Enclosure and Key: ABS plastic
Probe: Stainless steel | SE |
| Measurement
Accuracy | $±0.1°C, 37.0°C ~ 39.0°C$
$±0.2°C ,35.0°C ~ 36.9°C, 39.1°C ~ 42.0°C$
$±0.3°C, 32.0°C ~ 34.9°C, 42.1°C ~ 43.0°C$
At Standard room temperature of
25°C (77.0°F) | 35.0°C ~ 39.0°C: ±0.1°C
95.0 ~ 102.0 °F: ±0.1°F
the rest: ±0.2°C
At Standard room temperature of
25°C (77.0°F) | SE
Note 2 |
| Measurement
Speed | 45s | 60s | SE
Note 2 |
| Elements of Comparison | Subject Device | Predicate Device | Remark |
| | Measurement site | Orally, axillary | DMT series (except DMT-455):
orally, rectally or under the arm
DMT-455:orally |
| Power ON/OFF | Switch the thermometer ON and OFF by shaking it or
Switch the thermometer ON and OFF by press the power button | Switch the thermometer ON and OFF by press the power button | SE
Note 1 |
| Describe and compare features | For model TM-3002 and TM-3102:
Voice feature
For model TM-2011: No voice feature
Other functions are the same | -- | SE
Note 1 |
| Probe cover use? | No | For rectal measurement only | SE |
| Complied Standard | IEC 60601-1,
ISO 80601-2-56,
IEC 60601-1-2,
IEC 60601-1-11,
ASTM E1112,
ISO 10993-1,
ISO 10993-5,
ISO 10993-10 | IEC 60601-1,
IEC 80601-2-56,
IEC 60601-1-2,
IEC 60601-1-11,
ASTM E1112,
ISO 10993-1,
ISO 10993-5,
ISO 10993-10 | SE |
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Note 1:
Although the "Voice function", "Measurement site", "Describe and compare features" and "Power ON/OFF" of subject device is a little different with predicate device, but they are just for indication and operation only, and the whole product are all compliance with safety standard and performance standards, these differences will not raise any safety or effectiveness issue.
Note 2:
Although there is a little difference between the "measurement accuracy" and "Measurement Speed", the subject device accuracy is compliance with ISO 80601-2-56 and ASTM E 1112 requirements. So, the difference of accuracy will not raise any safety of effectiveness issue.
Final Conclusion:
The subject device Digital Thermometers (Model: TM-2011, TM-3002, TM-3102) have all features of the predicate devices K101387. Thus, the subject device is substantially equivalent to the predicate devices