(333 days)
Not Found
No
The device description details a simple thermistor and ASIC-based system for temperature measurement, with no mention of AI/ML terms or complex data processing beyond basic signal processing and calculation. The performance studies focus on standard compliance and accuracy metrics, not AI/ML performance metrics.
No
The device is used for measurement and monitoring of body temperature, which is a diagnostic function, not a therapeutic one. It does not provide any treatment or therapy.
Yes
Explanation: The device measures and displays a physiological parameter (body temperature), which is used by doctors or consumers to monitor human body temperature, aiding in the assessment of health status.
No
The device description explicitly lists hardware components such as a thermistor, reference resistor, buzzer, ASIC, and LCD, indicating it is a physical device with integrated software, not a software-only medical device.
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 (like blood, urine, tissue) to provide information about a person's health.
- Device Function: This digital thermometer measures human body temperature directly, in vivo (within the living body), not by analyzing a sample in vitro (in a test tube or lab setting).
- Intended Use: The intended use clearly states "measurement and monitoring of human body temperature," which is a direct physiological measurement.
- Device Description: The description details components for sensing and processing temperature signals from the body, not for analyzing biological samples.
Therefore, based on the provided information, this digital thermometer is a medical device for in vivo measurement, not an IVD.
N/A
Intended Use / Indications for Use
Digital Thermometers are intended for the measurement and monitoring of human body temperature by doctor or consumers in the hospital or home.
It can be used for axillary measurement, oral measurement and rectal measurement.
Product codes (comma separated list FDA assigned to the subject device)
FLL
Device Description
Digital Thermometers comprises a thermistor for getting temperature signal, a reference resistor for comparing the resistance of the thermistor, a buzzer for sounding effect, an ASIC for processing the target temperature digitally, and a LCD for displaying the temperature result. The design principle of thermometer is based on thermos sensor and ASIC technology. A thermistor is used as thermos sensor. 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
axillary, oral, rectal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Doctor or consumers in the hospital or home.
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)
The whole product and manufacturing used for the Digital thermometer are identical to those of the predicate device, which were demonstrated to conform with the following standards:
- IEC 60601-1 (2005/(R)2012 and A1:2012) Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance
- IEC 80601-2-56 (2018) Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement.
- I IEC 60601-1-2 (2014) Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- I IEC 60601-1-11 (2015) Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
- . ASTM E1112-00 (2011) Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature
- " ISO 10993-5 (2009) Biological Evaluation of Medical Devices - Part 5: Tests for In Vitro cytotoxicity
- " ISO 10993-10 (2010) Biological Evaluation of Medical Devices - Part 10: Tests for irritation and skin sensitization
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Measurement Accuracy: 35.0 ~ 39.0°C : +/- 0.1°C The rest: +/- 0.2°C
Response Time: 60s
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
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November 23, 2020
Dongguan E-Test Technology Co., Ltd % Cassie Lee Manager Guangzhou GLOMED Biological Technology Co., Ltd. Suite 306, Kecheng Mansion, No.121 Science Road, Guangzhou Science Park Guangzhou, 510000 China
Re: K193621
Trade/Device Name: Digital Thermometer (Model BT-301, BT-302, BT-303, BT-305, BT-306, BT-308. BT-311. BT-318) Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: October 21, 2020 Received: October 28, 2020
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.
1
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.
for Payal Patel 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
2
Indications for Use
510(k) Number (if known) K193621
Device Name
Digital Thermometer (Model: BT-301, BT-302, BT-305, BT-306, BT-308, BT-311, BT-318)
Indications for Use (Describe)
Digital Thermometers are intended for the measurement and monitoring of human body temperature by doctor or consumers in the hospital or home.
It can be used for axillary measurement, oral measurement and rectal measurement.
| 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) |
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3
510(k) Summary -K193621
This summary of 510(K) information is being submitted in accordance with the requirements of
SMDA and 21 CFR 807.92.
Date: 11/20/2020
1. Submitter's Information
510(k) Owner's Name: DONGGUAN E-TEST TECHNOLOGY CO., LTD
Establishment Registration Number: Applying
Address: Room 201,301, Building 1, Changping Section No.1, Dongshen Road, Changping Town, Dongguan City, Guangdong, China.
Tel: +86-0769-81158038
Contact Person (including title): Victor Wan (Vice-president)
E-mail: victor@agelh.com
Application Correspondent:
Contact Person: Ms. Cassie Lee
DONGGUAN E-TEST TECHNOLOGY CO., LTD
Address: Room 201,301, Building 1, Changping Section No.1, Dongshen Road, Changping Town, Dongguan City, Guangdong, China
Tel: +86-0769-81158038 Email: regulatory@glomed-info.com
2. Subject Device Information
| Type of 510(k): | Traditional |
|---|---|
| Common Name: | Thermometer, electronic |
| Trade Name: | Digital Thermometer -(Model BT-301, BT-302, BT-303, BT-305, BT-306, BT-308, BT-311, BT-318) |
| Classification Name: | Thermometer, electronic, clinical |
| 510(K) Number: | K193621 |
| Review Panel: | General Hospital |
4
| Sponsor: | DONGGUAN E-TEST TECHNOLOGY CO., LTD |
|---|---|
| Subject Device: | Digital Thermometer, model: BT-301, BT-302, BT-303, BT-305, BT-306, BT-308, BT-311, BT-318 |
| File No.: | 510(k) Summary |
Product Code: FLL Regulation Number: 880.2910 Requlation Class: 2
3. Predicate Device Information
- 510(K) Number: K172508
Sponsor: Dongguan Ageless Health Industrial Co., Ltd.
Common Name: Thermometer, electronic
Trade Name: Ageless Health Medical Digital Thermometer
Classification Name: Thermometer, electronic, clinical
Review Panel: General Hospital
Product Code: FLL
Regulation Number: 880.2910
Regulation Class: 2
Device Description 4.
Digital Thermometers comprises a thermistor for getting temperature signal, a reference resistor for comparing the resistance of the thermistor, a buzzer for sounding effect, an ASIC for processing the target temperature digitally, and a LCD for displaying the temperature result. The design principle of thermometer is based on thermos sensor and ASIC technology. A thermistor is used as thermos sensor. 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.
5. Intended Use
Digital Thermometers are intended for the measurement and monitoring of human body temperature by doctor or consumers in the hospital or home.
It can be used for axillary measurement, oral measurement and rectal measurement.
Test Summary 6.
The whole product and manufacturing used for the Digital thermometer are identical to those of the predicate device, which were demonstrated to conform with the following standards:
5
| Sponsor: | DONGGUAN E-TEST TECHNOLOGY CO., LTD |
|---|---|
| Subject Device: | Digital Thermometer, model: BT-301, BT-302, BT-303, BT-305, BT-306, BT-308, BT-311, BT-318 |
| File No.: | 510(k) Summary |
- . IEC 60601-1 (2005/(R)2012 and A1:2012) Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance
- IEC 80601-2-56 (2018) Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement.
- I IEC 60601-1-2 (2014) Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- I IEC 60601-1-11 (2015) Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
- . ASTM E1112-00 (2011) Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature
- " ISO 10993-5 (2009) Biological Evaluation of Medical Devices - Part 5: Tests for In Vitro cytotoxicity
- " ISO 10993-10 (2010) Biological Evaluation of Medical Devices - Part 10: Tests for irritation and skin sensitization
7. Comparison to Predicate Device
Compare with predicate device, the subject device is very similar in design principle, intended use, indications for use, functions, material and the applicable standards.
| Elements of
| Comparison | Subject Device | Predicate Device | Remark |
|---|---|---|---|
| Company | DONGGUAN E-TEST | ||
| TECHNOLOGY CO., LTD | Ageless Health Industrial Co., | ||
| Ltd. | -- | ||
| Name and | |||
| Model | Digital Thermometer, models: | ||
| BT-301, BT-302, BT-303, | |||
| BT-305, BT-306, BT-308, | |||
| BT-311, BT-318 | Ageless Health Medical Digital | ||
| Thermometer, models: BT-301, | |||
| BT-302, BT-303, BT-305, | |||
| BT-306, BT-308, BT-311, BT-318 | -- | ||
| 510(k) | |||
| Number | K193621 | K172508 | -- |
| Thermometer | |||
| Type | Digital Thermometer | Digital Thermometer | SE |
| Intended Use | |||
| / Indication for | |||
| Use | Digital Thermometers are | ||
| intended for the measurement | |||
| and monitoring of human body | Ageless Health Medical Digital | ||
| Thermometers are intended for | |||
| the measurement and monitoring | SE |
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Sponsor:
DONGGUAN E-TEST TECHNOLOGY CO., LTD Digital Thermometer, model: BT-301, BT-302, BT-305, BT-306, BT-308, BT-311, Subject Device: BT-318 ary
| File No.: | 510(k) Summary |
|---|---|
| ----------- | ---------------- |
| Elements of
| Comparison | Subject Device | Predicate Device | Remark |
|---|---|---|---|
| temperature by doctor or | |||
| consumers in the hospital or | |||
| home. | |||
| It can be used for axillary | |||
| measurement, oral measurement | |||
| and rectal measurement. | of human body temperature by | ||
| doctor or consumers in the | |||
| hospital or home. | |||
| It can be used for axillary | |||
| measurement, oral measurement | |||
| and rectal measurement. | |||
| 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 |
| Measurement | |||
| Temperature | |||
| Range | 32.0°C ~ 42.9°C | 32.0°C ~ 42.9°C | SE |
| Measurement | |||
| Accuracy | 35.0 ~ 39.0°C : +/- 0.1°C | ||
| The rest: +/- 0.2°C | 35.0 ~ 39.0°C : +/- 0.1°C | ||
| The rest: +/- 0.2°C | SE | ||
| Ambient | |||
| Temperature | 10~35°C | 10~35°C | SE |
| Response | |||
| Time | 60s | 60s | SE |
| Complied | |||
| Standard | IEC 60601-1, IEC 80601-2-56, | ||
| IEC 60601-1-2, IEC 60601-1-11, | |||
| ASTM E1112, ISO 10993-5, ISO | |||
| 10993-10 | IEC 60601-1, IEC 80601-2-56, | ||
| IEC 60601-1-2, IEC 60601-1-11, | |||
| ASTM E1112, ISO 10993-5, ISO | |||
| 10993-10 | SE |
Conclusion
The subject device Digital Thermometer has all features of the predicate devices. No differences will affect the safety and effectiveness of the subject device. Thus, the subject device is substantially equivalent to the predicate device. All hardware and software of the subject device are based on that of the predicate device (K172508), since no new testing is presented in the submission.
8. Summary Prepared Date
20 November 2020