(223 days)
Not Found
No
The device description details a standard digital thermometer using a thermistor and basic electronic components to measure temperature. There is no mention of AI, ML, image processing, or any data processing beyond simple conversion and display.
No
The device measures body temperature, which is a diagnostic function, not a therapeutic one. It does not treat or alleviate any condition.
No.
A diagnostic device provides information to diagnose a disease or condition, whereas this device only measures body temperature, which is a physiological parameter and not a diagnosis in itself. It provides data that a healthcare professional might use as part of a diagnostic process, but the device itself does not diagnose.
No
The device description explicitly states it is a "hand held device" and lists physical components such as a temperature sensor, IC, LCD display, and buzzer. It also describes the physical process of placing the probe tip for measurement.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The Digital Thermometer QT001 measures human body temperature directly from the body (armpit, oral, rectal). It does not analyze any specimens taken from the body.
- Intended Use: The intended use is to measure body temperature, which is a physiological measurement taken directly from the patient, not an analysis of a biological sample.
Therefore, based on the provided information, the Digital Thermometer QT001 is a medical device, but it falls under the category of a non-IVD medical device.
N/A
Intended Use / Indications for Use
The Digital Thermometer QT001 is intended to measure the human body temperature in armpit, orally or rectally, and the device is reusable for clinical or home use on people of all ages.
Product codes
FLL
Device Description
The digital thermometer QT001 is hand held device which can measure human body's temperature at the site of armpit, orally or rectally, the device is reusable for clinical or home use on people of all ages. The results can be displayed on LCD. The QT001 has only one operating mode: direct mode.
The digital thermometer measures temperatures of human body by placing the probe tip into the armpit, oral, rectum directly with the measuring time about 3 minutes.
The digital thermometer consists of a temperature sensor, low power consumption integrated circuit(IC),LCD display and buzzer. The resistance of sensor changes with temperature and the IC converts the resistance to frequency and calculates the temperature according to the relation of resistance and frequency. The calculated temperature is displayed on the LCD.
The thermistor sensor(Type:503F) reacts to temperature. In different temperature, the thermistor has a different resistance value. The essence of temperature measurement is actually measuring the resistance of the sensor, usually is to change the resistance into voltage or current and other analog signals, and digital signals, and then the processor converts the signals to the corresponding temperatures.
QT001 has several functions, such as beep alarm, unit switchable, low battery detection, memories, backlight, auto power off functions.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
armpit, orally or rectally
Indicated Patient Age Range
people of all ages
Intended User / Care Setting
clinical or 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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical test:
Digital Thermometer conforms to applicable standards that include:
- ASTM E1112-00(2018) Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature
- IEC 60601-1:2012, Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance
- IEC 60601-1-2:2014, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility
- 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
- IEC 62304:2006+AMD1:2015 Medical Device Software - Software Life Cycle Processes
- IEC60601-1-11:2015 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
- ISO 80601-2-56:2017/AMD 1:2018 Medical electrical equipment - part 2-56: particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy: +/-0.1 degree Celsius, 34.0 degrees Celsius - 42.0 degrees Celsius (+/-0.2 degrees Fahrenheit, 93.2 degrees Fahrenheit -107.6 degrees Fahrenheit )+/- 0.2 degrees Celsius under34.0 degrees Celsius or over42.0 degrees Celsius(+/- 0.4 degrees Fahrenheit under 93.2 degrees Fahrenheit or over107.6 degrees Fahrenheit ).
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
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 10, 2023
Shen Zhen Rong Feng Technology Co., Ltd Jett Lee Regulation Manager 3/F R Building ShaSi Industrial Park, Shajing Town BaoAn District Shenzhen, Guangdong China
Re: K223044
Trade/Device Name: Digital Thermometer (Model QT001) Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: April 9, 2023 Received: April 10, 2023
Dear Jett 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.
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
1
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,
David Walloschek
David Wolloscheck, Ph.D. 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 Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K223044
Device Name Digital Thermometer (Model: OT001)
Indications for Use (Describe)
The Digital Thermometer OT001 is intended to measure the human body temperature in armpit, or rectally, and the device is reusable for clinical or home use on people of all ages.
| 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
K223044
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
Summary Prepared Date: 25 April 2023
1. Submitter Information
Sponsor Company Name: SHEN ZHEN RONG FENG TECHNOLOGY CO.,LTD
Address: 3/F R building ShaSi Industrial Park,Shajing Town,BaoAn district,ShenZhen city,GuangDong
Province.China
Phone: +86-13715151187
Contact Person (including title): Hong Xiao Lan (Engineer)
E-mail: 844352259@qq.com
Application Correspondent: SHEN ZHEN RONG FENG TECHNOLOGY CO.,LTD
Address: 3/F R building ShaSi Industrial Park,Shajing Town,BaoAn district,ShenZhen city,GuangDong Province.China
- � Contact Person: Iris Fung
- � Tile: Requlation Manager
- Tel: +86-13211147965 �
- � Email: jianda-lee@foxmail.com; mdc-fs@foxmail.com;
2. Subject Device Information
Type of 510(k) submission: Traditional Common Name: Clinical Electronic Thermometer Trade Name: Digital thermometer (Model: QT001) Classification Name: Clinical electronic thermometer Review Panel: General Hospital Product Code: FLL Regulation Number: 21 CFR 880.2910 Requlation Class: II
3. Predicate Device Information
Sponsor: JOYTECH HEALTHCARE CO., LTD. Trade Name: Digital Thermometer
4
510(k) number: K200599 Review Panel: General Hospital Product Code: FLL Regulation Number: 21 CFR 880.2910 Regulation Class: II
4. Device Description
The digital thermometer QT001 is hand held device which can measure human body's temperature at the site of armpit, orally or rectally, the device is reusable for clinical or home use on people of all ages. The results can be displayed on LCD. The QT001 has only one operating mode: direct mode.
The digital thermometer measures temperatures of human body by placing the probe tip into the armpit, oral, rectum directly with the measuring time about 3 minutes.
The digital thermometer consists of a temperature sensor, low power consumption integrated circuit(IC),LCD display and buzzer. The resistance of sensor changes with temperature and the IC converts the resistance to frequency and calculates the temperature according to the relation of resistance and frequency. The calculated temperature is displayed on the LCD.
The thermistor sensor(Type:503F) reacts to temperature. In different temperature, the thermistor has a different resistance value. The essence of temperature measurement is actually measuring the resistance of the sensor, usually is to change the resistance into voltage or current and other analog signals, and digital signals, and then the processor converts the signals to the corresponding temperatures.
QT001 has several functions, such as beep alarm, unit switchable, low battery detection, memories, backlight, auto power off functions.
5. Indication for use
The Digital Thermometer QT001 is intended to measure the human body temperature in armpit, orally or rectally, and the device is reusable for clinical or home use on people of all ages.
6. Comparison to Predicate Device
A comparison of key technological characteristics between the subject devices and predicate device was listed as below:
| Elements of
| Comparison | Subject Device | Predicate Device | Verdict |
|---|---|---|---|
| Manufacturer | SHEN ZHEN RONG FENG | ||
| TECHNOLOGY CO., LTD | Joytech Healthcare Co., Ltd | -- | |
| Elements of | |||
| Comparison | Subject Device | Predicate Device | Verdict |
| 510 (k) Number | K223044 | K200599 | -- |
| Product Name | Digital Thermometer | Digital Thermometer | -- |
| Models | QT001 | DMT-4756 | -- |
| Intended Use | The Digital Thermometer QT001 | ||
| is intended to measure the | |||
| human body temperature in | |||
| armpit, orally or rectally, and the | |||
| device is reusable for clinical or | |||
| home use on people of all ages. | The Digital Thermometer DMT- | ||
| 4756 is intended to measure the | |||
| human body temperature in regular | |||
| mode orally, rectally or under the | |||
| arm, and the device is reusable | |||
| for clinical or home use on people | |||
| of all age, including children under 8 | |||
| with adult supervision. | Similar | ||
| There is minor | |||
| difference, but the | |||
| user manual have | |||
| been indicated in | |||
| the instructions that | |||
| children should not | |||
| be allowed to | |||
| perform the test | |||
| unsupervised | |||
| It will not affect | |||
| safety and | |||
| effectiveness. | |||
| Fundamental | |||
| technology& | |||
| Operating | |||
| principle | A change of thermistor | ||
| resistance, | |||
| caused by changes of | |||
| temperature. The resistance is | |||
| measured by MCU, so changes | |||
| of temperature will correspond to | |||
| changes of resistance | A change of thermistor resistance, | ||
| caused by changes of temperature. | |||
| The resistance is measured by | |||
| MCU, so changes of temperature | |||
| will correspond to changes of | |||
| resistance | Identical | ||
| Sensor | Thermistor | Thermistor | Identical |
| Signal | |||
| processing | |||
| and display | Internal firmware and local LCD | ||
| display | Internal firmware and local LCD | ||
| display | Identical | ||
| Measurement | |||
| Site | armpit, orally or rectally | orally, rectally or under the arm | Identical |
| Measuring | |||
| Range | $32.0~42.9 °C (89.6°F ~ 109.2°F)$ | $32.0°C | Different(Note 1) |
| Accuracy | $±0.1°C,34.0°C-42.0°C (±0.2°F,93.2°F -107.6°F )± 0.2 °C under34.0 °C or over42.0°C( ± 0.4°F under 93.2°F or over107.6°F )$ | $±0.1°C between 35.5°C to42.0°C(±0.2°F,95.9°F-107.6°F),±0.2°C under 35.5°C or over42.0°C(±0.4°F under 95.9°F or over107.6°F )$ | Different(Note 2) |
| Display | |||
| resolution | $0.1 °C/0.1 °F$ | $0.1 °C/0.1 °F$ | Identical |
| Components | Sensor, buzz film, housing, | ||
| stainless steel cap, LCD display, | |||
| measurement control module. | Sensor, buzz film, housing, | ||
| stainless steel cap, LCD display, | |||
| measurement control module. | Identical | ||
| Sensor type | Thermopile | Thermopile | Identical |
| Material | ABS, TPE, Stainless steel | ABS, TPE, Stainless steel | Identical |
| Elements of | |||
| Comparison | Subject Device | Predicate Device | Verdict |
| Memories | For storing the last measured | ||
| value | 10 memories | Different(Note 3) | |
| Power Supply | One 3.0 V CR1225 battery | One 3.0V CR2032 battery | Identical |
| Operating range | Temperature: 5°C-40°C (41°F - | ||
| 104°F ) | |||
| Relative humidity:15%RH- | |||
| 95%RH | |||
| Atmospheric pressure: 70kPa- | |||
| 106kPa | Temperature: | ||
| 41°F ~104°F (5°C ~40°C ) | |||
| Relative humidity: 15%~95%RH | |||
| Atmospheric Pressure : | |||
| 700hPa ~ 1060hPa | Different(Note4) | ||
| Construction | Flexible tip | The probe is foldable into the body | |
| of the thermometer | Different(Note5) | ||
| Measurement | |||
| method & time | Approximate 3 minutes | 10s Predictive read | |
| 30s Final read. | Different(Note6) | ||
| Thermometer | |||
| Size | 138mm x 25mm x 12mm (L x W x | ||
| H) | 10.6cm3.2cm2.5cm(L x W x H) | Different(Note7) | |
| Weight | Approx. 10 grams including | ||
| battery | Approx. 40 grams including battery | Different(Note7) | |
| LCD Size | 2.0cm*0.7cm | 2.5cm*1.4cm | Different(Note7) |
| Color &Coding | White(R9003), Green(P294C) | White(R9003), | |
| Green(P564C) | Different(Note7) | ||
| Predictive mode | NO | Yes | Different(Note6) |
| Storage | |||
| and | |||
| transportation | |||
| condition | Temperature:-20℃~55℃(- | ||
| 4°F ~ 131°F ) | |||
| Relative humidity:15%RH- | |||
| 95%RH | |||
| Atmospheric pressure: 50kPa- | |||
| 106kPa | Temperature: | ||
| -4°F | |||
| Relative humidity: 15%~95%RH | |||
| Atmospheric Pressure: | |||
| 700hPa ~ 1060hPa | Different(Note4) | ||
| Safety | Complied with IEC 60601-1 | Complied with IEC 60601-1 | Identical |
| EMC | Complied with IEC 60601-1-2 | Complied with IEC 60601-1-2 | Identical |
| Biocompatibility | Complied with ISO 10993-5 and | ||
| ISO 10993-10 | Complied with ISO 10993-5 and | ||
| ISO 10993-10 | Identical | ||
| Performance | Complied with ISO 80601-2- | ||
| 56:2017/AMD 1:2018 and ASTM | |||
| E1112:00(2018). | Complied with ISO 80601-2- | ||
| 56:2017 | Different(Note8) | ||
| Backlight | |||
| warning function | 1.When measured temperature is | ||
| 35.9℃,the LCD without | |||
| backlight | |||
| 2.When measured temperature | |||
| ≥36℃ and ≤37.1℃, the LCD | |||
| shows green backlight | |||
| 3.When measured temperature | |||
| ≥37.2℃ and ≤37.4℃, the LCD | |||
| shows yellow backlight. | |||
| 4.When measured temperature |
=37.5°C and ≤42.9°C, the LCD | / | Different(Note9) |
| Elements of
Comparison | Subject Device | Predicate Device | Verdict |
| | shows red backlight.
The laboratory accuracy error no
greater than 0.3 °C | | |
5
6
7
Comparison discussion:
Note 1
The subject device and predicate device have different measurement range, but the measurement range of subject device meets the requirements of ASTM E1112:00 and ISO 80601-2-56. The difference does not raise any new or different safety and effectiveness questions. .
Note 2
The subject device and predicate device have different accuracy, but the accuracy of the subject device meets the requirements of ASTM E1112:00 and ISO 80601-2-56. The difference does not raise any new or different safety and effectiveness questions.
Note 3
The memory function difference: The software verification were conducted to demonstrate the performance of the function as intended. The memory function does not affect accuracy of measurement; so such difference does not impact the performance of subject device.
Note 4
Operating range, Storage and transportation condition difference: The subject device has been tested and the test results met the requirements of IEC60601-1 and ISO 80601-2-56. The difference does not raise any new or different safety and effectiveness questions.
Note 5
Construction difference: Performance testing shows the subject device complies with standard ISO 80601-2-56. The difference does not raise any new questions of safety and effectiveness.
Note 6
Measurement time, predictive mode difference: Performance test was conducted in accordance with ISO 80601-2-56. The test results demonstrated the subject device complies with performance standard. The differences do not raise any new questions of safety and effectiveness.
Note 7
Weight, size, color difference: Biocompatibility test and performance bench test met the requirements of ISO 10993-5 and ISO 10993-10. The differences do not raise any new questions of safety and effectiveness.
Note 8
Performance testing shows the subject device complies with standard ISO 80601-2-56:2017/AMD 1:2018 and ASTM E1112-00 (2018). The difference does not raise any new questions of safety and effectiveness.
8
Note 9
Backlight warning function does not affect accuracy of measurement; the software verification and validation were conducted to demonstrate the performance of the function as intended. So such difference does not raise any new safety and effectiveness questions.
7. Test Summary
Non-clinical test:
Digital Thermometer conforms to applicable standards that include:
- � ASTM E1112-00(2018) Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature
- � IEC 60601-1:2012, Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance
- � IEC 60601-1-2:2014, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility
- � 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
- � IEC 62304:2006+AMD1:2015 Medical Device Software - Software Life Cycle Processes
- � IEC60601-1-11:2015 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
- � ISO 80601-2-56:2017/AMD 1:2018 Medical electrical equipment - part 2-56: particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement
8. Conclusion
Based on comparison of the intended use, technological characteristics, applicable safety standards, verification and validation testing, the differences between subject device and the predicate device do not raise new issues of safety and effectiveness. Thus, the subject device is substantially equivalent to the predicate device.