(223 days)
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 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.
Here's a breakdown of the acceptance criteria and study information for the Digital Thermometer (Model QT001), based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Standard Requirement) | Reported Device Performance (Model QT001) | Verdict/Comment |
|---|---|---|
| Measurement Range | $32.0~42.9 °C (89.6°F ~ 109.2°F)$ | Meets ASTM E1112:00 and ISO 80601-2-56 requirements |
| Accuracy | $±0.1°C, 34.0°C-42.0°C (±0.2°F, 93.2°F-107.6°F)$$±0.2°C$ under $34.0°C$ or over $42.0°C$ ($±0.4°F$ under $93.2°F$ or over $107.6°F$) | Meets ASTM E1112:00 and ISO 80601-2-56 requirements |
| Display Resolution | $0.1 °C/0.1 °F$ | Identical to predicate device |
| Operating Range (Temperature) | $5°C-40°C (41°F -104°F)$ | Meets IEC60601-1 and ISO 80601-2-56 requirements |
| Operating Range (Relative Humidity) | $15%RH-95%RH$ | Meets IEC60601-1 and ISO 80601-2-56 requirements |
| Operating Range (Atmospheric Pressure) | $70kPa-106kPa$ | Meets IEC60601-1 and ISO 80601-2-56 requirements |
| Storage & Transport Temp. | $-20℃~55℃ (-4°F ~ 131°F)$ | Meets IEC60601-1 and ISO 80601-2-56 requirements |
| Storage & Transport Relative Humidity | $15%RH-95%RH$ | Meets IEC60601-1 and ISO 80601-2-56 requirements |
| Storage & Transport Atmospheric Pressure | $50kPa-106kPa$ | Meets IEC60601-1 and ISO 80601-2-56 requirements |
| Measurement Time | Approximate 3 minutes | Performance test conducted and meets ISO 80601-2-56 |
| Safety (Electrical) | Complied with IEC 60601-1 | Verified with standard |
| EMC | Complied with IEC 60601-1-2 | Verified with standard |
| Biocompatibility | Complied with ISO 10993-5 and ISO 10993-10 | Verified with standard |
| Performance Standard | Complied with ISO 80601-2-56:2017/AMD 1:2018 and ASTM E1112:00(2018) | Verified with standards |
| Software Life Cycle Processes | Complied with IEC 62304:2006+AMD1:2015 | Verified with standard |
| Home Healthcare Environment | Complied with IEC60601-1-11:2015 | Verified with standard |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions that "performance testing shows the subject device complies with standard ISO 80601-2-56," and "performance test was conducted in accordance with ISO 80601-2-56." and "software verification and validation were conducted". These standards, particularly ASTM E1112:00 and ISO 80601-2-56, define methodologies and requirements for testing clinical thermometers, which would inherently involve a test set of measurements. However, the specific number of subjects, measurements, or the origin of this data is not detailed in this summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This information is not provided in the document. For a clinical thermometer, the "ground truth" for temperature measurements would typically be established by highly accurate reference thermometers or methods in a controlled laboratory setting, rather than human experts in the way AI/radiology studies utilize them.
4. Adjudication Method for the Test Set:
This information is not provided in the document. Adjudication methods are typically relevant for studies involving human interpretation or subjective assessment. For a device like a digital thermometer measuring a physical parameter against a standard, the "adjudication" is inherent in the comparison to the reference standard's reading and the pass/fail criteria of the specified accuracy.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size:
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation and reader variability, such as medical imaging AI. The Digital Thermometer is a standalone measurement device; its performance is not evaluated in terms of how it "improves" human reader performance.
6. If a Standalone Study (i.e., algorithm only without human-in-the-loop performance) was done:
Yes, a standalone study was done. The entire "Test Summary" section describes the non-clinical tests conducted on the Digital Thermometer (Model QT001) to demonstrate its compliance with various international standards (ASTM E1112-00, IEC 60601-1, ISO 80601-2-56, etc.). This inherently means the device's performance was evaluated independently without human intervention influencing its measurement accuracy.
7. The Type of Ground Truth Used:
The ground truth used for calibration and accuracy verification is the readings from highly accurate reference thermometers or validated temperature sources that meet the requirements of the specified standards (e.g., ASTM E1112-00, ISO 80601-2-56). These standards outline the methods for generating and comparing measurements against known, precise temperatures.
8. The Sample Size for the Training Set:
The document does not mention a training set in the context of machine learning or AI models. This device is a traditional digital thermometer based on a thermistor and embedded firmware for calculation, not a machine learning algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established:
As there is no mention of a machine learning model or a training set, the establishment of ground truth for a training set is not applicable to this device described in the submission. The device's functionality relies on established physics and pre-programmed algorithms, not learned patterns from data.
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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
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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
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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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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
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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 ofComparison | Subject Device | Predicate Device | Verdict |
|---|---|---|---|
| Manufacturer | SHEN ZHEN RONG FENGTECHNOLOGY CO., LTD | Joytech Healthcare Co., Ltd | -- |
| Elements ofComparison | 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 QT001is intended to measure thehuman body temperature inarmpit, orally or rectally, and thedevice is reusable for clinical orhome use on people of all ages. | The Digital Thermometer DMT-4756 is intended to measure thehuman body temperature in regularmode orally, rectally or under thearm, and the device is reusablefor clinical or home use on peopleof all age, including children under 8with adult supervision. | SimilarThere is minordifference, but theuser manual havebeen indicated inthe instructions thatchildren should notbe allowed toperform the testunsupervisedIt will not affectsafety andeffectiveness. |
| Fundamentaltechnology&Operatingprinciple | A change of thermistorresistance,caused by changes oftemperature. The resistance ismeasured by MCU, so changesof temperature will correspond tochanges of resistance | A change of thermistor resistance,caused by changes of temperature.The resistance is measured byMCU, so changes of temperaturewill correspond to changes ofresistance | Identical |
| Sensor | Thermistor | Thermistor | Identical |
| Signalprocessingand display | Internal firmware and local LCDdisplay | Internal firmware and local LCDdisplay | Identical |
| MeasurementSite | armpit, orally or rectally | orally, rectally or under the arm | Identical |
| MeasuringRange | $32.0~42.9 °C (89.6°F ~ 109.2°F)$ | $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) |
| Displayresolution | $0.1 °C/0.1 °F$ | $0.1 °C/0.1 °F$ | 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 ofComparison | Subject Device | Predicate Device | Verdict |
| Memories | For storing the last measuredvalue | 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%RHAtmospheric pressure: 70kPa-106kPa | Temperature:41°F ~104°F (5°C ~40°C )Relative humidity: 15%~95%RHAtmospheric Pressure :700hPa ~ 1060hPa | Different(Note4) |
| Construction | Flexible tip | The probe is foldable into the bodyof the thermometer | Different(Note5) |
| Measurementmethod & time | Approximate 3 minutes | 10s Predictive read30s Final read. | Different(Note6) |
| ThermometerSize | 138mm x 25mm x 12mm (L x W xH) | 10.6cm3.2cm2.5cm(L x W x H) | Different(Note7) |
| Weight | Approx. 10 grams includingbattery | 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) |
| Storageandtransportationcondition | Temperature:-20℃~55℃(-4°F ~ 131°F )Relative humidity:15%RH-95%RHAtmospheric pressure: 50kPa-106kPa | Temperature:-4°F | 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 andISO 10993-10 | Complied with ISO 10993-5 andISO 10993-10 | Identical |
| Performance | Complied with ISO 80601-2-56:2017/AMD 1:2018 and ASTME1112:00(2018). | Complied with ISO 80601-2-56:2017 | Different(Note8) |
| Backlightwarning function | 1.When measured temperature is35.9℃,the LCD withoutbacklight2.When measured temperature≥36℃ and ≤37.1℃, the LCDshows green backlight3.When measured temperature≥37.2℃ and ≤37.4℃, the LCDshows yellow backlight.4.When measured temperature>=37.5°C and ≤42.9°C, the LCD | / | Different(Note9) |
| Elements ofComparison | Subject Device | Predicate Device | Verdict |
| shows red backlight.The laboratory accuracy error nogreater than 0.3 °C |
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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.
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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.
§ 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.