(87 days)
Not Found
No
The device description details a simple electronic circuit that converts sensor resistance to temperature using a direct calculation, with no mention of AI, ML, or complex algorithms.
No
The device is a thermometer used for measuring human body temperature, which is a diagnostic function, not a therapeutic one. It does not treat or alleviate any condition.
No
A diagnostic device is used to identify or determine the nature of a disease or condition. This device is a thermometer that measures body temperature, which is a vital sign, but it does not diagnose a specific medical condition on its own.
No
The device description explicitly states it is a hand-held device consisting of hardware components such as a temperature sensor, integrated circuit, buzzer, and battery, and measures temperature using a physical probe.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that this device "is intended to measure the human body temperature under the arm." This is a direct measurement of a physiological parameter on the body, not a test performed on a sample taken from the body.
Therefore, this medical electronic thermometer falls under the category of a general medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Medical Electronic Thermometer (FC01, FC02) is intended to measure the human body temperature under the arm. The devices are reusable for clinical or home use for people of all ages.
Product codes
FLL
Device Description
The Medical Electronic Thermometer (FC01, FC02) is a hand-held device which can measure human body temperature at the site of the armpit. The devices are reusable for clinical or home use for people of all ages. The results can be displayed on the LCD. The FC01 and FC02 have only one operating mode which is direct mode. The Medical Electronic Thermometer measures human body temperature by placing the probe tip under the armpit with a measuring time of about 300 seconds.
The Medical Electronic Thermometer consists of a temperature sensor (NTC), low power integrated circuit (IC), buzzer, and battery. The resistance of sensor changes with temperature and the integrated circuit (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.
Models FC01, FC02 of the subject device have a variety of functions, such as buzzer prompt, unit switching, low battery detection, memory, Indicator light, automatic power-off function. The difference between the two models is the color. The measuring range is 32.0 ℃ ~ 42.0 ℃, the minimum index value is 0.1 ℃, allowing the maximum error of ± 0.3 ℃, the operating environment is temperature +5 ℃~ +40 ℃ Humidity: ≤85% RH, and the atmospheric pressure is 70KPa ~ 106KPa. Users should avoid long-term use in environments with high temperatures, humidity, or direct sunlight.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
under the arm
Indicated Patient Age Range
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)
The following performance data were provided in support of the substantial equivalence determination.
- Biocompatibility Testing: The biocompatibility evaluation for the body-contacting components of the Medical electronic thermometer was conducted in accordance with the "Use of International Standard ISO 10993-1, 'Biological Evaluation of Medical Devices -Part 1: Evaluation and Testing Within a Risk Management Process, Document Issued on September 4, 2020", as recognized by FDA. The following testing was performed to, and passed, including:
- ISO 10993-5:2009, Biological evaluation of medical devices -Part 5: Tests for in vitro cytotoxicity
- ISO 10993-10:2021, Biological evaluation of medical devices -Part 10: Tests for skin sensitization
- ISO 10993-23:2021, Biological evaluation of medical devices -Part 23: Tests for skin irritation
- Electrical Safety and EMC: Electrical safety and EMC testing was performed to, and passed, as per the following standards:
- IEC 60601-1-2 Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests
- ANSI AAMI ES60601-1 Medical electrical equipment Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) [Including Amendment 2 (2021)]
- IEC 60601-1-11 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
- Performance testing:
- 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. [Including: Amendment 1 (2018)]
- ASTM E1112-00(2018) Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature
- Software Verification and Validation: Software documentation is consistent with moderate level of concern. System validation testing demonstrated that all software requirement specifications are met, and all software hazards have been mitigated to acceptable risk levels.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy:
Lower than 35.3 °C ± 0.3 °C ( 95.5 °F ± 0.5 °F )
35.3 °C ~ 36.9 °C ± 0.2 °C ( 95.5 °F ~ 98.4 °F ± 0.4 °F )
37.0 °C ~ 39.0 °C ± 0.1 °C ( 98.6 °F ~ 102.2 °F ± 0.2 °F )
39.1 °C ~ 41.0 °C ± 0.2 °C ( 102.4 °F ~ 105.8 °F ± 0.4 °F )
Higher than 41.0 °C ± 0.3 °C ( 105.8 °F ± 0.5 °F )
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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION".
April 12, 2024
Zhuzhou Goldenhot Medical Technology Co.,Ltd. % Meihua Cai RA Specialist Feiying Drug & Medical Consulting Technical Service Group Rm 2401 Zhenye International Business Center, No. 3101-90. Oianhai Road Shenzhen, Guangdong 518000 China
Re: K240109
Trade/Device Name: Medical electronic thermometer (FC01, FC02) Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: January 15, 2024 Received: January 16, 2024
Dear Meihua Cai:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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-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. Porsche Bennett Porsche Bennett for David Wolloscheck, Ph.D. 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
2
Indications for Use
510(k) Number (if known) K240109
Device Name Medical electronic thermometer (FC01, FC02)
Indications for Use (Describe)
The Medical Electronic Thermometer (FC0). FC02) is intended to measure the human body temperature under the arm. The devices are reusable for clinical or home use for people of all ages.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
K240109- 510(k) Summary
"510(k) Summary" as required by 21 CFR Part 807.92.
I. Submitter
Zhuzhou Goldenhot Medical Technology Co.,Ltd. Room 301, Plant C-3, Phase 5, Xinma Power Innovation Park, No. 889, Xianyue huan Road, Majiahe Street,Tianyuan District, Zhuzhou City, Hunan Province, China Post code: 412007 Tel .: +86 0731 28589339 Liu Xianwu Deputy Manager Tel: +86 13808497058 Email: 2569981973@qq.com
II. Application Correspondent
Name: Meihua Cai Title: RA Specialist Address: Feiying Drug & Medical Consulting Technical Service Group. Rm 2401 Zhenye International Business Center, No. 3101-90, Qianhai Road. Senzhen, Guangdong 518000, China Email address: meihuacai@yeah.net Phone Number: 86 (185) 666-67558 [voice]
III. Subject Device
510(k) Number: K240109 Trade Name: Medical electronic thermometer (FC01, FC02) Common or Usual Name: Thermometer, electronic, clinical Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Regulation Number: 21 CFR 880.2910
IV. Predicate Device
510(k) Number: K223044 Trade Name: Digital Thermometer (Model QT001) Common or Usual Name: Thermometer, electronic, clinical Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Regulation Number: 21 CFR 880.2910
4
V. Device Description
The Medical Electronic Thermometer (FC01, FC02) is a hand-held device which can measure human body temperature at the site of the armpit. The devices are reusable for clinical or home use for people of all ages. The results can be displayed on the LCD. The FC01 and FC02 have only one operating mode which is direct mode. The Medical Electronic Thermometer measures human body temperature by placing the probe tip under the armpit with a measuring time of about 300 seconds.
The Medical Electronic Thermometer consists of a temperature sensor (NTC), low power integrated circuit (IC), buzzer, and battery. The resistance of sensor changes with temperature and the integrated circuit (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.
Models FC01, FC02 of the subject device have a variety of functions, such as buzzer prompt, unit switching, low battery detection, memory, Indicator light, automatic power-off function. The difference between the two models is the color. The measuring range is 32.0 ℃ ~ 42.0 ℃, the minimum index value is 0.1 ℃, allowing the maximum error of ± 0.3 ℃, the operating environment is temperature +5 ℃~ +40 ℃ Humidity: ≤85% RH, and the atmospheric pressure is 70KPa ~ 106KPa. Users should avoid long-term use in environments with high temperatures, humidity, or direct sunlight.
VI. Indications for Use
The Medical Electronic Thermometer (FC01, FC02) is intended to measure the human body temperature under the arm. The devices are reusable for clinical or home use for people of all ages.
VII.Materials
| Component
| name | Material of Component | Body Contact Category | Contact Duration |
|---|---|---|---|
| Medical | |||
| electronic | |||
| thermometer | |||
| (Enclosure) | ABS, PC, Stainless Steel | Surface-contacting | |
| device: Intact skin | Less than 24 hours |
Comparison of Technological Characteristics With the Predicate Device VIII.
A comparison of key technological characteristics between the subject devices and predicate device was listed as below:
5
| Comparison
| Elements | Subject Device | Predicate Device | Remark |
|---|---|---|---|
| 510(k) Number | K240109 | K223044 | / |
| Trade name | Medical electronic thermometer | ||
| (FC01, FC02) | Digital Thermometer (Model | ||
| QT001) | / | ||
| Manufacturer | Zhuzhou Goldenhot Medical | ||
| Technology Co.,Ltd | Shen Zhen Rong Feng | ||
| Technology Co., Ltd | / | ||
| Regulation | |||
| number | 21 CFR 880.2910 | 21 CFR 880.2910 | Same |
| Product code | FLL | FLL | Same |
| Device | |||
| classification | Class II | Class II | Same |
| Indication for | |||
| Intended | |||
| use/ | |||
| use | The Medical Electronic | ||
| Thermometer (FC01, FC02) is | |||
| intended to measure the human | |||
| body temperature under the arm. | |||
| The devices are reusable for | |||
| clinical or home use for people of | |||
| all ages. | 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. | Different | ||
| Note 1 | |||
| Prescription or | |||
| OTC | OTC | OTC | Same |
| Principle | |||
| of | |||
| Operation | The thermistor placed at the top | ||
| of the measuring part is used as a | |||
| temperature sensing device, when | |||
| the temperature of the external | |||
| measured heat source is changed, | |||
| the resistance value | |||
| of the | |||
| thermistor will be changed | |||
| accordingly, the internal | |||
| microprocessor converts, | |||
| processes, and corrects the | |||
| change of resistance value of the | |||
| thermistor in the measuring | |||
| circuit, and then the measured | |||
| temperature will be shown in the | |||
| form of a number on the display | |||
| screen, and at the same time the | |||
| buzzer will beep, and the | |||
| measuring process will be | |||
| finished. | 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. | Different | ||
| Note 1 | |||
| Comparison | |||
| Elements | Subject Device | Predicate Device | Remark |
| Sensor | Thermistor | Thermistor | Same |
| Signal | |||
| processing and | |||
| display | Internal firmware and local LCD | ||
| display | Internal firmware and local | ||
| LCD display | Same | ||
| Measurement | |||
| Site | Armpit | armpit, orally or rectally | Different |
| Note 1 | |||
| Measuring | |||
| Range | $32 °C ~ 42.0 °C$ | ||
| $(89.6 °F ~ 107.6 °F)$ | $32 °C ~ 42.9 °C$ | ||
| $(89.6 °F ~ 109.2 °F)$ | Different | ||
| Note 2 | |||
| Accuracy | Lower than $35.3 °C ± 0.3 °C$ ( $95.5 °F ± 0.5 °F$ ) | ||
| $35.3 °C ~ 36.9 °C ± 0.2 °C$ ( $95.5 °F ~ 98.4 °F ± 0.4 °F$ ) | |||
| $37.0 °C ~ 39.0 °C ± 0.1 °C$ ( $98.6 °F ~ 102.2 °F ± 0.2 °F$ ) | |||
| $39.1 °C ~ 41.0 °C ± 0.2 °C$ ( $102.4 °F ~ 105.8 °F ± 0.4 °F$ ) | |||
| Higher than $41.0 °C ± 0.3 °C$ | |||
| ( $105.8 °F ± 0.5 °F$ ) | $± 0.1 °C, 34.0 °C ~ 42.0 °C$ | ||
| ( $± 0.2 °F, 93.2 °F - 107.6 °F$ ) | |||
| $± 0.2 °C$ under $34.0 °C$ or over | |||
| $42.0 °C (± 0.4 °F$ under $93.2 °F$ | |||
| or over $107.6 °F$ ) | Different | ||
| Note 3 | |||
| Display | |||
| resolution | $0.1 °C / 0.1 °F$ | $0.1 °C / 0.1 °F$ | Same |
| Components | Measurement module, Memory | ||
| module, Business function | |||
| module, Button module, Buzzer | |||
| module, Display module | Sensor, buzz film, housing, | ||
| stainless steel cap, LCD | |||
| display, measurement control | |||
| module. | Similar | ||
| Patient | |||
| Contacting | |||
| Materials | ABS, PC, Stainless Steel | ABS, TPE, Stainless steel | Different |
| Note 8 | |||
| Memories | 12 memories (including For | ||
| storing the last measured value) | For storing the last measured | ||
| value | Different | ||
| Note 4 | |||
| Power Supply | Power adapter specification: 5V | ||
| 1A | One 3.0 V CR1225 battery | Different | |
| Note 5 | |||
| Operation | |||
| environment | |||
| condition | Temperature: $5 °C$ - $40 °C$ ( $41 °F$ - | ||
| $104 °F$ ) | |||
| Relative humidity: ≤85%RH | |||
| Atmospheric | |||
| pressure: 70kPa- | |||
| 106kPa | Temperature: $5 °C$ - $40 °C$ ( $41 °F$ - | ||
| $104 °F$ ) | |||
| Relative | |||
| humidity: 15%RH- | |||
| 95%RH | |||
| Atmospheric pressure: 70kPa- | |||
| 106kPa | Different | ||
| Note 6 | |||
| Comparison | |||
| Elements | Subject Device | Predicate Device | Remark |
| Storage | |||
| and | |||
| transportation | |||
| condition | Temperature: -20°C-55°C (-4°F - | ||
| 131°F) | |||
| Relative humidity:10%RH- | |||
| 93%RH | |||
| Atmospheric pressure:70kPa- | |||
| 106kPa | Temperature:-20°C ~55°C (- | ||
| 4°F~131°F) | |||
| Relative humidity:15%RH- | |||
| 95%RH | |||
| Atmospheric pressure:50kPa- | |||
| 106kPa | Different | ||
| Note 6 | |||
| Measuring | |||
| Time | Approximately 5 minutes | Approximately 3 minutes | Different |
| Note 7 | |||
| Thermometer | |||
| Size | 135.6 (L)*15.8 (W)*8.5 (H)mm | 138mm x 25mm x 12mm (L x | |
| W x H) | Different | ||
| Note 8 | |||
| Weight | About 13.0g (including battery) | Approx. 10 grams including | |
| battery | Different | ||
| Note 8 | |||
| Shelf life | 3 years | 3 years | Same |
| Biocompatibili | |||
| ty | Complied with ISO 10993-5, | ||
| ISO 10993-10 and ISO 10993-23 | Complied with ISO 10993-5 | ||
| and ISO 10993-10 | Same | ||
| Electrical | |||
| safety | Complied with IEC 60601-1 | Complied with IEC 60601-1 | Same |
| EMC | Complied with IEC 60601-1-2 | Complied with IEC 60601-1-2 | Same |
| Performance | Complied with ISO 80601-2- | ||
| 56:2017/AMD 1:2018 | |||
| and | |||
| ASTM E1112-00(2018). | Complied with ISO 80601-2- | ||
| 56:2017/AMD 1:2018 | |||
| and | |||
| ASTM E1112-00(2018). | Same |
6
7
Comparison discussion:
Note 1
There is minor difference; the subject device is only used under the arm, where the predicate device measures at additional sites. The difference does not raise any new or different safety and effectiveness questions.
Note 2
The subject device and predicate device have different measurement ranges, 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 3
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.
8
Note 4
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 5
The Power supply of the subject device is different from the predicate device. The electrical safety and EMC test were conducted to demonstrate the difference does not raise any new performance or safety concerns.
Note 6
Operating range, Storage, and transportation condition difference: The subject device has been tested and the test results met the requirements of IEC 60601-1 and ISO 80601-2-56. The difference does not raise any new or different safety and effectiveness questions.
Note 7
After placing the thermometer on the measurement site, the measured result can only be displayed when the temperature is stable. Generally, the measurement time is not fixed at a certain value. The difference of measurement time will not raise any safety or effectiveness issue.
Note 8
Weight, size, materials: Biocompatibility test and performance bench test met the requirements of ISO 10993-5. ISO 10993-10 and ISO 10993-23. The differences do not raise any new questions of safety and effectiveness.
IX. Performance Data
The following performance data were provided in support of the substantial equivalence determination.
1) Biocompatibility Testing
The biocompatibility evaluation for the body-contacting components of the Medical electronic thermometer was conducted in accordance with the "Use of International Standard ISO 10993-1, 'Biological Evaluation of Medical Devices -Part 1: Evaluation and Testing Within a Risk Management Process, Document Issued on September 4, 2020", as recognized by FDA. The following testing was performed to, and passed, including:
-
ISO 10993-5:2009, Biological evaluation of medical devices -Part 5: Tests for in vitro cytotoxicity
-
ISO 10993-10:2021, Biological evaluation of medical devices -Part 10: Tests for skin sensitization
-
ISO 10993-23:2021, Biological evaluation of medical devices -Part 23: Tests for skin irritation
2) Electrical Safety and EMC
9
Electrical safety and EMC testing was performed to, and passed, as per the following standards:
-
IEC 60601-1-2 Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests
-
ANSI AAMI ES60601-1 Medical electrical equipment Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) [Including Amendment 2 (2021)]
-
IEC 60601-1-11 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
3) Performance testing
-
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. [Including: Amendment 1 (2018)]
-
ASTM E1112-00(2018) Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature
4) Software Verification and Validation
Software documentation is consistent with moderate level of concern. System validation testing demonstrated that all software requirement specifications are met, and all software hazards have been mitigated to acceptable risk levels.
X. Conclusions
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 questions of safety and effectiveness. Thus, the subject device is substantially equivalent to the predicate device.