(268 days)
Not Found
No
The description focuses on basic temperature sensing, Bluetooth communication, and a mobile app for display. There is no mention of AI/ML for data analysis, prediction, or interpretation.
No
The device is described as a thermometer for measuring and monitoring temperature, and explicitly states that "The temperature data of device is not intended to replace the advice, diagnosis, nor treatment recommendations of doctor." This indicates it provides information but does not actively treat or diagnose a condition.
No
The device is a Wearable Digital Thermometer, which measures and monitors human armpit temperature. The "Intended Use" section explicitly states, "The temperature data of device is not intended to replace the advice, diagnosis, nor treatment recommendations of doctor," indicating it is not for diagnostic purposes.
No
The device description explicitly states that the device consists of a "host, App software and stickers." It also mentions a "NTC temperature sensor" and a "rechargeable battery," which are hardware components. The software is described as accessing the host and receiving data from the thermometer, indicating it is part of a larger hardware system.
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 Wearable Digital Thermometer measures and monitors human armpit temperature. This is a direct measurement of a physiological parameter from the body, not a test performed on a sample taken from the body.
- Intended Use: The intended use is to measure and monitor body temperature, which is a vital sign, not to diagnose a disease or condition based on a sample.
Therefore, the Wearable Digital Thermometer falls under the category of a medical device that measures a physiological parameter, but it is not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Wearable Digital Thermometer is a battery-operated electronic device with intended use of measuring and monitoring human armpit temperature continuously via wireless signal transmission of the measuring result. Wearable Digital Thermometer is reusable and intended for armpit temperature monitoring for persons of all age. The temperature data of device is not intended to replace the advice, diagnosis, nor treatment recommendations of doctor. Wearable Digital Thermometer can be used at home and healthcare center.
Product codes
FLL
Device Description
The Wearable Digital Thermometer consists of a host, App software and stickers. A comprehensive Android and iOS App are provided to access the host from a smart device. It is used for measuring and monitoring armpit temperature in real-time continuously and remotely via Bluetooth to smart device. The medical double-sided sticker are used to fix and stick the host in the user`s axilla.
The NTC temperature sensor is located closely to the stainless steel sheet that make sure the accuracy of temperature data measured.
The subject device could measure and monitor temperature in real-time continuously and remotely via Bluetooth to smart phone.
The Temp Pal is the combination device of thermometer and Bluetooth communication unit intended to be worn at axilla to monitor the armpit temperature continuously. The subject device is a direct mode clinical thermometer where the output temperature is not adjusted.
For the monitoring operation, switch the thermometer on and stick the thermometer in the user's axilla. The thermometer will make a Bluetooth connection between the thermometer and the receiver automatically (User should setup Bluetooth properly on receiver). Then the thermometer starts to measure the body temperature.
The wireless thermometer uses a rechargeable battery for operation.
When the battery is low, internal circuit will detect the low battery condition automatically and send "low battery" signal through Bluetooth communication unit to receiver.
Power source: Battery 3.0V/10mAh
Operation mode: Direct mode
Measuring results display method: The measuring results are transmitted to smart phone and display by APP.
Data communication method: Wireless 2.4G Bluetooth BLE.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human armpit, armpit, Patients' armpit, axilla
Indicated Patient Age Range
all age
Intended User / Care Setting
at home and healthcare center.
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)
- Performance test: The Continuous measurement, Intermittent Determination and Direct clinical thermometer measure meet the specification of the product and the relevant standards are listed below: ASTM, E1112-00 (2018), Standard Specification for Electronic Thermometer for Intermittent A Determination of Patient Temperature; ISO 80601-2-56 Second edition 2017-03, Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement.
- Electromagnetic Compatibility and Electrical Safety: Electrical safety and EMC testing has been performed to, and passed, the following standards: IEC 60601-1 Edition 3.2 2020-08, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance; IEC 60601-1-2 Edition 4.1 2020-09. Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests; IEC 60601-1-11 Edition 2.1 2020-07, 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; ANSI C63.4-2014, FCC Part 15 Subpart B; ANSI C63.4-2014, FCC Part 15 Subpart C.
- Software Verification and Validation: Software documentation consistent with Basic Documentation Level of concern is submitted in this 510(k). System validation testing presented in this 510(k) demonstrated that all software requirement specifications have been met and all software hazards have been mitigated to acceptable risk levels. The relevant standards and guidance are listed below: IEC 62304 Edition 1.1 2015-06, Medical device software - Software life cycle processes; Content of Premarket Submissions for Device Software Functions-Guidance for Industry and Food and Drug Administration Staff; Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions-Guidance for Industry and Food and Drug Administration Staff.
- Biocompatibility: The biocompatibility evaluation for the body-contacting components of the Wearable Digital Thermometer has been 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" : Guidance for Industry and Food and Drug Administration Staff", as recognized by FDA. The testing has been performed to, and passed, including: 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.
- Shelf life: The Reliability Test of the Wearable Digital Thermometer has been conducted in accordance with relevant guidance and standards. The testing has been performed to, and passed, including: Guidance of Shelf Life of Medical Devices (1991).
- Usability: Usability testing has been performed to, and passed, the following standards: IEC 60601-1-6:2020 Medical electrical equipment –Part 1-6: General requirements for safety -Collateral standard: Usability.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy: ±0.1°C (35.00°C or39.00°C) - +0.18°F (95°F - 102.20°F) ±0.2°C (39.00°C) or 0.36°F (102.20°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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 30, 2024
Guangdong Genial Technology CO., Ltd. % Klem Hou RA Manager Constant Medical Technology Co., Ltd. No. 2021-6, 2nd Floor, No. 228 Huadi Avenue Middle Liwan District, Guangzhou Zhaoqing, Guangdong 526437 China
Re: K240333
Trade/Device Name: Wearable Digital Thermometer (T31) Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical electronic thermometer Regulatory Class: Class II Product Code: FLL Dated: September 30, 2024 Received: September 30, 2024
Dear Klem Hou:
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.
1
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" (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 (QS) 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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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-advice-comprehensive-regulatory
2
assistance/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. 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
3
Indications for Use
510(k) Number (if known) K240333
Device Name Wearable Digital Thermometer (T31)
Indications for Use (Describe)
Wearable Digital Thermometer is a battery-operated electronic device with intended use of measuring and monitoring human armpit temperature continuously via wireless signal transmission of the measuring result. Wearable Digital Thermometer is reusable and intended for armpit temperature monitoring for persons of all age. The temperature data of device is not intended to replace the advice, diagnosis, nor treatment recommendations of doctor. Wearable Digital Thermometer can be used at home and healthcare center.
| 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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K240333 - 510(k) Summary
1. Submission sponsor
Name: GUANGDONG GENIAL TECHNOLOGY CO., LTD.
Address: I-6-05-02 11th Road, Area B, Guangfozhao Economic Cooperation Zone, Zhagang
Town, Huaiji County, Zhaoqing City, Guangdong Province, 526437, P.R. China Zhaoqing
Guangdong 526437 China
Contact person: Jun Yu
Title: Deputy general manager
Tel: +86- 136 0284 9551
Email: admin@genial.cn
2. Submission correspondent
Name: Constant Medical Technology Co., Ltd. Address: No. 2021-6, 2nd Floor, No. 228 Huadi Avenue Middle, Liwan District, Guangzhou Zhaoqing Guangdong 526437 China Contact person: Klem Hou Title: RA manager Tel: +86 178 7557 1727 Email: pharmaklem@outlook.com
3. Device
Name of Device: Wearable Digital Thermometer
Model(s): T31
Common or Usual Name: Clinical Electronic Thermometer
Classification Name: Clinical Electronic Thermometer
Regulatory Class: II
Product Code: FLL
Regulation Number: 21 CFR 880.2910
5
4. Predicate device(s)
| Manufacturer | Predicate Device | 510(k) Number |
|---|---|---|
| iWEECARE Co., Ltd. | Temp Pal (Smart Thermometer Patch) | |
| Model Number: STP-MB01-1 | K222588 |
Device description న్.
The Wearable Digital Thermometer consists of a host, App software and stickers. A comprehensive Android and iOS App are provided to access the host from a smart device. It is used for measuring and monitoring armpit temperature in real-time continuously and remotely via Bluetooth to smart device. The medical double-sided sticker are used to fix and stick the host in the user`s axilla.
The NTC temperature sensor is located closely to the stainless steel sheet that make sure the accuracy of temperature data measured.
The subject device could measure and monitor temperature in real-time continuously and remotely via Bluetooth to smart phone.
The Temp Pal is the combination device of thermometer and Bluetooth communication unit intended to be worn at axilla to monitor the armpit temperature continuously. The subject device is a direct mode clinical thermometer where the output temperature is not adjusted.
For the monitoring operation, switch the thermometer on and stick the thermometer in the user's axilla. The thermometer will make a Bluetooth connection between the thermometer and the receiver automatically (User should setup Bluetooth properly on receiver). Then the thermometer starts to measure the body temperature.
The wireless thermometer uses a rechargeable battery for operation.
When the battery is low, internal circuit will detect the low battery condition automatically and send "low battery" signal through Bluetooth communication unit to receiver.
Power source: Battery 3.0V/10mAh
Operation mode: Direct mode
Measuring results display method: The measuring results are transmitted to smart phone and display by APP.
Data communication method: Wireless 2.4G Bluetooth BLE.
Indications for Use 6.
Wearable Digital Thermometer is a battery-operated electronic device with intended use of
6
measuring and monitoring human armpit temperature continuously via wireless signal transmission of the measuring result. Wearable Digital Thermometer is reusable and intended for armpit temperature monitoring for persons of all age. The temperature data of device is not intended to replace the advice, diagnosis, nor treatment recommendations of doctor. Wearable Digital Thermometer can be used at home and healthcare center.
7. Comparison of Technological Characteristics with the Predicate Device(s)
Wearable Digital Thermometer has the same intended use, mode of action and operational characteristics as the predicate devices. Any minor differences between the subject device and the listed predicate devices do not raise any issues of safety or efficacy. Performance data supports that the device is safe and as effective as the predicate device for its intended use.
Therefore, The Wearable Digital Thermometer may be found substantially equivalent to its predicate devices.
Wearable Digital Thermometer is compared with the following Predicate Devices in terms of intended use, design, material, specifications, and performance:
- K222588 (Predicate Device), " Temp Pal (Smart Thermometer Patch) ", manufactured by "
7
iWEECARE Co., Ltd."
| Comparison
Elements | Subject Device | Predicate
Device
(K222588) | Remark |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Device name | Wearable Digital Thermometer | Temp Pal (Smart Thermometer
Patch) | -- |
| Model | T31 | STP-MB01-1 | -- |
| Indications for
use | Wearable Digital Thermometer
is a battery-operated electronic
device with intended use of
measuring and monitoring
human armpit temperature
continuously via wireless signal
transmission of the measuring
result. Wearable Digital
Thermometer is reusable and
intended for armpit temperature
monitoring for persons of all
age. The temperature data of
device is not intended to replace
the advice, diagnosis, nor
treatment recommendations of
doctor. Wearable Digital
Thermometer can be used at
home and healthcare center. | Temp Pal is a battery-operated
electronic device with intended
use of measuring and
monitoring human armpit
temperature continuously via
wireless signal transmission of
the measuring result. This
system is reusable and intended
for armpit temperature
monitoring for persons of all
age. The temperature data of
device is not intended to
replace the advice, diagnosis,
nor treatment recommendations
of doctor. Temp Pal can be used
at home and healthcare center. | Same |
| Principle of
Operation | For the monitoring operation,
switch the thermometer on and
stick the thermometer in the
user's axilla. The thermometer
will make a Bluetooth
connection between the
thermometer and the receiver
automatically (User should setup
Bluetooth properly on receiver).
Then the thermometer starts to
measure the body temperature
by means of testing the NTC
resistor's resistance value and
calculates the body temperature
continuously and sends the
temperature data to the receiver
through Bluetooth connection. | For the monitoring operation,
switch the thermometer on and
stick the thermometer in the
user's axilla. The thermometer
will make a Bluetooth
connection between the
thermometer and the receiver
automatically (User should
setup Bluetooth properly on
receiver). Then the
thermometer starts to measure
the body temperature by
means of testing the NTC
resistor's resistance value and
calculates the body temperature
continuously and sends the
temperature data to the receiver
through Bluetooth connection. | Same |
| Thermometer
Type | Clinical Electronic Thermometer | Clinical Electronic Thermometer | Same |
| Anatomical
Application | Patients' armpit | Patients' armpit | Same |
| Sensor | NTC Resistor | NTC Resistor | Same |
8
| Display | iOS device display, Android
device display | iOS device display, Android
device display | Same |
|------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------|---------------------|
| Power
Requirements | Non-Rechargeable Battery
3.0V/10mAh | Rechargeable
Battery
3.7V/10mAh | Different
Note 1 |
| Temperature
range
(Measurement
Range) | 68-113°F (20-45°C) | 77-113°F (25-45°C) | Different
Note 2 |
| Accuracy | ±0.1°C (35.00°C or39.00°C) - +
0.18°F (95°F - 102.20°F)
±0.2°C (39.00°C)
or 0.36°F (102.20°F) | 0.09 °F (± 0.05 °C) | Different
Note 3 |
| Valid
transmission
distance | 10 meters | Up to 5 meters | Different
Note 4 |
| APP
Temperature
display | Display in either °C or°F | Display in either °C or°F | Same |
| Operation
mode | Direct mode | Direct mode | Same |
| Reusability | Reusable | Reusable | Same |
| shelf life | 5 years | 24 months | Different
Note 5 |
|----------------------------------------------------------------|----------------------------------------------------------------|----------------------------------------------------------------|---------------------|
| composition of
material that
contacts to the
patients | 304 Stainless Steel Probe and
double sided medical adhesive | 304 Stainless Steel Probe and
double sided medical adhesive | Same |
Comparison in Detail(s):
Note 1: Power Requirements
The subject device is powered by a non-rechargeable battery while the predicate device is powered by a rechargeable battery. If the low power signal displayed in APP, the subject device should change the battery and the predicate device should be recharged, and both of the subject device and the
9
predicate device should stop working.
The Power Requirements differences between the subject and predicate devices does not raise new concerns of safety and effectiveness for the clinical use.
Note 2: Temperature range (Measurement Range)
The maximum measured temperature of the subject device and predicate device are same and the minimum measured temperature of the subject device is a little lower than that of predicate device which is not important for that the human body temperature is not nearly close to 20°C.
The Temperature range (Measurement Range) differences between the subject and predicate devices does not raise new concerns of safety and effectiveness for the clinical use.
Note 3: Accuracy
The accuracy of the subject device is higher than that of the predicate device.
The accuracy of the subject device has met the requirement of ISO 80601-2-56:2017 and the accuracy differences between the subject and predicate devices does not raise new concerns of safety and effectiveness for the clinical use.
Note 4: Valid transmission distance
The transmission distance of the subject device is further than that of the predicate device.
The Valid transmission distance differences between the subject and predicate devices does not raise new concerns of safety and effectiveness for the clinical use.
Note 5: Shelf life
The shelf life of the subject device is further than that of the predicate device.
The shelf life differences between the subject and predicate devices does not raise new concerns of safety and effectiveness for the clinical use.
8. Performance Data
10
The following performance data are provided in support of the substantial equivalence determination.
1) Performance test
The Continuous measurement, Intermittent Determination and Direct clinical thermometer measure meet the specification of the product and the relevant standards are listed below.
-
ASTM, E1112-00 (2018), Standard Specification for Electronic Thermometer for Intermittent A
Determination of Patient Temperature -
ISO 80601-2-56 Second edition 2017-03, Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement
2) Electromagnetic Compatibility and Electrical Safety
Electrical safety and EMC testing has been performed to, and passed, the following standards:
-
IEC 60601-1 Edition 3.2 2020-08, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
-
IEC 60601-1-2 Edition 4.1 2020-09. Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- » IEC 60601-1-11 Edition 2.1 2020-07, 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
- A ANSI C63.4-2014, FCC Part 15 Subpart B
- 》 ANSI C63.4-2014, FCC Part 15 Subpart C
3) Software Verification and Validation
Software documentation consistent with Basic Documentation Level of concern is submitted in this 510(k). System validation testing presented in this 510(k) demonstrated that all software requirement specifications have been met and all software hazards have been mitigated to acceptable risk levels. The relevant standards and guidance are listed below.
- A IEC 62304 Edition 1.1 2015-06, Medical device software - Software life cycle processes
- A Content of Premarket Submissions for Device Software Functions-Guidance for Industry and Food and Drug Administration Staff
-
Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions-Guidance for Industry and Food and Drug Administration Staff
11
4) Biocompatibility
The biocompatibility evaluation for the body-contacting components of the Wearable Digital Thermometer has been 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" : Guidance for Industry and Food and Drug Administration Staff", as
recognized by FDA. The testing has been performed to, and passed, including:
- » 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
5) Shelf life
The Reliability Test of the Wearable Digital Thermometer has been conducted in accordance with relevant guidance and standards. The testing has been performed to, and passed, including:
-
Guidance of Shelf Life of Medical Devices (1991)
6) Usability
Usability testing has been performed to, and passed, the following standards:
-
IEC 60601-1-6:2020 Medical electrical equipment –Part 1-6: General requirements for safety -Collateral standard: Usability
7) Summary
Based on the above performance as documented in this application, the Wearable Digital
Thermometer is found to have a safety and effectiveness profile that is similar to the predicate device.
9. Conclusions
Based on the comparison of intended use, design, materials and performance, the Wearable Digital Thermometer is to be concluded substantial equivalent to its predicate devices.