Temp Pal
Device Facts
| Record ID | K202603 |
|---|---|
| Device Name | Temp Pal |
| Applicant | Iweecare Co., Ltd. |
| Product Code | FLL · General Hospital |
| Decision Date | Jul 22, 2021 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.2910 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Indications for Use
The 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 over two years old. The device is for home healthcare used by the layperson.
Device Story
Temp Pal is a wearable, battery-operated electronic thermometer; measures axillary temperature using an NTC resistor sensor. Device adheres to user's armpit; transmits temperature data via Bluetooth (2.4G BLE) to a smartphone or tablet running a dedicated Android/iOS app. App displays real-time temperature; transmits data to authorized caregivers via cloud service. Used in home healthcare settings by laypeople. Healthcare providers or caregivers view output via the app to monitor patient temperature trends; facilitates clinical decision-making regarding fever management or patient status. Benefits include continuous, remote monitoring without manual spot-checks.
Clinical Evidence
No clinical data. Substantial equivalence supported by bench testing, including life/shelf-life testing, cleaning validation, biocompatibility (ISO 10993), software validation, electromagnetic compatibility (IEC/EN 60601-1-2), electrical safety (IEC/EN 60601-1), and performance testing per ASTM E1112 and ISO 80601-2-56.
Technological Characteristics
Materials: TPE (biocompatible). Sensing: NTC resistor. Energy: Rechargeable 3.7V/10mAh battery. Connectivity: Bluetooth 2.4G BLE. Form factor: Wearable patch. Standards: ASTM E1112, ISO 80601-2-56, EN 60601-1, EN 60601-1-2, EN 60601-1-11, EN 12470-4. Software: App-based interface for Android/iOS.
Indications for Use
Indicated for continuous armpit temperature monitoring in persons over two years old. Intended for home healthcare use by laypersons.
Regulatory Classification
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.
Special Controls
(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.
Predicate Devices
- Wireless Thermometer (Model: WT701) (K132761)
Submission Summary (Full Text)
{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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 22, 2021
iWEECARE Co., Ltd. Shao-Chun Chen Official Correspondent 2625 Middlefield Road, #113 Palo Alto, California 94306
Re: K202603
Trade/Device Name: Temp Pal Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: June 11, 2021 Received: June 21, 2021
### Dear Shao-Chun Chen:
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 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
{1}------------------------------------------------
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 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-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,
Payal Patel Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices. and Human Factors OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
# Indications for Use
510(k) Number (if known) K202603
Device Name Temp Pal
Indications for Use (Describe)
The 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 over two years old.
The device is for home healthcare used by the layperson.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | <span style="text-decoration: overline;"> </span> |
|----------------------------------------------|---------------------------------------------------|
| Over-The-Counter Use (21 CFR 801 Subpart C) | <span style="text-decoration: overline;">X</span> |
#### CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
## 510(k) Summary
- 1. Date Prepared: 07/22/2021
- Type of Submission: Traditional 2.
- 3. Submitter's Name: iWEECARE Co., Ltd.
Address: 2F, No. 121, Sec. 2, Linong St., Beitou Dist., Taipei City 112, Taiwan, R.O.C. Phone: +886-2-28213597 E-mail: glen.tseng@iweecare.com Contact: Mr. Glen Tseng/ General Manager Establishment Registration Number: N/A
### 4. Identification of the Device:
Device Classification Name: Thermometer, Electronic, Clinical Device Name: Temp Pal Applicant Contact: Mr. Glen Tseng/ General Manager Correspondent: 2625 Middlefield Road, #113, Palo Alto, CA 94306, United States Phone: +650-8617086 Email: samson@mytracmo.com Correspondent Contact: Shao-Chun Chen Regulation Number: 880.2910 Classification Product Code: FLL Device Classification: II
#### 5. Predicate Device:
Predicate Device Name: Wireless Thermometer (Model: WT701) Manufacturer: Raiing Medical Company 510(k) Number or Clearance Information: K132761
#### Indications for Use: 6.
The Temp Pal is a battery-operated electronic device with intended use of measuring and monitoring human armpit temperature continuously via wireless
{4}------------------------------------------------
signal transmission of the measuring result. This system is reusable and intended for armpit temperature monitoring for persons over two years old. The device is for home healthcare used by the layperson.
### 7. Device Description:
The Temp Pal is designed for the following:
A comprehensive Android and iOS App are provided to access Temp Pal from a smart device. It is used for measuring and monitoring armpit temperature and transmitting measured results to authorized caregivers via a real-time cloud service.
#### Substantial Equivalent Determination 8.
The subject device "Temp Pal" is compared with the predicate device "Wireless Thermometer, WT701" in intended use, principle of operation, safety, and performance. Differences and Equivalences between these devices are cited as below.
| Item | Subject device | Predicate device | Substantial equivalence determination |
|--------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Temp Pal | Wireless Theromometer | |
| Model Name | STP-MB01-1 | WT701 | |
| 510(k) No. | K202603 | K132761 | |
| Product Code | FLL | FLL | Same |
| Classification | Class II | Class II | Same |
| Indications for Use | The Temp Pal is a<br>battery-operated electronic<br>device with intended use of<br>measuring and monitoring<br>human armpit temperature<br>continuously via wireless<br>signal transmission of the<br>measuring result. This system<br>is reusable and intended for<br>armpit temperature monitoring<br>for persons over two years old.<br>The device is for home | The Wireless Thermometer<br>(WT701) is a<br>battery-operated electronic<br>device with intended use of<br>measuring and monitoring<br>human armpit temperature<br>continuously via wireless<br>signal transmission of the<br>measuring result.<br>This system is reusable and<br>intended for armpit<br>temperature monitoring for | Same<br>Both devices are designed<br>to measure and monitor<br>human armpit temperature<br>continuously via wireless<br>signal transmission of the<br>result. |
| | healthcare used by the<br>layperson. | persons over two years old. | |
| Display Unit<br>Specification | iOS device Display | iOS device Display | Same |
| Working Voltage | DC3.7V | DC3V | Similar<br>The electrical safety of<br>subject device is verified<br>and met the pre-defined<br>criteria. This difference<br>does not raise new issues<br>of SE. |
| Battery | Rechargeable Battery<br>3.7V/10mAh | The button battery 3.0V,<br>210mAh | Similar<br>The electrical safety of<br>subject device is verified<br>and met the pre-defined<br>criteria. This difference<br>does not raise new issues<br>of SE. |
| Measurement<br>Range | 77~113°F (25~45°C) | 77~113°F (25~45°C) | Same |
| Accuracy | ±0.09°F (0.05°C) | ±0.09°F (0.05°C), range<br>95~101.3°F (35~38.5°C);<br>±0.18°F (0.10°C), range<br><94.9 and >101.3°F (<35 and<br>>38.5°C) | Similar<br>The measurement<br>accuracy of subject device<br>is verified and met the<br>pre-defined criteria. This<br>difference does not raise<br>new issues of SE. |
| Temperature Unit | °F or °C | °F or °C | Same |
| Signal<br>Transmission | Wireless 2.4G Bluetooth BLE | Wireless 2.4G Bluetooth<br>BLE | Same |
| Receiver | Smart phone, Tablet with<br>Bluetooth V4.0 running Apple<br>operation system iOS 10.0 or<br>later or Android operating | iPhone 4S, iPhone 5, iPad<br>(3rd generation), iPad (4th<br>generation), iPad mini, iPod<br>touch (5th generation) | Similar<br>The receiver of subject<br>device is verified and met<br>the pre-defined criteria. |
| | system 5.0 or later | | This difference does not<br>raise new issues of SE. |
| Valid Transmission<br>Distance | Up to 5 meters | Up to 5 meters | Same |
| Operation<br>Environment | 41~113°F (5~45°C),<br>15~95% RH | 41~104°F (5~40°C),<br>15~85% RH | Similar<br>The operation<br>environment of subject<br>device is verified and met<br>the pre-defined criteria.<br>This difference does not<br>raise new issues of SE. |
| Standards Met for<br>Bench and Clinical<br>Performance | 1. EN 60601-1;<br>2. EN 60601-1-2;<br>3. 47 CFR FCC Part 15<br>Subpart B;<br>4. 47 CFR FCC Part 15<br>Subpart C;<br>5. ASTM E1112;<br>6. EN 12470-4;<br>7. ISO 80601-2-56;<br>8. EN 60601-1-11. | 1. EN 60601-1;<br>2. EN 60601-1-2;<br>3. FCC Part 15 Subpart C<br>test FCC Part 15.247;<br>4. ASTM E1112;<br>5. EN 12470-4. | Equivalent<br>The subject device is<br>verified, validated, and<br>met the pre-defined<br>criteria. This difference<br>does not raise new issues<br>of SE. |
| Operational<br>Principles | For the monitoring<br>operation, switch the<br>thermometer on and stick<br>the thermometer in the user's<br>axilla. The thermometer will<br>make a Bluetooth<br>connection between the<br>thermometer and the<br>receiver automatically (User<br>should setup Bluetooth<br>properly on receiver). Then<br>the thermometer starts to<br>measure the body | For the monitoring<br>operation, switch the<br>thermometer on and stick<br>the thermometer in the<br>user's axilla. The<br>thermometer will make a<br>Bluetooth connection<br>between the thermometer<br>and the receiver<br>automatically (User should<br>setup Bluetooth properly<br>on receiver). Then the<br>thermometer starts to | Equivalent<br>The same mechanism is<br>used in measuring the<br>body temperature by<br>testing NTC resistor's<br>resistance value.<br>The difference in<br>temperature calculation<br>rate does not raise new<br>issues of SE. |
| | | | |
| | temperature by means of<br>testing the NTC resistor's<br>resistance value and<br>calculates the body<br>temperature every 10/30/60<br>seconds continuously and<br>sends the temperature data<br>to the receiver through<br>Bluetooth connection. | measure the body<br>temperature by means of<br>testing the NTC resistor's<br>resistance value and<br>calculates the body<br>temperature every 4<br>seconds continuously and<br>sends the temperature data<br>to the receiver through<br>Bluetooth connection. | |
| Sensor Type | NTC Resistor | NTC Resistor | Same |
| | | | Similar |
| Shelf Life | 13 months | 24 months | Validation up to 13<br>months for subject device. |
| Materials | TPE with Biocompatibility<br>verified and validated | ABS with<br>Biocompatibility verified<br>and validated | Equivalent |
| | | | The material of subject |
| | | | device is verified and met |
| | | | the pre-defined criteria. |
| | | | This difference does not |
| | | | raise new issues of SE. |
{5}------------------------------------------------
IWEECARE Co., Ltd. 510(k) Notification, K202603
{6}------------------------------------------------
IWEECARE Co., Ltd. 510(k) Notification, K202603
{7}------------------------------------------------
# 9. Non-clinical Testing Summary
A series of verification and validation activities were conducted on the subject device as below, and no clinical testing is performed to support the decision of substantial equivalence. All the test results demonstrate the subject device meets the requirement of its pre-defined acceptance criteria and intended use, and these can support the substantial equivalence to the predicate device.
- (1) Life Time and Shelf Life, including the battery cell cycle life test and the supporting shelf life test. The latter is performed by the reliability tests according to in-house standards.
- (2) Cleaning Validation,
{8}------------------------------------------------
tested by microorganisms and supported total organic carbon.
- (3) Biocompatibility. including In Vitro Cytotoxicity, Skin Irritation, and Skin Sensitization, which are in compliance with EN ISO 10993-5, ISO 10993-10, ISO 10993-12, and ISO 10993-1.
- (4) Software Validation, in compliance with FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices and ISO 14971.
- Electromagnetic Compatibility and Electrical Safety, (5) in compliance with IEC/EN 60601-1, EN 60601-1-2, 47 CFR FCC Part 15 Subpart B and Subpart C, and IEC/EN 60601-1-11.
- (6) Performance, in compliance with EN 12470-4, ASTM E1112, and ISO 80601-2-56.
- Human Factor (Usability), (7) in compliance with EN 60601-1-6 and EN 62366.
## 10. Conclusion
The Temp Pal has been compared with "Wireless Thermometer (WT701)". The subject device has same intended use, similar technological characteristics/ specification and performance as the predicate device. The subject device has undergone safety and performance tests, and the results complied with the test requests as the predicate device. Although there are some different specifications between the two devices, they do not raise new issues of substantial equivalence.
After analyzing the difference comparison and the non-clinical testing data, it can be concluded that the Temp Pal is substantially equivalent to the predicate device "Wireless Thermometer (WT701)".
