(317 days)
No
The summary describes a standard electronic thermometer with wireless transmission and a mobile app for monitoring. There is no mention of AI/ML algorithms for data analysis, prediction, or interpretation. The performance studies focus on standard device validation metrics.
No.
The device's sole stated intended use is for "measuring and monitoring human armpit temperature continuously." It does not mention any therapeutic purpose or intervention.
No
The device is a thermometer for continuous temperature monitoring, not a diagnostic device that identifies diseases or conditions.
No
The device description explicitly states it is a "battery-operated electronic device" and mentions hardware-related testing such as "Life Time and Shelf Life," "Cleaning Validation," "Biocompatibility," "Electromagnetic Compatibility and Electrical Safety," and "Performance" which are indicative of a physical hardware component. While it includes software (the Android and iOS App), it is not solely software.
Based on the provided information, the Temp Pal is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Temp Pal's Function: The Temp Pal measures and monitors human armpit temperature directly from the body. It does not analyze any biological specimens.
- Intended Use: The intended use clearly states "measuring and monitoring human armpit temperature continuously." This is a physiological measurement, not an in vitro test.
Therefore, the Temp Pal falls under the category of a medical device that performs a physiological measurement, not an IVD.
N/A
Intended Use / 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.
Product codes
FLL
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
armpit
Indicated Patient Age Range
persons over two years old
Intended User / Care Setting
layperson / home healthcare
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
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, 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.
Key Metrics
Not Found
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 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) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) | X |
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
-
- Date Prepared: 07/22/2021
- Type of Submission: Traditional 2.
-
- 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 | ||
| 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 | The Wireless Thermometer | ||
| (WT701) 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 | Same | ||
| Both devices are designed | |||
| to measure and monitor | |||
| human armpit temperature | |||
| continuously via wireless | |||
| signal transmission of the | |||
| result. | |||
| healthcare used by the | |||
| layperson. | persons over two years old. | ||
| Display Unit | |||
| Specification | iOS device Display | iOS device Display | Same |
| Working Voltage | DC3.7V | DC3V | Similar |
| The electrical safety of | |||
| subject device is verified | |||
| and met the pre-defined | |||
| criteria. This difference | |||
| does not raise new issues | |||
| of SE. | |||
| Battery | Rechargeable Battery | ||
| 3.7V/10mAh | The button battery 3.0V, | ||
| 210mAh | Similar | ||
| The electrical safety of | |||
| subject device is verified | |||
| and met the pre-defined | |||
| criteria. This difference | |||
| does not raise new issues | |||
| of SE. | |||
| Measurement | |||
| Range | 77 | 77 | Same |
| Accuracy | ±0.09°F (0.05°C) | ±0.09°F (0.05°C), range | |
| 95 | |||
| ±0.18°F (0.10°C), range | |||
| 101.3°F (38.5°C) | Similar | ||
| The measurement | |||
| accuracy of subject device | |||
| is verified and met the | |||
| pre-defined criteria. This | |||
| difference does not raise | |||
| new issues of SE. | |||
| Temperature Unit | °F or °C | °F or °C | Same |
| Signal | |||
| Transmission | Wireless 2.4G Bluetooth BLE | Wireless 2.4G Bluetooth | |
| BLE | Same | ||
| Receiver | Smart phone, Tablet with | ||
| Bluetooth V4.0 running Apple | |||
| operation system iOS 10.0 or | |||
| later or Android operating | iPhone 4S, iPhone 5, iPad | ||
| (3rd generation), iPad (4th | |||
| generation), iPad mini, iPod | |||
| touch (5th generation) | Similar | ||
| The receiver of subject | |||
| device is verified and met | |||
| the pre-defined criteria. | |||
| system 5.0 or later | This difference does not | ||
| raise new issues of SE. | |||
| Valid Transmission | |||
| Distance | Up to 5 meters | Up to 5 meters | Same |
| Operation | |||
| Environment | 41 | ||
| 15~95% RH | 41 | ||
| 15~85% RH | Similar | ||
| The operation | |||
| environment of subject | |||
| device is verified and met | |||
| the pre-defined criteria. | |||
| This difference does not | |||
| raise new issues of SE. | |||
| Standards Met for | |||
| Bench and Clinical | |||
| Performance | 1. EN 60601-1; |
- EN 60601-1-2;
- 47 CFR FCC Part 15
Subpart B; - 47 CFR FCC Part 15
Subpart C; - ASTM E1112;
- EN 12470-4;
- ISO 80601-2-56;
- EN 60601-1-11. | 1. EN 60601-1;
- EN 60601-1-2;
- FCC Part 15 Subpart C
test FCC Part 15.247; - ASTM E1112;
- EN 12470-4. | Equivalent
The subject device is
verified, validated, and
met the pre-defined
criteria. This difference
does not raise new issues
of SE. |
| Operational
Principles | 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 | 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 | Equivalent
The same mechanism is
used in measuring the
body temperature by
testing NTC resistor's
resistance value.
The difference in
temperature calculation
rate does not raise new
issues of SE. |
| | | | |
| | temperature by means of
testing the NTC resistor's
resistance value and
calculates the body
temperature every 10/30/60
seconds continuously and
sends the temperature data
to the receiver through
Bluetooth connection. | measure the body
temperature by means of
testing the NTC resistor's
resistance value and
calculates the body
temperature every 4
seconds continuously and
sends the temperature data
to the receiver through
Bluetooth connection. | |
| Sensor Type | NTC Resistor | NTC Resistor | Same |
| | | | Similar |
| Shelf Life | 13 months | 24 months | Validation up to 13
months for subject device. |
| Materials | TPE with Biocompatibility
verified and validated | ABS with
Biocompatibility verified
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)".