(317 days)
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.
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.
Here's an analysis of the acceptance criteria and study information for the Temp Pal device, based on the provided FDA 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The document explicitly states compliance with various standards rather than presenting a direct side-by-side comparison of specific numerical acceptance criteria and performance for all aspects. However, based on the "Differences and Equivalences" table and the "Non-clinical Testing Summary," we can infer the primary performance acceptance criterion:
| Acceptance Criterion (Inferred from Predicate/Standards) | Reported Device Performance (Temp Pal) |
|---|---|
| Measurement Accuracy: ±0.09°F (0.05°C), range 95 | ±0.09°F (0.05°C) (Reported for Temp Pal, implying it meets or exceeds the predicate's more stringent range) |
| Measurement Range: 77-113°F (25-45°C) | 77-113°F (25-45°C) |
| Electrical Safety | Verified and met pre-defined criteria (Compliance with IEC/EN 60601-1, IEC/EN 60601-1-11) |
| Electromagnetic Compatibility (EMC) | Verified and met pre-defined criteria (Compliance with EN 60601-1-2, 47 CFR FCC Part 15 Subpart B, 47 CFR FCC Part 15 Subpart C) |
| Biocompatibility | Verified and validated (Compliance with EN ISO 10993-5, ISO 10993-10, ISO 10993-12, ISO 10993-1) |
| Software Validation | In compliance with FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices and ISO 14971 |
| Human Factors (Usability) | In compliance with EN 60601-1-6 and EN 62366 |
| Lifetime and Shelf Life | Validation up to 13 months for subject device and supporting battery cell cycle life test |
| Cleaning Validation | Tested by microorganisms and supported total organic carbon |
| Performance (General) | Compliance with EN 12470-4, ASTM E1112, and ISO 80601-2-56 |
2. Sample Size Used for the Test Set and Data Provenance
The document states: "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." This indicates that the performance evaluation relied on non-clinical (bench) testing and comparison against established standards and a predicate device.
Therefore:
- Sample size for the test set: Not explicitly stated as this was non-clinical testing. The "sample" would refer to the physical devices and components tested.
- Data provenance: Non-clinical (bench) testing, likely conducted in a lab environment. Origin, if outside the manufacturer's own facilities, is not specified. It is inherently retrospective in the sense that the device's performance was evaluated against pre-defined criteria and standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Since no clinical testing was performed and the evaluation was based on non-clinical performance and compliance with standards, the concept of "experts" establishing ground truth for a clinical test set doesn't directly apply in this context. The "ground truth" for non-clinical performance is defined by the technical specifications of the standards (e.g., ASTM E1112 for thermometer accuracy) and the design requirements. Expert roles would be in the interpretation and application of these standards, typically by qualified engineers and quality assurance personnel.
4. Adjudication Method for the Test Set
Not applicable as there was no expert-adjudicated clinical test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. The document explicitly states "no clinical testing is performed." This type of study would involve human readers (e.g., clinicians) evaluating cases, which is not applicable here as the device is a thermometer, and its performance is assessed via direct measurement accuracy and adherence to technical standards.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
The device is a physical electronic thermometer, not an AI or algorithm-only device in the diagnostic sense. Its standalone performance refers to its ability to accurately measure temperature according to specified standards. All the non-clinical testing described (accuracy, electrical safety, EMC, biocompatibility, etc.) can be considered standalone (device-only) performance evaluations as they assess the device's inherent characteristics without direct human intervention as part of the measurement process itself, beyond operating the device.
7. The Type of Ground Truth Used
The ground truth used for evaluating the device's performance is primarily:
- Standard Specifications: Requirements outlined in international and national standards such as EN 12470-4, ASTM E1112, ISO 80601-2-56 for performance, and EN ISO 10993 series for biocompatibility, IEC/EN 60601 series for electrical safety and EMC.
- Predicate Device Specifications: The performance characteristics of the legally marketed predicate device (Wireless Thermometer, Model WT701, K132761) served as a benchmark for comparison to establish substantial equivalence.
8. The Sample Size for the Training Set
The concept of a "training set" is typically applicable to machine learning or AI models. Since the Temp Pal is an electronic thermometer and not an AI device in this context, there is no training set in the machine learning sense. The device's design and calibration would be based on engineering principles and validated through the non-clinical testing mentioned.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of medical device.
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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
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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
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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 |
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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
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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 abattery-operated electronicdevice with intended use ofmeasuring and monitoringhuman armpit temperaturecontinuously via wirelesssignal transmission of themeasuring result. This systemis reusable and intended forarmpit temperature monitoringfor persons over two years old.The device is for home | The Wireless Thermometer(WT701) is abattery-operated electronicdevice with intended use ofmeasuring and monitoringhuman armpit temperaturecontinuously via wirelesssignal transmission of themeasuring result.This system is reusable andintended for armpittemperature monitoring for | SameBoth devices are designedto measure and monitorhuman armpit temperaturecontinuously via wirelesssignal transmission of theresult. |
| healthcare used by thelayperson. | persons over two years old. | ||
| Display UnitSpecification | iOS device Display | iOS device Display | Same |
| Working Voltage | DC3.7V | DC3V | SimilarThe electrical safety ofsubject device is verifiedand met the pre-definedcriteria. This differencedoes not raise new issuesof SE. |
| Battery | Rechargeable Battery3.7V/10mAh | The button battery 3.0V,210mAh | SimilarThe electrical safety ofsubject device is verifiedand met the pre-definedcriteria. This differencedoes not raise new issuesof SE. |
| MeasurementRange | 77 | 77 | Same |
| Accuracy | ±0.09°F (0.05°C) | ±0.09°F (0.05°C), range95 | SimilarThe measurementaccuracy of subject deviceis verified and met thepre-defined criteria. Thisdifference does not raisenew issues of SE. |
| Temperature Unit | °F or °C | °F or °C | Same |
| SignalTransmission | Wireless 2.4G Bluetooth BLE | Wireless 2.4G BluetoothBLE | Same |
| Receiver | Smart phone, Tablet withBluetooth V4.0 running Appleoperation system iOS 10.0 orlater or Android operating | iPhone 4S, iPhone 5, iPad(3rd generation), iPad (4thgeneration), iPad mini, iPodtouch (5th generation) | SimilarThe receiver of subjectdevice is verified and metthe pre-defined criteria. |
| system 5.0 or later | This difference does notraise new issues of SE. | ||
| Valid TransmissionDistance | Up to 5 meters | Up to 5 meters | Same |
| OperationEnvironment | 41 | 41 | SimilarThe operationenvironment of subjectdevice is verified and metthe pre-defined criteria.This difference does notraise new issues of SE. |
| Standards Met forBench and ClinicalPerformance | 1. EN 60601-1;2. EN 60601-1-2;3. 47 CFR FCC Part 15Subpart B;4. 47 CFR FCC Part 15Subpart C;5. ASTM E1112;6. EN 12470-4;7. ISO 80601-2-56;8. EN 60601-1-11. | 1. EN 60601-1;2. EN 60601-1-2;3. FCC Part 15 Subpart Ctest FCC Part 15.247;4. ASTM E1112;5. EN 12470-4. | EquivalentThe subject device isverified, validated, andmet the pre-definedcriteria. This differencedoes not raise new issuesof SE. |
| OperationalPrinciples | For the monitoringoperation, switch thethermometer on and stickthe thermometer in the user'saxilla. The thermometer willmake a Bluetoothconnection between thethermometer and thereceiver automatically (Usershould setup Bluetoothproperly on receiver). Thenthe thermometer starts tomeasure the body | For the monitoringoperation, switch thethermometer on and stickthe thermometer in theuser's axilla. Thethermometer will make aBluetooth connectionbetween the thermometerand the receiverautomatically (User shouldsetup Bluetooth properlyon receiver). Then thethermometer starts to | EquivalentThe same mechanism isused in measuring thebody temperature bytesting NTC resistor'sresistance value.The difference intemperature calculationrate does not raise newissues of SE. |
| temperature by means oftesting the NTC resistor'sresistance value andcalculates the bodytemperature every 10/30/60seconds continuously andsends the temperature datato the receiver throughBluetooth connection. | measure the bodytemperature by means oftesting the NTC resistor'sresistance value andcalculates the bodytemperature every 4seconds continuously andsends the temperature datato the receiver throughBluetooth connection. | ||
| Sensor Type | NTC Resistor | NTC Resistor | Same |
| Similar | |||
| Shelf Life | 13 months | 24 months | Validation up to 13months for subject device. |
| Materials | TPE with Biocompatibilityverified and validated | ABS withBiocompatibility verifiedand validated | Equivalent |
| The material of subject | |||
| device is verified and met | |||
| the pre-defined criteria. | |||
| This difference does not | |||
| raise new issues of SE. |
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IWEECARE Co., Ltd. 510(k) Notification, K202603
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IWEECARE Co., Ltd. 510(k) Notification, K202603
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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,
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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)".
§ 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.