(175 days)
Not Found
No
The description focuses on basic temperature measurement, Bluetooth communication, and a mobile app for display. There is no mention of AI or ML algorithms for data analysis, prediction, or interpretation.
No
The device measures and monitors temperature but is explicitly stated as "not intended to replace the advice, diagnosis, nor treatment recommendations of doctor," indicating it is not for therapeutic purposes.
No
The device is described as measuring and monitoring temperature, and the text explicitly states, "The temperature data of device is not intended to replace the advice, diagnosis, nor treatment recommendations of doctor." This indicates it is for monitoring, not for diagnosing medical conditions.
No
The device description explicitly states it is a "combination device of thermometer and Bluetooth communication unit" and mentions a rechargeable battery and internal circuitry, indicating it includes hardware components beyond just software.
Based on the provided information, the Temp Pal device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. This testing is performed outside of the body (in vitro).
- Temp Pal's Function: The Temp Pal measures and monitors human armpit temperature directly on the body. It does not analyze any biological specimens.
- Intended Use: The intended use clearly states it's for "measuring and monitoring human armpit temperature continuously." This is a physiological measurement, not an in vitro diagnostic test.
Therefore, the Temp Pal falls under the category of a medical device that performs a physiological measurement, but it is not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
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 in real-time continuously and remotely via Bluetooth to smart device.
- 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 Rechargeable Battery 3.7V/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, axilla, Patients' armpit
Indicated Patient Age Range
all age
Intended User / Care Setting
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)
- Shelf life: Reliability Test
- Biocompatibility (Temp Pal-Smart Thermometer Patch): In Vitro Cytotoxicity Test, Skin Irritation Study in White Rabbit, Skin Sensitization Study in Guinea Pigs
- Biocompatibility (Medical Adhesive): In Vitro Cytotoxicity Test, MEM Elution, Primary Skin Irritation, Guinea Pig Sensitization
- Performance test: Continuous measurement, Intermittent Determination, Direct clinical thermometer measure, Degrees of protection
- Electromagnetic Compatibility and Electrical Safety: General requirements for basic safety and essential performance, Electromagnetic Compatibility
- Usability testing was performed and met the requirements.
- Shelf life test has been performed on the subject device, and the results complied with the test requests.
- A series of safety and performance tests have been performed on the subject device, and the results complied with the test requests.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 880.2910 Clinical electronic thermometer.
(a)
Identification. A clinical electronic thermometer is a device used to measure the body temperature of a patient by means of a transducer coupled with an electronic signal amplification, conditioning, and display unit. The transducer may be in a detachable probe with or without a disposable cover.(b)
Classification. Class II (performance standards). The device is exempt from the premarket notification procedures in part 807, subpart E of this chapter, subject to the limitations in § 880.9 and the following conditions for exemption:(1) Device is not a clinical thermometer with telethermographic functions;
(2) Device is not a clinical thermometer with continuous temperature measurement functions; and
(3) Appropriate analysis and testing (such as that outlined in the currently FDA-recognized editions, as appropriate, of ISO 80601-2-56, “Medical electrical equipment—Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement,” or ASTM E1965, “Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature,” or ASTM E1112, “Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature,” or ASTM E1104, “Standard Specification for Clinical Thermometer Probe Covers and Sheaths”) must validate specifications and performance of the device.
0
Image /page/0/Picture/0 description: The image shows the logo for 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, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue and "ADMINISTRATION" in a smaller font below.
February 17, 2023
iWEECARE Co., Ltd. Julia Yang Regulatory Manager 1F., No. 11, Ln. 382, Zhonghe St., Beitou Dist., Taipei City, 112 Taiwan
Re: K222588
Trade/Device Name: Temp Pal (Smart Thermometer Patch) Model Number: STP-MB01-1 Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: January 18, 2023 Received: January 20, 2023
Dear Julia Yang:
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
1
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 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 (OS) 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,
David Walloschek
David Wolloscheck, Ph.D. Acting 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)
K222588
Device Name
Temp Pal (Smart Thermometer Patch) Model Number: STP-MB01-1
Indications for Use (Describe)
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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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K222588 - 510(k) SUMMARY
- 5.1 Preparation Date: Feb. 9, 2023
| 5.2 Submitter: | iWEECARE Co., Ltd. |
|---|---|
| Address: | 1F., No. 11, Ln. 382, Zhonghe St., Beitou Dist.. |
| Taipei City 112, Taiwan | |
| Phone: | +886-2-2891-8636 |
| Contact: | Glen Tseng |
| glen.tseng@iweecare.com |
Identification of the Device: 5.3
| Proprietary/Trade Name: | Temp Pal (Smart Thermometer Patch) |
|---|---|
| Model Number: | STP-MB01-1 |
| Regulation Name: | Clinical Electronic Thermometer |
| Review Panel: | General Hospital |
| Regulation Number: | 880.2910 |
| Product Code: | FLL |
| Device Class: | II |
5.4 Identification of the Predicate Device:
| Predicate Device Name: | Temp Pal |
|---|---|
| Model Number: | STP-MB01-1 |
| 510(k) Number: | K202603 |
| Manufacturer: | iWEECARE Co., Ltd. |
| Regulation Number: | 880.2910 |
| Product Code: | FLL |
| Device Class: | Class II |
5.5 Intended Use/ Indications for Use of the Device
Temp Pal is a battery-operated electronic device with intended use of measuring and monitoring human armpit temperature continuously via wireless signal transmission
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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.
5.6 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 in real-time continuously and remotely via Bluetooth to smart device.
- · 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 Rechargeable Battery 3.7V/10mAh
- . operation mode Direct mode
- . measuring results display method The measuring results are transmitted to smart phone and display by APP.
- data communication method .
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Wireless 2.4G Bluetooth BLE.
5.7 Substantial Equivalence Determination
The Temp Pal (Smart Thermometer Patch) submitted in this 510(k) file is substantially equivalent in intended use, principles of operation, safety and performance to the cleared Temp Pal (K202603). Differences between the devices are cited.
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| Item | Subject device | Predicate device | Comparison |
|---|---|---|---|
| 510(k) No. | K222588 | K202603 | |
| Proprietary Name | Temp Pal (Smart | ||
| Thermometer Patch) | Temp Pal | N/A | |
| Model | STP-MB01-1 | STP-MB01-1 | |
| Manufacturer | iWEECARE Co., Ltd. | iWEECARE Co., Ltd. | |
| Product Code | FLL | FLL | Same |
| Classification | Class II | Class II | Same |
| Indications for use | 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. | 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. | Similar | ||
| Both devices are designed | |||
| to measure and monitor | |||
| human armpit temperature | |||
| continuously via wireless | |||
| signal transmission of the | |||
| result. | |||
| The subject device expands | |||
| the patient population to | |||
| include child under 2 years | |||
| old (comparing with | |||
| predicate device | |||
| (K202603). | |||
| Thermometer | Clinical Electronic | Clinical Electronic | Same |
| Item | Subject device | ||
| Temp Pal (Smart | |||
| Thermometer Patch) | Predicate device | ||
| Temp Pal | Comparison | ||
| Type | Thermometer | Thermometer | |
| 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 every 10 | |||
| seconds 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 every | |||
| 10/30/60 seconds | |||
| continuously and | |||
| sends the temperature | |||
| data to the receiver | |||
| through Bluetooth | |||
| connection. | Similar | ||
| Both devices measure the | |||
| body temperature | |||
| continuously by Bluetooth | |||
| connection between the | |||
| patch and smart device. | |||
| Subject device keeps only | |||
| 10 seconds measure | |||
| frequency. | |||
| Anatomical | Patients' armpit | Patients' armpit | |
| Item | Subject device | Predicate device | Comparison |
| Application | Temp Pal (Smart Thermometer Patch) | Temp Pal | |
| Sensor | NTC Resistor | NTC Resistor | Same |
| Signal | Wireless 2.4G | Wireless 2.4G | Same |
| Transmission | Bluetooth BLE | Bluetooth BLE | Same |
| Display | iOS device display, | ||
| Android device display | iOS device display, | ||
| Android device display | Same | ||
| Working Voltage | DC3.7V | DC3.7V | Same |
| Power Requirements | Rechargeable Battery | ||
| 3.7V/10mAh | Rechargeable Battery | ||
| 3.7V/10mAh | Same | ||
| Materials | TPE, 304 Stainless Steel Probe and double-sided medical adhesive | TPE, 304 Stainless Steel Probe and double-sided medical adhesive | Same |
| Maximum continuous measuring time | 24 hours | 24 hours | Same |
| Response time | Require up to 5 minutes to reach stable reading | Require up to 5 minutes to reach stable reading | Same |
| Device size | Size: 28.5 x 26.8 x 3.52 mm, Weight: 3.6 g | Size: 28.5 x 26.8 x 3.52 mm, Weight: 3.3 g | Similar |
| Reusability | Reusable | Reusable | Same |
| Temperature range (Measurement Range) | 77-113°F (25-45°C) | 77-113°F (25-45°C) | Same |
| Operation Environment | 41-113°F (5-45°C), 15-95%RH | 41-113°F (5-45°C), 15-95%RH | Same |
| Storage condition | -4-131°F (-20-55°C), 15-95%RH | -4-131°F (-20-55°C), 15-95%RH | Same |
| Accuracy | 0.09 °F (± 0.05 °C) | 0.09 °F (± 0.05 °C) | Same |
| Display | 0.01 °F (± 0.01 °C) | 0.01 °F (± 0.01 °C) | Same |
| Item | Subject device | Predicate device | Comparison |
| resolution | Temp Pal (Smart Thermometer Patch) | Temp Pal | |
| Valid transmission distance | Up to 5 meters | Up to 5 meters | Same |
| Shelf Life | 24 months | 13 months | Different |
| Reliability up to 24 months for subject device is tested. | |||
| APP name | Temp Pal APP | Temp Pal APP | N/A |
| APP description | The Temp Pal APP provides an interface to receive and display the temperature data transmitted from the Temp Pal device. | The Temp Pal APP provides an interface to receive and display the temperature data transmitted from the Temp Pal device. | Same |
| APP Operation Platform | iOS and Android | iOS and Android | Same |
| APP Temperature display | Display in either °C or°F | Display in either °C or°F | Same |
| APP Data Export | Enables temperature data to be exported via e-mail as csv file. | Enables temperature data to be exported via e-mail as csv file. | Same |
| APP Battery Capacity | Display with 5 scale | Display with 5 scale | Same |
| Operation mode | Direct mode | Direct mode | Same |
| Biocompatibility | Biocompatibility, including In Vitro Cytotoxicity, Skin Irritation, and Skin Sensitization | Biocompatibility, including In Vitro Cytotoxicity, Skin Irritation, and Skin Sensitization | Same |
| Item | Subject device | Predicate device | Comparison |
| Temp Pal (Smart | |||
| Thermometer Patch) | Temp Pal | ||
| which are in | which are in | ||
| compliance with EN | compliance with EN | ||
| ISO 10993-5, ISO | |||
| 10993-10, ISO | |||
| 10993-12, and ISO | |||
| 10993-1. | ISO 10993-5, ISO | ||
| 10993-10, ISO | |||
| 10993-12, and ISO | |||
| 10993-1. | |||
| Electric Safety | |||
| and EMC | 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. | 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. | Same | ||
| Performance | In compliance with EN | ||
| 12470-4, ASTM E1112, | |||
| ISO 80601-2-56 and IEC |
-
| In compliance with EN
12470-4, ASTM
E1112, ISO 80601-2-
56 and IEC 60529. | Same |
| | | | |
| | | | |
| | | | |
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5.8 Similarity and Difference
The subject device has similar intended use, principle of operation and device size, and different shelf life, as the predicate device.
The intended use of subject device expands patient population to include child under 2 years old compared with the previous cleared device (K202603). The performance testing was conducted in accordance with ISO 80601-2-56 and the results complied with the standard. In addition, the usability testing was performed and met the requirements. So that this difference does not raise new safety and effectiveness questions.
The principle of operation is similar, both devices measure the body temperature continuously by Bluetooth connection between the patch and smart device. The measuring frequency were every 10/30/60 seconds in predicate device, and the subject device only keeps 10 second measuring frequency. The performance testing has been performed on the subject device, and the results complied with the test requests. So that this difference does not raise new safety and effectiveness questions.
The one difference between the subject device and the predicate devices is the shelf life. The subject device extends the reliability test to 24 months. The shelf life test has been performed on the subject device, and the results complied with the test requests. So that this difference does not raise new safety and effectiveness questions.
Finally, the weight of subject device is increased from 3.3g of predicate device to 3.6g by adding a TPE cover. A series of safety and performance tests have been performed on the subject device, and the results complied with the test requests. So that this difference does not raise new safety and effectiveness questions.
5.9 Non-clinical Testing
A series of safety and performance tests were conducted on the subject device, Temp Pal (Smart Thermometer Patch):
- . Shelf life
- Reliability Test
12
- . Biocompatibility (Temp Pal-Smart Thermometer Patch)
- In Vitro Cytotoxicity Test
- Skin Irritation Study in White Rabbit i
- Skin Sensitization Study in Guinea Pigs i
- Biocompatibility (Medical Adhesive) ●
- In Vitro Cytotoxicity Test ।
- MEM Elution
- Primary Skin Irritation
- Guinea Pig Sensitization ।
- Performance test ●
- Continuous measurement -
- Intermittent Determination
- Direct clinical thermometer measure
- Degrees of protection ।
- Electromagnetic Compatibility and Electrical Safety .
- General requirements for basic safety and essential performance -
- Electromagnetic Compatibility
Please also find the applied standard for non-clinical testing:
| Testing Item | Standards applied |
|---|---|
| Reliability | |
| (Stability) | Guidance of Shelf Life of Medical Devices |
| (1991) | |
| Biocompatibility | 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. | |
| Performance | |
| 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. [Including: | |
| Amendment 1 (2018)]. | |
| IEC 60529:1989+A2:2013+C1:2019, and EN | |
| 60529:1991+A2:2013+AC:2019. Degrees of | |
| protection provided by enclosures (IP Code) | |
| IEC 62304:2006+AMD1:2015, Medical device | |
| software – Software life cycle processes | |
| Software | Guidance for the Content of Premarket |
| Submissions for Software Contained in Medical | |
| Devices: Guidance for Industry and FDA Staff. | |
| ANSI AAMI, ES60601-1:2005/(R)2012 and | |
| A1:2012, C1:2009/(R)2012 and | |
| A2:2010/(R)2012 (Consolidated Text), Medical | |
| electrical equipment - Part 1: General | |
| requirements for basic safety and essential | |
| performance (IEC 60601-1:2005, MOD) | |
| Electromagnetic | |
| Compatibility | |
| and Electrical | |
| Safety | EN 60601-1-2:2007, Medical Electrical |
| Equipment - Part 1-2: General Requirements For | |
| Basic Safety And Essential Performance - | |
| Collateral Standard: Electromagnetic | |
| Compatibility - Requirements And Tests | |
| IEC, 60601-1-11 Edition 2.0 2015-01, Medical | |
| electrical equipment - Part 1-11: General | |
| requirements for basic safety and essential | |
| Usability | 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 | |
| EN 60601-1-6 : 2007/ AC:2010, General | |
| requirements for basic safety and essential | |
| performance - Collateral standard: Usability | |
| EN 62366 : 2008, Application of usability | |
| engineering to medical devices | |
| Cybersecurity | Content of Premarket Submissions for |
| Management of Cybersecurity in Medical | |
| Devices | |
| Wireless | |
| Coexistence | Radio Frequency Wireless Technology in |
| Medical Devices - Guidance for Industry and | |
| Food and Drug Administration Staff | |
| AAMI, TIR69 Risk Management of Radio- | |
| Frequency Wireless Coexistence for Medical | |
| Devices and Systems | |
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5.10 Conclusion
After analyzing the intended use, technological characteristics, non-clinical laboratory studies and safety testing data, it can be concluded that Temp Pal (Smart Thermometer Patch) is substantially equivalent to the predicate device.