(175 days)
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 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.
The provided text describes the Temp Pal (Smart Thermometer Patch) and its substantial equivalence determination to a predicate device. However, it does not explicitly detail a "study that proves the device meets the acceptance criteria" in a format that would include the specific data points requested for a typical AI/ML-based device study (e.g., sample size for test set, expert qualifications, effect size for human readers with AI assistance).
The document focuses on non-clinical testing to demonstrate that the device meets various safety and performance standards for a clinical electronic thermometer. It compares the subject device to a predicate device and addresses how differences do not raise new safety and effectiveness questions.
Here's an attempt to extract and present the information based on the provided text, acknowledging that some requested fields might not be explicitly present for this type of medical device submission.
Acceptance Criteria and Device Performance (Clinical Electronic Thermometer)
The device's performance is gauged against established standards for clinical electronic thermometers. The primary acceptance criterion related to performance is accuracy.
| Acceptance Criteria (Performance) | Reported Device Performance |
|---|---|
| Accuracy (as per standards like EN 12470-4, ASTM E1112, ISO 80601-2-56) | 0.09 °F (± 0.05 °C) |
| Display Resolution | 0.01 °F (± 0.01 °C) |
| Max Continuous Measuring Time | 24 hours |
| Response Time | Requires up to 5 minutes to reach stable reading |
| Measurement Range | 77-113°F (25-45°C) |
| Shelf Life | 24 months (improved from 13 months of predicate) |
| Biocompatibility | In compliance with ISO 10993-5, ISO 10993-10, ISO 10993-12, and ISO 10993-1. |
| Electrical Safety & EMC | In compliance with IEC/EN 60601-1, EN 60601-1-2, 47 CFR FCC Part 15 Subpart B and C, and IEC/EN 60601-1-11. |
| Software Compliance | In compliance with IEC 62304. |
| Usability | In compliance with EN 60601-1-6 and EN 62366. |
Study Details (Based on provided text)
-
Sample size used for the test set and the data provenance:
- The document mentions "Performance test," including "Continuous measurement," "Intermittent Determination," and "Direct clinical thermometer measure." However, specific sample sizes for these performance tests are not provided in this summary.
- Data provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). The tests listed are general performance and safety tests, not clinical trials with human subjects for efficacy in the same way an AI/ML diagnostic might be reported. The "Indication for Use" mentions use for "persons of all age," and the subject device expands the patient population to include children under 2 years old, implying broader testing than the predicate.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable/provided in the context of this device's regulatory submission, as it's a direct measuring thermometer, not an AI/ML diagnostic device requiring expert interpretation for ground truth.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This information is not applicable/provided for this type of device.
-
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was not done. This device is a standalone thermometer, not an AI-assisted diagnostic tool that would involve human readers.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, the performance tests mentioned (continuous measurement, intermittent determination, direct clinical thermometer measure) assess the device's standalone accuracy and other performance metrics against established standards. The device itself is the "algorithm only" in the sense that it measures and transmits temperature.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the accuracy measurements, the ground truth would typically be established by highly accurate reference thermometers or calibration standards as defined by the relevant ISO and ASTM standards (e.g., ISO 80601-2-56, ASTM E1112). This is standard for clinical electronic thermometers.
-
The sample size for the training set:
- This information is not applicable/provided. This device is a traditional electronic thermometer, not an AI/ML model that requires a training set.
-
How the ground truth for the training set was established:
- This information is not applicable/provided as there is no training set for an AI/ML model for this device.
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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
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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
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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 Tsengglen.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 (SmartThermometer 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 electronicdevice with intendeduse of measuring andmonitoring humanarmpit temperaturecontinuously viawireless signaltransmission of themeasuring result. Thissystem is reusable andintended for armpittemperature monitoringfor persons of all age.The temperature data ofdevice is not intended toreplace the advice,diagnosis, nor treatmentrecommendations ofdoctor. Temp Pal can beused at home andhealthcare center. | The Temp Pal is abattery-operatedelectronic device withintended use ofmeasuring andmonitoring humanarmpit temperaturecontinuously viawireless signaltransmission of themeasuring result.This system is reusableand intended for armpittemperature monitoringforpersons over two yearsold. | SimilarBoth devices are designedto measure and monitorhuman armpit temperaturecontinuously via wirelesssignal transmission of theresult.The subject device expandsthe patient population toinclude child under 2 yearsold (comparing withpredicate device(K202603). |
| Thermometer | Clinical Electronic | Clinical Electronic | Same |
| Item | Subject deviceTemp Pal (SmartThermometer Patch) | Predicate deviceTemp Pal | Comparison |
| Type | Thermometer | Thermometer | |
| Principle ofOperation | For the monitoringoperation, switch thethermometer on andstick the thermometer inthe user's axilla.The thermometer willmake a Bluetoothconnection betweenthethermometer and thereceiver automatically(User should setupBluetooth properly onreceiver).Then the thermometerstarts to measure thebody temperature bymeans of testing theNTC resistor'sresistance value andcalculates the bodytemperature every 10seconds continuouslyand sends thetemperature data to thereceiver throughBluetooth connection. | For the monitoringoperation, switch thethermometer on andstick the thermometerin the user's axilla.The thermometer willmake a Bluetoothconnection betweenthethermometer and thereceiver automatically(User should setupBluetooth properly onreceiver).Then the thermometerstarts to measure thebody temperature bymeans of testing theNTC resistor'sresistance value andcalculates the bodytemperature every10/30/60 secondscontinuously andsends the temperaturedata to the receiverthrough Bluetoothconnection. | SimilarBoth devices measure thebody temperaturecontinuously by Bluetoothconnection between thepatch and smart device.Subject device keeps only10 seconds measurefrequency. |
| 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 Battery3.7V/10mAh | Rechargeable Battery3.7V/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 | DifferentReliability 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 (SmartThermometer Patch) | Temp Pal | ||
| which are in | which are in | ||
| compliance with EN | compliance with EN | ||
| ISO 10993-5, ISO10993-10, ISO10993-12, and ISO10993-1. | ISO 10993-5, ISO10993-10, ISO10993-12, and ISO10993-1. | ||
| Electric Safetyand EMC | In compliance withIEC/EN 60601-1, EN60601-1-2, 47 CFR FCCPart15 Subpart B andSubpart C, and IEC/EN60601-1-11. | In compliance withIEC/EN 60601-1, EN60601-1-2, 47 CFRFCC Part15 Subpart B andSubpart C, and IEC/EN60601-1-11. | Same |
| Performance | In compliance with EN12470-4, ASTM E1112,ISO 80601-2-56 and IEC60529. | In compliance with EN12470-4, ASTME1112, 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
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- . 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 ofmedical devices - Part 5: Tests for in vitrocytotoxicity. |
| ISO 10993-10:2010: Biological evaluation ofmedical devices - Part 10: Tests for irritation andskin sensitization. | |
| Performance | |
| ISO 80601-2-56 Second edition 2017-03,Medical electrical equipment - Part 2-56:Particular requirements for basic safety andessential performance of clinical thermometersfor body temperature measurement. [Including:Amendment 1 (2018)]. | |
| IEC 60529:1989+A2:2013+C1:2019, and EN60529:1991+A2:2013+AC:2019. Degrees ofprotection provided by enclosures (IP Code) | |
| IEC 62304:2006+AMD1:2015, Medical devicesoftware – Software life cycle processes | |
| Software | Guidance for the Content of PremarketSubmissions for Software Contained in MedicalDevices: Guidance for Industry and FDA Staff. |
| ANSI AAMI, ES60601-1:2005/(R)2012 andA1:2012, C1:2009/(R)2012 andA2:2010/(R)2012 (Consolidated Text), Medicalelectrical equipment - Part 1: Generalrequirements for basic safety and essentialperformance (IEC 60601-1:2005, MOD) | |
| ElectromagneticCompatibilityand ElectricalSafety | EN 60601-1-2:2007, Medical ElectricalEquipment - Part 1-2: General Requirements ForBasic Safety And Essential Performance -Collateral Standard: ElectromagneticCompatibility - Requirements And Tests |
| IEC, 60601-1-11 Edition 2.0 2015-01, Medicalelectrical equipment - Part 1-11: Generalrequirements for basic safety and essential | |
| Usability | performance - Collateral Standard:Requirements for medical electrical equipmentand medical electrical systems used in the homehealthcare 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, Generalrequirements for basic safety and essentialperformance - Collateral standard: Usability | |
| EN 62366 : 2008, Application of usabilityengineering to medical devices | |
| Cybersecurity | Content of Premarket Submissions forManagement of Cybersecurity in MedicalDevices |
| WirelessCoexistence | Radio Frequency Wireless Technology inMedical Devices - Guidance for Industry andFood and Drug Administration Staff |
| AAMI, TIR69 Risk Management of Radio-Frequency Wireless Coexistence for MedicalDevices 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.
§ 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.