Wearable Digital Thermometer 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. Wearable Digital Thermometer 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. Wearable Digital Thermometer can be used at home and healthcare center.

Device Description

The Wearable Digital Thermometer consists of a host, App software and stickers. A comprehensive Android and iOS App are provided to access the host 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 medical double-sided sticker are used to fix and stick the host in the user`s axilla. The NTC temperature sensor is located closely to the stainless steel sheet that make sure the accuracy of temperature data measured. 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.

AI/ML Overview

The provided document is a 510(k) summary for the Wearable Digital Thermometer (T31). While it lists performance data and standards met, it does not contain a detailed study report with specific acceptance criteria beyond general accuracy requirements, nor does it provide sample sizes, ground truth establishment methods for a test set, or information about expert involvement typically found in clinical validation studies for AI/ML devices.

The document refers to the device as a "Clinical Electronic Thermometer" and a "Wearable Digital Thermometer." It doesn't describe an AI or Machine Learning component. The "Performance Data" section primarily focuses on engineering and regulatory compliance testing rather than clinical study results that would typically be detailed for an AI/ML product.

Here's a breakdown of the information that can be extracted, and what is missing:

1. Table of acceptance criteria and the reported device performance:

Acceptance Criteria (Standard Reference)	Reported Device Performance
Accuracy: ±0.1°C (35.00°C to 39.00°C) or ±0.18°F (95°F to 102.20°F)	Accuracy: Met (stated as "met the requirement of ISO 80601-2-56:2017")
Accuracy: ±0.2°C (<35.00°C or >39.00°C) or ±0.36°F (<95°F or >102.20°F)	Accuracy: Met (stated as "met the requirement of ISO 80601-2-56:2017")
continuous measurement, intermittent determination, and direct clinical thermometer measure	Met product specifications and relevant standards (ASTM E1112-00 (2018), ISO 80601-2-56:2017)
Electrical Safety	Passed IEC 60601-1 Ed 3.2 2020-08, IEC 60601-1-11 Ed 2.1 2020-07
Electromagnetic Compatibility (EMC)	Passed IEC 60601-1-2 Ed 4.1 2020-09, ANSI C63.4-2014, FCC Part 15 Subpart B & C
Software Verification & Validation	All software requirement specifications met, all software hazards mitigated to acceptable risk levels (IEC 62304 Ed 1.1 2015-06, FDA Guidance documents)
Biocompatibility	Passed ISO 10993-5:2009 (Cytotoxicity), ISO 10993-10:2010 (Irritation & Skin Sensitization)
Shelf Life	Reliability test conducted and passed (Guidance of Shelf Life of Medical Devices (1991))
Usability	Passed IEC 60601-1-6:2020

Study Details:

Since the device is a "Wearable Digital Thermometer" and not an AI/ML-driven diagnostic or prognostic tool, the "study" described is a series of engineering and regulatory compliance tests rather than a clinical trial in the traditional sense for AI/ML validation.

2. Sample size used for the test set and the data provenance:

Sample size for accuracy testing: Not specified. The document only states that "Performance test" was conducted and "meet the specification of the product and the relevant standards." It doesn't explicitly mention the number of subjects or measurements for clinical accuracy validation.
Data provenance: Not specified if a specific clinical test set was used, beyond the general standards compliance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable / Not specified. For a digital thermometer, ground truth is typically established by comparing the device's readings against a highly accurate reference thermometer, rather than expert consensus on images or clinical assessments. The specific methodology for this comparison (e.g., how many reference measurements were taken) is not detailed.

4. Adjudication method for the test set:

Not applicable / Not specified. Adjudication methods like 2+1 or 3+1 are relevant for interpreting subjective data (e.g., radiology images) where experts might disagree. For a quantitative measurement like temperature, the ground truth is typically a direct measurement from a calibrated reference.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

No. An MRMC study is relevant for AI systems that assist human readers in interpreting complex data (e.g., medical images). This document describes a digital thermometer, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

Yes, in essence. The performance tests described (accuracy, electrical safety, EMC, biocompatibility, shelf life, usability) are evaluating the device's inherent function, without human interpretation as part of its core measurement capability. The "algorithm" here is the device's internal temperature measurement and display mechanism.

7. The type of ground truth used:

Reference standard/calibration: For accuracy testing, the ground truth would be established by comparing the device's temperature readings against a certified reference thermometer or a temperature standard, as outlined in standards like ISO 80601-2-56 and ASTM E1112. The specific details beyond "met the requirement" are not provided.

8. The sample size for the training set:

Not applicable / Not specified. This device, as described, is a traditional electronic thermometer. It does not appear to utilize machine learning or need a "training set" in the context of AI/ML. Its function is based on fixed physical principles (NTC resistor).

9. How the ground truth for the training set was established:

Not applicable. As a non-AI/ML device, there is no "training set" for an algorithm.

In summary: The provided document is a regulatory submission for a conventional medical device (a digital thermometer), not an AI/ML-powered one. Therefore, many of the questions asking for specifics related to AI/ML study design (like training/test sets, expert adjudication, MRMC studies) are not applicable or not detailed in this type of submission. The performance data focuses on demonstrating compliance with relevant electrical, safety, biocompatibility, and measurement accuracy standards for clinical thermometers.

Summary

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October 30, 2024

Guangdong Genial Technology CO., Ltd. % Klem Hou RA Manager Constant Medical Technology Co., Ltd. No. 2021-6, 2nd Floor, No. 228 Huadi Avenue Middle Liwan District, Guangzhou Zhaoqing, Guangdong 526437 China

Re: K240333

Trade/Device Name: Wearable Digital Thermometer (T31) Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical electronic thermometer Regulatory Class: Class II Product Code: FLL Dated: September 30, 2024 Received: September 30, 2024

Dear Klem Hou:

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 (the 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 available 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.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-regulatory

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assistance/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. 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) K240333

Device Name Wearable Digital Thermometer (T31)

Indications for Use (Describe)

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)

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K240333 - 510(k) Summary

1. Submission sponsor

Name: GUANGDONG GENIAL TECHNOLOGY CO., LTD.

Address: I-6-05-02 11th Road, Area B, Guangfozhao Economic Cooperation Zone, Zhagang

Town, Huaiji County, Zhaoqing City, Guangdong Province, 526437, P.R. China Zhaoqing

Guangdong 526437 China

Contact person: Jun Yu

Title: Deputy general manager

Tel: +86- 136 0284 9551

Email: admin@genial.cn

2. Submission correspondent

Name: Constant Medical Technology Co., Ltd. Address: No. 2021-6, 2nd Floor, No. 228 Huadi Avenue Middle, Liwan District, Guangzhou Zhaoqing Guangdong 526437 China Contact person: Klem Hou Title: RA manager Tel: +86 178 7557 1727 Email: pharmaklem@outlook.com

3. Device

Name of Device: Wearable Digital Thermometer

Model(s): T31

Common or Usual Name: Clinical Electronic Thermometer

Classification Name: Clinical Electronic Thermometer

Regulatory Class: II

Product Code: FLL

Regulation Number: 21 CFR 880.2910

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4. Predicate device(s)

Manufacturer	Predicate Device	510(k) Number
iWEECARE Co., Ltd.	Temp Pal (Smart Thermometer Patch)Model Number: STP-MB01-1	K222588

Device description న్.

The NTC temperature sensor is located closely to the stainless steel sheet that make sure the accuracy of temperature data measured.

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: Battery 3.0V/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.

Indications for Use 6.

Wearable Digital Thermometer is a battery-operated electronic device with intended use of

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measuring and monitoring human armpit temperature continuously via wireless signal transmission of the measuring result. Wearable Digital Thermometer 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. Wearable Digital Thermometer can be used at home and healthcare center.

7. Comparison of Technological Characteristics with the Predicate Device(s)

Wearable Digital Thermometer has the same intended use, mode of action and operational characteristics as the predicate devices. Any minor differences between the subject device and the listed predicate devices do not raise any issues of safety or efficacy. Performance data supports that the device is safe and as effective as the predicate device for its intended use.

Therefore, The Wearable Digital Thermometer may be found substantially equivalent to its predicate devices.

Wearable Digital Thermometer is compared with the following Predicate Devices in terms of intended use, design, material, specifications, and performance:

K222588 (Predicate Device), " Temp Pal (Smart Thermometer Patch) ", manufactured by "

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iWEECARE Co., Ltd."

ComparisonElements	Subject Device	PredicateDevice(K222588)	Remark
Device name	Wearable Digital Thermometer	Temp Pal (Smart ThermometerPatch)	--
Model	T31	STP-MB01-1	--
Indications foruse	Wearable Digital Thermometeris a battery-operated electronicdevice with intended use ofmeasuring and monitoringhuman armpit temperaturecontinuously via wireless signaltransmission of the measuringresult. Wearable DigitalThermometer is reusable andintended for armpit temperaturemonitoring for persons of allage. The temperature data ofdevice is not intended to replacethe advice, diagnosis, nortreatment recommendations ofdoctor. Wearable DigitalThermometer can be used athome and healthcare center.	Temp Pal is a battery-operatedelectronic device with intendeduse of measuring andmonitoring human armpittemperature continuously viawireless signal transmission ofthe measuring result. Thissystem is reusable and intendedfor armpit temperaturemonitoring for persons of allage. The temperature data ofdevice is not intended toreplace the advice, diagnosis,nor treatment recommendationsof doctor. Temp Pal can be usedat home and healthcare center.	Same
Principle ofOperation	For the monitoring operation,switch the thermometer on andstick the thermometer in theuser's axilla. The thermometerwill make a Bluetoothconnection between thethermometer and the receiverautomatically (User should setupBluetooth properly on receiver).Then the thermometer starts tomeasure the body temperatureby means of testing the NTCresistor's resistance value andcalculates the body temperaturecontinuously and sends thetemperature data to the receiverthrough Bluetooth connection.	For the monitoring operation,switch the thermometer on andstick the thermometer in theuser's axilla. The thermometerwill make a Bluetoothconnection between thethermometer and the receiverautomatically (User shouldsetup Bluetooth properly onreceiver). Then thethermometer starts to measurethe body temperature bymeans of testing the NTCresistor's resistance value andcalculates the body temperaturecontinuously and sends thetemperature data to the receiverthrough Bluetooth connection.	Same
ThermometerType	Clinical Electronic Thermometer	Clinical Electronic Thermometer	Same
AnatomicalApplication	Patients' armpit	Patients' armpit	Same
Sensor	NTC Resistor	NTC Resistor	Same

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Display	iOS device display, Androiddevice display	iOS device display, Androiddevice display	Same
PowerRequirements	Non-Rechargeable Battery3.0V/10mAh	RechargeableBattery3.7V/10mAh	DifferentNote 1
Temperaturerange(MeasurementRange)	68-113°F (20-45°C)	77-113°F (25-45°C)	DifferentNote 2
Accuracy	±0.1°C (35.00°C or39.00°C) - +0.18°F (95°F - 102.20°F)±0.2°C (<35.00°C or>39.00°C)or 0.36°F (<95°F or >102.20°F)	0.09 °F (± 0.05 °C)	DifferentNote 3
Validtransmissiondistance	10 meters	Up to 5 meters	DifferentNote 4
APPTemperaturedisplay	Display in either °C or°F	Display in either °C or°F	Same
Operationmode	Direct mode	Direct mode	Same
Reusability	Reusable	Reusable	Same

shelf life	5 years	24 months	DifferentNote 5
composition ofmaterial thatcontacts to thepatients	304 Stainless Steel Probe anddouble sided medical adhesive	304 Stainless Steel Probe anddouble sided medical adhesive	Same

Comparison in Detail(s):

Note 1: Power Requirements

The subject device is powered by a non-rechargeable battery while the predicate device is powered by a rechargeable battery. If the low power signal displayed in APP, the subject device should change the battery and the predicate device should be recharged, and both of the subject device and the

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predicate device should stop working.

The Power Requirements differences between the subject and predicate devices does not raise new concerns of safety and effectiveness for the clinical use.

Note 2: Temperature range (Measurement Range)

The maximum measured temperature of the subject device and predicate device are same and the minimum measured temperature of the subject device is a little lower than that of predicate device which is not important for that the human body temperature is not nearly close to 20°C.

The Temperature range (Measurement Range) differences between the subject and predicate devices does not raise new concerns of safety and effectiveness for the clinical use.

Note 3: Accuracy

The accuracy of the subject device is higher than that of the predicate device.

The accuracy of the subject device has met the requirement of ISO 80601-2-56:2017 and the accuracy differences between the subject and predicate devices does not raise new concerns of safety and effectiveness for the clinical use.

Note 4: Valid transmission distance

The transmission distance of the subject device is further than that of the predicate device.

The Valid transmission distance differences between the subject and predicate devices does not raise new concerns of safety and effectiveness for the clinical use.

Note 5: Shelf life

The shelf life of the subject device is further than that of the predicate device.

The shelf life differences between the subject and predicate devices does not raise new concerns of safety and effectiveness for the clinical use.

8. Performance Data

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The following performance data are provided in support of the substantial equivalence determination.

1) Performance test

The Continuous measurement, Intermittent Determination and Direct clinical thermometer measure meet the specification of the product and the relevant standards are listed below.

ASTM, E1112-00 (2018), Standard Specification for Electronic Thermometer for Intermittent A
Determination of Patient Temperature
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

2) Electromagnetic Compatibility and Electrical Safety

Electrical safety and EMC testing has been performed to, and passed, the following standards:

IEC 60601-1 Edition 3.2 2020-08, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 60601-1-2 Edition 4.1 2020-09. Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
» IEC 60601-1-11 Edition 2.1 2020-07, Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
A ANSI C63.4-2014, FCC Part 15 Subpart B
》 ANSI C63.4-2014, FCC Part 15 Subpart C

3) Software Verification and Validation

Software documentation consistent with Basic Documentation Level of concern is submitted in this 510(k). System validation testing presented in this 510(k) demonstrated that all software requirement specifications have been met and all software hazards have been mitigated to acceptable risk levels. The relevant standards and guidance are listed below.

A IEC 62304 Edition 1.1 2015-06, Medical device software - Software life cycle processes
A Content of Premarket Submissions for Device Software Functions-Guidance for Industry and Food and Drug Administration Staff
Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions-Guidance for Industry and Food and Drug Administration Staff

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4) Biocompatibility

The biocompatibility evaluation for the body-contacting components of the Wearable Digital Thermometer has been conducted in accordance with the "Use of International Standard ISO 10993-

1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk

management process" : Guidance for Industry and Food and Drug Administration Staff", as

recognized by FDA. The testing has been performed to, and passed, including:

» 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

5) Shelf life

The Reliability Test of the Wearable Digital Thermometer has been conducted in accordance with relevant guidance and standards. The testing has been performed to, and passed, including:

Guidance of Shelf Life of Medical Devices (1991)

6) Usability

Usability testing has been performed to, and passed, the following standards:

IEC 60601-1-6:2020 Medical electrical equipment –Part 1-6: General requirements for safety -Collateral standard: Usability

7) Summary

Based on the above performance as documented in this application, the Wearable Digital

Thermometer is found to have a safety and effectiveness profile that is similar to the predicate device.

9. Conclusions

Based on the comparison of intended use, design, materials and performance, the Wearable Digital Thermometer is to be concluded substantial equivalent to its predicate devices.

Regulation Number and Section

§ 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.