The Bluetooth Wearable Thermometer, model HMT-100 is a battery-operated electronic device with an intended use of measuring human armpit temperature and transmitting wireless signal of the measuring results to a mobile device, monitoring armpit body temperature for home use. This product is a non-invasive and re-usable electronic device for multiple patients at home. This product is intended for non-urgent ambulatory continuous armpit body temperature monitoring from ages 29 days and older.

Device Description

The Bluetooth Wearable Thermometer is a contact electronic thermometer using a sensor to measure armpit temperature. The Sensor detects heat and measures the temperature using a resistance that changes with heat. Displays the highest temperature among consecutive temperature readings. Its software performs a calculation that factors in room temperature, and then a calculated temperature is displayed on the mobile device. This product is in conjunction with the App, and information can be checked through a mobile device. Application Name: H-Health. The control unit transmits the measurement data to the application wirelessly through the antenna at intervals of 20 seconds. The application displays the corresponding data on a mobile device. In addition, the application alerts the user by sound or vibration when the temperature is below the user-set minimum temperature or above the maximum temperature.

AI/ML Overview

The document provided is a 510(k) summary for a medical device, the Fever Garde (Model: HMT-100), a Bluetooth Wearable Thermometer. While it details the device's non-clinical testing and comparison to a predicate device, it does not contain information about a clinical study involving human participants for demonstrating performance against acceptance criteria in the way typically seen for AI/ML-based medical devices or comparative effectiveness studies with human readers.

The document focuses on demonstrating substantial equivalence to a predicate device (Fever Scout™ Continuous Monitoring Thermometer, K181013) through non-clinical performance testing and compliance with various international standards. The "acceptance criteria" here are primarily tied to meeting specific performance parameters verified through laboratory testing and engineering benchmarks, rather than clinical endpoints from a human study.

Given the nature of the device (a thermometer) and the provided document, I will extract information related to the technical performance testing rather than a clinical study in the typical sense of a comparative effectiveness study with human readers assisting AI.

Here's the breakdown of the acceptance criteria and the technical performance testing as described in the document:

Acceptance Criteria and Reported Device Performance

The device's performance acceptance criteria are derived from the applicable standards and internal testing specifications for a clinical electronic thermometer. The document primarily focuses on demonstrating that the device meets these technical specifications and that the differences from the predicate device do not impact safety or effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

Test/Characteristic	Acceptance Criteria (Standard/Benchmark)	Reported Device Performance
Accuracy	±0.1°C (from 37~~39°C) and ±0.2°C (from 35~~37°C and 39~42°C) * (Predicate's specified accuracy)	±0.1°C (Reported for Fever Garde, Model: HMT-100) and Verified by Laboratory Accuracy Test which states "Equation(0.1°C)" and a rated output range of 34~42°C.
Measurement Range	~~35-42°C (based on predicate, with subject having 34~~42°C)	34~~42°C (Fever Garde). Deemed "Similar 2" to predicate (35~~42°C), noting subject device's range is 1°C wider and complies with performance standards.
Time Response-heating transient time	Not explicitly stated as a general acceptance criterion, but predicate had 8 minutes.	171.3 Seconds (Fever Garde). This is considerably faster than the predicate's 8 minutes and was tested according to IEC60601-1.
Time Response-cooling transient time	Not explicitly stated.	113.8 Seconds (Fever Garde).
Monitoring Distance	Predicate: 1.5m (4.9ft). Subject claims "longer" distance.	3~5m. Tested and confirmed connection for 24 hours at 3m. Deemed "Different 5" but passed relevant standards (EN 300 328 and EN 62479).
Biocompatibility	Conformance to ISO 10993-1, -5, -10	Conformed to ISO 10993-1, -5, and -10. Specifically, Cytotoxicity (Noncytotoxic), Sensitization (No evidence), Acute Intracutaneous Reactivity (No evidence).
Electrical Safety	Conformance to IEC 60601-1	Conformed to IEC 60601-1.
Electromagnetic Compatibility	Conformance to IEC 60601-1-2	Conformed to IEC 60601-1-2.
Usability	Conformance to IEC 60601-1-6	Conformed to IEC 60601-1-6.
Home Healthcare Environment Requirements	Conformance to IEC 60601-1-11	Conformed to IEC 60601-1-11.
Software Verification & Validation	"Moderate" level of concern, in accordance with FDA Guidance.	Conducted and confirmed.
Cybersecurity	Appropriate information security controls to preserve integrity, confidentiality, and availability based on FDA Guidance.	Testing performed; confirmed appropriate controls implemented.
Movement Test	H-Health application alarm sounds within 30s without movement; not sounded during movement.	Before test: alarm sounded within 30s without moving sample. During test: alarm not sounded while sample moving. After test: alarm sounded within 30s without moving sample.
Adhesion Test	Product attached for 24 hours without falling.	The product was attached to the armpit with an adhesive band for 24 hours and checked to ensure that it did not fall.
Data Transfer Test	Body temperature data transmitted to all participants.	After attaching the product, it was checked the body temperature data was transmitted to all participants.
Charging Operation	Device not operating during charging.	Confirmed.
Communication Failure	Notification indicated.	Confirmed.
Temperature Notification	High and Low indication displayed.	Confirmed.
Internal Battery status	Internal battery status displayed.	Confirmed.

2. Sample Size Used for the Test Set and Data Provenance

The document describes non-clinical performance and engineering validation tests. There is no mention of a "test set" in the context of a clinical study with human subjects providing data. The tests performed are laboratory-based and include:

Laboratory Accuracy: Implies a test setup to verify the stated accuracy. No specific sample size (e.g., number of temperature readings or devices tested) is given.
Time Response (heating/cooling): Likely performed on a few devices in controlled environments. No specific sample size is given.
Movement Test: Involves observation of alarm behavior during movement. No specific sample size is given.
Adhesion Test: "The product was attached to the armpit with an adhesive band for 24 hours". It doesn't specify if this was on a human or a simulated armpit, or how many "products" or "armpits" were tested.
Monitoring Distance Test: "product and mobile device were not disconnected for all participants." This suggests human participants, but the number of participants is not specified.
Data Transfer Test: "body temperature data was transmitted to all participants." Again, suggests human participants, but the number is not specified.

The provenance of this data is from the manufacturer's (HuBDIC Co., Ltd.) internal testing, which would be prospective for the purpose of this submission. The origin is implied to be where the testing labs are located (e.g., Korea, given the manufacturer's address).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

Not applicable in the context of this 510(k) summary. The document describes engineering and laboratory performance tests, not a clinical study where expert consensus establishes ground truth for medical image interpretation or diagnosis. The "ground truth" for the technical tests would be established by calibrated reference standards (e.g., precise temperature sources, timers).

4. Adjudication Method for the Test Set

Not applicable. There's no mention of an adjudication method as would be used in a clinical study with multiple human reviewers.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. This document does not refer to an MRMC comparative effectiveness study. The device is a thermometer, and the submission is for substantial equivalence to a predicate, not for demonstrating improved diagnostic performance for human readers using AI assistance.

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

The device is a measurement device. Its core function is to measure temperature. The "performance" described is its standalone performance (e.g., accuracy, response time, signal transmission). There's no complex algorithm for interpretation or diagnosis that would typically be evaluated with a separate "standalone" study in the context of AI/ML.

7. The Type of Ground Truth Used

For the technical performance tests:

Laboratory Accuracy: Likely against a calibrated reference thermometer or temperature bath.
Biocompatibility: In vitro and in vivo laboratory assays following ISO standards.
Electrical Safety & EMC: Compliance with international safety and electromagnetic compatibility standards, typically verified through measurements against defined limits.
Software/Cybersecurity: Verification against established software development lifecycle (SDLC) processes, requirements, and industry best practices.
Functional tests (Display, Charging, Communication, etc.): Verification against documented functional requirements.

There is no mention of "expert consensus," "pathology," or "outcomes data" as ground truth.

8. The Sample Size for the Training Set

Not applicable. This device is a traditional electronic thermometer. It does not employ machine learning or AI that would require a "training set" of data.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no training set for an AI/ML algorithm.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 18, 2020

HuBDIC Co., Ltd. % Peter Chung President Plus Global 300 Atwood Pittsburgh, Pennsylvania 15213

Re: K191978

Trade/Device Name: Fever Garde, Model: HMT-100 Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: November 16, 2020 Received: November 16, 2020

Dear Peter Chung:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

{1}------------------------------------------------

801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

CAPT Alan Stevens Acting 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) K191978

Device Name Fever Garde, Model: HMT-100

Indications for Use (Describe)

This product is a non-invasive and re-usable electronic device for multiple patients at home.

This product is intended for non-urgent ambulatory continuous armpit body temperature monitoring from ages 29 days and older.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510(k) Summary

510(k) Summarv

K191978

[as required by 807.92(c)]

1. Applicant

1 ) Company : HuBDIC Co., Ltd.

2 ) Address : 301, 53, jeonpa-ro, Manan-gu, Anyang-si, Gyeonggi-do Korea, 14084

Tel : +82-31-441-8637
Fax :+82-31-442-4994
Contact person : Peter Chung, 412-512-8802
Contact person address : 300, Atwood Street, Pittsburgh, PA, 15213, USA
Date Prepared: December. 08, 2020

2. Device Information

1. Trade Name: Fever Garde, Model HMT-100
1. Common Name : Bluetooth Wearable Thermometer
1. Classification Name : Clinical Electronic Thermometer

Product Code : FLL

1. RegulationNumber: 21 CFR 880.2910
1. Class of device: Class II
1. Panel : General Hospital

3. The legally marketed device to which we are claiming equivalence:

K181013, Fever Scout™Continuous Monitoring Thermometer

4. Device description :

This product is in conjunction with the App, and information can be checked through a mobile device.

Application Name: H-Health

The control unit transmits the measurement data to the application wirelessly through the antenna at intervals of 20 seconds. The application displays the corresponding data on a mobile device. In addition, the application alerts the user by sound or vibration when the temperature is below the user-set minimum temperature or above the maximum temperature.

5. Indications for Use:

{4}------------------------------------------------

6. Comparison of technological characteristics with the predicate device

The comparison of features and operation principles between the subject device Fever Garde (HMT-100) and predicate device Fever Scout™Continuous Monitoring Thermometer is listed as follows:

Proprietary	Subject Device	Predicate DeviceFever Scout™ContinuousMonitoring Thermometer	SubstantiallyEquivalent orNotSubstantiallyEquivalent
510(k) Number	K191978	K181013	N/A
Common Name	Bluetooth Wearablethermometer	Armpit thermometer	N/A
Trade Name	Fever Garde, Model HMT-100	Fever Scout™ContinuousMonitoring Thermometer	N/A
Manufacturer	HuBDIC Co., Ltd.	VivaLNK Inc.	N/A
ProductClassification	II	II	Same
Indications for use	The Bluetooth WearableThermometer, model HMT-100 is a battery-operatedelectronic device with anintended use of measuringhuman armpit temperatureand transmitting wirelesssignal of the measuringresults to a mobile device,monitoring armpit bodytemperature for home use.This product is a non-invasive and re-usableelectronic device formultiple patients at home.This product is intendedfor non-urgent ambulatorycontinuous armpit bodytemperature monitoringfrom ages 29 days andolder.	The wireless Fever ScoutContinuous Monitoringthermometer is a non-invasive and re-usableelectronic device forhome use. This product inintended for non-urgentambulatory continuousarmpit body temperaturemonitoring from ages 29days and older	Similar 1
Display UseSpecification	Apple device and Androiddevice display	Apple device and Androiddevice display	Same
Working Voltage	3.7 V DC	3.0 V DC	Different 1
Battery	Lithium-polymerRechargeable Battery 3.7V	MS Lithium RechargeableBattery 3.0V	Different 2
Measurement Range	34~42°C	35~42°C	Similar 2
Accuracy	±0.1°C	±0.1°C From 37~~39°C±0.2°C From 35~~37°C and39~42°C	Same
Signal Transmission	Wireless 2.4GBluetooth BLE	Wireless 2.4GBluetooth BLE	Same
Contact area	Skin(Surface device)	Skin(Surface device)	Same
Contact duration	A-Limited(<24hours)	A-Limited(<24hours)	Same
Receiver	Bluetooth: 4.2+/ IOS system:IOS 8.0+/ Android system:5.0(lollipop)+)	Wireless 2.4GBluetooth BLE enabledsmart devices runningApple devices:iPhone 5S+ or later, andiOS 8.0 or later, andAndroid device: 4.3 orlater.	Different 3
AnatomicalApplication	Axillary(armpit)temperature measuringand monitoring	Axillary(armpit)temperature measuringand monitoring	Same
Principle ofoperation	The Sensor detects heatand measures thetemperature using aresistance that changeswith heat. Displays thehighest temperature amongconsecutive temepraturereadings.	The Sensor detects heatand measures thetemperature using aresistance that changeswith heat. Displays thehighest temperatureamong consecutivetemeprature readings.	Same
Re-useable Band	Re-useable Band	Re-useable Band	Same
Device majorcomponents	Contact SkinBand	Contact SkinBand	Same
Patient containmaterials	Silicone and Acrylate	Silicone and Acrylate	Same
Specificationincluding operationenvironmenttemperature andhumidity level	10~~40°C/15~~90%	10~~40°C/15~~85%	Different 4
Transmissiondistance	3~5m	4.9ft	Different 5
Response time	170 Seconds	8 minutes	Different 6
Biocompatibility	Conformed to ISO 10993-1,ISO10993-5,andISO10993-10	Conformed to ISO 10993-1, ISO 10993-5, and ISO10993-10	Same
Electrical Safety	Conformed to IEC 60601-1	Conformed to IEC 60601-1	Same
ElectromagneticCompatibility	Conformed to IEC 60601-1-2	Conformed to IEC 60601-1-2	Same

{5}------------------------------------------------

• Similar 1

The indications for use of the subject device Fever Garde, Model HMT- 100 is similar to the predicate device. Both subjectdevice and predicate contain characteristics of data transferring, battery-operated and home use. The indications for use of the subject device includes these characteristics but not described in the predicate device. The difference does not affect safety and effectiveness.

• Similar 2

The measuring range of the subject device and the predicate device is similar. The measuring range of the subject device is 1℃ wider that complies with performance standard. It does not affect safety and effectiveness.

{6}------------------------------------------------

• Different 1

The rated voltage is 0.7V higher than the predicatedevice, but the IEC60601-1 electric sfety test was conducted, and it does not affect safety and effectiveness.

• Different 2

Although the battery specifications are different, the subject device has passed the IEC60601 - 1 test and it does not affect safety and effectiveness.

• Different 3

Reciever's specifications are different, the subject passed the test according to EN 300 328 and EN 62479 standards, and it does not affect safety and effectiveness.

• Different 4:

The operating temperature is the same. but the operating humidity is different. The operating humidity range of the subject device is wider than the predicate device. The performance test was conducted within the operating environment for the subject device. The difference does not affect safety and effectiveness.

• Different 5:

The monitoring distance of the subject device is longer than the predicate device. The subject device passed the test according to the standards of EN 300 328 and EN 62479, and it does not affect safety and effectiveness.

• Different 6:

The response time of the subject device is shorter than the predicate. The subject device has been tested for response time according to IEC60601-1. The difference does not affect safety and effectiveness.

No.	Test Identification	Test method
		Test Criteria	Test result
1	Evaluation and Testing	ISO 10993-1: Evaluation and testing	Pass
2	Cytotoxicity MEM ElutionMethod (Cytotoxicity)	ISO10993-5: Tests for Cytotoxicity, in vitro Methods
		Cytotoxicity: 0Interpretation: Noncytotoxic	Not cytotoxic(Pass)
3	Sensitization	ISO 10993-10: Test for Irritation and sensitization 6.2 Maximizationsensitization test
		Grading scale: 0Patch test reaction: No visiblechange	No evidence(Pass)
4	Acute IntracutaneousReactivity	ISO10993-10: Test for Irritation and sensitization5.4 Intracutaneous reactivity test
		The requirements of the test are metIf the difference between the testsample and the vehicle blank meanscore is 1.0 or less	No evidence(Pass)

7. Non-Clinical Testing

IEC60601-1 Medical electrical equipment Part1: Generalrequirementsfor safety and essential performance
IEC60601-1 Medical electrical equipment Part1-6 – General requirements for safety and essential performance - Collateral Standard: Usability
IEC60601-1 Medical electrical equipment Part1-11 - General requirements for safety and essential

performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment

ISO80601-2-56 Medical electrical equipment – Part2-56: Particular requirements for basic safety Page4 / 5

{7}------------------------------------------------

and essential performance of clinical thermometers for body temperature measurement

IEC60601-1-2 Medicalelectrical equipment General requirements for basic safety and essential

performance collateral standard Electromagnetic compatibility Requirements and tests

No.	Title	Results summary
1	Display	Measured value displayed
2	Charging operation	Device not operating
3	Communication failure	Notification indicated
4	Temperaturenotification	High and Low indication displayed
5	Internal battery status	Internal battery status displayed
6	Laboratory Accuracy	Rated Output Range: 34~42°CEquation(0.1°C)
7	Time Response-heatingtransient time	171.3 Seconds
8	Time Response-coolingtransient time	113.8 Seconds
9	Movement test
9-1	Before the test	Within 30s without moving the sample,H-Health application alarm sounded
9-2	During the test	While the sample was moving, H-Healthapplication alarm not sounded
9-3	After the test	Within 30s without moving the sample,H-Health application alarm sounded
10	Adhesion Test	The product was attached to the armpitwith an adhesive band for 24 hours andchecked to ensure that it did not fall.
11	Monitoring DistanceTest	After moving the product and mobiledevice to a distance of 3m, it wasconfirmed that the connection was notdisconnected for 24 hours, and theproduct and mobile device were notdisconnected for all participants.
12	Data Transfer Test	After attaching the product, it waschecked the body temperature datawas transmitted to all participants.

Software Verification and Validation Testing

Software verification and validation testingwere conducted in accordance with FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software of the subject device was considered as a "moderate" level of concern.

Cybersecurity Testing

Cybersecurity testing was performed for the subject device. This testing confirmed that appropriate information security controls are implemented to preserve the integrity, confidentiality, and availability of its information based on considerations of FDA's Guidance for Industry and FDA Staff, "Guidance for Industry and Food and Drug Administration Staff: Contentof Premarket Submissions for Management of Cybersecurity in Medical Devices".

8. Conclusion:

Based on the performance testing, comparison, and analysis, the substantially equivalent to the predicate device.

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.