The Medical Electronic Thermometer (FC0). FC02) is intended to measure the human body temperature under the arm. The devices are reusable for clinical or home use for people of all ages.

Device Description

The Medical Electronic Thermometer (FC01, FC02) is a hand-held device which can measure human body temperature at the site of the armpit. The devices are reusable for clinical or home use for people of all ages. The results can be displayed on the LCD. The FC01 and FC02 have only one operating mode which is direct mode. The Medical Electronic Thermometer measures human body temperature by placing the probe tip under the armpit with a measuring time of about 300 seconds. The Medical Electronic Thermometer consists of a temperature sensor (NTC), low power integrated circuit (IC), buzzer, and battery. The resistance of sensor changes with temperature and the integrated circuit (IC) converts the resistance to frequency and calculates the temperature according to the relation of resistance and frequency. The calculated temperature is displayed on the LCD.

AI/ML Overview

The provided text is a 510(k) summary for a medical electronic thermometer. It details the device, its intended use, and a comparison to a predicate device to demonstrate substantial equivalence. However, it does not contain information about a study proving the device meets specific acceptance criteria for AI/ML performance, nor does it mention any AI or machine learning components within the device itself.

The document discusses the device's accuracy and performance in relation to established standards for clinical thermometers, which are relevant to device performance but not to the acceptance criteria of an AI/ML model.

Therefore, I cannot fulfill the request to provide acceptance criteria and a study proving an AI/ML device meets those criteria based on the provided text. The text describes a standard medical electronic thermometer and its regulatory clearance process, not an AI-powered device.

To answer your request, if this were an AI/ML medical device, the information you're asking for would typically be found in detailed clinical validation studies, often submitted as part of a 510(k) or PMA submission for AI-driven technologies.

Based only on the provided text, here’s what I can extract regarding device performance, acknowledging that it's for a traditional thermometer, not an AI/ML device:

1. A table of acceptance criteria and the reported device performance

The document refers to adherence to international standards for thermometer performance. The acceptance criteria for the thermometer's performance are defined by these standards, specifically ISO 80601-2-56 and ASTM E1112-00(2018).

Criterion Type	Acceptance Criteria (from standards)	Reported Device Performance (as stated in document)
Measurement Range	ISO 80601-2-56 & ASTM E1112-00 standards requirements	32.0 °C ~ 42.0 °C (89.6 °F ~ 107.6 °F) - meets standard requirements (Note 2)
Accuracy	ISO 80601-2-56 & ASTM E1112-00 standards requirements	Lower than 35.3 °C ± 0.3 °C 35.3 °C ~ 36.9 °C ± 0.2 °C 37.0 °C ~ 39.0 °C ± 0.1 °C 39.1 °C ~ 41.0 °C ± 0.2 °C Higher than 41.0 °C ± 0.3 °C (meets standard requirements, Note 3)
Biocompatibility	ISO 10993-5, -10, -23 compliance	Passed tests for in vitro cytotoxicity, skin sensitization, and skin irritation.
Electrical Safety	IEC 60601-1-2, ANSI AAMI ES60601-1, IEC 60601-1-11 compliance	Passed electrical safety and EMC tests.
EMC	IEC 60601-1-2 compliance	Passed EMC tests.
Operating Environment	Requirements of IEC 60601-1 and ISO 80601-2-56	Temperature: 5 °C - 40 °C; Relative humidity: ≤85%RH; Atmospheric pressure: 70kPa-106kPa (tested to meet requirements, Note 6)
Storage & Transportation Condition	Requirements of IEC 60601-1 and ISO 80601-2-56	Temperature: -20°C-55°C; Relative humidity: 10%RH-93%RH; Atmospheric pressure: 70kPa-106kPa (tested to meet requirements, Note 6)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify sample sizes for performance testing. It states that "Performance data were provided in support of the substantial equivalence determination" and lists the standards adhered to. For a traditional thermometer, performance testing generally involves laboratory bench testing rather than large-scale clinical trials with "test sets" in the way an AI/ML model would use them. No information on data provenance (country, retrospective/prospective) is provided, as this is not detailed for a standard thermometer's testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This device is a standard medical electronic thermometer, not an AI/ML device requiring expert ground truth for image interpretation or diagnosis. Its performance is validated against physical reference standards and established protocols for temperature measurement.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. See point 3.

5. 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

Not applicable. This device is a standard medical electronic thermometer and does not involve AI assistance for human readers/clinicians, nor does it process medical images.

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

Not applicable. The device itself is standalone in its function as a thermometer, but there is no "algorithm" in the sense of an AI/ML model being assessed for standalone performance. Its performance is evaluated against physical measurement standards.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The ground truth for thermometer performance is based on traceable temperature standards and established metrology principles, as outlined in the referenced ISO and ASTM standards. It's not based on expert consensus, pathology, or outcomes data in the context of diagnostic accuracy.

8. The sample size for the training set

Not applicable. This device does not use a training set as it is not an AI/ML model.

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

Not applicable. See point 8.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION".

April 12, 2024

Zhuzhou Goldenhot Medical Technology Co.,Ltd. % Meihua Cai RA Specialist Feiying Drug & Medical Consulting Technical Service Group Rm 2401 Zhenye International Business Center, No. 3101-90. Oianhai Road Shenzhen, Guangdong 518000 China

Re: K240109

Trade/Device Name: Medical electronic thermometer (FC01, FC02) Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: January 15, 2024 Received: January 16, 2024

Dear Meihua Cai:

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.

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"

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(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 (OS) 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.

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-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. Porsche Bennett Porsche Bennett for 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

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Indications for Use

510(k) Number (if known) K240109

Device Name Medical electronic thermometer (FC01, FC02)

Indications for Use (Describe)

The Medical Electronic Thermometer (FC0). FC02) is intended to measure the human body temperature under the arm. The devices are reusable for clinical or home use for people of all ages.

Type of Use (Select one or both, as applicable)
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Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

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K240109- 510(k) Summary

"510(k) Summary" as required by 21 CFR Part 807.92.

I. Submitter

Zhuzhou Goldenhot Medical Technology Co.,Ltd. Room 301, Plant C-3, Phase 5, Xinma Power Innovation Park, No. 889, Xianyue huan Road, Majiahe Street,Tianyuan District, Zhuzhou City, Hunan Province, China Post code: 412007 Tel .: +86 0731 28589339 Liu Xianwu Deputy Manager Tel: +86 13808497058 Email: 2569981973@qq.com

II. Application Correspondent

Name: Meihua Cai Title: RA Specialist Address: Feiying Drug & Medical Consulting Technical Service Group. Rm 2401 Zhenye International Business Center, No. 3101-90, Qianhai Road. Senzhen, Guangdong 518000, China Email address: meihuacai@yeah.net Phone Number: 86 (185) 666-67558 [voice]

III. Subject Device

510(k) Number: K240109 Trade Name: Medical electronic thermometer (FC01, FC02) Common or Usual Name: Thermometer, electronic, clinical Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Regulation Number: 21 CFR 880.2910

IV. Predicate Device

510(k) Number: K223044 Trade Name: Digital Thermometer (Model QT001) Common or Usual Name: Thermometer, electronic, clinical Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Regulation Number: 21 CFR 880.2910

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V. Device Description

The Medical Electronic Thermometer consists of a temperature sensor (NTC), low power integrated circuit (IC), buzzer, and battery. The resistance of sensor changes with temperature and the integrated circuit (IC) converts the resistance to frequency and calculates the temperature according to the relation of resistance and frequency. The calculated temperature is displayed on the LCD.

Models FC01, FC02 of the subject device have a variety of functions, such as buzzer prompt, unit switching, low battery detection, memory, Indicator light, automatic power-off function. The difference between the two models is the color. The measuring range is 32.0 ℃ ~ 42.0 ℃, the minimum index value is 0.1 ℃, allowing the maximum error of ± 0.3 ℃, the operating environment is temperature +5 ℃~ +40 ℃ Humidity: ≤85% RH, and the atmospheric pressure is 70KPa ~ 106KPa. Users should avoid long-term use in environments with high temperatures, humidity, or direct sunlight.

VI. Indications for Use

The Medical Electronic Thermometer (FC01, FC02) is intended to measure the human body temperature under the arm. The devices are reusable for clinical or home use for people of all ages.

VII.Materials

Componentname	Material of Component	Body Contact Category	Contact Duration
Medicalelectronicthermometer(Enclosure)	ABS, PC, Stainless Steel	Surface-contactingdevice: Intact skin	Less than 24 hours

Comparison of Technological Characteristics With the Predicate Device VIII.

A comparison of key technological characteristics between the subject devices and predicate device was listed as below:

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ComparisonElements	Subject Device	Predicate Device	Remark
510(k) Number	K240109	K223044	/
Trade name	Medical electronic thermometer(FC01, FC02)	Digital Thermometer (ModelQT001)	/
Manufacturer	Zhuzhou Goldenhot MedicalTechnology Co.,Ltd	Shen Zhen Rong FengTechnology Co., Ltd	/
Regulationnumber	21 CFR 880.2910	21 CFR 880.2910	Same
Product code	FLL	FLL	Same
Deviceclassification	Class II	Class II	Same
Indication forIntendeduse/use	The Medical ElectronicThermometer (FC01, FC02) isintended to measure the humanbody temperature under the arm.The devices are reusable forclinical or home use for people ofall ages.	The Digital ThermometerQT001 is intended to measurethe human body temperaturein armpit, orally or rectally,and the device is reusable forclinical or home use on peopleof all ages.	DifferentNote 1
Prescription orOTC	OTC	OTC	Same
PrincipleofOperation	The thermistor placed at the topof the measuring part is used as atemperature sensing device, whenthe temperature of the externalmeasured heat source is changed,the resistance valueof thethermistor will be changedaccordingly, the internalmicroprocessor converts,processes, and corrects thechange of resistance value of thethermistor in the measuringcircuit, and then the measuredtemperature will be shown in theform of a number on the displayscreen, and at the same time thebuzzer will beep, and themeasuring process will befinished.	A change of thermistorresistance, caused by changesof temperature. The resistanceis measured by MCU, sochanges of temperature willcorrespond to changes ofresistance.	DifferentNote 1
ComparisonElements	Subject Device	Predicate Device	Remark
Sensor	Thermistor	Thermistor	Same
Signalprocessing anddisplay	Internal firmware and local LCDdisplay	Internal firmware and localLCD display	Same
MeasurementSite	Armpit	armpit, orally or rectally	DifferentNote 1
MeasuringRange	$32 °C ~ 42.0 °C$$(89.6 °F ~ 107.6 °F)$	$32 °C ~ 42.9 °C$$(89.6 °F ~ 109.2 °F)$	DifferentNote 2
Accuracy	Lower than $35.3 °C ± 0.3 °C$ ( $95.5 °F ± 0.5 °F$ )$35.3 °C ~ 36.9 °C ± 0.2 °C$ ( $95.5 °F ~ 98.4 °F ± 0.4 °F$ )$37.0 °C ~ 39.0 °C ± 0.1 °C$ ( $98.6 °F ~ 102.2 °F ± 0.2 °F$ )$39.1 °C ~ 41.0 °C ± 0.2 °C$ ( $102.4 °F ~ 105.8 °F ± 0.4 °F$ )Higher than $41.0 °C ± 0.3 °C$( $105.8 °F ± 0.5 °F$ )	$± 0.1 °C, 34.0 °C ~ 42.0 °C$( $± 0.2 °F, 93.2 °F - 107.6 °F$ )$± 0.2 °C$ under $34.0 °C$ or over$42.0 °C (± 0.4 °F$ under $93.2 °F$or over $107.6 °F$ )	DifferentNote 3
Displayresolution	$0.1 °C / 0.1 °F$	$0.1 °C / 0.1 °F$	Same
Components	Measurement module, Memorymodule, Business functionmodule, Button module, Buzzermodule, Display module	Sensor, buzz film, housing,stainless steel cap, LCDdisplay, measurement controlmodule.	Similar
PatientContactingMaterials	ABS, PC, Stainless Steel	ABS, TPE, Stainless steel	DifferentNote 8
Memories	12 memories (including Forstoring the last measured value)	For storing the last measuredvalue	DifferentNote 4
Power Supply	Power adapter specification: 5V1A	One 3.0 V CR1225 battery	DifferentNote 5
Operationenvironmentcondition	Temperature: $5 °C$ - $40 °C$ ( $41 °F$ -$104 °F$ )Relative humidity: ≤85%RHAtmosphericpressure: 70kPa-106kPa	Temperature: $5 °C$ - $40 °C$ ( $41 °F$ -$104 °F$ )Relativehumidity: 15%RH-95%RHAtmospheric pressure: 70kPa-106kPa	DifferentNote 6
ComparisonElements	Subject Device	Predicate Device	Remark
Storageandtransportationcondition	Temperature: -20°C-55°C (-4°F -131°F)Relative humidity:10%RH-93%RHAtmospheric pressure:70kPa-106kPa	Temperature:-20°C ~~55°C (-4°F~~131°F)Relative humidity:15%RH-95%RHAtmospheric pressure:50kPa-106kPa	DifferentNote 6
MeasuringTime	Approximately 5 minutes	Approximately 3 minutes	DifferentNote 7
ThermometerSize	135.6 (L)15.8 (W)8.5 (H)mm	138mm x 25mm x 12mm (L xW x H)	DifferentNote 8
Weight	About 13.0g (including battery)	Approx. 10 grams includingbattery	DifferentNote 8
Shelf life	3 years	3 years	Same
Biocompatibility	Complied with ISO 10993-5,ISO 10993-10 and ISO 10993-23	Complied with ISO 10993-5and ISO 10993-10	Same
Electricalsafety	Complied with IEC 60601-1	Complied with IEC 60601-1	Same
EMC	Complied with IEC 60601-1-2	Complied with IEC 60601-1-2	Same
Performance	Complied with ISO 80601-2-56:2017/AMD 1:2018andASTM E1112-00(2018).	Complied with ISO 80601-2-56:2017/AMD 1:2018andASTM E1112-00(2018).	Same

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Comparison discussion:

Note 1

There is minor difference; the subject device is only used under the arm, where the predicate device measures at additional sites. The difference does not raise any new or different safety and effectiveness questions.

Note 2

The subject device and predicate device have different measurement ranges, but the measurement range of subject device meets the requirements of ASTM E1112-00 and ISO 80601-2-56. The difference does not raise any new or different safety and effectiveness questions.

Note 3

The subject device and predicate device have different accuracy, but the accuracy of the subject device meets the requirements of ASTM E1112-00 and ISO 80601-2-56. The difference does not raise any new or different safety and effectiveness questions.

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Note 4

The memory function difference: The software verification were conducted to demonstrate the performance of the function as intended. The memory function does not affect accuracy of measurement, so such difference does not impact the performance of subject device.

Note 5

The Power supply of the subject device is different from the predicate device. The electrical safety and EMC test were conducted to demonstrate the difference does not raise any new performance or safety concerns.

Note 6

Operating range, Storage, and transportation condition difference: The subject device has been tested and the test results met the requirements of IEC 60601-1 and ISO 80601-2-56. The difference does not raise any new or different safety and effectiveness questions.

Note 7

After placing the thermometer on the measurement site, the measured result can only be displayed when the temperature is stable. Generally, the measurement time is not fixed at a certain value. The difference of measurement time will not raise any safety or effectiveness issue.

Note 8

Weight, size, materials: Biocompatibility test and performance bench test met the requirements of ISO 10993-5. ISO 10993-10 and ISO 10993-23. The differences do not raise any new questions of safety and effectiveness.

IX. Performance Data

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

1) Biocompatibility Testing

The biocompatibility evaluation for the body-contacting components of the Medical electronic thermometer was 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, Document Issued on September 4, 2020", as recognized by FDA. The following testing was performed to, and passed, including:

ISO 10993-5:2009, Biological evaluation of medical devices -Part 5: Tests for in vitro cytotoxicity
ISO 10993-10:2021, Biological evaluation of medical devices -Part 10: Tests for skin sensitization
ISO 10993-23:2021, Biological evaluation of medical devices -Part 23: Tests for skin irritation

2) Electrical Safety and EMC

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Electrical safety and EMC testing was performed to, and passed, as per the following standards:

IEC 60601-1-2 Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests
ANSI AAMI ES60601-1 Medical electrical equipment Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) [Including Amendment 2 (2021)]
IEC 60601-1-11 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

3) Performance testing

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. [Including: Amendment 1 (2018)]
ASTM E1112-00(2018) Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature

4) Software Verification and Validation

Software documentation is consistent with moderate level of concern. System validation testing demonstrated that all software requirement specifications are met, and all software hazards have been mitigated to acceptable risk levels.

X. Conclusions

Based on comparison of the intended use, technological characteristics, applicable safety standards, verification and validation testing, the differences between subject device and the predicate device do not raise new questions of safety and effectiveness. Thus, the subject device is 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.