Electronic Thermometer (XHF2001, XHF2002)

• K Number: K211352
• Device Name: Electronic Thermometer (XHF2001, XHF2002)
• Manufacturer: Putian Hanjiang Huafeng Plastic Co., Ltd.
• Date Cleared: 2021-09-09 ( 129 days)
• Product Code: FLL
• Regulation Number: 880.2910

Intended Use

The Electronic Thermometer (XHF2001, XHF2002) is intended to measure the body temperature under the arm and to be used by consumers in household environments for the people of one month of age and above.

Device Description

The Electronic Thermometer is hand-held, predictive, thermistor-based, stick themometer capable of measuring temperature. The thermometer uses a negative temperature coefficient thermistor embedded in a measurement tip that is in contact with the measurement site. As the themistor changes tem perature, the resistance of the thermistor also changes, which is measured by the thermometer and converted to a measurement of the temperature of the the thermometer. This temperature, following the use of the predictive a lgorithm, is then displayed to theend user. Because the thermometer displays the measurement for the physiological site at which it is used, it does not need to convert this temperature via clinical offset. The Electronic Thermometer comprises a probe which includes a thermistor for getting temperature signal, a buzzer for sounding effect, an build-in software for processing the target temperature digitally, battery compartment with cover, a LCD for displaying the temperature result and indicator information, and a Power (On/Off) switch key. There are two models of Electronic Thermometer, XHF2002. The two models share same specification, main components (such as LCD, probe, electric circuit and CPU), the only differences are size and appearance. The size XHF2001 is 105 x 22 x 12 mm, and the XHF2002 is 125 x 18 x 9.5 mm.

Predicate Devices

K202791

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document mentions a "predictive algorithm" but provides no details suggesting it uses AI/ML. The description focuses on standard thermistor technology and basic digital processing. There is no mention of AI, ML, training data, or complex computational methods typically associated with AI/ML in medical devices.

Therapeutic

No
The device is an electronic thermometer, which is used to measure body temperature for diagnostic purposes, not to treat or cure a disease or condition.

Diagnostic

Yes

Explanation: The device is intended to measure body temperature, which is a physiological parameter used to identify or monitor a medical condition (e.g., fever). Therefore, it serves a diagnostic purpose in a broad sense, even if it doesn't provide a definitive diagnosis on its own.

SaMD (Software as a Medical Device)

No

The device description clearly outlines physical hardware components such as a probe, thermistor, buzzer, battery compartment, LCD, and power switch. While it mentions "build-in software," it is integrated into a physical device, not a standalone software application.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
• Device Function: The Electronic Thermometer measures body temperature directly from the body (under the arm). It does not analyze samples taken from the body.
• Intended Use: The intended use is to measure body temperature, which is a physiological measurement, not a diagnostic test performed on a sample.

Therefore, the Electronic Thermometer described is a medical device, but it falls under a different classification than an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Electronic Thermometer (XHF2001, XHF2002) is intended to measure the body temperature under the arm and to be used by consumers in household environments for the people of one month of age and above.

Product codes

FLL

Device Description

The Electronic Thermometer is hand-held, predictive, thermistor-based, stick themometer capable of measuring temperature. The thermometer uses a negative temperature coefficient thermistor embedded in a measurement tip that is in contact with the measurement site. As the themistor changes temperature, the resistance of the thermistor also changes, which is measured by the thermometer and converted to a measurement of the temperature of the the thermometer.

This temperature, following the use of the predictive a lgorithm, is then displayed to theend user. Because the thermometer displays the measurement for the physiological site at which it is used, it does not need to convert this temperature via clinical offset.

The Electronic Thermometer comprises a probe which includes a thermistor for getting temperature signal, a buzzer for sounding effect, an build-in software for processing the target temperature digitally, battery compartment with cover, a LCD for displaying the temperature result and indicator information, and a Power (On/Off) switch key.

There are two models of Electronic Thermometer, XHF2002. The two models share same specification, main components (such as LCD, probe, electric circuit and CPU), the only differences are size and appearance.

The size XHF2001 is 105 x 22 x 12 mm, and the XHF2002 is 125 x 18 x 9.5 mm.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

under the arm (Axillary)

Indicated Patient Age Range

one month of age and above.

Intended User / Care Setting

consumers in household environments

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Controlled human clinica I studies were conducted on proposed device with predicates in a ccordance with ISO 80601-2-56, clinical bias, clinical consistency and clinical repeatability have been evaluated per clinical validation for the thermometer.

Total 110 subjects and three age groups, including age 1 month - 1 year (35 subjects), age 1~5 years (35 subjects) and age above 5 years (40 subjects) are included in each clinical study, including febrile and a febrile persons.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Study Type: Clinical accuracy testing, controlled human clinical studies.
Sample Size: 110 subjects, categorized into age groups: 1 month - 1 year (35 subjects), 1-5 years (35 subjects), and above 5 years (40 subjects). The studies included both febrile and afebrile persons.
Key Results: The clinical consistency and clinical repeatability of the proposed device comply with ISO 80601-2-56. The results demonstrated that the proposed device meets the performance parameters claimed in the user manual. The clinical bias, consistency, and repeatability were evaluated and found to comply with the standard. The performance testing also demonstrated that the differences in measurement range, accuracy, and operating/storage environment do not raise new performance concerns. Biocompatibility tests were conducted in accordance with ISO 1093 series.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K202791

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

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). 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

September 9, 2021

Putian Hanjiang Huafeng Plastic Co., Ltd. % Ray Wang General Manager Beijing Believe-Med Technology Service Co., Ltd Rm. 912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District Beijing, 102401 China

Re: K211352

Trade/Device Name: Electronic Thermometer (XHF2001, XHF2002) Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: August 6, 2021 Received: August 10, 2021

Dear Ray Wang:

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.

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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 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

For Payal Patel 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K211352

Device Name

Electronic Thermometer (XHF2001, XHF2002)

Indications for Use (Describe)

The Electronic Thermometer (XHF2001, XHF2002) is intended to measure the body temperature under the arm and to be used by consumers in household environments for the people of one month of age and above.

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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K211352 - 510(k) Summary

• 1. Date of Preparation: 09/09/2021
• 2. Sponsor Identification

Putian Hanjiang Huafeng Plastic Co., Ltd.

40M Road, Jiangkou Town, Hanjiang District, Putian City, Fujian Province, China 351100

Contact Person: Yiqian Deng Position: Manager Tel: [phone] Email: [e-mail]

• 3. Designated Submission Correspondent

Beijing Believe-Med Technology Service Co., Ltd.

Rm.912, Building#15, XiYueHui, No.5, YiHe North Rd., FangShan District, BeiJing, China 102401

Ray Wang General Manager Tel: [phone] Fax: [phone] Email: [e-mail]

• Identification of Proposed Device 4.
  Trade Name: Electronic Thermometer Model(s): XHF2001, XHF2002 Common Name: Clinical Electronic Thermometer

Regulatory Information Classification Name: Clinical electronic thermometer Classification: Class 2 Product Code: FLL Regulation Number: CFR 880.2910 Review Panel: General Hospital

• 5. Identification of Predicate Device(s) 510(k) Number: K202791 Product Name: iHealth Clinical Digital Thermometer

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Model Name: PT1 Manufacturer: Andon Health Co., Ltd.

• 6. Indications For Use Statement:
     The Electronic Thermometer (XHF2001, XHF2002) is intended to measure the body temperature under the arm and to be used by consumers in household environments for the people of one month of a ge and above.
• 7. Device Description
     The Electronic Thermometer is hand-held, predictive, thermistor-based, stick themometer capable of measuring temperature. The thermometer uses a negative temperature coefficient thermistor embedded in a measurement tip that is in contact with the measurement site. As the themistor changes tem perature, the resistance of the thermistor also changes, which is measured by the thermometer and converted to a measurement of the temperature of the the thermometer.

This temperature, following the use of the predictive a lgorithm, is then displayed to theend user. Because the thermometer displays the measurement for the physiological site at which it is used, it does not need to convert this temperature via clinical offset.

The Electronic Thermometer comprises a probe which includes a thermistor for getting temperature signal, a buzzer for sounding effect, an build-in software for processing the target temperature digitally, battery compartment with cover, a LCD for displaying the temperature result and indicator information, and a Power (On/Off) switch key.

There are two models of Electronic Thermometer, XHF2002. The two models share same specification, main components (such as LCD, probe, electric circuit and CPU), the only differences are size and appearance.

The size XHF2001 is 105 x 22 x 12 mm, and the XHF2002 is 125 x 18 x 9.5 mm.

• Non-Clinica1TestConclusion 8.
  The test results demonstrated that the proposed device complies with the following standards:

• a. ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1 :2005, MOD)

• IEC 60601-1-2 Edition 4.02014-02, Medical Electrical Equipment Part 1 -2: General Requirements b. For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Disturbances -Requirements And Tests.

• C. ISO 80601-2-56 Second edition 2017-03 Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement. [Including: Amendment 1 (2018)].

• d. ASTM E1112-00 (R2011) Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature

• ISO 10993-5:2009 Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity e.

• f. ISO 10993-10:2010 Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization

The software verification and validation were conducted in a cordance with the "Guidance for the

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Content of Premarket Submissions for Software Contained in Medical Devices," dated May 1 1 , 2005. The test results demonstrated the software function met the requirements.

9. ClinicalTest Conclusion

Controlled human clinica I studies were conducted on proposed device with predicates in a ccordance with ISO 80601-2-56, clinical bias, clinical consistency and clinical repeatability have been evaluated per clinical validation for the thermometer.

Total 110 subjects and three age groups, including age 1 month - 1 year (35 subjects), age 1~5 years (35 subjects) and age above 5 years (40 subjects) are included in each clinical study, including febrile and a febrile persons. Compared statistical result of clinical repeatability of two comparison groups, the results of proposed device meet the performance parameters claimed in user manual, and the proposed device complies with ISO 80601-2-56.

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10. Substantially Equivalent (SE) Comparison

Table 1 Comparison of Technology Characteristics

Item	Proposed Device (K211352)	Predicate Device (K202791)	Remark
Device name	Electronic Thermometer (XHF2001, XHF2002)	iHealth Clinical Digital Thermometer PT1	/
Indications For Use	The Electronic Thermometer (XHF2001, XHF2002) is intended to measure the body temperature under the arm and to be used by consumers in household environments for the people of one month of age and above.	The Clinical Digital Thermometer is intended to measure the body temperature oral or axillaries (under the arm) and to be used by consumers in household environments. It is intended for use on adults and children ages 4 and up.	Similar
(Analysis 1)
Principle of Operation	The thermometer uses a negative temperature coefficient thermistor embedded in a measurement tip that is in contact with the measurement site. As the thermistor changes temperature, the resistance of the thermistor also changes, which is measured by the thermometer and converted to a measurement of the temperature of the tip of the thermometer. This temperature, following the use of the predictive algorithm, is then displayed to the end user.	The thermometer uses a negative temperature coefficient thermistor embedded in a measurement tip that is in contact with the measurement site. As the thermistor changes temperature, the resistance of the thermistor also changes, which is measured by the thermometer and converted to a measurement of the temperature of the tip of the thermometer. This temperature, following the use of the predictive algorithm, is then displayed to the end user.	SAME
Measurement Site	Axillary	Oraland Axillary	Similar
(Analysis 2)
Main Components	On/Off Button, Sensor, Microcontroller, LCD	On/Off Button, Sensor, Microcontroller, LCD	SAME
Sensor	Thermistor	Thermistor	SAME
Measurement Range	32°C42.9°C (89.6°F109.22°F)	32°C43°C(89.6°F109.46°F)	Similar
(Analysis 3)

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| Accuracy | $32 ~ 36.9°C±0.2°C(89.6°F98.42°F)$ $37 ~ 39°C±0.1°C (98.6°F102.2°F)$ $39.1 ~ 42.9°C±0.2°C (102.38°F109.22°F)$ | $89.6°F102.2°F (32°C-39°C) ±0.2°F$ $102.3°F109.4°F (39.1°C-43°C) ±0.3°F$ | Different
(Analysis 4) |
|---------------------------------|------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|---------------------------|
| Display Resolution | 0.1°F(0.1°C) | 0.1°F(0.1°C) | SAME |
| Signaloutputand
display | LCD, Buzzer | LCD, Buzzer | SAME |
| Operating Environment | Temperature:+41°F+104°F (5°C-40°C) | Temperature: +41°F~+104°F (5°C-40°C) | Similar
(Analysis 5) |
| | Humidity: 15-95%RH | Humidity: ≤85%RH | |
| Storage Environment | Temperature: -4°F~+140°F (-20°C-60°C)
Humidity: ≤85%RH | Temperature: -4°F~+131°F (-20°C-55°C)
Humidity: ≤95%RH | Similar
(Analysis 6) |
| | Power Supply | One 1.5V LR41 button | |
| Measuring Time | 32 seconds | 30 seconds | Similar
(Analysis 8) |
| Patient Contacting
Materials | ABS + Stainless Steel | ABS, PET, PP and SUS | Different
(Analysis 9) |
| Biocompatibility | ISO10993-5&ISO10993-10 | ISO10993-5&ISO10993-10 | SAME |
| Electrical Safety | IEC60601-1 | IEC60601-1 | SAME |
| EMC | IEC60601-1-2 | IEC60601-1-2 | SAME |
| Performance | ISO 80601-2-56
ASTM E1112 | ISO 80601-2-56
ASTM E1112 | SAME |

Difference & Similar Analysis

Analysis 1

There is a minor difference in the indications for used for the people of onemonth of ageand above, we have conducted the clinical accuracy testing in acordance with ISO 8060 1-2-56, the clinical consistency and clinical compy with the standard. We believe the differences

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do not raise new or different performance questions.

Analysis 2

The measurement site of the subject device and predicate is different. The subject device is subset of the predicate device. We have conducted the clinical a ccurance with ISO 80601-2-56, the clinical bias, clinical consistency and clinical repeatability comply with the standard. We believe the differences do notraise new or different performance questions.

Analysis 3

The measuring range of proposed device is similar with the performace testing and clinical accuracy testing contucted demonstrated the difference does not raise any new performance concerns. It complies with ISO 80601-2-56.

Analysis 4

The accuracy of the proposed device is different from the performance testing and the clinical a councy testing were conducted to demonstrate the difference does not raise any new performance concerns, and it is consistent with ISO 80601-2-56.

Analysis 5

The operating en vironment of the proposed device. The performance test demonstated the difference does not raise any new performance concerns.

Analysis 6

The storage environment of the proposed device. The pedicate device. The performance test demonstated the difference does not raise any new performance.concerns.

Analysis 7

The Powerswoply of the proposed device is different for the lettres last EMC test were conducted to demorstate differenced os not raise any new performance or safety concerns.

Analysis 8

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The Measuring Time of the proposed device, the differencebetweenthem is minor, and this spectication has been validated by the testing per ISO 80601-2-56. The difference does not raise any new performance or sa fety concerns.

Analysis 9

The Patient Contacting materials of the proposed device. The biocompatibility tests were conducted in accordance with ISO 1093 series to demonstrate the difference does not raise any new performance or sa fety concerns.

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11. Substantially Equivalent (SE) Conclusion

The differences between the predicate and the subject device do not raise any new or different questions of safety and effectiveness. Based on the safety and performance testing and compliance with voluntary standards, we believe that the Electronic Thermometer (XHF2002) is substantially equivalent to the predicate device (K202791).