Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on standard infrared temperature measurement technology and basic electronic features, with no mention of AI or ML.

Therapeutic

No
The device is an infrared forehead thermometer for measuring and monitoring body temperature, not for treating illness or disease.

Diagnostic

No

Explanation: The device is an infrared forehead thermometer used for intermittent measurement and monitoring of human body temperature. While temperature can be a symptom, the device itself only measures a physiological parameter and does not provide a diagnosis of a disease or condition.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "hand-held, battery powered IR thermometer" and lists several hardware features like an LCD display, backlight, and low battery detection, indicating it is a physical device with integrated software, not software only.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
This device's function: The infrared forehead thermometer measures body temperature by detecting infrared radiation emitted from the forehead. It does not analyze any biological specimens.

Therefore, based on the provided information, this device falls under the category of a medical device but not specifically an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The infrared forehead thermometer is non-sterile, reusable, non-contact and handheld device for the intermittent measurement and monitoring of human body temperature from the center of the forehead from a measurement distance of 3-5 cm. It can be used by consumers in homecare environment and doctors in clinic. It is intended for measuring human body temperature of people of all ages.

Product codes (comma separated list FDA assigned to the subject device)

FLL

Device Description

The infrared forehead thermometer, Model of QY-EWQ-02 is a hand-held, battery powered IR thermometer. It is intended to measure the temperature of human body from forehead without contact to human body. It is indicated for use by people of all ages in the home.

The infrared forehead thermometer has the following features:

1. This device can be used for measuring the forehead temperature;
1. Body and object temperature switching
1. Two temperature unit conversion, °C or °F;
1. LCD display with backlight;
1. Automatic range selection; resolution is 0.1℃ (0.1℃F)
1. The latest 20 measurement data can be memorized and stored;
Three color backlight display (Red, Orange, Green); 7)
1. Low battery detection;
Turn on/off the prompt tone; ;
1. High temperature alarm limit setting;
1. Ambient temperature detection;
1. Malfunction indication;
1. Low and high temperature alarm

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Infrared radiation detection

Anatomical Site

Forehead

Indicated Patient Age Range

people of all ages

Intended User / Care Setting

consumers in homecare environment and doctors in clinic.

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

Not Found

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

Clinical study was conducted in according to ASTM E1965-98(Reapproved 2016). This clinical study is a randomization, simple blind homologous control, pairing design of clinical investigation, consisting of 150 subjects, of which 50 subjects are infants, 50 subjects are children and the rest 50 subjects are adults (NOTE: Infants---newborn to one year; Children--- greater than one to five years; Adults---greater than five years old.). The clinical test report demonstrated that the clinical data, represented by clinical bias and clinical repeatability met the acceptance criteria of the clinical study protocol.

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

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K191829

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

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.

February 10, 2021

Hangzhou Qingyuan Medical Equipment Technology Co., Ltd. % Yoyo Chen Consultant Shenzhen Joyantech Consulting Co., Ltd. 1713A, Block A, Zhongguan Times Square, Liuxian Avenue Xili Town Shenzhen, Guangdong 518000 China

Re: K201536

Trade/Device Name: Infrared Forehead Thermometer Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: December 28, 2020 Received: January 4, 2021

Dear Yoyo Chen:

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

For Payal Patel Acting Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K201536

Device Name Infrared Forehead Thermometer, Model QY-EWQ-02

Indications for Use (Describe)

The infrared forehead thermometer is non-sterile, reusable, non-contact and handheld device for the intermittent measurement and monitoring of human body temperature from the center of the forehead from a measurement distance of 3-5 cm. It can be used by consumers in homecare environment and doctors in clinic. It is intended for measuring human body temperature of people of all ages.

Type of Use (Select one or both, as applicable)

| | Prescription Use (Part 21 CFR 801 Subpart D)

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

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K201536 510(k) Summary

This summary of 510(K) safety and effectiveness information is submitted As Required by requirements of SMDA and 21 CFR §807.92.

1. Administrative Information

Submission Date	February 10, 2021
Manufacturer information	Hangzhou Qingyuan Medical Equipment Technology Co., Ltd.
Address:
No.688 Dong'an 1st Road, Xintang Street, Xiaoshan District,
Hangzhou, China 311200
Contact person: Jenny
TEL: +86(0571) 82623931
E-Mail: Jenny@aodicharger.com;
Submission Correspondent	Shenzhen Joyantech Consulting Co., Ltd.
1713A, 17th Floor, Block A, Zhongguan Times Square, Liuxian
Avenue, Xili Town, Nanshan District, Shenzhen, Guangdong
Province, China. 518000
Contact person: Ms. Yoyo Chen
TEL:+86(755) 86069197
E-Mail: yoyo@cefda.com; field@cefda.com
Image: Logo
Establishment registration number	3016658659

2. Device Information

Device Name:	Infrared Forehead Thermometer
Model:	QY-EWQ-02
Classification Name:	Clinical Electronic Thermometer (Infrared Thermometer)
Review Panel:	General Hospital
Device Class:	2
Regulation Number:	21 CFR 880.2910
Product Code:	FLL

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3. Predicate Device

Manufacturer	Microlife Intellectual Property GmbH
Device name	Microlife Non-Contact Infrared Forehead Thermometer
Model	FR1DG1 (NC200)
510(K) Number:	K191829
Product Code	FLL

4. Device Description

The infrared forehead thermometer, Model of QY-EWQ-02 is a hand-held, battery powered IR thermometer. It is intended to measure the temperature of human body from forehead without contact to human body. It is indicated for use by people of all ages in thehome.

The infrared forehead thermometer has the following features:

1. This device can be used for measuring the forehead temperature;
1. Body and object temperature switching
1. Two temperature unit conversion, °C or °F;
1. LCD display with backlight;
1. Automatic range selection; resolution is 0.1℃ (0.1℃F)
1. The latest 20 measurement data can be memorized and stored;
Three color backlight display (Red, Orange, Green); 7)
1. Low battery detection;
Turn on/off the prompt tone; റി
1. High temperature alarm limit setting;
1. Ambient temperature detection;
1. Malfunction indication;
1. Low and high temperature alarm

5. Indication for Use

The infrared forehead thermometer is non-sterile, reusable, non-contact and handheld device for the intermittent measurement and monitoring of human body temperature from the center of the forehead from a measurement distance of 3-5 cm. It can be used by consumers in homecare environment and doctors in clinic. It is intended for measuring human body temperature of people of all ages.

6. Comparison with predicate device

The subject device Infrared Forehead Thermometer (Model QY-EWQ-02) is substantially equivalent to the predicate device (K191829). The comparison of technological characteristics between the subject device and predicate device is listed as follows:

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| Items | Subject Device
(K201536) | Predicate Device
(K191829) | Comparison |
|--------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| Intended use | The infrared forehead
thermometer is intended for
the intermittent measurement
and monitoring of human
body temperature. The device
is indicated for use by people
of all ages in the home. | The Microlife Non-Contact
Infrared Forehead
Thermometer, Model
FR1DG1 (NC200) is intended
for the intermittent
measurement and monitoring
of human body temperature.
The device is indicated for use
by people of all ages in the
home. | Same |
| Thermometer
type | Infrared thermometer
Non-contact | Infrared thermometer
Non-contact | Same |
| Device
Measurement
Technology | Infrared radiation detection | Infrared radiation detection | Same |
| Measurement
location | Forehead | Forehead | Same |
| Measurement
Range | $32.0°C 43.0°C$
$(89.6°F109.4°F);$ | $32.0°C 43.0°C$
$(89.6°F109.4°F);$ | Same |
| Measurement
accuracy | $±0.2 °C: 32.0°C ~ 43.0 °C$
$±0.4 °F: 89.6°F~109.4°F$ | $±0.2 °C: 35.0 ~ 42.0 °C$
$±0.3 °C: 34°C ~ 34.9°C,$
$42.1°C ~43°C,$

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Note 1: Measurement accuracy, Clinical Repeatability

Compare with predicate device, the measurement accuracy and clinical repeatability is different. But The difference does not affect the performance and accuracy which was evaluated in the performance testing of ISO 80601-2-56 and ASTM E1965-98. The different will not arise new safety and effectiveness issue.

Note 2: Measurement time

The measurement time of subject device is much quicker than predicate device, the accuracy of measurement has been validated during performance testing. The difference does not raise new issues on the device safety and effectiveness.

Note 3: Measurement data memories

This function has been verified during software verification. The difference does not raise new issues on the device safety and effectiveness.

Note 4: Date and time setting

Although there is no date and time setting functions for subject device, but both subject device and predicate device are meet the basic safety requirement of IEC 60601-1, ASTM E1965-98, and ISO 80601-2-56. The difference does not raise new issues on the device safety and effectiveness.

Note 5: Backlight

The subject device and predicate device are all tested in according to ISO 80601-2-56 and ASTM E1965-98. The difference does not raise new issues on the device safety and effectiveness.

Note 6: Auto-off time

Both subject device and predicate device are met the basic safety requirement of ISO 80601-2-56 and ASTM E1965-98. The difference does not raise new issues on the device safety and effectiveness.

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Note 7: Error

Although the icons are different, but the purpose means are the same. It does not affect device's performance, safety and effectiveness.

Note 8: High temperature alarm

Even though the beeping time is different, but the purpose means are the same. It does not affect device's performance, safety and effectiveness.

Note 9: Auto measurement

The purpose of body temperature measurement can be achieved for subject device and predicate device. The subject device performance complies with ISO 80601-2-56 and ASTM E1965-98. The difference does not raise new issues on the device safety and effectiveness.

Note 10: Sensor type, IC

The subject device was tested to conform with same safety and performance standard IEC 60601-1, ASTM E1965-98, and ISO 80601-2-56. A clinical study was carried out on the subject device in accordance with ASTM E1965-98. The different will not arise new safety and effectiveness issues.

Note 11: Housing material, Button material

Although the housing material and button material for subject device and predicate device are different, but they are all compliance with the biocompatibility standards ISO 10993-5 and ISO 10993-10. The difference does not raise new issues on the device safety and effectiveness.

Note 12: Physical Dimensions

The appearance of the subject device and predicate device is different. The subject device has been tested and confirmed according to IEC 60601-1-2, IEC 60601-1, and ISO 80601-2-56 standards. The difference does not raise new issues on the device safety and effectiveness.

7. Non-Clinical Test Summary

7.1. Electromagnetic Compatibility and Electrical Safety Test

The subject device has passed safety testing in according to following standards.

1. IEC 60601-1:2005+AMD 1: 2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
1. IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests

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1. IEC 60601-1-11:2015 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

7.2. Biocompatibility Test

The subject device has passed biocompatibility tests in according to following standards.

ISO 10993-5:2009 Biological evaluation of medical devices Part 5: Tests for in vitro 1) cytotoxicity
1. ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization

7.3. Performance Test-Bench

The subject device has passed performance testing in according to following standard.

ISO 80601-2-56:2017+AMD2018 Medical electrical equipment Part 2-56: Particular 1) requirements for basic safety and essential performance of clinical thermometers for body temperature measurement
1. ASTM E1965-98 (Reapproved 2016) Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature

7.4. Software Validation

Software documentation consistent with moderate level of concern was submitted in this 510(k) in according to FDA guidance - Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, issued on May 11, 2005.

8. Clinical Accuracy Validation Study

Clinical study was conducted in according to ASTM E1965-98(Reapproved 2016). This clinical study is a randomization, simple blind homologous control, pairing design of clinical investigation, consisting of 150 subjects, of which 50 subjects are infants, 50 subjects are children and the rest 50 subjects are adults (NOTE: Infants---newborn to one year; Children--- greater than one to five years; Adults---greater than five years old.). The clinical test report demonstrated that the clinical data, represented by clinical bias and clinical repeatability met the acceptance criteria of the clinical study protocol.

9. Conclusion

Based on the performance testing, technological characteristics and analysis, the subject device is substantially equivalent to the predicate device, Microlife Non-Contact Infrared Forehead Thermometer cleared under K191829.