Infrared Forehead Thermometer

K220084 · Qingdao Yasee Medical Device Co., Ltd. · FLL · Sep 12, 2022 · General Hospital

Device Facts

• Record ID: K220084
• Device Name: Infrared Forehead Thermometer
• Applicant: Qingdao Yasee Medical Device Co., Ltd.
• Product Code: FLL · General Hospital
• Decision Date: Sep 12, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2910
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Intended Use

Infrared Forehead Thermometers (model1:JA-11A; model2: JA-11S; model3: JA- 11C) are non-sterile, reusable, non-contact and handheld devices. They can be used by consumers in homecare environment and doctors in clinic as reference. They are intended for measuring human body temperature of people over one month old by detecting infrared heat from the forehead.

Device Story

Handheld, battery-powered infrared thermometer; measures body temperature by detecting infrared radiation emitted from forehead (1-3 cm distance). Device comprises probe, LCD display, and two buttons. User aims probe at forehead, presses button; device emits alert sound after ~1 second, displays result, and activates color-coded backlight. Stores 32 measurements. Used by consumers (home) or clinicians (clinic). Provides quick, non-contact temperature readings to assist in clinical decision-making; benefits patient by enabling non-invasive, rapid temperature monitoring.

Clinical Evidence

Bench testing only. Device performance validated per ASTM 1965-98, ISO 10993 (biocompatibility), IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), and IEC 60601-1-11 (home healthcare environment). No clinical trial data provided.

Technological Characteristics

Handheld infrared thermometer; ABS plastic enclosure. Powered by 2x AAA batteries (DC 3V). Features LCD display, 32-measurement memory, and °C/°F switchable units. Measurement range 34°C-43°C. Conforms to ISO 10993-1/5/10, IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, and ISO 80601-2-56.

Indications for Use

Indicated for measuring human body temperature in people over one month old via non-contact infrared detection from the forehead. Suitable for homecare and clinical use.

Regulatory Classification

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.

Special Controls

(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.

Predicate Devices

• Infrared Thermometer (K193253)

Submission Summary (Full Text)

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September 12, 2022

Qingdao Yasee Medical Device Co., Ltd. % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114

Re: K220084

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: April 17, 2022 Received: May 23, 2022

Dear Prithul Bom:

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.

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 Ouality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K220084

Device Name Infrared Forehead Thermometer

#### Indications for Use (Describe)

Infrared Forehead Thermometers (model2: JA-11S; model3: JA-11C) are non-sterile, reusable, noncontact and handheld devices. They can be used by consumers in homecare environment and doctors in clinic as reference. They are intended for measuring human body temperature of people over one month old by detecting infrared heat from the forehead.

| Type of Use (Select one or both, as applicable) | <table border="0"><tr><td></td><td></td></tr></table> | | |
|-------------------------------------------------|-------------------------------------------------------|--|--|
| | | | |

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

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

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# 510(k) Summary

This summary of 510k safety and effectiveness information is being submitted in accordance with the requirements of 21CFR 807.92

#### Submitter & Foreign Manufacture Identification

Qingdao Yasee Medical Device Co., Ltd. No.9 Xiuyuan Road, High-tech Industrial Development Zone, Qingdao City, 266112 Shandong Province, P.R. China Tel: [phone] Submitter's FDA Registration Number: N/A

#### Contact Person

Name: Xiangqun Ye Company : JL Management and Consulting LLC Address: 755 Watershed Ct., Ann Arbor, MI 48105 USA Tel: [phone] Email: [e-mail]

## Date of Summary: April 14, 2022

#### Device Name

| Trade name | Infrared Forehead Thermometers |
|-----------------------|-----------------------------------|
| Regulation Name | clinical electrical thermometer |
| Common Name | clinical electrical thermometer |
| Classification Name | Thermometer, Electronic, Clinical |
| Device Classification | II |
| Regulation Number | 21 CFR 880.2910 |
| Panel | General Hospital |
| General Product Code | FLL |

#### Predicate Device Information:

K193253, "Infrared Thermometer", manufactured by "Shenzhen Changkun (1) Technology Co., Ltd."

| Trade name | Infrared Thermometer, models: CK-T1501, CK-T1502, CK-T1503 |
|-----------------------|------------------------------------------------------------|
| Common Name | clinical electrical thermometer |
| Classification Name | Thermometer, Electronic, Clinical |
| Device Classification | II |
| Regulation Number | 21 CFR 880.2910 |
| Panel | General Hospital |
| Product Code | FLL |

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## Device Description:

Infrared Forehead Thermometers (model1: JA-11A; model2: JA-11S; model3: JA-11C) are hand-held, battery powered, Infrared Forehead Thermometers that covert a user's forehead temperature, using the infrared energy emitted in the area around the user's forehead to an equivalent temperature when measuring from 1-3 cm of the subject's forehead with no contact.

It is composed of a probe, a display, two buttons (start button and power button), an enclosure and a battery cover.

It is used to measure human body temperature based on the relationship between temperature and measurable infrared radiation. Simply aim the unit's probe toward the surface to be measured to obtain a quick and accurate temperature.

When measuring body temperature, users need to measure in body mode from 1-3 cm from their forehead. Press the measuring key and then release it. The instrument will start measuring the target temperature. After about 1 second, the buzzer emits the corresponding alert sound, the measurement result is displayed on the LCD, and the backlight of the corresponding color is turned on. After about 3 seconds, the backlight is turned off, the unit symbol flashes, and the buzzer beeps shortly. Wait until the key is pressed to measure the temperature again. Start the thermometer without any operation, or no operation after temperature measurement, the thermometer will shut off and LCD go out with one short beep in 60 s ± 20 s.

It can store 32 sets of measurements. Press the 【M】button to cycle through them.

User contact components are the enclosure and keys. The materials of the components are ABS plastic.

The thermometer is for intermittent use.

#### Indications for Use:

Infrared Forehead Thermometers (model1:JA-11A; model2: JA-11S; model3: JA- 11C) are non-sterile, reusable, non-contact and handheld devices. They can be used by consumers in homecare environment and doctors in clinic as reference. They are intended for measuring human body temperature of people over one month old by detecting infrared heat from the forehead.

#### Testing Summary:

To prove the safety and effectiveness of Infrared Forehead Thermometers, we tested the device according to corresponding standards.

Infrared Forehead Thermometer conforms to the following standards:

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ISO 10993-1, Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process

ISO 10993-5, Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity

ISO 10993-10, Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization

IEC60601-1, Electrical safety

IEC 60601-1-11 Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance

IEC 60601-1-2 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance

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

## Technological Comparison with Predicate Device

The following table shows similarities and differences between our device and the predicate devices.

| Description | Subject Device | Predicate Device (K193253) | Comparison |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Indication For<br>Use | Infrared Forehead<br>Thermometers (model1: JA-<br>11A: model2: JA-11S: model3:<br>JA-11C) are non-sterile,<br>reusable, non-contact and<br>handheld devices. They can be<br>used by consumers in homecare<br>environment and doctors in<br>clinic as reference. They are<br>intended for measuring human<br>body temperature of people<br>over one month old by<br>detecting infrared heat from the<br>forehead. | Infrared Thermometer (model:<br>CK-T1501, CK-T1502, CK-<br>T1503) is a non-sterile,<br>reusable, non-contact and<br>handheld device. It can be used<br>by consumers in homecare<br>environment and doctors in<br>clinic as reference. It is<br>intended for measuring human<br>body temperature of people<br>over one month old by detecting<br>infrared heat from the forehead. | Same |
| Product Code | FLL | FLL | Same |
| Classification<br>Name | Clinical Electronic<br>Thermometer | Clinical Electronic<br>Thermometer | Same |
| Use<br>Environment | at home and hospital | at home and hospital | Same |

| | | | Table 1: Comparison of Intended Use. Mechanism, and Design | |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|--|
| | | | | |
| Patient<br>population | people over one month old | people over one month old | Same | |
| Contact/Non-<br>Contact | Non-Contact | Non-Contact | Same | |
| Biocompatibility | ISO 10993-1<br>ISO 10993-5<br>ISO 10993-10 | ISO 10993-1<br>ISO 10993-5<br>ISO 10993-10 | Same | |
| Standards<br>conformance | IEC60601-1 IEC60601-1-2<br>IEC60601-1-11<br>ISO80601-2-56 | IEC60601-1 IEC60601-1-2<br>IEC60601-1-11<br>ISO80601-2-56 | Same | |
| Weight | 50 g | unknown | Different. The weight<br>does not affect the<br>performance. | |
| Dimensions | 149X38.5X38.5 mm | unknown | Different. The<br>dimensions do not<br>affect the performance. | |
| Storage<br>environment | -13 °F - 131 °F (-25 °C - 55 °C)<br>with a relative humidity of up to<br>85% (non-condensing) | -13 °F - 131 °F (-25°C - 55°C)<br>with a relative humidity of up to<br>85% (non-condensing) | Same | |
| Operational<br>Environment | 10 °C - 40 °C<br>15 % - 90% RH | 10°C - 40 °C<br>15 % - 90% RH | Same | |
| Display | LCD | LCD | Same | |
| Measurement<br>Range | 34 °C - 43 °C | 32 °C - 42.5 °C | Similar. Both ranges<br>are sufficient to<br>measure the human<br>body temperature. | |
| C/F switchable | °C/°F Switchable | °C/°F Switchable | Same | |
| Measurement<br>Accuracy | 34.0 °C - 35.4 °C (93.2 °F -<br>95.7 °F: ±0.3 °C/±0.5 °F)<br>35.5 °C - 42.0 °C (95.0 °F -<br>107.6 °F): ±0.2 °C/±0.4 °F<br>42.1 °C - 43.0 °C (107.8 °F -<br>109.4 °F): ±0.3 °C/±0.5 °F | 32 °C-34.9 °C: ± 0.3 °C (89.6<br>°F - 94.8 °F: ±0.5 °F)<br>35 °C-42 °C: ±0.2 °C/95.0°F-<br>107.6 °F: ±0.4 °F<br>42.1 °C-42.5 °C: ±0.3 °C/107.8<br>°F-108.5 °F: ±0.5 °F | Different. In the range<br>of 34.0 °C - 42.0 °C,<br>the measurement<br>accuracy is the same<br>(±0.2°C). | |
| Measurement<br>distance | 1-3 cm | 3-5 cm | Different.<br>Measurement distance<br>does not affect<br>performance. | |
| Thermometer<br>Type | Infrared Forehead Thermometer | Infrared Forehead Thermometer | Same | |
| Mechanism | Infrared radiation detection | Infrared radiation detection | Same | |
| Anatomy Site | Forehead | Forehead | Same | |
| User Control | Manual On/Off Switch | Manual On/Off Switch | Same | |
| Memory | 32 sets | 32 sets | Same | |
| Power Source | DC 3V (2 of AAA alkaline<br>batteries) | DC 3V (2 of AAA alkaline<br>batteries) | Same | |
| Material | ABS | ABS | Different due to<br>unknown<br>polymerization<br>specifications. It does<br>not affect performance. | |
| Display | LCD | LCD | Same | |
| OTC/Prescription | OTC | OTC | Same | |

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Our device is essentially identical to the predicate device in terms of indications for use, design, mechanism between subject device and the predicate device. The several minor differences do not affect the safety and effectiveness of the device.

# Performance Testing

| Software | Software verification and validation per the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005) for a Moderate Level of Concern |
|-----------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Electrical Safety | Electrical Safety testing per IEC 60601-1 Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance |
| EMC | Electromagnetic Compatibility and Wireless testing was evaluated per the following: IEC 60601-1-2 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance |
| Medical Electrical Equipment-home health care environment | 60601-1-11 Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance |
| Device performance | ASTM 80601-2-56 Medical electrical equipment — Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement ASTM 1965-98 Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature |
| Reprocessing/Cleaning | Validation per the FDA Guidance for Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling (March 17, 2015) confirmed cleaning and disinfection instruction provided in instructions for use |
| Biocompatibility | Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing ISO 10993-5 Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity |

Table 2: Standards Used for Testing

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| • | ISO 10993-10 Biological evaluation of medical devices — Part 10:<br>Tests for skin sensitization |
|---|--------------------------------------------------------------------------------------------------|
|---|--------------------------------------------------------------------------------------------------|

## Clinical Accuracy Validation

| ASTM 1965-98 | • Sample size, Patient population age, compared to reference<br>thermometer, reference thermometer, designed per ASTM 1965-98:<br>Standard Specification for Infrared Thermometers for Intermittent<br>Determination of Patient Temperature |
|--------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|--------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

## Substantial Equivalence Conclusion

Based on the comparison of intended use, design, biocompatibility, and performance, "Infrared Forehead Thermometer (model1: JA-11A; model2: JA-11S; model3: JA-11C)" manufactured by "Qingdao Yasee Medical Device Co., Ltd." is substantially equivalent to its predicate devices.