Infrared Ear/Forehead Thermometer

K190873 · Joytech Healthcare Co. , Ltd. · FLL · Jul 26, 2019 · General Hospital

Device Facts

• Record ID: K190873
• Device Name: Infrared Ear/Forehead Thermometer
• Applicant: Joytech Healthcare Co. , Ltd.
• Product Code: FLL · General Hospital
• Decision Date: Jul 26, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2910
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

Infrared Ear/Forehead Thermometer DET-218 is intended for the intermittent measurement of human body temperature by people of all ages. The devices are reusable for home use only.

Device Story

Hand-held, battery-powered infrared thermometer; measures thermal radiation from tympanic membrane or forehead via thermopile sensor and integrated thermistor. Operates by capturing infrared energy; converts to temperature reading displayed on local LCD. Features Bluetooth Low Energy (BLE) for data transmission to mobile devices (iOS/Android) running 'Healthforyou' app. App provides data recording, curve display, and alarm functions. Device includes visual alarm (green/red light bar) for temperatures ≥38.0°C (100.4°F). Used by patients or caregivers in home settings. Output allows users to track temperature trends; aids in monitoring fever status.

Clinical Evidence

Clinical study conducted on 150 subjects across three age groups: infants (newborn to 1 year), children (>1 to 5 years), and adults (>5 years). Testing performed per ASTM E1965-98 (2016) protocol. Results demonstrated compliance with ASTM E1965-98 requirements for clinical performance.

Technological Characteristics

Materials: ABS enclosure, stainless steel/ABS probe. Sensing: Thermopile sensor with integrated thermistor. Energy: DC 3V (2x AAA batteries). Connectivity: BLE 4.0. Form factor: Hand-held. Standards: ISO 80601-2-56, IEC 60601-1, IEC 60601-1-2, ASTM E1965-98, ISO 10993-5/10. Software: Firmware for local processing and BLE transmission.

Indications for Use

Indicated for intermittent measurement of human body temperature in patients of all ages. Intended for home use only.

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

• DET-215 (K181239)

Submission Summary (Full Text)

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

July 26, 2019

Joytech Healthcare Co., Ltd. Mr. Yunhua Ren General Manager No.365, Wuzhou Road, Yuhang Economic Development Zone Hangzhou City Hangzhou, Zhejiang, 311100 China

Re: K190873

Trade/Device Name: Infrared Ear/Forehead Thermometer, DET-218 Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: June 26, 2019 Received: July 1, 2019

Dear Mr. Yunhua Ren:

We have reviewed vour 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/cfpmp/pmn.cfm_identifies_combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal

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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 medical devices and radiation-emitting products, including information about labeling regulations, please see Device (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 Alan Stevens 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) K190873

Device Name

Infrared Ear/Forehead Thermometer DET-218

Indications for Use (Describe)

Infrared Ear/Forehead Thermometer DET-218 is intended for the intermittent measurement of human body temperature by people of all ages. The devices are reusable for home use only.

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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# 510(k) Summary

The assigned 510(k) number is: K190873

#### 1. Date Prepared: 2019.07.10

#### Submitter's Identification: 2.

Name: Joytech Healthcare Co.,Ltd. Add.: No,365,Wuzhou Road,Yuhang Economic Development Zone, Hangzhou City,311100 Zhejiang,China Contact Person: Yunhua Ren Phone: [phone] Fax: [phone] Email: [e-mail]

### 3. Name of the Device:

Device Name:Infrared Ear/Forehead Thermometer Trade Name:Infrared Ear/Forehead Thermometer Including models:DET-218 Classification name:Clinical Electronic Thermometer

## 4. Classification Information:

Product Code: FLL Device Class: II Panel: 80 Regulation number:880.2910

#### Predicate Device Information: 5.

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The Infrared Ear/Forehead Thermometer DET-218 is substantially equivalent to the following device:

| 510k number | model | Product code | manufacturer |
|-------------|---------|--------------|------------------------------|
| K181239 | DET-215 | FLL | JOYTECH HEALTHCARE CO., LTD. |

### 6. Intended use / Indication for Use:

Infrared Ear/Forehead Thermometer DET-218 is intended for the intermittent measurement of human body temperature by people of all ages.The devices are reusable for home use only.

## 7. Device Description:

The Infrared Ear/Forehead Thermometer is a hand-held, battery powered device designed to measure human body temperature from the auditory canal or forehead. Its operation is based on measuring the natural thermal radiation from the tympanic membrane or forehead.

The Infrared Ear/Forehead Thermometer use a thermopile sensor with integrated thermistor for the target reading, a thermistor mounted in the head of the thermometer for ambient temperature readings, a thermopile collect, the infrared energy emitted from the forehead.The results can be displayed on LCD. And, the results measured by DET-218 can also be transmitted to mobile device (i.e. iPhone) with Bluetooth and the application APP installed on a mobile device using the iOS system or the Android system. The thermometer is reusable for home use on people of all ages with adult supervision. The device can be used with as a stand-alone device or in conjunction with the App on a compatible BLE enabled smartphone.

The purpose of data transfer to a mobile device is convenient for users to view the measured data through the APP. The APP operating system is IOS 9.0+ system , Android 5.0+ system.

The name of APP is "Healthforyou",it adopts AES+RSA combination to encrypt and decrypt interface parameters and the data transmission between APP and server adopts HTTP+SSL mode to ensure the security of information.

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The App only visualizes the Measurements from the device via. bluetooth to smart phone. The APP receives and records data, and displays measurement on smart phone in correspondence with DET-218 Measurement site (Ear/Forehead) set. The App has the following functions:

l. data recording;

II. curve display;

III. alarm functions.

The light bar of DET-218 turns on green light when the measurement is < 38.0 ℃ (100.4 °F ). The alarm function refers to the light bar of the device DET-218 turns on red light when the measurement is ≥38.0 ℃ (100.4 下 ), the APP will give an alarm when the measurement received simultaneously from DET-218 displays≥38.0℃.

## 8.Substantial Equivalence Comparison:

| SE Comparison | Subject Device<br>Model:DET-218 | Predicate Device<br>Model:DET-215 | Note |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|
| 510k number | K190873 | K181239 | -- |
| Regulation<br>number | 21 CFR 880.2910 | 21 CFR 880.2910 | Same |
| Product Code | FLL | FLL | Same |
| Intended Use/<br>Indications for use | Infrared Ear/Forehead<br>Thermometer DET-218 is<br>intended for the intermittent<br>measurement of human body<br>temperature by people of all<br>ages. The devices are reusable<br>for home use only. | Thermometer DET series<br>are intended for the<br>intermittent measurement of<br>human body temperature by<br>people of all ages. The devices<br>are reusable for home use<br>only. | Same |
| Measure Method | Infrared radiation detection | Infrared radiation detection | Same |
| Measurement<br>Range | Ear/Forehead mode: 34.0°C<br>~43.0°C (93.2°F~109.4°F) | Ear/Forehead mode: 34.0°C<br>~43.0°C (93.2°F~109.4°F) | Same |
| Accuracy | Ear/Forehead mode:<br>±0.2°C (0.4°F) during 35.5°C<br>~42.0°C (95.9°F~107.6°F)<br>at 15°C~35°C (59.0°F~95.0°F)<br>operating temperature range<br>±0.3°C (0.5°F) for other<br>measuring and operating<br>temperature range | Ear/Forehead mode:<br>±0.2°C (0.4°F) during 35.5°C<br>~42.0°C (95.9°F~107.6°F)<br>at 15°C~35°C (59.0°F~95.0°F)<br>operating temperature range<br>±0.3°C (0.5°F) for other<br>measuring and operating<br>temperature range | Same |
| | | | |
| Display | 0.1℃ (0.1℉) | 0.1℃ (0.1℉) | Same |
| Measurement | Forehead | Forehead | Same |
| Place | Ear | Ear | Same |
| Response Time | Approx. 1s | Ear mode/Object mode:<br>Approx. 1s<br>Forehead: Approx. 3s | Different<br>(Note3) |
| Sensor Type | Thermopile | Thermopile | Same |
| Scale Selection | ℃/℉ | ℃/℉ | Same |
| Signal processing<br>and display | -Internal firmware and local LCD display<br>-Also able to transfer transmit<br>data to mobile device for<br>secondary display | Internal firmware and local LCD<br>display | Different<br>(Note1) |
| Wireless Interface | Bluetooth Low Energy (BLE) | None | Different<br>(Note 1) |
| Memory | Ear/forehead/ object<br>measurements sharing 30<br>memories | Each 10 sets memories for<br>ear,forehead and object<br>measurements | Different<br>(Note 2) |
| Signal<br>transmission | Bluetooth 4.0 | / | Different<br>(Note 1) |
| Receiver (mobile<br>terminal) | iOS9.0 or above mobile device<br>Android5.0 or above mobile<br>device | / | Different<br>(Note 1) |
| Auto power-off<br>while no operation | Yes | Yes | Same |
| Buzzer | Yes | Yes | Same |
| Voice Function | No | Yes | Different<br>(Note4) |
| Power Source | DC3V(2×AAA battery) | DC3V(2×AAA battery) | Same |
| Patient contact<br>materials | Enclosure:ABS;<br>Probe: Stainless steel&.ABS; | Enclosure:ABS;<br>Probe: Stainless steel&.ABS; | Same |
| Biocompatibility | Cytotoxicity, Skin irritation,<br>Skin sensitization | Cytotoxicity, Skin irritation,<br>Skin sensitization | Same |
| Conformance<br>standard | ISO 80601-2-56(Performance)<br>IEC 60601-1(Safety)<br>IEC 60601-1-2(EMC)<br>ASTM E1965-98<br>ISO 10993-5 and ISO 10993-10<br>(Biocompatibility) | ISO 80601-2-56(Performance)<br>IEC 60601-1(Safety)<br>IEC 60601-1-2(EMC)<br>ASTM E1965-98<br>ISO 10993-5 and ISO<br>10993-10 (Biocompatibility) | Same |

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## Analysis

From the comparison table, the subject device and predicate device have the same

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Intended use & Indications for Use, same measurement places, unit change, battery source& Auto power-off. There are several differences between the subject device and predicate device as follows:

| S/N. | Change from predicate<br>device | Comments |
|-------|-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Note1 | Add blue tooth data<br>transmission | FCC, EN301489-1, EN301489-17, EN 300328<br>and wireless<br>coexistence test passed. |
| Note2 | Memory set changes | Software Validation Passed. |
| Note3 | Response time changes | Our device has shorter response time to<br>measure from 3s to 1s the temperature,and all<br>tests passed,so this difference does not raise<br>new performance questions |
| Note4 | No voice function | Software Validation Passed. |

The differences between the subject device and predicate device have been analyzed and tests performed accordingly. It has been shown that the differences do not raise new questions of safety and effectiveness for DET-218.

## 9. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:

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

Performance testing was conducted to validate and verify that Infrared Ear/Forehead Thermometer, DET-218 met all requirements of related international standards, including electrical safety, EMC, biocompatibility, software validation and product specifications. Results of these tests demonstrate compliance to the requirements of the below consensus standards.

Electrical Safety and performance requirements:

- AAMI / ANSI ES60601-1:2005/(R)2012 And A1:2012,C1:2009/(R)2012 And A2:2010/(R)2012 Medical Electrical Equipment
- · ISO 80601-2-56:2017 · Medical electrical equipment Part 2-56 Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement
- · ASTM E 1965-98 Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature

Home-used medical equipment requirements and environmental test:

- · IEC 60601-1-11:2015 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

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Electromagnetic compatibility requirements:

- 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
- . EN300328:Electromagnetic compatibility and Radio spectrum Matters (ERM); Wideband transmission systems; Data transmission equipment operating in the 2,4 GHz ISM band and using wide band modulation techniques;
- . ETSI EN 301489-1: Electromagnetic compatibilityand Radio spectrum Matters(ERM); ElectroMagnetic Compatibility (EMC)standard for radio equipment and services;Part 1:Common technical requirements;
- . ETSI EN 301489-17: Electromagnetic compatibility and Radio spectrum Matters (ERM);ElectroMagnetic Compatibility (EMC) standard for radio equipment; Part 17: Specific conditions or Broadband Data Transmission Systems;

Biocompatibility Evaluation for patient contacting components:

- ISO 10993-5:2009 Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity
- · ISO10993-10:2010 Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization

### Guidance Document:

· Guidance on the content of Premarket Notifications [510(k)] Submissions for clinical electronic thermometers

The software/firmware verification and validation was provided in accordance with the "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," dated May 11, 2005.

## 12. Discussion of Clinical Tests Performed:

Clinical tests were conducted on the DET-218.The clinical tests evaluated 150 of subjects. Each model was evaluated in three groups 1) infants-newborn to one year; 2) children-greater than one to five years; and 3) adults-greater than five years old. The clinical performance test protocol and data analysis is conducted as the requirement of ASTM E1965-98 (2016). The test report showed the clinical performance of the subject device complied with the requirement of ASTM E1965-98 (2016).

#### 13. Conclusions:

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Based on the information provided in this submission, the submit Infrared

Ear/Forehead Thermometer DET-218 is substantially equivalent to the predicate device.