Non-contact Forehead Thermometer

K161735 · Shenzhen Dongdixin Technology Co., Ltd. · FLL · Nov 17, 2016 · General Hospital

Device Facts

• Record ID: K161735
• Device Name: Non-contact Forehead Thermometer
• Applicant: Shenzhen Dongdixin Technology Co., Ltd.
• Product Code: FLL · General Hospital
• Decision Date: Nov 17, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2910
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Non-contact Forehead Thermometer is a non-sterile, reusable clinical thermometer intended for the intermittent determination of human body temperature in a touch and no touch mode on the centre of the forehead as the measurement site on people of all ages.

Device Story

Hand-held, battery-powered infrared thermometer; measures human body temperature via forehead. Inputs: infrared radiation from forehead; ambient temperature from internal thermistor; distance data from infrared distance sensor. Operation: thermopile sensor detects infrared energy; CPU processes signals to calculate temperature; compensates for ambient conditions and distance (0-5cm). Output: temperature reading in °C or °F on LCD. Used in clinical or home settings by patients or clinicians. Provides rapid, non-invasive temperature assessment to assist in clinical decision-making regarding fever management.

Clinical Evidence

Clinical evaluation conducted per ASTM E1965-98. Study demonstrated clinical accuracy is substantially equivalent to the predicate device. No specific sample size or p-values provided in summary.

Technological Characteristics

ABS plastic enclosure; infrared thermopile sensor; thermistor for ambient compensation; infrared distance sensor; LCD display; 3V DC power. Standards: IEC 60601-1, ISO 80601-2-56, ASTM E1965-98, IEC 60601-1-11, IEC 60601-1-2. Biocompatibility per ISO 10993-5 and ISO 10993-10. Software level of concern: Moderate.

Indications for Use

Indicated for intermittent determination of human body temperature in people of all ages via touch or non-contact measurement on the center of the forehead.

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

• NTF 3000 No Touch+Forehead Thermometer (K134043)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 17, 2016

Shenzhen Dongdixin Technology Co., Ltd. Siping Yuan R.A. Specialist No. 3 Building Xilibaimang Xusheng Industrial Estate Nanshan, Shenzhen, 518108 CHINA

Re: K161735

Trade/Device Name: Non-contact Forehead Thermometer TH1009N Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: October 11, 2016 Received: October 13, 2016

Dear Siping Yuan:

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. 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

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Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known) K161735

#### Device Name

Non-contact Forehead Thermometer TH1009N

Indications for Use (Describe)

The Non-contact Forehead Thermometer is a non-sterile, reusable clinical thermometer intended for the intermittent determination of human body temperature in a touch mode on the centre of the forehead as the measurement site on people of all ages.

Prescription Use (Part 21 CFR 801 Subpart D)

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

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001_510 (k) Summary ് Version: 1.6

# 510(k) Summary

## K161735

Non-contact Forehead Thermometer

| Date of Prepared: | 06/17/2016 |
|-------------------|------------------------------------------------------------------------------------------|
| Submitter's Name: | Shenzhen Dongdixin Technology Co., Ltd |
| Address: | No. 3 Building, xilibaimang Xusheng Industrial Estate<br>Nanshan, Shenzhen, CHINA 518108 |
| Contact person: | Siping Yuan |
| TEL: | [phone] |
| FAX: | [phone] |
| E-mail: | [e-mail] |

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Image /page/4/Picture/0 description: The image shows the logo for DONGDIXIN TECHNOLOGY CO., LTD. The logo is in blue and orange, with the company name in English and Chinese. The English name is in a bold, sans-serif font, and the Chinese name is in a traditional font. The logo is simple and modern, and it conveys a sense of technology and innovation.

This 510(K) Summary of information is being submitted in accordance with requirements of Title 21 CFR Section 807.92.

#### 1. Proposed Device:

- 1.1. Device Trade Name: Non-contact Forehead Thermometer TH1009N
- 1.2. Regulation numbers and common names: 21 CFR 880.2910 Clinical electronic thermometer
- 1.3. Classification: Class II
- 1.4. Product Code: FLL

#### 2. Predicate Device:

Legally Marketed Device: NTF 3000 No Touch+Forehead Thermometer 510(k) Number: K134043 Submitter: Kaz USA, Incorporated

#### Description of Proposed Device: 3.

The Non-contact Forehead Thermometer (Model TH1009N) is a hand-held, battery powered device designed to measure human body temperature. The TH1009N is a kind of medical device that utilize infrared radiation to measure body temperature. The Non-contact Forehead Thermometer is intended to measure forehead temperature.

The Non-contact Forehead Thermometer uses a thermopile sensor with integrated thermistor for the target reading, a thermistor mounted in the head of the thermometer for ambient temperature readings, and an infrared distance sensor for detection of contact or non-contact (at a distance of approximately 0-5cm) use and compensation of the temperature reading.

#### 4. Indications for Use

The Non-contact Forehead Thermometer is a non-sterile, reusable clinical thermometer intended for the intermittent determination of human body temperature in a touch and no touch mode on the center of the forehead as the measurement site on people of all ages.

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Image /page/5/Picture/0 description: The image shows the logo for DONGDIXIN TECHNOLOGY CO., LTD. The logo is in blue and orange. The text is in a sans-serif font.

#### Technical and Performance Comparison 5.

The following table compares the device to the predicate device with basic technological characteristics.

| Items | Subject device | Predicate device | Discussion |
|-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| 510K# | K161735 | K134043 | N/A |
| Classification | Clinical Electronic thermometer<br>Class II 21 CFR 880.2910 | Clinical Electronic thermometer<br>Class II 21 CFR 880.2910 | Same |
| Device Name | Non-contact Forehead<br>Thermometer TH1009N | NTF 3000 No Touch+Forehead<br>Thermometer | N/A |
| Manufacturer | Shenzhen Dongdixin<br>Technology Co., Ltd. | Kaz USA, Incorporated | N/A |
| Indications<br>for use | The Non-contact Forehead<br>Thermometer is a non-sterile,<br>reusable clinical thermometer<br>intended for the intermittent<br>determination of human body<br>temperature in a touch and no<br>touch mode on the centre of<br>the forehead as the<br>measurement site on people of<br>all ages. | The No Touch + Forehead<br>Thermometer(Model NTF3000US)<br>is a non-sterile, reusable clinical<br>thermometer intended for the<br>intermittent determination of<br>human body temperature in a<br>touch and no touch mode on the<br>centre of the forehead as the<br>measurement site on people of all<br>ages. | Same |
| Target<br>Population | People all ages | People all ages | Same |
| Components | Enclosure, Sensor, CPU, LCD | Enclosure, Sensor, CPU,<br>LCD, Protective cap | Different |
| Principle of<br>operation | Infrared Sensor technology | Infrared Sensor technology | Same |
| Material | ABS | ABS | Same |
| Measure site | Forehead | Forehead | Same |
| Measure<br>distance | 0-5 cm | 0-5 cm | Same |
| Unit of<br>measurement | °C/°F | °C/°F | Same |
| Body measuring<br>range | 32.0-42.9 °C<br>(89.6-109.3°F) | 34.4 - 42.2 °C<br>(93.9 -108 °F) | Different |
| Accuracy | ±0.2 °C (0.4°F) for<br>35.0°C (95.0°F)-42.0°C (107.6°F),<br>±0.3 °C (0.5°F) for Other range | ± 0.4°F for the range 95°-107.6°F<br>(± 0.2°C for 35-42°C) | Same |
| Ambient range | 5.0 °C-59.9°C (41.0°F-104°F) | 15 °C - 40°C (59.0°F-104.0°F) | Different |
| Display type | LCD | LCD | Same |
| Power<br>requirements | 3V DC | 3V DC | Same |
| Operating | 15.0°C - 40.0°C (59.0°F - 104.0°F) | 59 °F - 104 °F (15 °C - 40 °C) | Same |
| temperature | with a relative humidity of<br>15%~85%, Atmosphere pressure:<br>700hPa-1060hPa | | |
| Storage and<br>transport<br>temperature | -20°C - 55°C (-4°F - 131°F) with a<br>relative humidity of 15%~90%,<br>Atmosphere pressure:<br>700hPa-1060hPa | -13 °F to 140 °F (-25 °C to 60 °C)<br>Humidity: 15 - 95% non condensing,<br>700-1060hPA (0.7-1.06 atm) | Different |

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### Discussion:

The following differences exist between the subject and predicate devices are as follows:

- Components – There is no sensor protective cap with subject device. The cap protects thermometer sensor from dust. However, when there is dust on the sensor, user can clean it according to user manual. So this difference has no effect on functionality of the thermometer.
- . Body measuring range — The subject device has wider measurement temperature range than predicate device, the subject device complies to the standard ISO 80601-2-56 and ASTM E1965-98. This difference does not pose any new performance questions.
- . Ambient range – The subject device has wider displayed room temperature range than predicate device, the subject device complies to the standard ISO 80601-2-56 and ASTM E1965-98. The software verification and validation test met the requirements of the standards. This difference does not pose any new performance questions.
- . Storage and transport temperature — The subject device has wider storage and transport conditions, the subject device complies to the standard IEC 60601-1-11. This difference does not pose any new performance questions.

The similarities and differences described in the comparison table demonstrate that the Non-contact forehead thermometer TH1009N is substantially equivalent to predicate and does not raise new performance questions.

#### 6. Non-clinical performance data

The following non-clinical performance data are provided in support of the substantial equivalence determination. Performance testing was conducted to validate and verify that Non-contact Forehead Thermometer, model TH1009N meets all requirements of related international standards, including electrical safety, EMC, biocompatibility, software validation and product cleaning. Results of these tests demonstrate compliance to the requirements of the below consensus standards.

### ElectricalSafetyandperformancerequirements:

- . IEC 60601-1:2005+A1:2012 Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance
- . ISO 80601-2-56:2009 Medical electrical equipment Part 2-56 Particular requirements for basic

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Image /page/7/Picture/1 description: The image shows the logo for DONGDIXIN TECHNOLOGY CO., LTD. The logo is in blue and yellow, with the company name in English and Chinese. The English name is in a bold, sans-serif font, and the Chinese name is in a more traditional font. The logo is simple and modern, and it is likely used on the company's website and marketing materials.

TECHNOLOGY

safety and essential performance of clinical thermometers for body temperature measurement

- . ASTM E1965-98(Reapproved 2009) Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature
### Home-usedmedicalequipmentrequirementsandenvironmentaltest:

- . IEC 60601-1-11:2010 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
### Electromagneticcompatibilityrequirements:

- . IEC 60601-1-2:2007 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests
### BiocompatibilityEvaluationforpatientcontactingcomponents:

- . 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

### SoftwareVerificationandValidationTesting:

In addition to the compliance of voluntary standards, Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "Moderate" level of concern. IEC 62304 was followed.

#### 7. Clinical testing data

Clinical evaluation of Non-contact Forehead Thermometer was conducted by Shenzhen Dongdixin Technology Co., Ltd in compliance with ASTM E1965-98(Reapproved 2009) Standard. The validation study demonstrated that the clinical accuracy of the Non-contact Forehead Thermometer is substantially equivalent to the predicate device.

Both the clinical and non-clinical testing detailed in this submission supports the substantial equivalence of the device.

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#### Conclusions: 8.

The proposed device has the same intended use and similar characteristics as the predicate device, the NTF 3000 No Touch+Forehead Thermometer. Moreover, performance tests demonstrate that any differences in their technological characteristics do not raise any new performance questions. In the other words, those engineering differences do not affect the intended use or alter the fundamental scientific technology of the device.

Thus, Non-contact Forehead Thermometer TH1009N is substantially equivalent to the predicate device.