No-contact Forehead Thermometer

K173048 · Dongguan Simzo Electronic Technology Co., Ltd. · FLL · Dec 6, 2018 · General Hospital

Device Facts

• Record ID: K173048
• Device Name: No-contact Forehead Thermometer
• Applicant: Dongguan Simzo Electronic Technology Co., Ltd.
• Product Code: FLL · General Hospital
• Decision Date: Dec 6, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2910
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Non-contact Forehead Thermometer is an infrared thermometer intended for the intermittent measurement of human body temperature in people of all ages.

Device Story

Hand-held, battery-powered infrared thermometer; measures human body temperature via infrared energy emitted from forehead. Device utilizes thermopile sensor, integrated thermistor for target reading, ambient thermistor, and parabolic mirror for focusing. Infrared distance sensor detects distance (5-8cm or 1-2cm depending on model) to provide temperature compensation. Used in home or clinical settings by patients or healthcare providers. Output displayed on LCD; provides fever alarm and memory storage. Enables non-invasive, rapid temperature monitoring to assist in clinical decision-making regarding patient health status.

Clinical Evidence

Clinical study conducted on 96 subjects across three age groups: infants (newborn to 1 year), children (>1 to 5 years), and adults (>5 years), with 32 patients per group. 30% of subjects exhibited temperatures ≥38.0°C. Results confirmed compliance with ASTM E1965-98 (2016) performance requirements.

Technological Characteristics

Infrared thermopile sensor; parabolic mirror; ambient thermistor; LCD display. Powered by 2x AAA batteries. Conforms to EN60601-1 (safety), IEC60601-1-2 (EMC), and ASTM E1965-98 (performance). Materials evaluated per ISO 10993-5 (cytotoxicity) and ISO 10993-10 (sensitization/irritation).

Indications for Use

Indicated for intermittent measurement of human body temperature in people of all ages.

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

• Non-contact Clinical Thermometer, Model THB0F (K121428)

Submission Summary (Full Text)

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December 6, 2018

Dongguan SIMZO Electronic Technology Co. Ltd. Mei Tan OA Manager No.81, Tianxin Street, Chongkong, Shijie Town Dongguan, Guangdong, China

Re: K173048

Trade/Device Name: Non-contact Forehead Thermometer, Model: HW-2/HW-2S/HW-3/HW-4 /HW-4S/HW-302/HW-303 Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: October 22, 2018 Received: October 25, 2018

Dear Mei Tan:

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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Geeta K. Pamidimukkala -S

for 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) K173048

#### Device Name

Non-contact Forehead Thermometer, Model: HW-2/HW-2S/HW-3/HW-4/HW-4S/HW-302/HW-303

Indications for Use (Describe)

The Non-contact Forehead Thermometer is an infrared thermometer intended for the intermittent measurement of human body temperature in 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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# 510(K)Summary

### K173048

# Prepared Date: 2018/12/4 Submitter Information

Name : Dongquan SIMZO Electronic Technology Co.Ltd. Address: No.81,Tianxin Street,Chongkong,Shijie Town,Dongguan,Guangdong,China Tel.[phone] Fax.[phone] Contact person: Mei Tan E-mail: [e-mail]

## Subject Device Information

Trade name: Non-contact Forehead Thermometer Model: HW-2/HW-2S/HW-3/HW-4 /HW-4S/HW-302/HW-303 Common name: Non-contact Clinical Thermometer Classification name: Clinical electronic thermometer Production requlation: 21 CFR 880.2910 Product code: FLL

# Predicate Device

Non-contact Clinical Thermometer, Model THB0F. (Radiant Innovation Inc,K121428)

# Description

The Non-contact Forehead Thermometers are hand-held, battery powered devices designed to measure human body temperature. The subject devices are Infrared thermometers that convert a user's forehead temperature using the infrared energy emitted in the area around the user's forehead to an oral equivalent temperature when placed in the distance from subject's forehead up to 5-8cm(HW-2,HW-2S,HW-3,HW-302 and HW-303) or 1-2cm(HW-4 and HW-4S).

The thermometers 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 parabolic mirror to help focus the infrared energy emitted from the forehead, and an infrared distance sensor for detection with the distance from forehead up to 5~8cm(HW-2,HW-2S,HW-3,HW-302 and HW-303) or 1-2cm(HW-4 and HW-4S) and compensation of the temperature reading.

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### Indications for Use

The Non-contact Forehead Thermometer is an infrared thermometer intended for the intermittent measurement of human body temperature in people of all ages.

# Summary of technological characteristics of device compared to the predicate devices (K121428), see the table1

A comparison of key technological characteristics between the subject devices and predicate device was listed as below:

| | Subject device(SD) | Predicate device(PD) | Note |
|----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| | SIMZO HW series | Rdiant THB0F | |
| 510K number | K173048 | K121428 | -- |
| Intended Use&<br>Indication for<br>use | The Non-contact Forehead<br>Thermometer is an infrared<br>thermometer intended for the<br>intermittent measurement of<br>human body temperature in<br>people of all ages. | The Non-contact Clinical<br>Thermometer, Model<br>THBOF is an infrared<br>thermometer intended for<br>the intermittent<br>measurement of human<br>body temperature in<br>people of all ages. | Same |
| Measurement<br>Method | Infrared radiation detection | Infrared radiation<br>detection | Same |
| Measurement<br>Range | Forehead mode:<br>35.5°C ~42.9°C<br>(95.9°F~109.2°F) | Forehead mode:<br>34.0°C ~42.2°C<br>(93.2°F ~108.0°F) | Similar |
| Accuracy | Forehead mode:<br>±0.2°C (0.4°F) within<br>35.5°C~42.9°C<br>(95.9°F ~109.2°F),<br>±0.3°C(0.5°F) other range | Forehead mode:<br>±0.2°C (0.4°F) within<br>36~39°C(96.8~102°F),<br>±0.3°C(0.5°F) other<br>range | Similar |
| Display | 0.1°C(0.1°F) | 0.1°C(0.1°F) | Same |
| Measurement<br>distance | HW-2/HW-2S/HW-3/HW-302/<br>HW-303:5-8cm<br>HW-4/HW-4S:1-2cm | 2-3cm | Similar |
| Measurement<br>place | Forehead | Forehead | same |
| Response time | 1S | 1S | same |

Table 1

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## DONGGUAN SIMZO ELECTRONIC TECHNOLOGY CO.,LTD.

| Sensor type | Thermopile | Thermopile | Same |
|-----------------------------------------|----------------------------------------------------------------------|----------------------------------------------------------|---------|
| Fever alarm | Yes | Yes | Same |
| Scale selection | °C / °F | °C/°F | same |
| Display screen | LCD | LCD | same |
| Memory | HW-2/2S:32 sets<br>HW-3/4/4S: 1 set<br>HW-302/303:64 Sets | 60sets | Similar |
| Fever alarm | Yes | Yes | same |
| Buzzer | Yes | Yes | same |
| Auto power-off<br>while no<br>operation | Yes | Yes | Same |
| Power supply | 2 x AAA | 2 x AAA | Same |
| Operation | 10~40°C(50°F ~104 °F) | 10~40°C(50°F ~104 °F) | Same |
| Environment | RH < 85% | 15-85% RH | Similar |
| Storage | -25℃-+55℃(-13°F-+131°F) | -20℃-+55(-4°F-+131°F) | Similar |
| Environment | RH≤90% | RH≤90% | --- |
| Dimension | 93*153*41mm | 180.3*47.5*29.2mm | --- |
| Weight | 90-125 g | 104.7g | --- |
| Conformance standard | EN60601-1(Safety),<br>IEC60601-1-2(EMC)<br>ASTME1965-98(performance) | EN60601-1(Safety),<br>IEC60601-1-2(EMC)<br>ASTM E1965-98 | Same |

#### Analysis

From the comparison table1, the subject devices and predicate device have the same Intended use & Indications for Use, Measurement place, Scale selection, Display screen, Auto power-off while no operation & Conformance standard. There are slightly differences between the devices and predicate device as follows.

| Difference clause | Discussion |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Measurement<br>Range&Accuracy | Both devices have different measurement range, but they have<br>the same accuracy and the measurement range of subject<br>devices meet the requirements of ASTME1965-98 |
| Measurement distance | Measurement distance of the subject devices is 5-8cm or<br>1-2cm, the predicate device's will be in the range of 2-3cm. But<br>the performance test result of subject device shows the<br>accuracy meets the requirements within the distance range. |
| Memory | The memory capacity of predicate devices in K121428 is<br>difference from subject devices ,but that does not impact the |

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| | performance of subject devices. | |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------|--|
| Operation &Storage<br>Environment | Both devices have slightly different Operation &Storage<br>Environment, but the subject devices meet the requirements | |
| | of IEC60601-1 | |

#### Non-Clinical Data

The Non-contact Forehead Thermometer has been tested according to the following applicable standards:

| Test name | Report description | Result |
|-------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Electrical<br>Safety | Test report / IEC 60606-1:Medical Electrical Equipment -<br>Part 1: General Requirements for Safety | Pass |
| EMC | Test report / IEC 60601-1-2 Medical Electrical<br>Equipment-Part 1-2: General Requirements for Safety -<br>Collateral Standard: Electromagnetic Compatibility -<br>Requirements and Tests | Pass |
| Cytotoxicity | Cytotoxicity test report /ISO 10993-5 Biological evaluation of<br>medical devices -- Part 5: Tests for in vitro cytotoxicity | Pass |
| Sensitization | Sensitization test report /ISO 10993-10 Biological<br>evaluation of medical devices -- Part 10: Tests for irritation<br>and skin sensitization | Pass |
| Irritation | Irritation test report /ISO10993-10 Biological evaluation of<br>medical devices -- Part 10: Tests for irritation and skin<br>sensitization | Pass |
| Performance<br>test in home<br>healthcare<br>environment | Test report/IEC60601-1-11 Medical electrical equipment<br>-Part 1-11: General requirements for basic safety and<br>essential performance - Collateral Standard: Requirements<br>for medical electrical equipment and medical electrical<br>systems used in the home healthcare environment | Pass |
| Performance<br>(Shock test,<br>Storage test,<br>Laboratory<br>accuracy test ) | Test report/ASTM E 1965-98 Standard Specification for<br>Infrared Thermometers for Intermittent Determination of<br>Patient Temperature | Pass |
| Cleaning and<br>Disinfection | Cleaning and Disinfection validation report /ASTM E 1837 – 96<br>(Reapproved 2014), Standard Test Method to Determine<br>Efficacy of Disinfection Processes for Reusable Medical Devices<br>(Simulated Use Test) | Pass |
| Shelf life | Shelf life test report /scanner switch on/off cycles 136875<br>times(use life 5years) | Pass |
| Software | Guidance for the Content of Premarket Submissions for | Pass |
| validation and | Software Contained in Medical Devices,dated May 11, 2005 | |
| verification | | |

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#### Clinical data

Clinical tests were conducted on HW-2,HW-2S,HW-3,HW-4,HW-4S,HW-302 and HW-303. The clinical tests evaluated 96 subjects which were divided into three group age ranges-infant (new born to 1 year), children (greater than 1 to 5 years old) and adult(greater than5 years old). Each group has 32 patients and 30% of them got temperature equaling or exceeding 38.0℃.

Based on the result, the clinical performance of the subject device complied with the requirement of ASTM E1965-98 (2016).

### Conclusion

Based on the performance testing and compliance with acceptable voluntary standards, we believe that the Non-contact Forehead Thermometer is substantially equivalent to its predicate device in K121428.