Infrared Forehead Thermometer (Model IR-FT)

K191668 · Comper Chuangxiang (Beijing) Technology Co., Ltd. · FLL · Oct 18, 2019 · General Hospital

Device Facts

• Record ID: K191668
• Device Name: Infrared Forehead Thermometer (Model IR-FT)
• Applicant: Comper Chuangxiang (Beijing) Technology Co., Ltd.
• Product Code: FLL · General Hospital
• Decision Date: Oct 18, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2910
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

This device is a non-sterile, reusable, contact Infrared Forehead Thermometer (Model IR-FT) intended for intermittent determination of human body temperature through a touch on the center of the forehead as the measurement site on people of all ages. The Infrared Forehead Thermometer (Model IR-FT) can be used in clinical and home environments.

Device Story

Hand-held, battery-powered infrared forehead thermometer; measures infrared energy emitted from forehead skin. Device uses thermopile sensor with integrated thermistor for target reading and secondary thermistor for ambient temperature compensation. Operates via contact with center of forehead. Displays body temperature reading on integrated LCD; provides audible feedback via buzzer. Used by clinicians or patients in clinical and home environments. Output assists in clinical decision-making regarding patient temperature status. Benefits include non-invasive, rapid temperature determination.

Clinical Evidence

Clinical comparison study and repeatability testing performed per ISO 80601-2-56 across three age groups (0-12 months, 12 months-5 years, >5 years). Compared against vitreous thermometer. Results demonstrated high correlation, with clinical bias and repeatability within acceptable limits defined by ISO 80601-2-56.

Technological Characteristics

Hand-held infrared thermometer; thermopile sensor (OTP-336); thermistor for ambient compensation. Materials: PC (cover, battery cover, chamber, button) and ABS+TPU (front cover). Power: 3V DC (2 AAA batteries). Standards: ISO 80601-2-56, ASTM E1965-98, IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11. Biocompatibility: ISO 10993-1, -5, -10.

Indications for Use

Indicated for intermittent human body temperature measurement via forehead contact in patients of all ages in clinical and home settings.

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

• No Touch + Forehead Thermometer (K134043)

Submission Summary (Full Text)

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October 18, 2019

Comper Chuangxiang (Beijing) Technology Co., Ltd. Han Du Official Correspondent Room 102-103 1st Floor, Building 4 No. 1 Kangding Street Daxing District, Beijing 100176 China

Re: K191668

Trade/Device Name: Infrared Forehead Thermometer (Model IR-FT) Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: September 13, 2019 Received: September 13, 2019

Dear Han Du:

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.

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

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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 (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 (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 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,

for Geeta Pamidimukkala 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) K191668

Device Name

Infrared Forehead Thermometer (Model IR-FT)

Indications for Use (Describe)

This device is a non-sterile, reusable, contact Infrared Forehead Thermometer (Model IR-FT) intermittent determination of human body temperature through a touch on the center of the measurement site on people of all ages. The Infrared Forehead Thermometer (Model IR-FT) can be used in clinical and home environments.

| 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

Prepared in accordance with the requirements of 21 CFR Part 807.92

### Prepared Date: 18 October 2019

## 1. Submitter's Information

The submitter of this pre-market notification is:

| Name: | Comper Chuangxiang (Beijing) technology Co., Ltd. | | |
|-----------------|---------------------------------------------------------------------------------------------------|--|--|
| Address: | Room 102-103 1st Floor, Building 4 No.1 Kangding Street,<br>Daxing District Beijing, CHINA 100176 | | |
| Contact person: | Han Du | | |
| Title: | Manager | | |
| E-mail: | [e-mail] | | |
| Tel: | [phone] | | |

## 2. Device Identification

| Trade/Device Name: | Infrared Forehead Thermometer |
|--------------------|---------------------------------|
| Models: | IR-FT |
| Regulation Number: | 21 CFR 880.2910 |
| Regulation Name: | Clinical electronic thermometer |
| Regulation Class: | Class II |
| Product Code: | FLL |

# 3. Predicate Device

| 510(K) number: | K134043 |
|--------------------|---------------------------------|
| Device Name: | No Touch + Forehead Thermometer |
| Manufacturer: | KAZ USA, Inc. |
| Regulation Number: | 21 CFR 880.2910 |
| Regulation Name: | Clinical electronic thermometer |
| Regulation Class: | Class II |
| Product Code: | FLL |

# 4. Device Description

The Infrared Forehead Thermometer (Model IR-FT) is a hand-held, battery powered device designed to measure human body temperature. This Forehead Thermometer takes the body temperature by measuring the infrared energy emitted from the forehead skin above the evebrows. The Forehead Thermometer adopts gentle-touch, user friendly and non-invasive measurement design. It instantly displays the reading of the body temperature with a forehead touch.

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# 5. Indication for use

This device is a non-sterile, reusable, contact Infrared Forehead Thermometer (Model IR-FT) intended for intermittent determination of human body temperature through a touch on the center of the forehead as the measurement site on people of all ages. The Infrared Forehead Thermometer (Model IR-FT) can be used in clinical and home environments.

# 6. Comparison of technological characteristics with the Predicate Device

Comparison to the predicate devices, the subject device has same intended use, similar product design, same performance effectiveness, performance safety as the predicate device as summarized in the following table

| Feature | Subject device | Predicate device | Discussion | |
|-----------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| 510(k) Number | K191668 | K134043 | | |
| Indication for<br>use | This device is a non-<br>sterile, reusable, contact<br>Infrared Forehead<br>Thermometer (Model IR-<br>FT) intended for<br>intermittent determination<br>of human body<br>temperature through a<br>touch on the center of the<br>forehead as the<br>measurement site on<br>people of all ages. The<br>Infrared Forehead<br>Thermometer (Model IR-<br>FT) can be used in<br>clinical and home<br>environments. | The No Touch + Forehead<br>Thermometer (Model<br>NTF3000US) is a non-sterile,<br>reusable clinical<br>thermometer intended for the<br>intermittent determination of<br>human body temperature in<br>a touch and no touch on the<br>centre of the forehead as the<br>measurement site on people<br>of all ages. | The intended use is<br>similar to the predicate<br>device, however, the<br>subject device may be<br>used only in contact<br>mode. Additionally the<br>subject device defines<br>the use environment as<br>both clinical and home-<br>use. | |
| Thermometer<br>type | Infrared forehead | Infrared forehead | Same | |
| Components | The product is mainly<br>composed of a<br>temperature sensor, a<br>housing, a circuit board<br>and a battery<br>compartment. | The product is mainly<br>composed of a temperature<br>sensor, a housing, a circuit<br>board and a battery<br>compartment. | The same structure | |
| Temperature<br>Measurement<br>Technology | The thermometer uses a<br>thermopile sensor with<br>integrated thermistor for<br>the target reading, a<br>thermistor mounted in the<br>head of the thermometer<br>for ambient temperature<br>readings, and an infrared | The thermometer uses a<br>thermopile sensor with<br>integrated thermistor for the<br>target reading, a thermistor<br>mounted in the head of the<br>thermometer for ambient<br>temperature readings, a<br>parabolic mirror to help focus | Similar, our device<br>have not a parabolic<br>mirror, but the<br>performance has been<br>verified according to<br>the ISO 80601-2-56<br>and ASTM E1965, the<br>result shows that our | |
| | proximity sensor for<br>detection of contact use<br>and compensation of the<br>temperature reading. | the infrared energy emitted<br>from the forehead, and an<br>infrared proximity sensor for<br>detection of contact or non-<br>contact use and<br>compensation of the<br>temperature reading. | device has the same<br>specification to<br>predicate device. | |
| Key<br>Temperature<br>Sensor | Thermopile Sensor<br>OTP-336 manufactured<br>by Oriental system<br>technology inc. | Thermopile Sensor | Same type, but<br>different manufacturer.<br>We performed the<br>performance test<br>according to the ISO<br>80601-2-56 and ASTM<br>D1965, therefore it do<br>not raise different<br>questions of safety and<br>effectiveness. | |
| Power<br>requirements | D.C. 3 V (2 AAA dry<br>batteries) | D.C. 3 V (2 AAA dry<br>batteries) | Same | |
| Materials | Patient contacting<br>materials include PC (Top<br>cover, battery cover,<br>chamber, button power)<br>and ABS+TPU (front<br>cover). | Patient contacting materials<br>include ABS (device housing<br>/ handle and power button)<br>and<br>TPR (temperature button and<br>nose / forehead touch<br>bumper). | Different, but both of<br>our device and<br>predicate device have<br>performed the<br>Biocompatibility test<br>according to the ISO<br>10993-1, both two<br>devices meet the<br>requirements of ISO<br>10993. therefore it is<br>substantially equivalent<br>on Biocompatibility<br>risk. | |
| Temperature<br>range | 32.0°C ~43.0°C (89.6°F -<br>109.4°F) | 34.4°C to 42.2°C<br>(93.9°F to 108.0°F) | Our measurement<br>range is greater than<br>predicate device, but<br>we performed accuracy<br>test according to the<br>ASTM E1965 and ISO<br>80601-2-56, therefore<br>it is substantially<br>equivalent on<br>performance. | |
| | | | | |
| Accuracy for<br>body<br>temperature<br>measurement | ≤±0.2°C (0.4°F), for the<br>range 35°C -42°C (95°F -<br>107.6°F);<br>≤±0.3°C (0.5°F),for the<br>range 32°C -34.9°C<br>(89.6°F -94.8°F) and<br>42.1-43°C (107.8°F -<br>109.4°F). | ± 0.2°C / 0.36°F<br>35.0°C to 42.0°C<br>(95.0°F to 107.6°F);<br>± 0.3°C / 0.54°F<br>31.0°C to 35.0°C<br>(87.8°F to 95.0°F);<br>± 0.3°C / 0.54°F<br>Above 42.0°C<br>(Above 107.6°F) | Same | |
| | Resolution of<br>display | 0.1°C / 0.1°F | 0.1°C / 0.1°F | Same |
| | | Signal output<br>And display | LCD, Buzzer | LCD, Buzzer |
| | Biocompatibility | | ISO 10993-1 | ISO 10993-1 |
| Voluntary<br>standards<br>for Clinical<br>Electronic<br>Thermometers, | ISO 80601-2-56<br>ASTM E1965 | ASTM E 1965 and<br>ISO 80601-2-56 | Same | |
| | Medical<br>Electrical<br>Safety and<br>EMC | IEC 60601-1, IEC 60601-<br>1-2 | IEC 60601-1, IEC 60601-1-2 | Same |

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### Comper Chuangxiang (Beijing) technology Co., Ltd

The required testing demonstrated that the differences do not raise new questions of safety and

effectiveness between the subject and the predicate device.

# 8. Performance Data

#### Non-clinical data

Cleaning Validation:

We performed the cleaning validation according to the method of instruction for use, the validation result shows that the method of cleaning meets the cleaning requirements.

Safety:

- 1. ANSI/AAMI ES60601-1:2005/(R)2012 AND A1:2012 Medical electrical equipment Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD)
- 2. AAMI/ANSI ES60601-1-2:2014 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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- 3. 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
#### Performance:

- 4. 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.
- 5. ASTM E1965-98(2016) Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature

#### Clinical accuracy validation:

A comparison study and clinical repeatability testing was performed on the following three age groups: 0-12 months, 12 months - 5 years - 5 years older in accordance with ISO 80601-2-56 to compare the Infrared Forehead Thermometer (Model IR-FT) with Vitreous thermometer. This clinical comparison study demonstrated that the temperatures obtained with the Infrared Forehead Thermometer (Model IR-FT) were highly related when compared to the Vitreous thermometer, the clinical bias with stated uncertainty and clinical repeatability as defined in the ISO 80601-2-56 standard were within clinical acceptability, the results shows substantial equivalence.

#### Biocompatibility:

- 6. ISO 10993-1:2018 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
- 7. ISO 10993-5:2009 Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity
- 8. ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization

The tests were selected to show substantial equivalence between the subject device and the predicate.

### 9. Conclusion

Based on the safety and performance testing and compliance with acceptable voluntary standard, we believe that the Infrared Forehead Thermometer (Model IR-FT) is substantially equivalent to the predicate device (K134043), and does not raise any new safety and effectiveness issues.