Non-contact infrared body thermometer

K171888 · Hetaida Technology Co., Ltd. · FLL · Jul 23, 2018 · General Hospital

Device Facts

• Record ID: K171888
• Device Name: Non-contact infrared body thermometer
• Applicant: Hetaida Technology Co., Ltd.
• Product Code: FLL · General Hospital
• Decision Date: Jul 23, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2910
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The HeTaiDa non-contact infrared body thermometers HTD8818A,HTD8816C, HTD8808C are non-sterile, reusable thermometers intended for the intermittent determination of human body temperature measured at the patients' forehead without contact. The devices are intended for use on people of all ages. The HTD8818A, HTD8816C, HTD8808C are intended for use in clinical and home use environment.

Device Story

Hand-held, battery-powered infrared thermometer; measures human body temperature without patient contact. Device detects blackbody radiation emitted from patient forehead; lens focuses infrared thermal radiation onto detector; radiant power converted to electrical signal; signal processed to display temperature. Operates in 'Body Mode' (adjusted mode, converts to axillary equivalent) or 'Surface Mode' (direct mode). Used by clinicians or patients in clinical/home settings. Output displayed on LCD; assists healthcare providers in monitoring patient temperature. Benefits include non-invasive, rapid temperature assessment.

Clinical Evidence

Clinical investigation evaluated bias, accuracy, and repeatability across four age groups (0-3 months, 3 months-1 year, 1-5 years, >5 years). Compared against reference contact clinical electronic thermometer (BT-21H) measuring axillary temperature. Results: clinical bias -0.027, clinical accuracy ±0.14, clinical repeatability 0.07. Metrics within acceptable ranges per ISO 80601-2-56:2009 and ASTM 1965-68.

Technological Characteristics

Non-contact infrared thermometer; battery-powered (1.5V AAA x 2). Features infrared sensor, LCD backlight, 50-measurement memory. Operating range: 15°C-35°C. Complies with IEC 60601-1, IEC 60601-1-11, IEC 60601-1-2, ISO 80601-2-56, and ASTM E1965-98. Biocompatibility per ISO 10993-5 and ISO 10993-10.

Indications for Use

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

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 infrared Body thermometer FT-100A (K160802)

Reference Devices

• BT-21H (clinical reference thermometer)

Submission Summary (Full Text)

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#### K171888

## 5. 510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.

Date: July 15th, 2018

- 1. Company making the submission: Name - HeTaiDa Technology Co., Ltd Address - 4F, BaiShiDa High-Tech Park, XiangDong Industrial Area, DaLingShan Town, DongGuan City, Guangdong, China. Tel: [phone] Contact – Tom ZhenGuang Chen General Manager Email - [e-mail]
- 2. U.S. Correspondent and Contact Name: Elliot Medical Solutions Address: 18586 Parkland Drive, Shaker Heights, Ohio, 44122, U.S.A. Contact: Roman Huang General Manager Tel: [phone] Email: [e-mail]
- 3. Device Name: Non-contact Infrared Body Thermometer Trade name: HeTaiDa-Thermometer Models: HTD8818A,HTD8816C,HTD8808C Common Name: Clinical electronic thermometer Classification Name: Thermometer, electronic, clinical Regulatory Class: II Product Code: FLL Type of 510(k) submission: Traditional
- 4. Predicate Device.

| Manufacturer | Predicate<br>Device | 510(k)<br>number |
|--------------------------------------------------|--------------------------------------------------------|------------------|
| Hangzhou<br>Universal<br>Electronic Co.,<br>Ltd. | Non-contact<br>infrared Body<br>thermometer<br>FT-100A | K160802 |

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- 5. Description.
The HeTaiDa infrared body thermometer, Models HTD8818A, HTD8816C, HTD8808C are hand-held device powered by batteries and designed to measure human body temperature without contacting patient' forehead. The thermometer can switch modes between "Body Mode" and "Surface Mode". The "Surface Mode" is DIRECT MODE and the "Body Mode" is ADJUSTED MODE. Forehead temperature of the ADJUSTED MODE is calculated by converting the measured temperature of the DIRECT MODE to an axillary equivalent temperature without contacting the patients' forehead.

The thermometers HTD8818A, HTD8816C and HTD8808C infer temperature from the blackbody radiation emitted from the patient. Temperature is calculated from the knowledge of the amount of infrared energy emitted from the human body. The thermometer design consists lens to focus the infrared thermal radiation on to a detector, which converts the radiant power to an electrical signal that can be displayed in units of temperature. This permits temperature measurement from a distance without contact with the object to be measured.

The three models HTD8818A,HTD8816C,HTD8808C are bundled in this one 510k submission based on the Guidance for Industry and FDA Staff; Bundling Multiple Devices or Multiple Indications in a Single Submission. The HTD8818A, HTD8816C, HTD8808C thermometers present scientific and regulatory issues that can be addressed during one review. Their indications for use, safety and performance data, biocompatibility, clinical evaluation data, and electromagnetic compatibility data are identical. The only differences among the HTD8818A, HTD8816C, HTD8808C thermometers are size, weight, shape of enclosure, printed circuit board (PCB) layout and measuring distances.

- 6. Indication for use.
The HeTaiDa non-contact infrared body thermometers HTD8818A,HTD8816C, HTD8808C are non-sterile, reusable thermometers intended for the intermittent determination of human body temperature measured at the patients' forehead without contact. The devices are intended for use on people of all ages. The HTD8818A, HTD8816C, HTD8808C are intended for use in clinical and home use environment.

- 7. Similarities/Differences between the subject and predicate device.

| Element of<br>Comparison | Subject Device(s) | Predicate Device | Comparison |
|--------------------------|--------------------------------------------------------------------------------------------|-------------------------------------------------------------------|------------|
| Type of<br>Thermometer | Non-Contact Infrared<br>forehead thermometer<br>(Models: HTD8818A<br>HTD8816C<br>HTD8808C) | Non-contact Infrared<br>forehead thermometer,<br>(model: FT-100A) | Identical |

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| 510(k) | N/A | K160802 | N/A |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------|
| Indication for Use | The HeTaiDa electronic<br>thermometers<br>HTD8818A, HTD8816C<br>and HTD8808C are<br>infrared thermometers<br>which use infrared sensor<br>to detect human body<br>temperature of patients of<br>all ages. It is intended to<br>be used on forehead to<br>detect body temperature.<br>The HTD8818A,<br>HTD8816C and<br>HTD8808C are intended<br>for use in the clinical and<br>homecare environment. | The FT-100A<br>Electronic<br>thermometer is an<br>infrared thermometer<br>which uses an infrared<br>sensor to detect human<br>body temperature of<br>patients of all ages. It<br>is intended to be used<br>on forehead to detect<br>body temperature. The<br>FT-100A is intended<br>for home and clinical<br>use. | Identical |
| Temperature unit | °C or °F | °C or °F | Identical |
| Measurement<br>Range | Forehead:<br>34°C to 42.9°C (93.2°F to<br>109.2°F)<br>Surface (Object):<br>0°C to 100°C (32°F to<br>212°F) | Forehead:<br>32°C to 43°C (89.6°F<br>to 109.4°F)<br>Object:<br>0°C to 100°C (32°F to<br>212°F) | Similar |
| Operating<br>Temperature | 15°C to 35°C (59°F to<br>95°F) | 16°C to 40°C (60.8°F<br>to 104°F) | Similar |
| Operating<br>humidity | 85% RH or less | 95% RH or less | Similar |
| Storage<br>temperature | -20°C to 55°C (-4°F to<br>131°F) | -25°C to 55°C (-13°F<br>to 131°F) | Similar |
| Storage humidity | 93% RH or less | 95% RH or less | Similar |
| Accuracy | FOR BODY MODE:<br>34.0~34.9°C: ±0.3°C<br>(93.2-94.8°F: ±0.5°F);<br>35.0~42.0°C: ±0.2°C<br>(95.0-107.6°F: ±0.4°F);<br>42.1~42.9°C: ±0.3°C<br>(107.8-109.2°F: ±0.5°F);<br><br>FOR SURFACE MODE:<br>± 2°C (± 3.6 °F) | FOR BODY MODE:<br>±0.2°C (±0.4°F) from<br>36.0°C (96.8°F) to<br>39.0°C(102.2°F);<br>±0.3°C (±0.54°F) from<br>32.0°C (89.6°F) to<br>35.9°C (96.6°F) and<br>from 39.1°C (102.4°F)<br>to 43.0°C (109.4°F)<br><br>FOR OBJECT<br>MODE: | Technological<br>characteristics<br>are similar |
| | | ± 4°C (±7.2°F) from<br>0°C (32°F) to 4.9°C<br>(40.8°F)<br>± 1°C (±2°F) from 5°C<br>(40.8°F) to 60°C<br>(140°F)<br>± 4°C (±7.2°F) from<br>60.1°C (140.1°F) to<br>100°C (199.9°F) | |
| Memory capacity | 50 measurements | 20 measurements | Technological<br>characteristics<br>are similar |
| Power down time | 18s or less | 1 min | Similar |
| Battery type | 1.5V AAA x 2 | 1.5V AAA x 2 | Identical |
| LCD Backlight | Available | Available | Identical |
| Fundamental<br>technology | Infrared technology that<br>converts a user's forehead<br>temperature using the<br>infrared energy emitted in<br>the area around the user's<br>forehead to a reference<br>site equivalent<br>temperature. | Infrared technology<br>that converts a user's<br>forehead temperature<br>using the infrared<br>energy emitted in the<br>area around the user's<br>forehead to a reference<br>site equivalent<br>temperature. | Identical |
| Display resolution | 0.1°C/0.1°F | 0.1°C/0.1°F | Identical |

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- 8. Comparison of Technological Characteristics with Predicate Device.
The technological characteristics of the HeTaiDa HTD8818A, HTD8816C and HTD8808C thermometers and the predicate device (FT-100A) are similar. Both convert user's forehead temperature using the infrared energy emitted in the area around the user's forehead to a reference site equivalent temperature. The differences between the HeTaiDa HTD8818A, HTD8816C and HTD8808C thermometers and the predicate device FT-100 do not raise different questions of safety and effectiveness. The HeTaiDa Technology Co., Ltd believes that the noncontact infrared body thermometers HTD8818A, HTD8816C, HTD8808C are substantially equivalent to the (K160802) non-contact infrared body thermometer FT-100A of Universal Electronic Co., Ltd.

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# 9. Safety and Performance Data.

Bench Data are listed in Table as below.

| Model | Bench Tests | Standards | Results | Report<br>File No. |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|---------|-----------------------------|
| HTD8818A<br>HTD8808C<br>HTD8816C | General requirements<br>for basic safety and<br>essential performance | IEC 60601-1:2005<br>(Third Edition) +<br>CORP. 1:2006 +<br>CORP. 2:2007 +<br>A1:2012 | Pass | GZME160<br>500034301<br>-01 |
| | General requirements<br>for basic safety and<br>essential performance<br>– Collateral Standard:<br>Requirements for<br>medical electrical<br>equipment and<br>medical electrical<br>systems used in the<br>home healthcare<br>environment | IEC 60601-1-11 (First<br>Edition): 2010 | Pass | GZME160<br>500034302<br>-01 |
| | General requirements<br>for basic safety and<br>essential performance<br>- Collateral Standard:<br>Electromagnetic<br>compatibility | IEC 60601-1-2:2014 | Pass | GZME170<br>100001901 |
| | EMC TEST | CFR 47 FCC Part 15,<br>Subpart B, Class B<br>2016 | Pass | NTC17051<br>46FV00 |
| | Particular<br>requirements for<br>basic safety and<br>essential performance<br>of clinical<br>thermometers for<br>body temperature<br>measurement | ISO 80601-2-56:2009<br>(First Edition) for use<br>in conjunction with<br>IEC 60601-1:2005<br>(Third edition) | Pass | GZME160<br>500034303<br>-01 |
| | Standard<br>specification for<br>infrared<br>thermometers for<br>intermittent<br>determination of<br>patient temperature | ASTM E1965-98<br>(Reapproved 2009) | Pass | GZME170<br>100001801 |

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# Biocompatibility data are listed in Table as below.

| Model | Biocompatibility<br>Tests of Final<br>Finished Device | Standards | Results | Report File No. |
|----------------------------------|-------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|---------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| HTD8818A<br>HTD8808C<br>HTD8816C | In vitro<br>cytotoxicity with<br>10% FBS | ISO 10993-5:2009:<br>Biological<br>evaluation of<br>medical devices:<br>part 5: Tests for in<br>vitro cytotoxicity | Pass | SDWH-<br>M201800599-1<br>(HTD8808C),<br>SDWH-<br>M201800600-1<br>(HTD8816C),<br>SDWH-<br>M201800601-1<br>(HTD8818A) |
| | Skin sensitization<br>0.9%SC | ISO 10993-10,<br>Biological<br>evaluation of<br>medical device -<br>Part 10: Tests for<br>irritation and skin<br>sensitization. | Pass | SDWH-<br>M201800599-2<br>and -3<br>(HTD8808C), |
| | Skin sensitization<br>Cotton seed oil | | | SDWH-<br>M201800600-2<br>and -3<br>(HTD8816C),<br>SDWH-<br>M201800601-2<br>and -3<br>(HTD8818A) |
| | Skin irritation<br>0.9%SC | ISO 10993-10,<br>Biological<br>evaluation of<br>medical device -<br>Part 10: Tests for<br>irritation and skin<br>sensitization. | Pass | SDWH-<br>M201800599-4<br>and -5<br>(HTD8808C),<br>SDWH-<br>M201800600-4<br>and -5<br>(HTD8816C),<br>SDWH-<br>M201800601-4<br>and -5<br>(HTD8818A) |
| | Skin irritation<br>Cotton seed oil | | | |

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A clinical investigation was performed to evaluate the clinical bias, clinical accuracy and clinical repeatability. The four groups of subjects being tested were:

- (1) 0 3 months, (2) 3 months 1 year old, (3) 1 5 years old, and (4) >5 years older.
Each group of subjects underwent a series of temperature measurement at their forehead using HTD8818A, HTD8816C and HTD8808C non-contact infrared body thermometers. All the subject groups also underwent a series of temperature measurement using a reference contact clinical electronic thermometer BT-21H, which temperatures were measured in the axillary of patients. These temperature measurements were then each compared to the temperature measurements taken by the HeTaiDa non-contact infrared body thermometers. The clinical bias, clinical accuracy and clinical repeatability of the HeTaiDa-thermometers are calculated to be -0.027, ±0.14, and 0.07, respectively, which are within the clinically acceptable range as required by ISO 80601-2-56:2009 and ASTM 1965-68 (Reapproved 2009). These clinical results indicate that the HeTaiDa non-contact infrared thermometers produce effective and accurate temperature measurements.

The design of the submitted device specifications is substantially the same as the predicate, with minor difference in the operating temperature and humidity range, and storage temperature and humidity range.

#### 11. Conclusions.

The HeTaiDa non-contact infrared body thermometers HTD8818A, HTD8816C and HTD8808C have similar intended use, principle of operation, and similar technological characteristics as the predicate device identified. Performance testing contained in this submission demonstrates the minor differences in technological characteristics between the subject device and the predicate do not raise different questions of safety and effectiveness. Thus, in accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part807 and based on the information provided in this premarket notification, HeTaiDa Technology Co., Ltd. concludes that the Infrared Forehead Thermometers HTD8818A, HTD8816C, HTD8808C are substantially equivalent to predicate device.

End.

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July 23, 2018

Hetaida Technology Co., Ltd % Roman Huang Elliiot Medical Solutions 18586 Parkland Drive Shaker Heights, Ohio 44122

Re: K171888

Trade/Device Name: Non-contact infrared body thermometer, HTD8818A, HTD8816C, and HTD8808C Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: June 15, 2018 Received: July 6, 2018

Dear Roman Huang:

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.

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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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### Page 2 - Roman Huang

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 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,

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