Non-contact Infrared Body Thermometer, Model HTD8808C, HTD8818A, HTD8816C

K203332 · Hetaida Technology Co., Ltd. · FLL · Feb 25, 2021 · General Hospital

Device Facts

• Record ID: K203332
• Device Name: Non-contact Infrared Body Thermometer, Model HTD8808C, HTD8818A, HTD8816C
• Applicant: Hetaida Technology Co., Ltd.
• Product Code: FLL · General Hospital
• Decision Date: Feb 25, 2021
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.2910
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The HeTaiDa electronic thermometers HTD8818A, HTD8816C, HTD8808C are infrared thermometers which use Infrared sensor to detect human body temperature of patients of all ages, It is intended to be used on one's forehead to detect body temperature. The HTD8818A, HTD8816C, HTD8808C are intended for use in home and clinical environment.

Device Story

Hand-held, battery-powered non-contact infrared thermometer; measures forehead temperature; uses infrared thermopile sensor with integrated thermistor; ASIC converts sensor signals to digital values; displays temperature on LCD; operates in 'Body Mode' (adjusted) or 'Surface Mode' (direct); used by clinicians or patients in home/clinical settings; provides rapid temperature readings; aids in fever detection and patient monitoring.

Clinical Evidence

No clinical data required for substantial equivalence. Bench testing performed including laboratory accuracy tests under various environmental conditions (ISO 80601-2-56:2017), electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), and software verification (IEC 62304). Accelerated aging tests validated 5-year shelf life.

Technological Characteristics

Infrared thermopile sensor with integrated thermistor; ABS plastic housing; battery-powered (2x AAA); LCD display; 0.1°C/0.1°F resolution; operating range 15°C-40°C; measurement range 34°C-43.0°C; software life-cycle per IEC 62304; biocompatibility per ISO 10993-5/10.

Indications for Use

Indicated for patients of all ages to detect body temperature via forehead measurement in home and clinical 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 (K171888)

Submission Summary (Full Text)

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May 4, 2021

HeTaiDa Technology Co., Ltd. Karen Ren Official Correspondent 4F, BaiShiDa High-Tech Park, XiangDong Industrial Area DaLingShan Town DongGuan City, Guangdong 523820 China

Re: K203332

Trade/Device Name: Non-contact Infrared Body Thermometer, Model HTD8808C, HTD8818A, HTD8816C Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical electronic thermometer Regulatory Class: Class II Product Code: FLL

Dear Karen Ren:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated February 25, 2021. Specifically, FDA is updating this SE Letter due to a typo in the applicant name as an administrative correction.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Payal Patel, OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices, [phone], [e-mail].

Sincerely,

# James M. Simpson Jr -

## S7

for Payal Patel 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

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Image /page/1/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.

HeiTaiDa Technology Co., Ltd. Karen Ren Official Correspondent 4F, BaiShiDa High-Tech Park, XiangDong Industrial Area DaLingShan Town DongGuan City, Guangdong 523820 China

Re: K203332

Trade/Device Name: Non-contact Infrared Body Thermometer, Model HTD8808C, HTD8818A, HTD8816C Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: January 22, 2021 Received: January 26, 2021

Dear Karen Ren:

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 (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-devices/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,

Pror

Paval Patel 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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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

#### Indications for Use

510(k) Number (if known)

K203332

Device Name

Non-Contact Infrared Body Thermometer HTD8818A, HTD8816C, and HTD8808C

#### Indications for Use (Describe)

The HeTailDa electronic thermometers HTD8818A, HTD8808C are infrared thermometers which use infrared sensor to detect human body temperature of all ages. It is intended to be used on one's forehead to detect body temperature. The HTD8816C, HTD8816C, HTD8808C are intended for use in home and clinical environment.

| 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

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

### 1. Submitter's Information 1.1 Contact person of Applicant

| Name: | HeTaiDa Technology Co., Ltd |
|--------------------|--------------------------------------------------------------------------------------------------------------|
| Address: | 4F, BaiShiDa High-Tech Park, XiangDong Industrial Area,<br>DaLingShan Town, DongGuan City, Guangdong, China. |
| Phone No: | [phone] |
| Fax No: | [phone] |
| Contact<br>Person: | Tom Chen |
| Email | [e-mail] |

#### 1.2 Contact person of the submission

| Name: | HeTaiDa Technology Co., Ltd |
|---------------------------|--------------------------------------------------------------------------------------------------------------|
| Address: | 4F, BaiShiDa High-Tech Park, XiangDong Industrial Area,<br>DaLingShan Town, DongGuan City, Guangdong, China. |
| Phone No: | [phone] |
| Fax No: | [phone] |
| Contact<br>Person: | Karen Ren |
| Email | [e-mail] |
| Date Summary<br>Prepared: | July 31th, 2020 |

#### 2. Device information

| Type of 510(k) submission: | Special |
|----------------------------|---------------------------------------|
| Device Common Name: | Clinical electronic thermometer |
| Name: | Non-contact Infrared Body Thermometer |
| Model | HTD8808C, HTD8818A, HTD8816C |
| 510(k) number | K203332 |
| Classification name: | thermometer, electronic, clinical |
| Product Code: | FLL |
| Regulation Class: | II |

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| Regulation | 880.2910 |
|------------|----------|
| Number: | |

#### 3. Predicate Device(s)

| Manufacturer | Predicate Device | 510(k) number |
|---------------------------------|------------------------------------------|---------------|
| Hetaida Technology<br>Co., Ltd. | Non-contact infrared Body<br>thermometer | K171888 |

#### 4. Device 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's 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.

This submission is to notify that a legally marketed device (predicate) are modified by extending output range of body mode to 34°C ~43°C ,operating mode to 15°C~40°C, deleting offset parameter settings, shelf-life change from 3 years to 5 years.

#### 5. Indication for Use.

No changes to the indication for use are proposed by this submission. The indication for Use are as follows:

The HeTaiDa electronic thermometers HTD8818A, HTD8816C, HTD8808C are infrared thermometers which use Infrared sensor to detect human body temperature of patients of all ages, It is intended to be used on one's forehead to detect body temperature. The HTD8818A, HTD8816C, HTD8808C are intended for use in home and clinical environment.

#### 6. Comparison of Technological Characteristics

The modified HeTaiDa HTD8818A, HTD8816C and HTD8808C thermometers expand the measurement range of body mode from 34°C -42.9°C to 34°C -43.0°C, operating temperature from 15°C~35°C to 15°C~40°C, deleting offset parameter settings compared with unmodified HTD8818A, HTD8816C and HTD8808C thermometers. No changes have been made to the device's indications for use, intended use, algorithm or fundamental scientific technology as a result of the modification that has prompted this submission.

| Element of<br>Comparison | Subject device(s) | Predicate device(s) | Comparison |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Type of<br>Thermometer | Non-Contact Infrared body<br>thermometer | Non-Contact Infrared body<br>thermometer | Identical |
| Model | HTD8818A, HTD8816C,<br>HTD8808C | HTD8818A, HTD8816C,<br>HTD8808C | / |
| 510(K) | K203332 | K171888 | / |
| Principles of<br>operation | Based on Infrared Sensor<br>technology. The IR sensor can<br>output different signal when<br>measuring different object<br>temperature or in different ambient<br>temperature, and the ASIC can turn<br>the signal from IR Sensor to a<br>digital value and<br>display it on the LCD. | Based on Infrared Sensor<br>technology. The IR sensor<br>can output different signal<br>when measuring different<br>object temperature or in<br>different ambient<br>temperature, and the ASIC<br>can turn the signal from IR<br>Sensor to a digital value<br>and display it on the LCD. | Identical |
| Indication for<br>Use | The HeTaiDa electronic<br>thermometers HTD8818A,<br>HTD8816C, HTD8808C are infrared<br>thermometers which use Infrared<br>sensor to detect human body<br>temperature of patients of all ages,<br>It is intended to be used on one's<br>forehead to detect body<br>temperature. The HTD8818A,<br>HTD8816C, HTD8808C are<br>intended for use in home and<br>clinical environment. | The HeTaiDa electronic<br>thermometers HTD8818A,<br>HTD8816C, HTD8808C are<br>infrared thermometers which<br>use Infrared sensor to detect<br>human body temperature of<br>patients of all ages, It is<br>intended to be used on one's<br>forehead to detect body<br>temperature. The<br>HTD8818A, HTD8816C,<br>HTD8808C are intended for<br>use in home and clinical<br>environment. | Identical |
| labeling | Instructions for use, package,<br>and label | Instructions for use, package,<br>and label | Identical |
| components | Power / temperature measurement<br>button, Mode button, Memory button,<br>Set button, sensor, microcontroller,<br>& LCD | Power / temperature<br>measurement button, Mode<br>button, Memory button, Set<br>button, sensor,<br>microcontroller, & LCD | Identical |
| Sensor | The thermometer uses an infrared<br>thermopile sensor with integrated<br>thermistor mounted in the head of<br>the thermometer for the target<br>reading and ambient<br>temperature reading | The thermometer uses an<br>infrared thermopile sensor<br>with integrated thermistor<br>mounted in the head of the<br>thermometer for the target<br>reading and ambient<br>temperature reading | Identical |
| Power Supply | Two (2), AAA batteries | Two (2), AAA batteries | Identical |
| Materials | User contacting materials include<br>ABS (device housing / handle, power /<br>temperature button, memory<br>button, mode button).<br>Patient contact materials: None as<br>non-contact with patient | User contacting materials<br>include ABS (device housing<br>/ handle, power / temperature<br>button, memory button, mode<br>button).<br>Patient contact materials: None<br>as non-contact with patient | Identical |
| Biocompatibili<br>ty | 1. Type of contact: direct contact for<br>users, non-contact for patients.<br>2. Nature of body contact category:<br>Surface Contact class: A (<24 h)<br>3. Meets ISO 10993-5 and ISO<br>10993-10 | 1. Type of contact: direct<br>contact for users, non-contact<br>for patients.<br>2. Nature of body contact<br>category: Surface Contact<br>class: A (<24 h)<br>3. Meets ISO 10993-5 and<br>ISO 10993-10 | Identical |
| Operating<br>environment | Temperature: 15°C ~ 40°C<br>R.H.: ≤85%for HTD8808C,<br>HTD8816C,<br>≤95% for HTD8818A<br>700-1060 hPA | Temperature: 15°C ~ 35°C<br>R.H.: ≤85% 700-1060 hPA | Similar<br>The operating<br>temperature<br>environment of the<br>subject and<br>devices have pass<br>ISO80601-2-56<br>and<br>IEC60601-1-11<br>test, meet these<br>performance<br>standards. and the<br>difference does not<br>affect the<br>determination of<br>substantial<br>equivalence. |
| Storage<br>environment | -20°C -55°C / -4 °F - 131°F,<br>≤93% R.H. for HTD8808C,<br>HTD8816C,<br>-25°C -55°C / -13 °F - 131°F,<br>≤95% R.H. for HTD8818A<br>700-1060 hPA | -20°C -55°C / -4 °F - 131°F,<br>≤93% R.H.; 700-1060 hPA<br>(0.7-1.06 atm) | Similar<br>The storage<br>condition of subject<br>device has passed<br>the safety test, and<br>the Instructions for<br>Use provides the<br>storage condition,<br>so the difference<br>between the<br>operating conditions<br>of subject device<br>and predicate<br>device will not affect<br>the determination of<br>substantial<br>equivalence. |
| Display<br>resolution | 0.1°F /0.1 °C | 0.1 °F /0.1 °C | Identical |
| Measurement<br>Range | 34℃~43.0℃ | 34°C~42.9°C | Technological<br>characteristics<br>are similar |
| | | | |
| Accuracy | $34.0℃~34.9℃:±0.3℃/ 93.2°F -94.8°F:±0.5°F;35.0 °C~42.0 °C:±0.2 °C/95.0°F -107.6°F:±0.4°F;42.1°C~43.0℃:±0.3℃/107.8°F -109.4°F: ±0.5°F;$ | $34.0℃~34.9℃:±0.3℃/ 93.2°F -94.8°F:±0.5°F;35.0℃~42.0℃ : ±0.2℃ /95.0°F -107.6°F:±0.4°F;42.1 ℃~42.9℃ :±0.3 ℃ /107.8°F-109.2°F: ±0.5°F;$ | Technological characteristics are similar |
| Response time | ≤2 seconds | ≤2 seconds | Identical |
| Feature | Memory capacity:<br>50 readings for HTD8808C,<br>HTD8816C, 10 readings for<br>HTD8818A<br><br>Parameter setting:<br>F1-Unit<br>F2-Fever alert setting<br>F3-Sound on/off setting for<br>HTD8808C and HTD8816C,<br>Unit setting/Prompt Sound on/off<br>setting for HTD8818A | Memory capacity :<br>50 readings<br><br>Parameter setting:<br>F1-Unit<br>F2-Fever alert setting<br>F3-Sound on/off<br>setting<br>F4- Overall temperature offset | Similar, the difference does not affect the<br>determination of substantial<br>equivalence.<br><br>Similar, the difference does not affect the<br>determination of substantial<br>equivalence. |
| Fundament<br>al technology | Infrared technology that converts a<br>user's forehead temperature using<br>the infrared energy emitted in the<br>area around the user's forehead to<br>a reference site equivalent<br>temperature. | 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 site<br>equivalent temperature. | Identical |
| Performance | Meets<br>ISO 80601-2-56:2017 | Meets<br>ISO 80601-2-56:2009 | Substantially<br>Equivalent |
| Electrical<br>Safety | Meets ANSI / AAMI / IEC<br>60601-1:2012 | Meets ANSI / AAMI / IEC<br>60601-1:2012 | Substantially<br>Equivalent |
| EMC | Meets IEC 60601-1-2:2014 | Meets IEC 60601-1-2:2014 | Substantially<br>Equivalent |
| Shelf life | 5 years | 3 years | Substantially<br>Equivalent |

## Substantial Equivalence Comparison Table

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#### 7. Substantial Equivalence – Non-Clinical Evidence

The modifications to the device have been designed and assessed under design control processes compliant with FDA 21 CFR 820. Non-clinical testing has been performed todemonstrate that the safety and efficacy of the device remains substantially equivalent to its predicate.

| Model | Bench Tests | Standards | Results | Report File No. | |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------|------------------|------------------|
| HTD8818A<br>HTD8808C<br>HTD8816C | General requirements<br>for basic safety and<br>essential performance | IEC 60601-<br>1:2005 (Third<br>Edition) +<br>CORP. 1:2006<br>+ CORP.<br>2:2007 | Pass | GZME180100000901 | |
| | | 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-<br>11: 2015 | Pass | GZME180100000902 |
| | | General requirements<br>for basic safety and<br>essential performance<br>– Collateral Standard:<br>Electromagnetic<br>compatibility | IEC 60601-1-<br>2:2014 | Pass | GZME180100001001 |
| | Particular<br>requirements for basic<br>safety and essential<br>performance of clinical<br>thermometers for body<br>temperature<br>measurement | ISO 80601-2-<br>56:2017 | Pass | GZME180100000903 | |
| | Medical device<br>software - Software<br>life-cycle processes | IEC 62304:<br>2006+A1:2015 | Pass | ZHTF-CE-01-006 | |

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| Device Change | Risks | Verification/Validation<br>Method(s) | Acceptance<br>Criteria | Summary of<br>Results |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Parameters<br>Information on<br>labeling change | The parameters<br>information on labeling<br>doesn't update on time,<br>that would make user<br>error operation | Labeling and User manual<br>are checked according to<br>IEC 60601-1 clause 7.9<br>Accompany documents,<br>IEC60601-1-11 clause 7.4<br>instructions for use,<br>IEC60601-1-2 for EMC<br>declaration, ISO 80601-2-<br>56:2017 clause 201.7.9<br>Accompany document.<br>Please refer to Appendix 6<br>and Appendix 7 | All applicable<br>items for the<br>devices shall meet<br>the requirements. | All the changes<br>have been added<br>on labeling |
| Operating<br>environment<br>change | Inaccuracy reading to<br>delay in patient treatment<br>in extended environment | 1.Environmental operating<br>conditions-continuous<br>operating conditions test<br>was done by SGS<br>laboratory according to IEC<br>60601-1-11:2015<br>Please refer to Appendix 6<br>2. Clinical accuracy test<br>based on the change<br>was done, which is<br>compliance with ASTM<br>E1965-98<br>Please refer to Appendix 11 | 1. Device comply<br>with its<br>specifications and all<br>requirements<br>of<br>standard when<br>operated in<br>normal use within<br>Temperature.<br>2. The bias of the<br>test thermometer is<br>non-inferior to the<br>bias of the predicate<br>thermometer<br>when<br>compared<br>to<br>the<br>reference<br>thermometer.<br>The<br>repeatability for the<br>test article is less<br>than or equal to ±<br>0.3°C. | 1. The accuracy of<br>laboratory under<br>operating<br>environment were<br>with ±0.3°C<br>2. The clinical bias<br>is equal to<br>0.05°C/0.07°<br>C/-0.04°C with<br>uncertainty of<br>±0.20/±0.19/±0.18<br>respectively for<br>group I (Infants),<br>group II (children)<br>and group III<br>(adults). The<br>"Repeatability" is:<br>0.13. It's<br>considered<br>reasonably small<br>and not to pose a<br>problem for<br>diagnostic<br>purposes. |
| Storage<br>environment<br>change for<br>HTD8818A | -Inaccuracy reading to<br>delay in patient treatment<br>after storage<br>-Damage to device,<br>device couldn't work. | Environmental<br>transportation<br>and storage test was done<br>by SGS laboratory<br>according<br>to IEC 60601-1-11:2015<br>Please refer to Appendix 6 | Device allowed to<br>return and<br>stabilize at<br>operation<br>conditions of<br>normal use, and<br>provides basic<br>safety and<br>essential<br>performance | After storage with<br>lowest condition<br>and highest<br>condition of<br>transportation and<br>storage, basic<br>safety and<br>essential<br>performance met<br>the requirements<br>of devices. |
| Measurement<br>Range change | -Inaccuracy reading to<br>delay in patient treatment<br>in extended range, but<br>very low risk as very34-42.9°C to 34-<br>43.0°C, and very low<br>possibility to have<br>high temperature for<br>human | 1. Laboratory accuracy test<br>for<br>lower limit and upper limit of<br>measurement range under<br>five<br>different<br>environments combined<br>upper and lower limits of<br>environmental<br>temperature and humidity<br>were done, which is<br>compliance with ISO<br>800601-2-56:2017<br>Please refer to Appendix<br>8<br>2. Clinical accuracy test<br>based on the change<br>was done, which is<br>compliance with ASTM<br>E1965-98<br>Please refer to Appendix<br>11 | 1. Laboratory<br>accuracy for lower<br>limit and upper<br>limit of<br>measurement<br>range under five<br>different<br>environments<br>shall be within<br>±0.3°C<br>2. The bias of the test<br>thermometer is non-<br>inferior to the bias of<br>the predicate<br>thermometer when<br>compared to the<br>reference<br>thermometer. The<br>repeatability for the<br>test article is less than<br>or equal to ± 0.3°C. | 1. The accuracy of<br>laboratory under<br>operating<br>environment were<br>with ±0.3°C<br>2. The clinical bias<br>is equal to 0.05°<br>C/0.07°C/-0.04°C<br>with uncertainty of<br>±0.20/±0.19/±0.18<br>respectively for<br>group I (Infants),<br>group II (children)<br>and group III<br>(adults). The<br>"Repeatability" is:<br>0.13. It's<br>considered<br>reasonably small<br>and not to pose a<br>problem for<br>diagnostic<br>purposes. |
| Temperature range<br>for Accuracy<br>change | -Inaccuracy reading to<br>delay in patient treatment<br>in extended range, | Laboratory accuracy test for<br>lower limit and upper limit of<br>measurement range under<br>five different environments<br>combined upper and lower<br>limits of environmental<br>temperature and humidity<br>were done, which is<br>compliance with ISO<br>800601-2-56:2017<br>Please refer to Appendix 8 | Laboratory<br>accuracy for lower<br>limit and upper<br>limit of<br>measurement<br>range under five<br>different<br>environments<br>shall be within<br>±0.3°C | The accuracy of<br>laboratory under<br>operating<br>environment were<br>with ±0.3°C |
| Feature: Memory<br>change | Decreasing memory size<br>doesn't impact the safety<br>and effectiveness of<br>medical device, so no<br>risk | According to procedure of<br>IEC62304:2015, software<br>was verified and validated<br>from risk analysis, flowchart<br>of procedure, unit testing,<br>integrated testing and<br>system testing.<br>Please refer to Appendix 9<br>software verification report | The device shall<br>perform right<br>functions, and<br>don't introduce<br>any bug. | The devices<br>perform right<br>functions, and<br>don't introduce<br>any bug. |
| Feature: parameter setting change | | | | |
| The function isn't related<br>with basic performance,<br>deleting the function<br>doesn't impact the safety<br>and effectiveness of<br>medical device, so no<br>risk | According to procedure of<br>IEC62304:2015, software<br>was verified and validated<br>from risk analysis, flowchart<br>of procedure, unit testing,<br>integrated testing and<br>system testing.<br>Please refer to Appendix 9<br>software verification report | The device shall<br>perform right<br>functions, and<br>don't introduce<br>any bug. | The devices<br>perform right<br>functions, and<br>don't introduce<br>any bug. | |
| Shelf life change | -The device damage or<br>couldn't work in the<br>prolonged shelf life | Using accelerated aging test<br>to verify the shelf life:<br>1.Placed samples in the<br>chamber with75°C and<br>93%RH condition for<br>48Hours, then take them<br>out,<br>placed them in the normal<br>working condition for 24<br>hours for check, that called<br>a<br>cycle<br>2.Start the second cycle<br>once the first cycle is<br>finished<br>3. Repeated this cycle until<br>the device some of its<br>function fails work or<br>reaches<br>the former expected life<br>time.<br>Then test is over.<br>Please refer to Appendix 10<br>Shelf life validation report | All the functions<br>and performance<br>shall meet the<br>requirements after<br>each cycle in the<br>expected shelf-<br>life. | The test from July<br>3rd, 2017 to<br>October 20th,<br>2017, totally 107<br>days and 22<br>cycles, Total test<br>time is 2112<br>hours, the<br>accelerated aging<br>test time is 1056<br>hours under 75°C,<br>93%RH condition,<br>the life is 5 years<br>after calculation. |

## Design control activities summary Table

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#### 8. Substantial Equivalence - Clinical Evidence

The design of the submitted device specifications is substantially the same as the predicate, with minor difference in the measurement range, operating temperature and humidity range, and storage temperature and humidity range. Clinical evidence was not necessary to demonstrate substantial equivalence.

#### 9. Conclusion

The HeTaiDa non-contact infrared body thermometers HTD8818A, HTD8816C and HTD8808C with changes described have similar intended use, principle of operation, and similar technological characteristics as the predicate device identified. The risk analysis and 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. And we have verified that the mitigations based on risk analysis. 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 with changes described in this premarked notification are substantially equivalent to predicate device.