Infrared Non-contact Thermometer, Model ACT8100

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract image of a human figure, represented by three overlapping profiles facing to the right, with a stylized wave or ribbon element below them. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 March 10, 2017 Easywell Biomedicals, Inc. Arthur Chen Quality Assurance Manager Suite 2, 2F, No.9, Jhanye 1st Rd, Hsinchu Science Park Hsinchu, 30078 TAIWAN Re: K162509 Trade/Device Name: Infrared Non-contact Thermometer, Model ACT8100 Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: January 26, 2017 Received: February 15, 2017 Dear Arthur Chen: 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. {1}------------------------------------------------ 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely, Image /page/1/Picture/8 description: The image contains a signature and the name "Tina Kiang". There is also a "-5" below the name. The signature is a series of loops and curves. 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K162509 Device Name Infrared Non-Contact Thermometer, Model ACT8100 Indications for Use (Describe) The Infrared Non-Contact Thermometers, ACT8100, is non-sterile, reusable clinical thermometers intended for the intermittent determination of human body temperature measured at the center of the forehead without contact. The device is intended for use on people of all ages, except pre-term babies or very small (small for gestational age). The device is intended for use in clinical and home use 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for Easywell Biomedicals. The logo features the word "EASYWELL" in blue, with a green checkmark-like symbol incorporated into the "W". Below the word "EASYWELL" is the word "Biomedicals" in a smaller font. A curved line of green dots appears below the word "Biomedicals", adding a visual element to the logo. # K162509 510(k) Summary #### I. Submitter ### EASYWELL BIOMEDICALS, INC. Suite 2, 2F, No.9, Jhanye 1st Rd., Hsinchu Science Park, 30078 Hsinchu, TAIWAN Phone:+886-3-666-9596 FAX: +886-3-666-9697 Contact Person:Richard Hsieh Date: January 25, 2017 #### II. Device Trade Name:Infrared Non-Contact Thermometer, Model ACT8100 Common Name: Infrared Thermometer Regulation Number: 21 CFR 880. 2910 Regulation Name:Clinical Electronic Thermometer Regulatory Class : II Product Code:FLL ### III. Predicate Device K134043 : BRAUN No Touch + Forehead Thermometer; ModelNTF3000US (US Model) ### Reference Device K031905: Actherm Digital Clinical Thermometer ACT 2130 #### IV. Device Description The Infrared Non-Contact Thermometer, ACT8100 is a hand-held device powered by batteries and designed to measure human body temperature without contacting patients. This thermometer can switch modes between forehead and ambient temperatures. The ambient temperature mode is DIRECT MODE and the forehead temperature mode is ADJUSTED MODE. The forehead temperature of the ADJUSTED MODE is calculated by converting the measured temperature of the DIRECT MODE to an oral equivalent temperature without contacting the patient's forehead. Infrared Non-Contact Thermometer, ACT8100 uses a thermopile integrated with a thermistor, a thermistor mounted on the head of the thermometer for ambient temperature readings, and an optoelectronic mechanism that focuses the infrared energy emitted from the user s forehead for the detection of noncontact use and calibration of temperature reading. {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for Easywell Biomedicals. The logo has the word "EASYWELL" in blue, with the "V" in "EASYWELL" being a lighter shade of blue. Below the word "EASYWELL" is the word "Biomedicals" in a smaller font. Below the word "Biomedicals" is a curved line of blue dots. Physical and Performance characteristics: | Dimension | 163×44×26mm approximately | |--------------------|---------------------------------------------------------------------------| | Weight | Approximately 75g without battery; 88g with batteries | | Measuring<br>Range | 32.0 °C ~ 43.9 °C (89.6 °F ~ 111.0 °F) | | Accuracy | ± 0.2 °C (for 35.0~42.0°C); ± 0.3°C (for below 34.9°C or above<br>42.1°C) | #### V. Indication for Use The Infrared Non-Contact Thermometers, ACT8100, is non-sterile, reusable clinical thermometers intended for the intermittent determination of human body temperature measured at the center of the forehead without contact. The device is intended for use on people of all ages, except pre-term babies or very small (small for gestational age). The device is intended for use in clinical and home use environments. ## VI. Conformance Standards The Infrared Non-Contact Thermometers conform to the following standards: - 1. ISO 80601-2-56:2009 Medical electrical equipment Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement. - 2. ASTM E1965-98:2009 Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature. - 3. IEC 60601-1:2012 Medical electrical equipment Part 1: General requirements for basic safety and essential performance - 4. IEC 60601-1-2:2014 Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral standard Electromagnetic compatibility -Requirements and tests - 5. IEC 60601-1-11:2010 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 - 6. ISO 14971:2007 Medical Devices: Application of Risk Management to Medical Devices. - 7. Software: FDA Guidance for the Content of Premarket Submissions for Software contained in Medical Device - 8. ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process. - 9. ISO 10993-5:2009 Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity. - 10. ISO 10993-10: 2010 Biological evaluation of medical devices. Tests for irritation and delayedtype hypersensitivity {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for Easywell Biomedicals. The logo is in blue and features the word "EASYWELL" in a stylized font. Below the word is the word "Biomedicals" in a smaller font. Underneath the words is a curved line made of blue-green dots. | | VII. Similarities/Differences between the subject and predicate device: | | | | |--|-------------------------------------------------------------------------|--|--|--| | | | | | | | | Subject Device(s) | Predicate Device | | |--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------| | ELEMENT OF<br>COMPARISON | ACT8100 | No touch + forehead<br>thermometer<br>(NTF3000US) | Comparison | | Classification | Thermometer<br>Clinical Electronic,<br>Class II Device | Thermometer<br>Clinical Electronic,<br>Class II Device | The device<br>classifications are<br>identical | | Intended Use | A non-sterile, reusable<br>clinical thermometer<br>intended for the<br>intermittent<br>determination of human<br>body temperature<br>measured at the center<br>of the forehead without<br>contact. The device is<br>intended for use on<br>people of all ages,<br>except pre-term babies<br>or very small (small for<br>gestational age). The<br>device is intended for<br>use in clinical and home | A non-sterile, reusable<br>clinical thermometer<br>intended for the<br>intermittent<br>determination of the<br>human's body<br>temperature in a touch<br>and no touch on the<br>center of the forehead<br>as the measurement site<br>on people of all ages. | The intended use<br>statements are<br>similar | | Sensor | Infrared: converts a<br>user's forehead<br>temperature using the<br>infrared energy emitted<br>in the area around the<br>user's forehead to an<br>oral equivalent<br>temperature when<br>placed up to 2-8cm<br>away. | Infrared: converts a<br>user's<br>forehead<br>temperature using the<br>infrared energy emitted<br>in the area around the<br>user's forehead to an<br>oral equivalent<br>temperature when<br>placed in contact with<br>the subject's forehead<br>or up to 2 inches away. | Technological<br>characteristics are<br>similar | | ELEMENT OF<br>COMPARISON | Subject Device(s) | Predicate Device | Comparison | | Power<br>Requirement | ACT8100:<br>1.5V AAA size Alkaline battery *2 | 1.5V AA size battery *2 | Battery size different, but the power requirements are similar (voltage outputs are the same) | | | Dimensions:<br>163×44×26 mm | Dimensions:<br>Length:148<br>Head: 44×26 mm<br>Body: 37×24 mm | Head dimension is similar, the body length is different. | | Functionality | Materials:<br>All skin contacting materials have been tested in accordance with ISO 10993-1、-5、-10. | Materials:<br>All skin contacting materials have been tested in accordance with ISO 10993-1、-5、-10. | Material characteristics all meet biological requirements | | | Measuring ranges:<br>$32.0 °C ~ 43.9 °C$ | Measuring ranges:<br>$34.4 °C ~ 42.2 °C$ | All meet ASTM E 1965-98:2009 | | | Accuracy:<br>$35.0 °C ~ 42.0 °C: ± 0.2 °C$<br>$<35.0 °C$ or $>42.0 °C: ± 0.3 °C$ | Accuracy:<br>$35.0 °C ~ 42.0 °C: ± 0.2 °C$<br>Out of above range: ± 0.3 °C | All meet ASTM E 1965-98:2009 | | | Forehead measuring distance:<br>2~8 cm | Forehead measuring distance:<br>0~5 cm | Similar | {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for Easywell Biomedicals. The logo features the word "EASYWELL" in a stylized font, with the "V" in "WELL" replaced by a green checkmark. Below the word "EASYWELL" is the word "Biomedicals" in a smaller, sans-serif font. A curved line of green dots appears below the word "Biomedicals". ### VIII. Comparison of Technological Characteristics with the Predicate Device: The technological characteristics of ACT8100 and predicate device (NTF3000US) are similar. Both convert user's forehead temperature using the infrared energy emitted in the area around the user 's forehead to an oral equivalent temperature. The differences between ACT 8100 and predicate device (NTF3000US) do not raise different questions of safety or effectiveness. {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for Easywell Biomedicals. The logo is in blue and green, with the word "EASYWELL" in large, bold letters. Below the word "EASYWELL" is the word "Biomedicals" in smaller letters. A curved line of blue and green dots appears below the word "Biomedicals". | Difference | Difference Description | Reasons why not raising new questions | |-------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Battery size | ACT 8100 using AAA size,<br>the predicated device<br>(NTF3000US) using AA size | The output voltage is the same, and the<br>differences are verified not to raise new<br>questions regarding safety and effectiveness<br>requirements within standard IEC60601-1<br>electrical safety requirements and IEC 60601-<br>1-2 EMC test. | | Dimensions | The design of shape is not<br>very similar. | The differences are verified not to raise new<br>questions regarding safety and effectiveness<br>requirements within standard IEC60601-1<br>electrical safety requirements & ASTM E<br>1965-98:2009 | | Ambient<br>measuring<br>ranges | ACT 8100 (32.0°C ~ 43.9°C)<br>is a little wider than The No<br>Touch + Forehead<br>Thermometer (34.4°C ~<br>42.2°C). | The differences are verified not to raise new<br>questions regarding safety and effectiveness<br>requirements within standard IEC60601-1<br>electrical safety requirements & ASTM E<br>1965-98:2009 | | Forehead<br>measuring<br>distance(sensor) | The predicated device<br>(NTF3000US) designed for<br>both contact and no-contact.<br>ACT 8100 is designed for<br>only non-contact. | The differences are verified not to raise new<br>questions regarding safety and effectiveness<br>requirements within standard IEC60601-1<br>electrical safety requirements & ASTM E<br>1965-98:2009 | # IX. Non-Clinical Safety and Performance Testing Non-clinical performance tests used to demonstrate the substantial equivalence of ACT 8100 to the predicate device. The device conforms to the requirements of laboratory accuracy, general electrical safety, electromagnetic compatibility and biocompatibility. Thus, the device has the same performance characteristics as the predicate device. | Non-Clinical Performance<br>Testing | Standard/Guidance Applied and Conformed | |-------------------------------------|-------------------------------------------| | Laboratory accuracy | ASTM E1965-98:2009<br>ISO 80601-2-56:2009 | | General Electrical Safety | IEC 60601-1:2012<br>IEC 60601-1-11:2010 | | Electromagnetic<br>Compatibility | IEC 60601-1-2:2014 | | Biocompatibility | ISO 10993-1;ISO 10993-5; ISO 10993-10 | | Software | IEC 62304 | | Usability | IEC 62366 | | Risk Management | ISO 14971 | {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the logo for Easywell Biomedicals. The logo is blue and features the word "EASYWELL" in a stylized font. Below the word "EASYWELL" is the word "Biomedicals" in a smaller font. Underneath the word "Biomedicals" is a curved line of blue-green dots. #### X. Clinical Testing A clinical study was performed to determine the clinical accuracy and to provide comparison with the predicate device. The three groups of subjects being tested were: (1) Infants of under 1 year old, (2) Children between 1 to 5 years old, (3) Adults Each group of subjects underwent a series of temperature measurement at their forehead and back of ear using ACT 8100 and BRUAN Infrared no touch + forehead thermometer NTF 3000. This series of measurement was intended to indicate and ultimately compare the repeatability of ACT 8100 and NTF 3000. The repeatability of both devices is found to be under 0.3℃. which is within the acceptable range as required by EN12470-5:2003, subclause 6.3.4. In addition, the repeatability of the both devices were found to be similar, further indicating that the ACT 8100 has reasonable accuracy and reliability. The three subject groups underwent a series of temperature measurement using the reference thermometer, Actherm Digital Clinical Thermometer ACT 2130 (K031905), either at the rectal, oral, or axillary site depending on their age group. These temperature measurements were then each compared to the temperature measurements taken by ACT 8100 and that of NTF 3000. The clinical biases of these measurements taken by ACT 8100 were found to be similar to that of NTF 3000, indicating that ACT 8100 produces effective and accurate temperature measurements. ### XI. Conclusion Infrared Non-Contact Thermometers, ACT8100 has similar intended use, principles 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. Results from the clinical study demonstrate substantial equivalence of accuracy and reliability of ACT 8100 and its similarity with NTF 3000. Thus, the Infrared Non-Contact Thermometer is substantially equivalent to the predicate device.