Advocate Non-Contact Infrared Thermometer

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. September 5, 2019 BroadMaster Biotech, Corp. % Dr. Ke-Min Jen Contact Person Chinese-European Industrial Research Society No. 58. Fu-Chiun St Hsin-Chu City, 30067 Taiwan Re: K191004 Trade/Device Name: Advocate Non-Contact Infrared Thermometer, Model EF001S Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: July 19, 2019 Received: August 6, 2019 Dear Dr. Ke-Min Jen: 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. {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 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-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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, for Alan Stevens 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K191004 Device Name Advocate Non-Contact Infrared Thermometer, EF001S Indications for Use (Describe) Advocate Non-Contact Infrared Thermometer is a non-sterile, reusable, handheld device. It can be used by consumers in homecare environment and doctors in clinic as reference. It is intended for measuring human body temperature of all ranges of people by detecting infrared heat from the forehead. | 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 Broadmaster Biotech. The logo is in blue and features the words "BROADMASTER" in large, bold letters. Below "BROADMASTER" is the word "BIOTECH" in smaller letters. To the right of the words is a stylized image of a butterfly. BroadMaster Biotech, Corp. 1F., 2F., No. 91, Xiyuan Rd., Zhongli Dist., Taoyuan City 32057,Taiwan (R.O.C.) Tel:+886-3-451-7600 Fax:+886-3-451-9500 Website: www.broadmaster-biotech.com # 510(k) Summary (Per 21 CFR 807.92) # 510(k) number: K191004 | Trade or proprietary name | Advocate Non-Contact Infrared Thermometer,<br>model EF001S | |---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Common Name | Digital Thermometer | | Classification Name | Clinical Electronic Thermometer | | Class | 21 CFR 880.2910 | | Panel | II | | Product Code | 80 General Hospital | | Owner/Operator | FLL | | | BroadMaster Biotech, Corp. | | | 1F., 2F., No. 91, Xiyuan Rd., Zhongli Dist., Taoyuan<br>City 32057, Taiwan (R.O.C.) | | | Tel: +886-3-451-7600 | | | Fax: +886-3-451-9500 | | | Website:www.broadmaster-biotech.com | | Date prepared | July 19, 2019 | | Application Correspondent | Dr. Jen, Ke-Min<br>ROC Chinese-European Industrial Research Society<br>No. 58, Fu-Chiun St., Hsin-Chu City, 30067, Taiwan<br>Tel: +886-3-5208829<br>Fax: +886-3-5209783<br>Email: ceirs.jen@msa.hinet.net | | Predicate Device | | | | Manufacturer: BroadMaster Biotech, Corp. | | | Product name: Advocate Non-Contact Infrared Thermometer | | | Model No: EF001A | #### ● Indications for Use: Advocate Non-Contact Infrared Thermometer is a non-sterile, reusable, handheld device. It can be used by consumers in homecare environment and doctors in clinic as reference. It is intended for measuring human body temperature of all ranges of people by detecting infrared heat from the forehead. {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for Broadmaster Biotech. The logo is in blue and features the words "BROADMASTER" in large, bold letters. Below that, in smaller letters, is the word "BIOTECH". To the right of the words is a stylized image of a butterfly. BroadMaster Biotech, Corp. 1F., 2F., No. 91, Xiyuan Rd., Zhongli Dist., Taoyuan City 32057,Taiwan (R.O.C.) Tel:+886-3-451-7600 Fax:+886-3-451-9500 Website: www.broadmaster-biotech.com #### ● Descriptions: The Advocate Non-Contact Infrared Thermometer, model EF001S, measures temperatures of people by detecting the infrared energy radiated directly from the forehead without physical contact. The device is composed of a Probe of metals with infrared sensor inside to detect the infrared energy, an LCD Display, a SCAN button to start measuring temperatures, a Power switch button to switch on or off the device, a Body/Ambient button to switch between two measuring modes, and an Enclosure of ABS, , as shown in the following diagram. The device has the following features: one-second measuring time, measuring Body or Ambient temperature, 12-memory recalls, "F/"C unit switchable, over range message (Hi/Lo), low battery indication, auto display for the last reading when power is on, auto shut-off when the device is idle for 60 seconds and voice function. When the device starts, "Please measure" in English or "Mira la temperature" in Spanish will be heard. When completes, the result will be heard in additional to the data display. The Advocate Non-Contact Infrared Thermometer, model EF001S, including the voice function, is not intended for use by the visually impaired individuals. Image /page/4/Figure/5 description: The image shows two views of a thermometer. The left side of the image shows the front of the thermometer, which is red and black. The front of the thermometer has a display screen, a measuring button, and a power switch button. The right side of the image shows the back of the thermometer, which is black and has a probe, a body/ambient button, and a battery cover. Components of EF001S #### ● Principle Operation The Advocate® Non-Contact Infrared Thermometer measures temperatures of people by detecting the infrared energy radiated directly from the forehead without physical contact. As soon as the distance between the probe and the forehead is within 2 -3.94 inches(5-10 cm), the IR radiation sensor is activated, and the measurement will be taken instantly by detection of the infrared heat. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for Broadmaster Biotech. The logo is in blue and features the word "BROAD" stacked on top of the word "MASTER". Below the word "MASTER" is the word "BIOTECH" in a smaller font. To the right of the word "BROAD" is a butterfly-like design. BroadMaster Biotech, Corp. 1F, 100 St, 100 - 100 - 10 - 10 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 7 - 1 - 7 - 1 - 7 - 1 - 7 - 1 - Fax:+886-3-451-9500 Website: www.broadmaster-biotech.com #### Substantial Equivalence Comparison Table ● | Comparison Items | Predicate Device | Subject Device | Remarks | |-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------| | Applicant | BroadMaster Biotech, Corp. | BroadMaster Biotech, Corp. | Same | | Proprietary (Trade) | Advocate Non-Contact Infrared | Advocate Non-Contact Infrared | Same | | Name | Thermometer | Thermometer | | | Model | EF001A | EF001S | Series<br>model | | 510(k) No. | K180355 | K191004 | -- | | Classification Name<br>and Regulation<br>Number | thermometer, electronic, clinical<br>21 CFR 880.2910 | thermometer, electronic, clinical<br>21 CFR 880.2910 | Same | | Product Code | FLL | FLL | Same | | Device Class | II | II | Same | | Intended uses | Advocate Non-Contact Infrared<br>Thermometer is a non-sterile, reusable,<br>handheld device. It can be used by<br>consumers in homecare environment and<br>doctors in clinic as reference. It is intended<br>for measuring human body temperature of<br>all ranges of people by detecting infrared<br>heat from the forehead. | Advocate Non-Contact Infrared<br>Thermometer is a non-sterile, reusable,<br>handheld device. It can be used by<br>consumers in homecare environment and<br>doctors in clinic as reference. It is intended<br>for measuring human body temperature of<br>all ranges of people by detecting infrared<br>heat from the forehead. | Same | | Intended users | Lay user and professional | Lay user and professional | Same | | Measurement<br>method | Infrared radiation detection | Infrared radiation detection | Same | | Measurement mode | Forehead measurement mode | Forehead measurement mode | Same | | Measuring range | Body measurement mode:<br>89.6°F to 109.4°F(32°C - 43 °C) | Body measurement mode:<br>89.6 °F-109.4 °F (32 °C - 43 °C) | Same | | Display resolution | 0.1°F/ 0.1°C | 0.1°F/0.1°C | Same | | C/F unit switchable | Yes | Yes | Same | | Measuring accuracy | Body measurement mode:<br>+0.5 °F / 0.3 °C<br>(93.2 °F -94.8 °F, 34.0 °C-34.8ºC)<br>±0.4 °F/0.2°C<br>(95.0 °F -107.6 °F, 35.0 °C-42.0 °C)<br>±0.5ºF/0.3ºC<br>(107.8 °F-109.4°F, 42.1°C-43.0 °C) | Body measurement mode:<br>±0.5 °F / 0.3 °C<br>(93.2 °F -94.8 °F, 34.0 °C-34.8ºC)<br>±0.4 °F/0.2°C<br>(95.0 °F -107.6 °F, 35.0°C-42.0 °C)<br>±0.5°F/0.3 °C<br>(107.8 °F-109.4 °F, 42.1°C-43.0 °C) | Same | | Display | LCD display | LCD display | Same | | Measurement<br>distance | 2-3.94 inch ( 5-10 cm) | 2-3.94 inch ( 5-10 cm) | Same | | Memory set | 12 sets | 12 sets | Same | | Power source | Two 1.5V AAA alkaline batteries | Two 1.5V AAA alkaline batteries | Same | | Low battery<br>indication | Yes | Yes | Same | | Degree of protection | IP20 | IP20 | Same | | Operating condition | 50.0 °F- 104.0 °F (10.0 °C-40.0 °C)<br>≤ 80% RH | 50.0 °F- 104.0 °F (10.0 °C-40.0 °C)<br>≤ 80% RH | Same | | Storage condition | -13.0 °F-131 °F (-25.0 °C-55.0 °C)<br>≤ 95% RH | -13.0 °F-131 °F (-25.0 °C-55.0 °C)<br>≤ 95% RH | Same | | Cleaning method | The thermometer enclosure and probe can<br>be cleaned and disinfected by 70% alcohol. | The thermometer enclosure and probe can<br>be cleaned and disinfected by 70% alcohol. | Same | | Human -contacting<br>materials | Enclosure of red & black ABS, LCD Lens of<br>PMMA and Probe of Metals | Enclosure of red &black ABS, LCD Lens of<br>PMMA and Probe of Metals | Same | | Biocompatibility | EN ISO 10993-5:2009 &<br>ISO 10993-10:2010 | Complying EN ISO 10993-1:2009 | Same | | Software | Software validation report | Revised software validation report | Different | | Voice function | No | Yes, extra 5 voice hardware: U3, U3A, C10<br>(10 uF), C13(0.1 uF) and Speaker | Different | | EMC | IEC 60601-1-2:2014<br>FCC 47 CFR Part 18, Subpart B | IEC 60601-1-2:2014<br>FCC 47 CFR Part 18, Subpart B | Same | | Electrical Safety | IEC 60601-1: 2005/A1:2012 | ANSI AAMI ES60601-1:2005<br>IEC 60601-1: 2005/A1:2012 | Same | | Performance | ASTM E1965-98(2016)<br>ISO 80601-2-56:2017 | *Declaration of conformity to ASTM<br>E1965-98(2016)<br>*Declaration of conformity to ISO<br>80601-2-56:2017 | Same | | РСВ | FR4 PCB | FR4 PCB | Same | | Materials | Patient contacting materials is ABS (device<br>housing / handle and button). | Patient contacting materials is ABS (device<br>housing / handle and button). | Same | | MCU | HYCON HY11P13<br>8-Bit RISC-like Mixed Signal<br>Microcontroller<br>Embedded 4x20 LCD Driver<br>Low Noise Amplifier<br>18-Bit ADC | HYCON HY11P13<br>8-Bit RISC-like Mixed Signal Microcontroller<br>Embedded 4x20 LCD Driver<br>Low Noise Amplifier<br>18-Bit ADC | Same | | Sensor | GE THERMOPILE IR SENSOR ZTP-148SR | GE THERMOPILE IR SENSOR ZTP-148SR | Same | | LCD | TN LCD | TN LCD | Same | | Speaker | Buzzer | Speaker | Different | {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for Broadmaster Biotech. The logo is in blue and features the words "BROADMASTER" in large, bold letters. Below the main text, the word "BIOTECH" is written in smaller letters. To the right of the text is a stylized image of a butterfly. ## BroadMaster Biotech, Corp. 1F., 2F., No. 91, Xiyuan Rd., Zhongli Dist., Taoyuan City 32057,Taiwan (R.O.C.) Tel:+886-3-451-7600 Fax:+886-3-451-9500 Website: www.broadmaster-biotech.com #### ● Comparison discussion Because the subject device is almost identical to the predicate device, except for the voice function, we will discuss the differences raised by the existence of voice function for the subject device. The software is different due to the addition of the voice function. However, software validation was performed and this difference of software did not raise any new or different questions of safety and effectiveness for the subject device. The extra 5 hardware components used by EF001S due to addition of the voice function are voice ICs:U3, U3A, C10 (10 uF), C13 (0.1 uF) and Speaker. Thus, we subjected the subject {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for Broadmaster Biotech. The logo is in blue and features the words "BROADMASTER" in large, bold letters. Below "BROADMASTER" is the word "BIOTECH" in smaller letters. To the right of the word "BROAD" is a stylized image of a butterfly. BroadMaster Biotech, Corp. 1F., 2F., No. 91, Xiyuan Rd., Zhongli Dist., Taoyuan City 32057,Taiwan (R.O.C.) Tel:+886-3-451-7600 Fax:+886-3-451-9500 Website: www.broadmaster-biotech.com device EF001S to meeting the provisions of Safety and EMC standards, i.e., ANSI AAMIES60601-1:2005, IEC 60601-1-2:2014, and FCC 47 CFR Part 18, Subpart B. This voice function is not intended for use by vision-impaired patients, and it is an auxiliary function for the lay users and medical professionals. So the voice function brings some convenience to the lay users and professionals. Regarding the extra 5 hardware components used by the subject device, there is no different or new safety and effectiveness questions. #### Non-Clinical Testing ● | Testing name | Referenced standard | Summary result | Verdict | |--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------| | Electric safety testing | ANSI AAMIES60601-1:2005<br>Medical electrical equipment - Part 1:<br>General requirements for basic safety<br>and essential performance<br>FDA recognition number: 19-4 | The subject device complies with<br>the applicable requirements set<br>forth in the referenced electric<br>safety standard, ANSI<br>AAMIES60601-1:2005. | Pass | | EMC testing | IEC60601-1-2:2014 Medical electrical<br>equipment - Part 1-2: General<br>requirements for basic safety and<br>essential performance - Collateral<br>Standard: Electromagnetic<br>disturbances- Requirements and tests,<br>FDA recognition number: 19-8 | The subject device complies with<br>the applicable requirements set<br>forth in the referenced EMC<br>standard, IEC 60601-1-2:2014. | Pass | | | FCC 47 CFR Part 18: Industrial,<br>Scientific, And Medical Equipment,<br>Subpart B:Applications and<br>Authorizations | The subject device complies with<br>the applicable requirements set<br>forth in the referenced EMC<br>standard, FCC 47 CFR Part 18. | Pass | | Performance testing | ISO 80601-2-56: 2017.<br>Medical electrical equipment –<br>Part 2-56: Particular requirements for<br>basic safety and essential performance<br>of clinical thermometers for body<br>temperature measurement<br>FDA recognition number: 6-403 | The subject device complies with<br>the applicable requirements set<br>forth in the referenced<br>performance standard, ISO<br>80601-2-56:2017. | Pass | | Biocompatibility testing | EN ISO 10993-1:2018<br>Biological evaluation of medical<br>devices -- Part 1: Evaluation and testing<br>within a risk management process<br>FDA recognition number: 2-258 | The subject device EF001S has<br>the same human-contacting<br>materials as predicate device<br>EF001A. There is no need to<br>proceed the biocompatibility<br>evaluation according to EN ISO<br>10993-1-2018 | Pass | {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the logo for Broadmaster Biotech. The logo is blue and features the words "BROADMASTER" in large, bold letters. Below the word "MASTER" is the word "BIOTECH" in smaller letters. To the right of the word "BROAD" is a stylized image of a butterfly. ## BroadMaster Biotech, Corp. 1F., 2F., No. 91, Xiyuan Rd., Zhongli Dist., Taoyuan City 32057,Taiwan (R.O.C.) Tel:+886-3-451-7600 Fax:+886-3-451-9500 Website: www.broadmaster-biotech.com | Revised Software<br>Validation Report | Guidance for the Content of Premarket<br>Submissions for Software Contained in<br>Medical Devices, issued on May<br>11,2005 | The software contained inthe<br>subject devicecomplies with the<br>applicable requirements setforth<br>in the referenced guidance<br>document, “Guidance for the<br>Contentof Premarket<br>Submissions forSoftware<br>Contained, issue done May 11,<br>2005. | Pass | |---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------| |---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------| #### ● Clinical Testing | Name of<br>clinical<br>testing | Referenced standard | Summary of testing | Patient<br>population (age<br>groups,<br>number of<br>subjects) | Verdict | |--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|---------| | EF001Clinical<br>Accuracy | *ASTM E1965-98(2016)<br>Standard Specification for<br>Infrared Thermometers for<br>Intermittent Determination of<br>Patient Temperature<br>FDA recognition number: 6-125 | The methods and criteria of<br>EF001 Clinical Test had been<br>clinically assessed to meet the<br>requirements of clinical<br>accuracy per the referenced<br>standards. | 40 subjects in<br>each age group,<br>infants (0-1<br>year), children<br>(1-5 years) and<br>adults (>5 years)<br>(Total 120<br>subjects) | Pass | #### ● Conclusion Non-clinical performance and clinical tests were conducted on the subject device and all tests met specified criteria. Based on the information provided in this submission the subject device, Advocate Non-Contact Infrared Thermometer, EF001S, is substantially equivalent to the predicate device, EF001A.