Braun BFH175 Infrared Forehead Thermometer

{0}------------------------------------------------ Image /page/0/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. July 18, 2018 Kaz USA, Inc., a Helen of Troy Company Matt J. Baun Associate Director of Clinical & Regulatory Affairs 400 Donald Lynch Boulevard, Suite 300 Marlborough, Massachusetts 01752 Re: K181015 Trade/Device Name: Braun BFH175 Infrared Forehead Thermometer Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: June 21, 2018 Received: June 22, 2018 Dear Mr. Matt J. Baun: 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); {1}------------------------------------------------ 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. 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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) K181015 Device Name Braun BFH175 Infrared Forehead Thermometer Indications for Use (Describe) The Braun BFH175 Infrared Forehead Thermometer is a non-sterile, clinical thermometer intended for the intermittent determination of human body temperature in a touch mode using the center of the forehead as the measurement site on people of all ages. | 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. 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SUBMITTER Kaz USA, Inc., a Helen of Troy Company 400 Donald Lynch Blvd., Suite 300 Marlborough, MA 01752 Phone: (508) 490-7240 Fax: (508) 251-1048 Contact Person: Matt J. Baun, Associate Director of Clinical & Requlatory Affairs Date Prepared: 7-May-2018 #### II. DEVICE Name of Device: Braun BFH175 Infrared Forehead Thermometer Common or Usual Name: Infrared Skin Thermometer Regulation Medical Specialty / 510k Review Panel: General Hospital Classification Name: Thermometer, Clinical, Electronic (21CFR 880.2910) Requlatory Class: II Product Code: FLL #### = PREDICATE DEVICE Braun No Touch + Forehead NTF3000 Thermometer, 510(k) # K163516 #### IV. DEVICE DESCRIPTION The Braun BFH175 Infrared Forehead Thermometer is a hand-held, battery powered, infrared thermometer that converts a user's forehead temperature, using the infrared energy emitted in the user's forehead, to an oral equivalent temperature when placed in contact with the subject's forehead. It uses a thermopile sensor with integrated thermistor for the target reading and a thermistor mounted in the head of the thermometer for ambient temperature readings. #### V. INDICATIONS FOR USE The Braun BFH175 Infrared Forehead Thermometer is a non-sterile, reusable, clinical thermometer intended for the intermittent determination of human body temperature in a touch mode using the center of the forehead as the measurement site on people of all ages. | Element of<br>Comparison | Subject Device: Braun<br>BFH175 Infrared Forehead<br>Thermometer | Predicate Device: Braun No<br>Touch + Forehead NTF3000<br>Thermometer | Discussion | |----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer<br>(Legal) | Kaz USA, Inc., a Helen of Troy<br>Company | Kaz USA, Inc., a Helen of Troy<br>Company | | | Contract<br>Manufacturer | AVITA Corporation | AVITA Corporation | | | Thermometer<br>Type | Infrared Forehead Thermometer | Infrared Forehead Thermometer | The devices have the<br>same fundamental<br>scientific technology<br>and use the same<br>physiologic temperature<br>measurement site. | | Models<br>(Configuration) | Braun BFH175 Infrared<br>Forehead Thermometer | The Braun No Touch + Forehead<br>NTF3000 Thermometer | | | Element of<br>Comparison | Subject Device: Braun<br>BFH175 Infrared Forehead<br>Thermometer | Predicate Device: Braun No<br>Touch + Forehead NTF3000<br>Thermometer | Discussion | | 510(k) Number | K181015 | K163516 | | | Intended Use | The Braun BFH175 Infrared<br>Forehead Thermometer is a<br>non-sterile, reusable, clinical<br>thermometer intended for the<br>intermittent determination of<br>human body temperature in a<br>touch mode using the center of<br>the forehead as the<br>measurement site on people of<br>all ages. | The Braun No Touch + Forehead<br>NTF3000 Thermometer is a non-<br>sterile, reusable, clinical<br>thermometer intended for the<br>intermittent determination of<br>human body temperature in a<br>touch and no touch mode using<br>the center of the forehead as the<br>measurement site on people of<br>all ages. | The intended use of the<br>modified device is<br>restricted to only the<br>"Touch" measurement<br>mode, which is part of<br>the intended use of the<br>original, predicate<br>device. | | Labeling | Instructions for use, package,<br>and rating label | Instructions for use, package,<br>and rating label | The change in labeling<br>is restricted to "Touch"<br>mode only temperature<br>measurement and the<br>memory feature of the<br>modified device. | | Components | Power button, temperature<br>measurement button, scanner,<br>silent mode switch, protective<br>cap, microcontroller, & LCD | Power button, temperature<br>measurement button, scanner,<br>silent mode switch, protective<br>cap, microcontroller, & LCD | Identical | | Features | Fever Insight temperature<br>guidance feature and memory<br>feature | Fever Insight temperature<br>guidance feature | The modified device<br>has a memory feature<br>to store the most recent<br>temperature reading. It<br>does not affect the<br>safety or effectiveness<br>of the device. | | Sensor | Infrared | Infrared | Identical | | Principles of<br>Operation | The thermometer uses a<br>thermopile sensor with<br>integrated thermistor for the<br>target reading and a thermistor<br>mounted in the head of the<br>thermometer for ambient<br>temperature readings. | The thermometer uses a<br>thermopile sensor with integrated<br>thermistor for the target reading, a<br>thermistor mounted in the head of<br>the thermometer for ambient<br>temperature readings, a parabolic<br>mirror to help focus the infrared<br>energy emitted from the forehead,<br>and an infrared proximity sensor<br>for detection of contact or non-<br>contact use and compensation of<br>the temperature reading. | The modified device<br>does not have a<br>proximity sensor due to<br>removal of "No Touch"<br>temperature<br>measurement mode. | | Operating<br>Environment<br>(Specifications) | 15°C to 40°C<br>(59°F to 104°F);<br>15-95% Relative Humidity | 15°C to 40°C<br>(59°F to 104°F);<br>15-95% Relative Humidity | Identical | | Storage<br>Environment<br>(Specifications) | -25°C to 55°C<br>(-13°F to 131°F);<br>15-95% Relative Humidity<br>700-1060 hPA<br>(0.7-1.06 atm) | -25°C to 60°C<br>(-13°F to 140°F);<br>15-95% Relative Humidity<br>700-1060 hPA<br>(0.7-1.06 atm) | The modified device<br>has a lower storage<br>temperature maximum<br>limit. This does not<br>affect the safety or<br>effectiveness of the<br>device. | | Resolution of<br>Display | 0.1°C / 0.1°F | 0.1°C / 0.1°F | Identical | | Element of<br>Comparison | Subject Device: Braun<br>BFH175 Infrared Forehead<br>Thermometer | Predicate Device: Braun No<br>Touch + Forehead NTF3000<br>Thermometer | Discussion | | Measurement<br>Range | 34.0°C to 43.0°C<br>(93.2°F to 109.4°F) | 34.4°C to 42.2°C<br>(93.9°F to 108.0°F) | The modified device<br>has a slightly larger<br>measurement range.<br>This does not affect the<br>safety or effectiveness<br>of the device. | | Accuracy<br>(Specifications) | ± 0.2°C (± 0.36°F)<br>35.0°C to 42.0°C<br>(95.0°F to 107.6°F);<br>± 0.3°C (± 0.54°F)<br>34.0°C to 35.0°C<br>(93.2°F to 95.0°F);<br>± 0.3°C (± 0.54°F)<br>Above 42.0°C<br>(Above 107.6°F); | ± 0.2°C (± 0.36°F)<br>35.0°C to 42.0°C<br>(95.0°F to 107.6°F);<br>± 0.3°C (± 0.54°F)<br>34.4°C to 35.0°C<br>(93.9°F to 95.0°F);<br>± 0.3°C (± 0.54°F)<br>Above 42.0°C<br>(Above 107.6°F); | Identical from 35.0°C to<br>42.0°C (95.0°F to<br>107.6°F). The modified<br>device has a slightly larger<br>measurement range,<br>extending the range for<br>which it is accurate to ±<br>0.3°C (±0.54°F). This<br>does not affect the safety<br>or effectiveness of the<br>device. | | MCU | Sonix SN8P2949 - A high-<br>performance, 8-bit micro-<br>controller with 8K-word OTP<br>ROM, including 256 bytes of<br>RAM, one 8-bit basic timer<br>function, two 8-bit counters /<br>timers, a watchdog timer, 6-<br>source interrupts, in-system<br>programming ROM function with<br>VPP voltage generation internally<br>for calibration data programming<br>in ROM, a 20-bit ADC, a PGIA,<br>three voltage regulators including<br>AVDDR, AVE+ & VLED module<br>for LED driving, an integrated R &<br>C-Type LCD driver for 4-common<br>x 32-segments LCD panel, 8-<br>level stack register, & a dual<br>clock system (4MHz high-speed<br>RC oscillator, on-chip low speed<br>RC oscillator circuit). | Weltrend WT5075F - A high-<br>speed, high-performance and low<br>power consumption 8-bit micro-<br>controller, including Turbo 8052<br>CPU, 64K bytes embedded<br>Flash, 256-byte direct-or-indirect-<br>addressing SRAM, 2K-byte<br>indirect-addressing-only SRAM,<br>40x4(max.) LCD driver, a Time-<br>Base Timer, 4 multi-function<br>timer/counters, 2-channel 12-bit<br>PWM, 1-channel divider output,<br>serial interface (UART and SPI),<br>19-channel (15 external and 4<br>internal) 12-bit AD converter, 4<br>high-performance OPs, analog<br>switches and three clock<br>generators (32.768kHz crystal<br>oscillator, high-speed crystal<br>oscillator and high-speed RC<br>oscillator) on chip. | Similar. Functionally<br>equivalent, alternate<br>part, which does not<br>affect the safety or<br>effectiveness of the<br>device. | | Power Supply | Two (2), AAA batteries | Two (2), AA batteries | Similar | | Signal Output<br>and Display | LCD, Buzzer | LCD, Buzzer | Identical | | Battery Life | At least 500 readings | At least 1000 readings | Similar | | Materials | User contacting materials<br>include ABS (device housing /<br>handle and power button), TPR<br>(temperature button and<br>forehead touch bumper), and<br>PMMA (LCD lens and protective<br>scanner cap). | User contacting materials<br>include ABS (device housing /<br>handle and power button), TPR<br>(temperature button and<br>forehead touch bumper), and<br>PMMA (LCD lens and protective<br>scanner cap). | Identical | | Biocompatibility | Meets ISO 10993-1:2009,<br>10993-5:2009, 10993-10:2010,<br>& FDA Guidance Document,<br>"Use of International Standard<br>ISO 10993-1:2009", June 16, 2016 | Meets ISO 10993-1, 10993-5,<br>and 10993-10, and FDA<br>Bluebook memo G95-1 | No change in materials | | Element of<br>Comparison | Subject Device: Braun<br>BFH175 Infrared Forehead<br>Thermometer | Predicate Device: Braun No<br>Touch + Forehead NTF3000<br>Thermometer | Discussion | | Performance | Meets ASTM E 1965:2016 and<br>ISO 80601-2-56:2017 | Meets ASTM E 1965 and ISO<br>80601-2-56 | Identical | | Safety | Meets EN 60601-1:2014 | Meets IEC 60601-1 | Identical | | EMC | Meets IEC 60601-1-2:2014 | Meets IEC 60601-1-2 | Identical | #### VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE {4}------------------------------------------------ {5}------------------------------------------------ {6}------------------------------------------------ Based on the comparison chart above, there have been no changes to the intended use or product specifications of the Braun BFH175 Infrared Forehead Thermometer from those of the predicate device, the Braun No Touch + Forehead NTF3000 Thermometer, the fundamental operating principle of the thermometer is identical to that of the predicate device, and there was no change to any material on the outside of the unit from those used on the Braun No Touch + Forehead NTF3000 Thermometer. The changes associated with the removal of the digital proximity sensor and updated industrial design. which include a different PCB lavout. different microprocessor, and some different hardware components, have been verified and validated via laboratory testing and a pivotal clinical study. Through the verification and validation process, it has been shown that the differences do not raise new questions of safety and effectiveness. #### NON-CLINICAL TESTING & PERFORMANCE DATA VII. The entire Hazard Analysis for the Braun BFH175 Infrared Forehead Thermometer was evaluated to identify all the risks / hazards that could be affected by the modifications to the Braun No Touch + Forehead NTF3000 Thermometer. These risks were mitigated using planned measures that included testing to recognized FDA consensus standards. Changes in software were verified and validated using the software development process. The clinical accuracy of the thermometer was validated through a multi-center, randomized clinical study. All results were within the acceptance criteria. The following table, which includes a summary of non-clinical testing data conducted according to FDA recognized consensus standards, is provided in support of the substantial equivalence determination: | Device<br>Modification | Associated<br>Risks | Performance Standard | Acceptance Criteria | Result | |--------------------------------------------------------------|--------------------------------------------------------------------|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------| | Updated<br>industrial<br>design with<br>PCB layout<br>change | Incorrect<br>reading or<br>minor<br>electrical<br>shock to<br>user | EN 60601-1:2014: | Touch current:<br>100 µA NC; 500 µA<br>Patient leakage current:<br>10 µA NC; 50 µA SFC (DC current)<br>Patient leakage current w/ mains on the<br>BF-type applied parts:<br>Type BF: 5000 µA | Pass | | Updated<br>industrial<br>design with<br>PCB layout<br>change | Incorrect<br>reading | IEC 60601-1-2:2014: | Radiated RF EM fields:<br>10 V/m; 80 MHz – 2.7 GHz<br>RF wireless communications equipment<br>immunity:<br>9 - 28 V/m; 385 – 5785 MHz;<br>0.2 to 2.0 Watts at 1 m;<br>Multiple services and modulations<br>Rated power frequency magnetic fields:<br>30 A/m; 50 Hz or 60 Hz | Pass | {7}------------------------------------------------ | Device<br>Modification | Associated<br>Risks | Performance Standard | Acceptance Criteria | Result | |----------------------------------------------|--------------------------------------------------------------------|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------| | Updated<br>industrial<br>design | Incorrect<br>reading or<br>minor<br>electrical<br>shock to<br>user | IEC 60601-1-11:2015: | Ingress Protection:<br>IP22 | Pass | | Updated<br>industrial<br>design | Incorrect<br>reading or<br>minor<br>electrical<br>shock to<br>user | ASTM E1965-98:2016: | Shock / Drop:<br>Absolute value of the largest error out<br>of five (5) measurements of a<br>blackbody at 37 ± 0.5°C, in an ambient<br>environment of 20 - 26°C and 40 - 70%<br>relative humidity, taken after the device<br>is subjected to a fall from a height of 1<br>meter, is less than or equal to ± 0.2°C | Pass | | Removal of<br>digital<br>proximity<br>sensor | Incorrect<br>reading | ISO 80601-2-56:2017 | Bias:<br>Bias for the test device should be non-<br>inferior to the bias of the predicate<br>device when compared to the<br>reference, and ≤ ±0.20°C<br>Standard Deviation:<br>Standard Deviation for test device<br>should be equivalent to or less than the<br>Standard Deviation of the predicate<br>device<br>Repeatability:<br>Repeatability for test device should be<br>≤ ±0.3°C | Pass | #### VIII. CLINICAL TESTING A controlled human clinical study was conducted using the Braun BFH175 Infrared Forehead Thermometer. The test report demonstrated that the clinical data, represented by Clinical Bias, with its Standard Deviation or Limits of Agreement, and Clinical Repeatability, met the acceptance criteria of the clinical study protocol. developed in accordance with ASTM E1965-98:2016 and ISO 80601-2-56:2017. #### IX. CONCLUSION A risk analysis was performed to identify risks associated with the device modifications. Verification and validation tests have been performed to demonstrate that the identified risks have been mitigated. The testing demonstrates that the modified Braun BFH175 Infrared Forehead Thermometer is substantially equivalent to the predicate device.