(92 days)
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.
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.
The Braun BFH175 Infrared Forehead Thermometer was evaluated through non-clinical and clinical testing.
Here's a breakdown of the acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
| Device Modification | Associated Risks | Performance Standard | Acceptance Criteria | Result |
|---|---|---|---|---|
| Updated industrial design with PCB layout change | Incorrect reading or minor electrical shock to user | EN 60601-1:2014 | Touch current: 100 µA NC; 500 µAPatient leakage current: 10 µA NC; 50 µA SFC (DC current)Patient leakage current w/ mains on the BF-type applied parts: Type BF: 5000 µA | Pass |
| Updated industrial design with PCB layout change | Incorrect reading | IEC 60601-1-2:2014 | Radiated RF EM fields: 10 V/m; 80 MHz – 2.7 GHzRF wireless communications equipment immunity: 9 - 28 V/m; 385 – 5785 MHz; 0.2 to 2.0 Watts at 1 m; Multiple services and modulationsRated power frequency magnetic fields: 30 A/m; 50 Hz or 60 Hz | Pass |
| Updated industrial design | Incorrect reading or minor electrical shock to user | IEC 60601-1-11:2015 | Ingress Protection: IP22 | Pass |
| Updated industrial design | Incorrect reading or minor electrical shock to user | ASTM E1965-98:2016 | Shock / Drop: Absolute value of the largest error out of five (5) measurements of a blackbody at 37 ± 0.5°C, in an ambient environment of 20 - 26°C and 40 - 70% relative humidity, taken after the device is subjected to a fall from a height of 1 meter, is less than or equal to ± 0.2°C | Pass |
| Removal of digital proximity sensor (Clinical Performance) | Incorrect reading | ISO 80601-2-56:2017 | Bias: Bias for the test device should be non-inferior to the bias of the predicate device when compared to the reference, and ≤ ±0.20°CStandard Deviation: Standard Deviation for test device should be equivalent to or less than the Standard Deviation of the predicate deviceRepeatability: Repeatability for test device should be ≤ ±0.3°C | Pass |
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated in the provided text for the clinical study. It is referred to as a "controlled human clinical study."
- Data Provenance: The nature of the clinical study (multi-center, randomized) suggests it was a prospective study. The country of origin of the data is not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document.
4. Adjudication method for the test set
This information is not provided in the document.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
An MRMC study was not conducted. This device is an infrared thermometer, not an AI-assisted diagnostic tool that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone performance evaluation was done as part of the clinical study, specifically for the device's accuracy (bias, standard deviation, repeatability) against a reference. The device being a thermometer, its primary function is standalone measurement.
7. The type of ground truth used
For the clinical performance, the ground truth was a reference measurement against which the device's bias, standard deviation, and repeatability were compared. The specific nature of this reference is implicitly tied to the ASTM E1965-98:2016 and ISO 80601-2-56:2017 standards, which typically involve highly accurate reference thermometers.
8. The sample size for the training set
The document does not describe a "training set" as would be relevant for machine learning models. The clinical study described is for validation, not training.
9. How the ground truth for the training set was established
Not applicable, as there is no mention of a training set for a machine learning model.
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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);
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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely. Geeta K. Pamidimukkala -ഗ
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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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)
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Section 5: 510(k) Summary
l. 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 ofComparison | Subject Device: BraunBFH175 Infrared ForeheadThermometer | Predicate Device: Braun NoTouch + Forehead NTF3000Thermometer | Discussion |
|---|---|---|---|
| Manufacturer(Legal) | Kaz USA, Inc., a Helen of TroyCompany | Kaz USA, Inc., a Helen of TroyCompany | |
| ContractManufacturer | AVITA Corporation | AVITA Corporation | |
| ThermometerType | Infrared Forehead Thermometer | Infrared Forehead Thermometer | The devices have thesame fundamentalscientific technologyand use the samephysiologic temperaturemeasurement site. |
| Models(Configuration) | Braun BFH175 InfraredForehead Thermometer | The Braun No Touch + ForeheadNTF3000 Thermometer | |
| Element ofComparison | Subject Device: BraunBFH175 Infrared ForeheadThermometer | Predicate Device: Braun NoTouch + Forehead NTF3000Thermometer | Discussion |
| 510(k) Number | K181015 | K163516 | |
| Intended Use | The Braun BFH175 InfraredForehead Thermometer is anon-sterile, reusable, clinicalthermometer intended for theintermittent determination ofhuman body temperature in atouch mode using the center ofthe forehead as themeasurement site on people ofall ages. | The Braun No Touch + ForeheadNTF3000 Thermometer is a non-sterile, reusable, clinicalthermometer intended for theintermittent determination ofhuman body temperature in atouch and no touch mode usingthe center of the forehead as themeasurement site on people ofall ages. | The intended use of themodified device isrestricted to only the"Touch" measurementmode, which is part ofthe intended use of theoriginal, predicatedevice. |
| Labeling | Instructions for use, package,and rating label | Instructions for use, package,and rating label | The change in labelingis restricted to "Touch"mode only temperaturemeasurement and thememory feature of themodified device. |
| Components | Power button, temperaturemeasurement button, scanner,silent mode switch, protectivecap, microcontroller, & LCD | Power button, temperaturemeasurement button, scanner,silent mode switch, protectivecap, microcontroller, & LCD | Identical |
| Features | Fever Insight temperatureguidance feature and memoryfeature | Fever Insight temperatureguidance feature | The modified devicehas a memory featureto store the most recenttemperature reading. Itdoes not affect thesafety or effectivenessof the device. |
| Sensor | Infrared | Infrared | Identical |
| Principles ofOperation | The thermometer uses athermopile sensor withintegrated thermistor for thetarget reading and a thermistormounted in the head of thethermometer for ambienttemperature readings. | The thermometer uses athermopile sensor with integratedthermistor for the target reading, athermistor mounted in the head ofthe thermometer for ambienttemperature readings, a parabolicmirror to help focus the infraredenergy emitted from the forehead,and an infrared proximity sensorfor detection of contact or non-contact use and compensation ofthe temperature reading. | The modified devicedoes not have aproximity sensor due toremoval of "No Touch"temperaturemeasurement mode. |
| OperatingEnvironment(Specifications) | 15°C to 40°C(59°F to 104°F);15-95% Relative Humidity | 15°C to 40°C(59°F to 104°F);15-95% Relative Humidity | Identical |
| StorageEnvironment(Specifications) | -25°C to 55°C(-13°F to 131°F);15-95% Relative Humidity700-1060 hPA(0.7-1.06 atm) | -25°C to 60°C(-13°F to 140°F);15-95% Relative Humidity700-1060 hPA(0.7-1.06 atm) | The modified devicehas a lower storagetemperature maximumlimit. This does notaffect the safety oreffectiveness of thedevice. |
| Resolution ofDisplay | 0.1°C / 0.1°F | 0.1°C / 0.1°F | Identical |
| Element ofComparison | Subject Device: BraunBFH175 Infrared ForeheadThermometer | Predicate Device: Braun NoTouch + Forehead NTF3000Thermometer | Discussion |
| MeasurementRange | 34.0°C to 43.0°C(93.2°F to 109.4°F) | 34.4°C to 42.2°C(93.9°F to 108.0°F) | The modified devicehas a slightly largermeasurement range.This does not affect thesafety or effectivenessof the device. |
| Accuracy(Specifications) | ± 0.2°C (± 0.36°F)35.0°C to 42.0°C(95.0°F to 107.6°F);± 0.3°C (± 0.54°F)34.0°C to 35.0°C(93.2°F to 95.0°F);± 0.3°C (± 0.54°F)Above 42.0°C(Above 107.6°F); | ± 0.2°C (± 0.36°F)35.0°C to 42.0°C(95.0°F to 107.6°F);± 0.3°C (± 0.54°F)34.4°C to 35.0°C(93.9°F to 95.0°F);± 0.3°C (± 0.54°F)Above 42.0°C(Above 107.6°F); | Identical from 35.0°C to42.0°C (95.0°F to107.6°F). The modifieddevice has a slightly largermeasurement range,extending the range forwhich it is accurate to ±0.3°C (±0.54°F). Thisdoes not affect the safetyor effectiveness of thedevice. |
| MCU | Sonix SN8P2949 - A high-performance, 8-bit micro-controller with 8K-word OTPROM, including 256 bytes ofRAM, one 8-bit basic timerfunction, two 8-bit counters /timers, a watchdog timer, 6-source interrupts, in-systemprogramming ROM function withVPP voltage generation internallyfor calibration data programmingin ROM, a 20-bit ADC, a PGIA,three voltage regulators includingAVDDR, AVE+ & VLED modulefor LED driving, an integrated R &C-Type LCD driver for 4-commonx 32-segments LCD panel, 8-level stack register, & a dualclock system (4MHz high-speedRC oscillator, on-chip low speedRC oscillator circuit). | Weltrend WT5075F - A high-speed, high-performance and lowpower consumption 8-bit micro-controller, including Turbo 8052CPU, 64K bytes embeddedFlash, 256-byte direct-or-indirect-addressing SRAM, 2K-byteindirect-addressing-only SRAM,40x4(max.) LCD driver, a Time-Base Timer, 4 multi-functiontimer/counters, 2-channel 12-bitPWM, 1-channel divider output,serial interface (UART and SPI),19-channel (15 external and 4internal) 12-bit AD converter, 4high-performance OPs, analogswitches and three clockgenerators (32.768kHz crystaloscillator, high-speed crystaloscillator and high-speed RCoscillator) on chip. | Similar. Functionallyequivalent, alternatepart, which does notaffect the safety oreffectiveness of thedevice. |
| Power Supply | Two (2), AAA batteries | Two (2), AA batteries | Similar |
| Signal Outputand Display | LCD, Buzzer | LCD, Buzzer | Identical |
| Battery Life | At least 500 readings | At least 1000 readings | Similar |
| Materials | User contacting materialsinclude ABS (device housing /handle and power button), TPR(temperature button andforehead touch bumper), andPMMA (LCD lens and protectivescanner cap). | User contacting materialsinclude ABS (device housing /handle and power button), TPR(temperature button andforehead touch bumper), andPMMA (LCD lens and protectivescanner cap). | Identical |
| Biocompatibility | Meets ISO 10993-1:2009,10993-5:2009, 10993-10:2010,& FDA Guidance Document,"Use of International StandardISO 10993-1:2009", June 16, 2016 | Meets ISO 10993-1, 10993-5,and 10993-10, and FDABluebook memo G95-1 | No change in materials |
| Element ofComparison | Subject Device: BraunBFH175 Infrared ForeheadThermometer | Predicate Device: Braun NoTouch + Forehead NTF3000Thermometer | Discussion |
| Performance | Meets ASTM E 1965:2016 andISO 80601-2-56:2017 | Meets ASTM E 1965 and ISO80601-2-56 | 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
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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:
| DeviceModification | AssociatedRisks | Performance Standard | Acceptance Criteria | Result |
|---|---|---|---|---|
| Updatedindustrialdesign withPCB layoutchange | Incorrectreading orminorelectricalshock touser | EN 60601-1:2014: | Touch current:100 µA NC; 500 µAPatient leakage current:10 µA NC; 50 µA SFC (DC current)Patient leakage current w/ mains on theBF-type applied parts:Type BF: 5000 µA | Pass |
| Updatedindustrialdesign withPCB layoutchange | Incorrectreading | IEC 60601-1-2:2014: | Radiated RF EM fields:10 V/m; 80 MHz – 2.7 GHzRF wireless communications equipmentimmunity:9 - 28 V/m; 385 – 5785 MHz;0.2 to 2.0 Watts at 1 m;Multiple services and modulationsRated power frequency magnetic fields:30 A/m; 50 Hz or 60 Hz | Pass |
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| DeviceModification | AssociatedRisks | Performance Standard | Acceptance Criteria | Result |
|---|---|---|---|---|
| Updatedindustrialdesign | Incorrectreading orminorelectricalshock touser | IEC 60601-1-11:2015: | Ingress Protection:IP22 | Pass |
| Updatedindustrialdesign | Incorrectreading orminorelectricalshock touser | ASTM E1965-98:2016: | Shock / Drop:Absolute value of the largest error outof five (5) measurements of ablackbody at 37 ± 0.5°C, in an ambientenvironment of 20 - 26°C and 40 - 70%relative humidity, taken after the deviceis subjected to a fall from a height of 1meter, is less than or equal to ± 0.2°C | Pass |
| Removal ofdigitalproximitysensor | Incorrectreading | ISO 80601-2-56:2017 | Bias:Bias for the test device should be non-inferior to the bias of the predicatedevice when compared to thereference, and ≤ ±0.20°CStandard Deviation:Standard Deviation for test deviceshould be equivalent to or less than theStandard Deviation of the predicatedeviceRepeatability:Repeatability for test device should be≤ ±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.
§ 880.2910 Clinical electronic thermometer.
(a)
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.(b)
Classification. Class II (performance standards). The device is exempt from the premarket notification procedures in part 807, subpart E of this chapter, subject to the limitations in § 880.9 and the following conditions for exemption:(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.