The Braun BNT400 No Touch + Forehead Thermometer is a non-sterile, reusable, clinical thermometer intended for the intermittent determination of human body temperature in a touch and no touch mode using the center of the forehead as the measurement site on people of all ages.

Device Description

The Braun BNT400 No Touch + Forehead Thermometer is a hand-held, battery powered, infrared thermometer that converts a user's forehead temperature, using the infrared energy emitted in the area around the user's forehead, to an oral equivalent temperature when placed in contact with the subject's forehead or within one inch of 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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and the study performed for the Braun BNT400 No Touch + Forehead Thermometer:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence to a predicate device (Braun No Touch + Forehead NTF3000 Thermometer, K163516). The acceptance criteria are largely based on meeting recognized consensus standards, particularly related to clinical accuracy and safety.

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Electrical Safety	EN 60601-1:2014: - Touch current: 100 µA NC; 500 µA- Patient 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
EMC	IEC 60601-1-2:2014: - Radiated RF EM fields: 10 V/m; 80 MHz - 2.7 GHz- RF wireless communications equipment immunity: 9 - 28 V/m; 385 - 5785 MHz; 0.2 to 2.0 Watts at 1 m; Multiple services and modulations- Rated power frequency magnetic fields: 30 A/m; 50 Hz or 60 Hz	Pass
Ingress Protection	IEC 60601-1-11:2015: - Ingress Protection: IP22	Pass
Shock / Drop	ASTM E1965-98:2016: - 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
Clinical Accuracy (Bias)	ISO 80601-2-56:2017: - Bias for the test device should be non-inferior to the bias of the predicate device when compared to the reference, and ≤ ±0.20°C	Pass
Clinical Accuracy (Std Dev)	ISO 80601-2-56:2017: - Standard Deviation for test device should be equivalent to or less than the Standard Deviation of the predicate device	Pass
Clinical Accuracy (Repeatability)	ISO 80601-2-56:2017: - Repeatability for test device should be ≤ ±0.3°C	Pass
Usability / Use Errors	IEC 62366-1:2015 & IEC 60601-1-6:2010: - No more than five (5) Use Errors observed for any Critical Task	Pass

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: The document states that a "controlled human clinical study was conducted" and tested to "ASTM E1965-98:2016 and ISO 80601-2-56:2017." However, the specific number of subjects/measurements (sample size) for this clinical study is not explicitly provided in the given text.
Data Provenance: The document only mentions "multi-center, randomized clinical study." It does not specify the country of origin of the data or whether it was retrospective or prospective. Given it's a clinical study, it would be prospective, but this is not explicitly stated.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

Not Applicable. For a clinical thermometer, the ground truth is typically established by comparing the device's readings against established reference temperature measurement methods (like rectal or oral temperatures in a clinical setting) using a standardized protocol outlined in standards like ASTM E1965 or ISO 80601-2-56. There isn't an "expert" consensus in the same way there would be for image interpretation.

4. Adjudication Method for the Test Set:

Not Applicable. As mentioned above, the assessment of a clinical thermometer's accuracy involves direct comparison to a reference standard, not expert adjudication of subjective findings.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

No. An MRMC study is relevant for diagnostic devices where human readers interpret data (e.g., medical images). This is a clinical thermometer, which is a direct measurement device. Therefore, an MRMC study was not conducted.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Yes, indirectly. The performance evaluation of the thermometer, particularly its clinical accuracy (bias, standard deviation, repeatability), represents the standalone performance of the device. The device is intended for direct temperature measurement, not as an assistive tool for a human.

7. The Type of Ground Truth Used:

Reference Standard Temperature Measurement. The ground truth for the clinical accuracy study was established by comparing the thermometer's readings against a "reference" measurement, as stipulated by the ASTM E1965-98:2016 and ISO 80601-2-56:2017 standards for clinical thermometers. These standards typically involve comparison to an invasive, highly accurate reference thermometer (e.g., rectal probe) in a controlled clinical setting. The document states "compared to the reference."

8. The Sample Size for the Training Set:

The document does not mention a training set sample size. Clinical thermometers, especially prior to the widespread use of sophisticated machine learning, are typically designed and calibrated based on engineering principles and validated through clinical testing, rather than "trained" in the machine learning sense. If there are internal algorithms for temperature compensation or conversion, their parameters would be derived from physical models or internal testing, not usually a distinct "training set" as understood in AI/ML contexts.

9. How the Ground Truth for the Training Set Was Established:

Not Applicable. (See point 8). If any internal calibration or algorithm tuning occurred, it would have been based on established physical laws and engineering principles, likely utilizing highly controlled laboratory conditions with reference temperature sources. The document does not describe such a process as "training."

Summary

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July 23, 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: K181242

Trade/Device Name: Braun BNT400 No Touch + Forehead Thermometer Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: June 29, 2018 Received: July 2, 2018

Dear 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 -S

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)

K181242

Device Name Braun BNT400 No Touch + Forehead Thermometer

Indications for Use (Describe)

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: 10-May-2018

II. DEVICE

Name of Device: Braun BNT400 No Touch + 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(S)

Braun No Touch + Forehead NTF3000 Thermometer, 510(k) # K163516

IV. DEVICE DESCRIPTION

V. INDICATIONS FOR USE

Element ofComparison	Subject Device: BraunBNT400 No Touch + ForeheadThermometer	Predicate Device: Braun NoTouch + Forehead NTF3000Thermometer	Reason forSubstantialEquivalence
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 technology anduse the samephysiologic temperaturemeasurement site.
Models(Configuration)	Braun BNT400 No Touch +Forehead Thermometer	The Braun No Touch + ForeheadNTF3000 Thermometer
Element ofComparison	Subject Device: BraunBNT400 No Touch + ForeheadThermometer	Predicate Device: Braun NoTouch + Forehead NTF3000Thermometer	Reason forSubstantialEquivalence
510(k) Number	K181242	K163516
Intended Use	The Braun BNT400 No Touch +Forehead Thermometer is a non-sterile, reusable, clinicalthermometer intended for theintermittent determination of humanbody temperature in a touch andno touch mode using the center ofthe forehead as the measurementsite on people of all ages.	The Braun No Touch + ForeheadNTF3000 Thermometer is a non-sterile, reusable, clinicalthermometer intended for theintermittent determination of humanbody temperature in a touch andno touch mode using the center ofthe forehead as the measurementsite on people of all ages.	The intended use of themodified device is thesame as the intendeduse of the original,predicate device.
Labeling	Instructions for use, package,and rating label	Instructions for use, package,and rating label	The change in labelingis restricted to thememory feature of themodified device.
Components	Power button, temperaturemeasurement button, scanner,silent mode switch, protectivecap, microcontroller, and LCD	Power button, temperaturemeasurement button, scanner,silent mode switch, protectivecap, microcontroller, and LCD	All components arefunctionally identical
Features	Fever Insight temperatureguidance feature and memoryfeature	Fever Insight temperatureguidance feature	The modified device hasa memory feature tostore the most recenttemperature reading.This does not affect thesafety or effectiveness ofthe device.
Sensor	Infrared	Infrared	Functionally identical
Principles ofOperation	The thermometer uses athermopile sensor with integratedthermistor for the target reading,a thermistor mounted in the headof the thermometer for ambienttemperature readings, and aninfrared proximity sensor fordetection of contact or non-contact use and compensation ofthe temperature reading.	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 sensor fordetection of contact or non-contactuse and compensation of thetemperature reading.	Functionally equivalent
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	In accordance withASTM E1965
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)	In accordance withASTM E1965
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)	In accordance withASTM E1965
Element ofComparison	Subject Device: BraunBNT400 No Touch + ForeheadThermometer	Predicate Device: Braun NoTouch + Forehead NTF3000Thermometer	Reason forSubstantialEquivalence
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);	In accordance withASTM E1965
Resolution ofDisplay	0.1°C / 0.1°F	0.1°C / 0.1°F	Identical
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.	Functionally equivalent,alternate part
Power Supply	Two (2), AAA batteries	Two (2), AA batteries	Functionally equivalent
Signal Outputand Display	LCD, Buzzer	LCD, Buzzer	Identical
Battery Life	At least 500 readings	At least 1000 readings	Functionally equivalent
Materials	User contacting materialsinclude ABS (device housing /handle, power button), TPR(temperature button & foreheadtouch bumper), & PMMA (LCDlens & protective scanner 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" - June 16, 2016	Meets ISO 10993-1, 10993-5,and 10993-10, and FDABluebook memo G95-1	No change in materials
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 BNT400 No Touch + Forehead Thermometer from those of the predicate device, the Braun No Touch + Forehead NTF3000 Thermometer, the fundamental operating princible 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 predicate device. The change associated with the 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 BNT400 No Touch + 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, and all risks were mitigated as low as possible. 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
Updatedindustrialdesign	Incorrectreading orminorelectricalshock touser	IEC 60601-1-11:2015:	Ingress Protection:IP22	Pass

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DeviceModification	AssociatedRisks	Performance Standard	Acceptance Criteria	Result
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
Addition offeatures	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
Updatedindustrialdesign andaddition offeatures	Improperuse	IEC 62366-1:2015IEC 60601-1-6:2010	Use Errors:No more than five (5) Use Errorsobserved for any Critical Task	Pass

CLINICAL TESTING VIII.

A controlled human clinical study was conducted using the Braun BNT400 No Touch + 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

The intended use of the subject device, the Braun BNT400 No Touch + Forehead Thermometer, is identical to that of the predicate device, the Braun No Touch + Forehead NTF3000 Thermometer, and there is no change to the operating principle and fundamental technological characteristics as a result of the modifications.

Therefore, the subject device, the Braun BNT400 No Touch + Forehead Thermometer, is substantially equivalent to the predicate device, the Braun No Touch + Forehead NTF3000 Thermometer (510(k) # K163516), which was cleared for marketing in the US in April 2017 for the same intended use.

Regulation Number and Section

§ 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.