(74 days)
Not Found
No
The summary describes a standard infrared thermometer using sensors and established standards (ASTM, ISO) for temperature measurement, with no mention of AI or ML.
No
The device is described as a clinical thermometer intended for the intermittent determination of human body temperature, which is a diagnostic function, not a therapeutic one. It does not treat or alleviate any condition.
No.
A diagnostic device typically identifies or diagnoses a disease or condition. This device is a clinical thermometer intended for the intermittent determination of human body temperature, which is a measurement rather than a diagnosis. While a fever might indicate an underlying condition, the thermometer itself does not diagnose the condition.
No
The device description explicitly states it is a "hand-held, battery powered, infrared thermometer" and mentions hardware components like a "thermopile sensor" and "thermistor," indicating it is a physical hardware device, not software only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body. This includes things like blood, urine, tissue, etc.
- The Braun BNT400 No Touch + Forehead Thermometer measures human body temperature directly from the forehead. It does not analyze any biological specimens.
The intended use and device description clearly state that it measures body temperature using infrared energy emitted from the forehead. This is a direct measurement of a physiological parameter, not an in vitro analysis of a specimen.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
FLL
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
center of the forehead
Indicated Patient Age Range
all ages
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Testing & Performance Data:
- Device Modification: Updated industrial design with PCB layout change
- Associated Risks: Incorrect reading or minor electrical shock to user
- Performance Standard: EN 60601-1:2014
- Acceptance Criteria: 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
- Result: Pass
- Device Modification: Updated industrial design with PCB layout change
- Associated Risks: Incorrect reading
- Performance Standard: IEC 60601-1-2:2014
- Acceptance Criteria: 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
- Result: Pass
- Device Modification: Updated industrial design
- Associated Risks: Incorrect reading or minor electrical shock to user
- Performance Standard: IEC 60601-1-11:2015
- Acceptance Criteria: Ingress Protection: IP22
- Result: Pass
- Device Modification: Updated industrial design
- Associated Risks: Incorrect reading or minor electrical shock to user
- Performance Standard: ASTM E1965-98:2016
- Acceptance Criteria: 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
- Result: Pass
- Device Modification: Addition of features
- Associated Risks: Incorrect reading
- Performance Standard: ISO 80601-2-56:2017
- Acceptance Criteria: 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°C Standard Deviation: Standard Deviation for test device should be equivalent to or less than the Standard Deviation of the predicate device Repeatability: Repeatability for test device should be ≤ ±0.3°C
- Result: Pass
- Device Modification: Updated industrial design and addition of features
- Associated Risks: Improper use
- Performance Standard: IEC 62366-1:2015 IEC 60601-1-6:2010
- Acceptance Criteria: Use Errors: No more than five (5) Use Errors observed for any Critical Task
- Result: Pass
Clinical Testing:
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows 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 is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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);
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.
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
2
Indications for Use
510(k) Number (if known)
K181242
Device Name Braun BNT400 No Touch + Forehead Thermometer
Indications for Use (Describe)
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.
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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3
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
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.
V. INDICATIONS FOR USE
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.
| Element of
Comparison | Subject Device: Braun
BNT400 No Touch + Forehead
Thermometer | Predicate Device: Braun No
Touch + Forehead NTF3000
Thermometer | Reason for
Substantial
Equivalence |
|----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer
(Legal) | Kaz USA, Inc., a Helen of Troy
Company | Kaz USA, Inc., a Helen of Troy
Company | |
| Contract
Manufacturer | AVITA Corporation | AVITA Corporation | |
| Thermometer
Type | Infrared Forehead Thermometer | Infrared Forehead Thermometer | The devices have the
same fundamental
scientific technology and
use the same
physiologic temperature
measurement site. |
| Models
(Configuration) | Braun BNT400 No Touch +
Forehead Thermometer | The Braun No Touch + Forehead
NTF3000 Thermometer | |
| Element of
Comparison | Subject Device: Braun
BNT400 No Touch + Forehead
Thermometer | Predicate Device: Braun No
Touch + Forehead NTF3000
Thermometer | Reason for
Substantial
Equivalence |
| 510(k) Number | K181242 | K163516 | |
| Intended Use | 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. | The Braun No Touch + Forehead
NTF3000 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. | The intended use of the
modified device is the
same as the intended
use of the original,
predicate device. |
| Labeling | Instructions for use, package,
and rating label | Instructions for use, package,
and rating label | The change in labeling
is restricted to the
memory feature of the
modified device. |
| Components | Power button, temperature
measurement button, scanner,
silent mode switch, protective
cap, microcontroller, and LCD | Power button, temperature
measurement button, scanner,
silent mode switch, protective
cap, microcontroller, and LCD | All components are
functionally identical |
| Features | Fever Insight temperature
guidance feature and memory
feature | Fever Insight temperature
guidance feature | The modified device has
a memory feature to
store the most recent
temperature reading.
This does not affect the
safety or effectiveness of
the device. |
| Sensor | Infrared | Infrared | Functionally identical |
| Principles of
Operation | The thermometer uses a
thermopile sensor with integrated
thermistor for the target reading,
a thermistor mounted in the head
of the thermometer for ambient
temperature readings, and an
infrared proximity sensor for
detection of contact or non-
contact use and compensation of
the temperature reading. | The thermometer uses a
thermopile sensor with integrated
thermistor for the target reading, a
thermistor mounted in the head of
the thermometer for ambient
temperature readings, a parabolic
mirror to help focus the infrared
energy emitted from the forehead,
and an infrared proximity sensor for
detection of contact or non-contact
use and compensation of the
temperature reading. | Functionally equivalent |
| Operating
Environment
(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 with
ASTM E1965 |
| Storage
Environment
(Specifications) | -25°C to 55°C
(-13°F to 131°F);
15-95% Relative Humidity
700-1060 hPA
(0.7-1.06 atm) | -25°C to 60°C
(-13°F to 140°F);
15-95% Relative Humidity
700-1060 hPA
(0.7-1.06 atm) | In accordance with
ASTM E1965 |
| Measurement
Range | 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 with
ASTM E1965 |
| Element of
Comparison | Subject Device: Braun
BNT400 No Touch + Forehead
Thermometer | Predicate Device: Braun No
Touch + Forehead NTF3000
Thermometer | Reason for
Substantial
Equivalence |
| 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 with
ASTM E1965 |
| Resolution of
Display | 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 OTP
ROM, including 256 bytes of
RAM, one 8-bit basic timer
function, two 8-bit counters /
timers, a watchdog timer, 6-
source interrupts, in-system
programming ROM function with
VPP voltage generation internally
for calibration data programming
in ROM, a 20-bit ADC, a PGIA,
three voltage regulators including
AVDDR, AVE+ & VLED module
for LED driving, an integrated R &
C-Type LCD driver for 4-common
x 32-segments LCD panel, 8-
level stack register, & a dual
clock system (4MHz high-speed
RC oscillator, on-chip low speed
RC oscillator circuit). | Weltrend WT5075F - A high-
speed, high-performance and low
power consumption 8-bit micro-
controller, including Turbo 8052
CPU, 64K bytes embedded
Flash, 256-byte direct-or-indirect-
addressing SRAM, 2K-byte
indirect-addressing-only SRAM,
40x4(max.) LCD driver, a Time-
Base Timer, 4 multi-function
timer/counters, 2-channel 12-bit
PWM, 1-channel divider output,
serial interface (UART and SPI),
19-channel (15 external and 4
internal) 12-bit AD converter, 4
high-performance OPs, analog
switches and three clock
generators (32.768kHz crystal
oscillator, high-speed crystal
oscillator and high-speed RC
oscillator) on chip. | Functionally equivalent,
alternate part |
| Power Supply | Two (2), AAA batteries | Two (2), AA batteries | Functionally equivalent |
| Signal Output
and Display | LCD, Buzzer | LCD, Buzzer | Identical |
| Battery Life | At least 500 readings | At least 1000 readings | Functionally equivalent |
| Materials | User contacting materials
include ABS (device housing /
handle, power button), TPR
(temperature button & forehead
touch bumper), & PMMA (LCD
lens & protective scanner cap). | User contacting materials
include ABS (device housing /
handle and power button), TPR
(temperature button and
forehead touch bumper), and
PMMA (LCD lens and protective
scanner cap). | Identical |
| Biocompatibility | Meets ISO 10993-1:2009,
10993-5:2009, 10993-10:2010,
& FDA Guidance Document,
"Use of International Standard
ISO 10993-1" - June 16, 2016 | Meets ISO 10993-1, 10993-5,
and 10993-10, and FDA
Bluebook memo G95-1 | No change in materials |
| Performance | Meets ASTM E 1965:2016 and
ISO 80601-2-56:2017 | Meets ASTM E 1965 and ISO
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 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:
| 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 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 |
| 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 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 |
| Updated
industrial
design | Incorrect
reading or
minor
electrical
shock to
user | IEC 60601-1-11:2015: | Ingress Protection:
IP22 | Pass |
7
| Device
Modification | Associated
Risks | Performance Standard | Acceptance Criteria | Result |
|----------------------------------------------------------------|--------------------------------------------------------------------|----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| 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 |
| Addition of
features | 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°C
Standard Deviation:
Standard Deviation for test device
should be equivalent to or less than the
Standard Deviation of the predicate
device
Repeatability:
Repeatability for test device should be
≤ ±0.3°C | Pass |
| Updated
industrial
design and
addition of
features | Improper
use | IEC 62366-1:2015
IEC 60601-1-6:2010 | Use Errors:
No more than five (5) Use Errors
observed 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.