(127 days)
Not Found
No
The description details standard infrared thermometry components and processes, with no mention of AI, ML, or related concepts like training/test sets.
No
The device is a thermometer, intended for measuring body temperature, not for treating any condition or disease.
Yes
The device is intended for the "intermittent determination of human body temperature," which is a diagnostic measurement used to assess a patient's health status.
No
The device description explicitly states it is a "hand-held, battery powered, infrared thermometer" and lists hardware components like a thermopile sensor, thermistor, parabolic mirror, and infrared proximity sensor. This indicates it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The Braun No Touch + Forehead NTF3000 Thermometer measures human body temperature by detecting infrared energy emitted from the forehead. It does not analyze any biological specimens taken from the body.
- Intended Use: The intended use is for the "intermittent determination of human body temperature," which is a direct measurement of a physiological parameter, not an analysis of a sample.
Therefore, based on the provided information, the Braun No Touch + Forehead NTF3000 Thermometer is a clinical thermometer, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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 on 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 No Touch + Forehead NTF3000 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 two inches of the subject's forehead.
The Braun No Touch + Forehead NTF3000 Thermometer uses a thermopile sensor with integrated thermistor for the target reading, a thermistor mounted in 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
forehead
Indicated Patient Age Range
all ages
Intended User / Care Setting
Over-The-Counter Use
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)
Laboratory and clinical accuracy testing was conducted on the Braun No Touch + Forehead NTF3000 Thermometer. The device complies with the following standard for intermittent determination of patient temperature by infrared thermometers:
- ASTM E1965-98:2009: Standard Specification for Infrared Thermometers for Intermittent ● Determination of Patient Temperature
Based on the clinical performance as documented in the pivotal clinical study, the Braun No Touch + Forehead NTF3000 Thermometer was found to be non-inferior to the predicate and reference thermometer, and therefore, substantially equivalent to the predicate thermometer.
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.
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. Inside the circle is an abstract image of three human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the most prominent.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 21, 2017
KAZ USA, Inc., a Helen of Troy Company Rajesh Kasbekar Global VP of Regulatory Affairs 400 Donald Lynch Boulevard, Suite 300 Marlborough, Massachusetts 01752
Re: K163516
Trade/Device Name: Braun No Touch + Forehead NTF3000 Thermometer Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: March 10, 2017 Received: March 22, 2017
Dear Mr. Rajesh Kasbekar:
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.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Tina Kiang -
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) K163516
Device Name
Braun No Touch + Forehead NTF3000 Thermometer
Indications for Use (Describe)
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 on the forehead as the measurement site on people of all ages.
Type of Use (Select one or both, as applicable)
| Residential Use (Part 21 CFR 601 Subpart E) |
|---|
| Over-The-Counter Use (21 CFR 601 Subpart C) |
__ Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
l. SUBMITTER
KAZ USA. Inc.. A Helen of Trov Company 400 Donald Lynch Blvd., Suite 300 Marlborough, MA 01752
Phone: (508) 490-7280 Fax: (508) 414-7057
Contact Person: Rajesh S. Kasbekar, Global VP of Requlatory Affairs Date Prepared: 1-March-2017
DEVICE IDENTIFICATION II.
Name of Device: Braun No Touch + Forehead NTF3000 Thermometer Common or Usual Name: Infrared Forehead Thermometer Classification Name: Thermometer, Clinical, Electronic Regulation Number: 21CFR 880.2910 Regulatory Class: II Product Code: FLL
PREDICATE DEVICE III.
NTF3000 No Touch + Forehead Infrared Thermometer, K134043
DEVICE DESCRIPTION IV.
The Braun No Touch + Forehead NTF3000 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 two inches of the subject's forehead.
The Braun No Touch + Forehead NTF3000 Thermometer uses a thermopile sensor with integrated thermistor for the target reading, a thermistor mounted in 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.
INDICATIONS FOR USE V.
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 on the center of the forehead as the measurement site on people of all ages.
| Elements of
| Comparison | Subject Device | Predicate Device | Comparison |
|---|---|---|---|
| Device Name | Infrared Thermometer | Infrared Thermometer | Same |
| Models | The Braun No Touch + | ||
| Forehead NTF3000 | |||
| Thermometer | The NTF3000 No Touch |
- Forehead Infrared
Thermometer | Similar |
| Elements of
Comparison | Subject Device | Predicate Device | Comparison |
| 510(k) Number | K163516 | K134043 | |
| Manufacturer
(Legal) | Kaz USA, Inc., a Helen of
Troy Company | Kaz USA, Inc., a Helen of
Troy Company | Same |
| Contract
Manufacturer | AViTA Corporation | AVITA Corporation | Same |
| Intended use | 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
on the center of the
forehead as the
measurement site on
people of all ages. | The NTF3000 No Touch - Forehead Infrared
Thermometer is a non-
sterile, reusable clinical
thermometer intended for
the intermittent
determination of human
body temperature in a
touch and no touch mode
on the center of the
forehead as the
measurement site on
people of all ages. | Same |
| 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, 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. | 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. | The fundamental operating
principle of the
thermometer is identical to
the predicate device.
There are no changes to
the intended use or product
specifications from the
previous revision of the
device. Other changes
associated with software
and the change in proximity
sensor have been verified
and validated. Therefore, it
is substantially equivalent. |
| Measurement
range | 34.4°C to 42.2°C
(93.9°F to 108.0°F) | 34.4°C to 42.2°C
(93.9°F to 108.0°F) | Same |
| Accuracy for
body
temperature
measurement | ± 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
31.0°C to 35.0°C
(87.8°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
31.0°C to 35.0°C
(87.8°F to 95.0°F);
± 0.3°C / 0.54°F
Above 42.0°C
(Above 107.6°F); | Same |
| Resolution of
display | 0.1°C / 0.1°F | 0.1°C / 0.1°F | Same |
| Sensor | Infrared sensor | Infrared sensor | Similar |
| Signal output
and
display | LCD, Buzzer | LCD, Buzzer | Same |
| Lens filter | No | No | Same |
| Power supply | Two (2) AA batteries | Two (2) AA batteries | Same |
| Elements of
Comparison | Subject Device | Predicate Device | Comparison |
| Materials | Patient contacting
materials include ABS
(device housing / handle
and power button) and
TPR (temperature button
and nose / forehead
touch bumper). | Patient contacting
materials include ABS
(device housing / handle
and power button) and
TPR (temperature button
and nose / forehead
touch bumper). | There was no change to
any material on the outside
of the unit. The only
material change was
internal to the unit, as the
analog infrared proximity
sensor was changed to a
digital, infrared proximity
sensor. |
| MCU | 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), an 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. | 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), an 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. | Same |
| Performance | Meets ASTM E 1965 and
150 80601-2-56 | Meets ASTM E 1965 and
ISO 80601-2-56 | Same |
| Biocompatibility | Meets ISO 10993 and
FDA Bluebook memo
G95-1 | Meets ISO 10993 and
FDA Bluebook memo
G95-1 | Same |
| Electrical Safety
EMC | Meets IEC 60601-1
Meets IEC 60601-1-2 | Meets IEC 60601-1
Meets IEC 60601-1-2 | Same
Same |
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
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5
Based on the comparison chart above, there have been no changes to the intended use or product specifications from those of the predicate device (the NTF3000 No Touch + Forehead 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 on the predicate device. The changes associated with software and the change in proximity sensor have been verified and validated via laboratory testing and a pivotal clinical study, and through the verification and validation process, it has been shown that the differences do not raise different questions of safety and effectiveness.
6
VII. NON-CLINICAL PERFORMANCE DATA
The entire Hazard Analysis for the Braun No Touch + Forehead NTF3000 Thermometer was evaluated to identify all the risks / hazards that could be affected by the modifications. The following summary of non-clinical performance data are provided in support of the substantial equivalence determination:
| Performance
| Standard | Test Performed | Acceptance Criteria | Result |
|---|---|---|---|
| Touch current | 100 μA NC; 500 μA | Pass | |
| IEC 60601-1:2012: | |||
| Medical electrical | |||
| equipment - Part 1: | |||
| General requirements | |||
| for basic safety and | |||
| essential performance | Patient leakage current | 10 μA NC; 50 μA SFC (d.c. current) | Pass |
| Patient leakage current w/ | |||
| mains on the F-type applied | |||
| parts | 5000 μA | Pass | |
| Shock / Drop test | 1 meter | Pass | |
| IEC 60601-1-2:2014: | |||
| Medical electrical | |||
| equipment - Part 1-2: | |||
| General requirements | |||
| for basic safety and | |||
| essential performance |
- Collateral Standard:
Electromagnetic
disturbances -
Requirements and
tests | Electrostatic discharge | ± 8 kV contact;
± 2 kV, ± 4 kV, ± 8 kV, ± 15 kV air | Pass |
| | Radiated RF EM fields | 10 V/m; 80 MHz – 2,7 GHz
80 % AM at 1 kHz | Pass |
| | Proximity fields from RF
wireless communications
equipment | 9 – 28 V/m; 385 – 5785 MHz
Multiple modulations | Pass |
| | Surges | ± 0,5 kV, ± 1 kV | Pass |
| | Rated power frequency
magnetic fields | 30 A/m
50 Hz or 60 Hz | Pass |
| IEC 60601-1-11:2015:
Medical electrical
equipment - Part 1-11:
General requirements
for basic safety and
essential performance - Collateral Standard:
Requirements for
medical electrical
equipment and
medical electrical
systems used in the
home healthcare
environment | Ingress protection rating | IP22 per product specifications | Pass |
| | Operating / storage
temperature range | -13 °F to 140 °F (-25 °C to 60 °C)
per product specifications | Pass |
| | Operating / storage
atmospheric pressure range | 700-1060hPA (0.7-1.06 atm)
per product specifications | Pass |
| | Operating / storage relative
humidity range | 15–95% non-condensing
per product specifications | Pass |
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VIII. CLINICAL TESTING DATA
Laboratory and clinical accuracy testing was conducted on the Braun No Touch + Forehead NTF3000 Thermometer. The device complies with the following standard for intermittent determination of patient temperature by infrared thermometers:
- ASTM E1965-98:2009: Standard Specification for Infrared Thermometers for Intermittent ● Determination of Patient Temperature
Based on the clinical performance as documented in the pivotal clinical study, the Braun No Touch + Forehead NTF3000 Thermometer was found to be non-inferior to the predicate and reference thermometer, and therefore, substantially equivalent to the predicate thermometer.
CONCLUSION IX.
The non-clinical data support the accuracy of the device and the hardware and software verification and validation demonstrate that the Braun No Touch + Forehead NTF3000 Thermometer should perform as intended in the specified use conditions. The clinical data demonstrate that the Braun No Touch + Forehead NTF3000 Thermometer performs comparably to its predicate device, the NTF3000 No Touch + Forehead Infrared Thermometer (510(k) K134043), which was cleared for marketing in the US in May 2014 for the same intended use. Therefore, the Braun No Touch + Forehead NTF3000 Thermometer is substantially equivalent to the predicate device, the NTF3000 No Touch + Forehead Infrared Thermometer (510(k) K134043).