Braun No Touch + Forehead NTF3000 Thermometer

K163516 · Kaz USA, Inc., A Helen of Troy Company · FLL · Apr 21, 2017 · General Hospital

Device Facts

• Record ID: K163516
• Device Name: Braun No Touch + Forehead NTF3000 Thermometer
• Applicant: Kaz USA, Inc., A Helen of Troy Company
• Product Code: FLL · General Hospital
• Decision Date: Apr 21, 2017
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.2910
• Device Class: Class 2
• Attributes: Pediatric

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.

Device Story

Hand-held, battery-powered infrared thermometer; measures forehead temperature via infrared energy emission. Device utilizes thermopile sensor with integrated thermistor for target reading, internal thermistor for ambient temperature compensation, parabolic mirror for infrared focusing, and infrared proximity sensor for distance/contact detection. Operates in touch or no-touch (within 2 inches) modes. Used in residential or clinical settings by patients or healthcare providers. Output displayed on LCD with buzzer notification. Provides oral-equivalent temperature readings. Benefits include non-invasive, rapid temperature assessment for all ages.

Clinical Evidence

Pivotal clinical study conducted to evaluate accuracy against predicate and reference thermometers. Device complies with ASTM E1965-98:2009. Results demonstrated non-inferiority to the predicate device, supporting substantial equivalence.

Technological Characteristics

Infrared thermometer; ABS housing/handle/button; TPR touch bumper. Sensing: thermopile sensor, thermistor, infrared proximity sensor. Power: 2 AA batteries. Connectivity: None. Sterilization: Non-sterile. Standards: ASTM E1965, ISO 80601-2-56, IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11. MCU: Weltrend WT5075F 8-bit microcontroller.

Indications for Use

Indicated for intermittent determination of human body temperature in people of all ages via forehead measurement site; usable in touch or no-touch modes.

Regulatory Classification

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.

Special Controls

(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.

Predicate Devices

• NTF3000 No Touch + Forehead Infrared Thermometer (K134043)

Submission Summary (Full Text)

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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.

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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 [phone] or [phone] 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 [phone] or [phone] 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)

| <input type="checkbox"/> <span>Residential Use (Part 21 CFR 601 Subpart E)</span> |
|----------------------------------------------------------------------------------------------|
| <input checked="" type="checkbox"/> <span>Over-The-Counter Use (21 CFR 601 Subpart C)</span> |

__ Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

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## 510(k) Summary

#### l. SUBMITTER

KAZ USA. Inc.. A Helen of Trov Company 400 Donald Lynch Blvd., Suite 300 Marlborough, MA 01752

Phone: [phone] Fax: [phone]

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<br>Comparison | Subject Device | Predicate Device | Comparison |
|----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Infrared Thermometer | Infrared Thermometer | Same |
| Models | The Braun No Touch +<br>Forehead NTF3000<br>Thermometer | The NTF3000 No Touch<br>+ Forehead Infrared<br>Thermometer | Similar |
| Elements of<br>Comparison | Subject Device | Predicate Device | Comparison |
| 510(k) Number | K163516 | K134043 | |
| Manufacturer<br>(Legal) | Kaz USA, Inc., a Helen of<br>Troy Company | Kaz USA, Inc., a Helen of<br>Troy Company | Same |
| Contract<br>Manufacturer | AViTA Corporation | AVITA Corporation | Same |
| Intended use | The Braun No Touch +<br>Forehead NTF3000<br>Thermometer is a non-<br>sterile, reusable clinical<br>thermometer intended for<br>the intermittent<br>determination of human<br>body temperature in a<br>touch and no touch mode<br>on the center of the<br>forehead as the<br>measurement site on<br>people of all ages. | The NTF3000 No Touch<br>+ Forehead Infrared<br>Thermometer is a non-<br>sterile, reusable clinical<br>thermometer intended for<br>the intermittent<br>determination of human<br>body temperature in a<br>touch and no touch mode<br>on the center of the<br>forehead as the<br>measurement site on<br>people of all ages. | Same |
| Principles of<br>Operation | The thermometer uses a<br>thermopile sensor with<br>integrated thermistor for<br>the target reading, a<br>thermistor mounted in the<br>head of the thermometer<br>for ambient temperature<br>readings, a parabolic<br>mirror to help focus the<br>infrared energy emitted<br>from the forehead, and an<br>infrared proximity sensor<br>for detection of contact or<br>non-contact use and<br>compensation of the<br>temperature reading. | The thermometer uses a<br>thermopile sensor with<br>integrated thermistor for<br>the target reading, a<br>thermistor mounted in the<br>head of the thermometer<br>for ambient temperature<br>readings, a parabolic<br>mirror to help focus the<br>infrared energy emitted<br>from the forehead, and an<br>infrared proximity sensor<br>for detection of contact or<br>non-contact use and<br>compensation of the<br>temperature reading. | The fundamental operating<br>principle of the<br>thermometer is identical to<br>the predicate device.<br>There are no changes to<br>the intended use or product<br>specifications from the<br>previous revision of the<br>device. Other changes<br>associated with software<br>and the change in proximity<br>sensor have been verified<br>and validated. Therefore, it<br>is substantially equivalent. |
| Measurement<br>range | 34.4°C to 42.2°C<br>(93.9°F to 108.0°F) | 34.4°C to 42.2°C<br>(93.9°F to 108.0°F) | Same |
| Accuracy for<br>body<br>temperature<br>measurement | ± 0.2°C / 0.36°F<br>35.0°C to 42.0°C<br>(95.0°F to 107.6°F);<br><br>± 0.3°C / 0.54°F<br>31.0°C to 35.0°C<br>(87.8°F to 95.0°F);<br><br>± 0.3°C / 0.54°F<br>Above 42.0°C<br>(Above 107.6°F); | ± 0.2°C / 0.36°F<br>35.0°C to 42.0°C<br>(95.0°F to 107.6°F);<br><br>± 0.3°C / 0.54°F<br>31.0°C to 35.0°C<br>(87.8°F to 95.0°F);<br><br>± 0.3°C / 0.54°F<br>Above 42.0°C<br>(Above 107.6°F); | Same |
| Resolution of<br>display | 0.1°C / 0.1°F | 0.1°C / 0.1°F | Same |
| Sensor | Infrared sensor | Infrared sensor | Similar |
| Signal output<br>and<br>display | LCD, Buzzer | LCD, Buzzer | Same |
| Lens filter | No | No | Same |
| Power supply | Two (2) AA batteries | Two (2) AA batteries | Same |
| Elements of<br>Comparison | Subject Device | Predicate Device | Comparison |
| Materials | Patient contacting<br>materials include ABS<br>(device housing / handle<br>and power button) and<br>TPR (temperature button<br>and nose / forehead<br>touch bumper). | Patient contacting<br>materials include ABS<br>(device housing / handle<br>and power button) and<br>TPR (temperature button<br>and nose / forehead<br>touch bumper). | There was no change to<br>any material on the outside<br>of the unit. The only<br>material change was<br>internal to the unit, as the<br>analog infrared proximity<br>sensor was changed to a<br>digital, infrared proximity<br>sensor. |
| MCU | Weltrend WT5075F - A<br>high-speed, high-<br>performance and low<br>power consumption 8-bit<br>micro-controller, including<br>Turbo 8052 CPU, 64K<br>bytes embedded Flash,<br>256-byte direct-or-<br>indirect-addressing<br>SRAM, 2K-byte indirect-<br>addressing-only SRAM,<br>40x4(max.) LCD driver, a<br>Time-Base Timer, 4 multi-<br>function timer/counters,<br>2-channel 12-bit PWM, 1-<br>channel divider output,<br>serial interface (UART<br>and SPI), an 19-channel<br>(15 external and 4<br>internal) 12-bit AD<br>converter, 4 high-<br>performance OPs, analog<br>switches and three clock<br>generators (32.768kHz<br>crystal oscillator, high-<br>speed crystal oscillator<br>and high-speed RC<br>oscillator) on chip. | Weltrend WT5075F - A<br>high-speed, high-<br>performance and low<br>power consumption 8-bit<br>micro-controller, including<br>Turbo 8052 CPU, 64K<br>bytes embedded Flash,<br>256-byte direct-or-<br>indirect-addressing<br>SRAM, 2K-byte indirect-<br>addressing-only SRAM,<br>40x4(max.) LCD driver, a<br>Time-Base Timer, 4 multi-<br>function timer/counters,<br>2-channel 12-bit PWM, 1-<br>channel divider output,<br>serial interface (UART<br>and SPI), an 19-channel<br>(15 external and 4<br>internal) 12-bit AD<br>converter, 4 high-<br>performance OPs, analog<br>switches and three clock<br>generators (32.768kHz<br>crystal oscillator, high-<br>speed crystal oscillator<br>and high-speed RC<br>oscillator) on chip. | Same |
| Performance | Meets ASTM E 1965 and<br>150 80601-2-56 | Meets ASTM E 1965 and<br>ISO 80601-2-56 | Same |
| Biocompatibility | Meets ISO 10993 and<br>FDA Bluebook memo<br>G95-1 | Meets ISO 10993 and<br>FDA Bluebook memo<br>G95-1 | Same |
| Electrical Safety<br>EMC | Meets IEC 60601-1<br>Meets IEC 60601-1-2 | Meets IEC 60601-1<br>Meets IEC 60601-1-2 | Same<br>Same |

#### VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS

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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.

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#### 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<br>Standard | Test Performed | Acceptance Criteria | Result |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------|------------------------------------------------------------------|--------|
| | Touch current | 100 μA NC; 500 μA | Pass |
| IEC 60601-1:2012:<br>Medical electrical<br>equipment - Part 1:<br>General requirements<br>for basic safety and<br>essential performance | Patient leakage current | 10 μA NC; 50 μA SFC (d.c. current) | Pass |
| | Patient leakage current w/<br>mains on the F-type applied<br>parts | 5000 μA | Pass |
| | Shock / Drop test | 1 meter | Pass |
| IEC 60601-1-2:2014:<br>Medical electrical<br>equipment - Part 1-2:<br>General requirements<br>for basic safety and<br>essential performance<br>- Collateral Standard:<br>Electromagnetic<br>disturbances -<br>Requirements and<br>tests | Electrostatic discharge | ± 8 kV contact;<br>± 2 kV, ± 4 kV, ± 8 kV, ± 15 kV air | Pass |
| | Radiated RF EM fields | 10 V/m; 80 MHz – 2,7 GHz<br>80 % AM at 1 kHz | Pass |
| | Proximity fields from RF<br>wireless communications<br>equipment | 9 – 28 V/m; 385 – 5785 MHz<br>Multiple modulations | Pass |
| | Surges | ± 0,5 kV, ± 1 kV | Pass |
| | Rated power frequency<br>magnetic fields | 30 A/m<br>50 Hz or 60 Hz | Pass |
| IEC 60601-1-11:2015:<br>Medical electrical<br>equipment - Part 1-11:<br>General requirements<br>for basic safety and<br>essential performance<br>- Collateral Standard:<br>Requirements for<br>medical electrical<br>equipment and<br>medical electrical<br>systems used in the<br>home healthcare<br>environment | Ingress protection rating | IP22 per product specifications | Pass |
| | Operating / storage<br>temperature range | -13 °F to 140 °F (-25 °C to 60 °C)<br>per product specifications | Pass |
| | Operating / storage<br>atmospheric pressure range | 700-1060hPA (0.7-1.06 atm)<br>per product specifications | Pass |
| | Operating / storage relative<br>humidity range | 15–95% non-condensing<br>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).