(127 days)
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 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.
The provided document, a 510(k) summary for the Braun No Touch + Forehead NTF3000 Thermometer, details the device's acceptance criteria and the studies conducted to prove it meets these criteria. Since this is a submission for a medical device (thermometer), the "AI" related questions are not applicable.
Here's an analysis based on the provided text, focusing on the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance:
The document primarily refers to regulatory and performance standards rather than specific acceptance criteria values in a table. However, in the "Performance Standards" section (pages 6-7), there is a table summarizing non-clinical performance data with "Acceptance Criteria" and "Result."
Table: Non-Clinical Performance Data, Acceptance Criteria, and Results
| Performance Standard | Test Performed | Acceptance Criteria | Result |
|---|---|---|---|
| IEC 60601-1:2012: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance | Touch current | 100 μA NC; 500 μA | Pass |
| 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 |
The document also states the device's accuracy specifications, which can be considered acceptance criteria for temperature measurement:
- Accuracy for body temperature measurement:
- ± 0.2°C / 0.36°F for 35.0°C to 42.0°C (95.0°F to 107.6°F)
- ± 0.3°C / 0.54°F for 31.0°C to 35.0°C (87.8°F to 95.0°F)
- ± 0.3°C / 0.54°F for Above 42.0°C (Above 107.6°F)
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: The document mentions a "pivotal clinical study" (page 7) but does not specify the sample size for this clinical study.
- Data Provenance: The document does not explicitly state the country of origin of the data. It also does not explicitly state whether the clinical study was retrospective or prospective, but "pivotal clinical study" generally implies a prospective design.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. For a thermometer, "ground truth" would typically refer to highly accurate reference temperature measurements (e.g., from a rectal thermometer or other core body temperature measurement device in a controlled setting) compared against the device's readings, rather than expert consensus on images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This concept is not applicable to a clinical study for a thermometer, where readings are quantitative and compared against a reference standard. Adjudication methods are typically relevant for subjective assessments, like image interpretation.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is a thermometer, not an AI-assisted diagnostic imaging tool that involves human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Partially applicable/Implied. The non-clinical performance data (pages 6-7) represents standalone device performance under various conditions (electrical safety, EMC, environmental). The clinical accuracy testing also evaluates the device's performance directly against a reference thermometer, which is a standalone assessment of its accuracy.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the clinical accuracy testing, the ground truth would be reference thermometer measurements (e.g., highly accurate core body temperature readings) from human subjects, as stated by its compliance with "ASTM E1965-98:2009: Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature." This standard outlines methods for clinical accuracy studies, typically involving comparison to an accepted reference thermometer.
8. The sample size for the training set:
- Not applicable. This device is a traditional electronic thermometer, not an AI/machine learning model that requires a "training set."
9. How the ground truth for the training set was established:
- Not applicable. As stated above, this device does not use a training set as it's not an AI/ML model.
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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 (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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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 ofComparison | Subject Device | Predicate Device | Comparison |
|---|---|---|---|
| Device Name | Infrared Thermometer | Infrared Thermometer | Same |
| Models | The Braun No Touch +Forehead NTF3000Thermometer | The NTF3000 No Touch+ Forehead InfraredThermometer | Similar |
| Elements ofComparison | Subject Device | Predicate Device | Comparison |
| 510(k) Number | K163516 | K134043 | |
| Manufacturer(Legal) | Kaz USA, Inc., a Helen ofTroy Company | Kaz USA, Inc., a Helen ofTroy Company | Same |
| ContractManufacturer | AViTA Corporation | AVITA Corporation | Same |
| Intended use | The Braun No Touch +Forehead NTF3000Thermometer is a non-sterile, reusable clinicalthermometer intended forthe intermittentdetermination of humanbody temperature in atouch and no touch modeon the center of theforehead as themeasurement site onpeople of all ages. | The NTF3000 No Touch+ Forehead InfraredThermometer is a non-sterile, reusable clinicalthermometer intended forthe intermittentdetermination of humanbody temperature in atouch and no touch modeon the center of theforehead as themeasurement site onpeople of all ages. | Same |
| Principles ofOperation | The thermometer uses athermopile sensor withintegrated thermistor forthe target reading, athermistor mounted in thehead of the thermometerfor ambient temperaturereadings, a parabolicmirror to help focus theinfrared energy emittedfrom the forehead, and aninfrared proximity sensorfor detection of contact ornon-contact use andcompensation of thetemperature reading. | The thermometer uses athermopile sensor withintegrated thermistor forthe target reading, athermistor mounted in thehead of the thermometerfor ambient temperaturereadings, a parabolicmirror to help focus theinfrared energy emittedfrom the forehead, and aninfrared proximity sensorfor detection of contact ornon-contact use andcompensation of thetemperature reading. | The fundamental operatingprinciple of thethermometer is identical tothe predicate device.There are no changes tothe intended use or productspecifications from theprevious revision of thedevice. Other changesassociated with softwareand the change in proximitysensor have been verifiedand validated. Therefore, itis substantially equivalent. |
| Measurementrange | 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 forbodytemperaturemeasurement | ± 0.2°C / 0.36°F35.0°C to 42.0°C(95.0°F to 107.6°F);± 0.3°C / 0.54°F31.0°C to 35.0°C(87.8°F to 95.0°F);± 0.3°C / 0.54°FAbove 42.0°C(Above 107.6°F); | ± 0.2°C / 0.36°F35.0°C to 42.0°C(95.0°F to 107.6°F);± 0.3°C / 0.54°F31.0°C to 35.0°C(87.8°F to 95.0°F);± 0.3°C / 0.54°FAbove 42.0°C(Above 107.6°F); | Same |
| Resolution ofdisplay | 0.1°C / 0.1°F | 0.1°C / 0.1°F | Same |
| Sensor | Infrared sensor | Infrared sensor | Similar |
| Signal outputanddisplay | LCD, Buzzer | LCD, Buzzer | Same |
| Lens filter | No | No | Same |
| Power supply | Two (2) AA batteries | Two (2) AA batteries | Same |
| Elements ofComparison | Subject Device | Predicate Device | Comparison |
| Materials | Patient contactingmaterials include ABS(device housing / handleand power button) andTPR (temperature buttonand nose / foreheadtouch bumper). | Patient contactingmaterials include ABS(device housing / handleand power button) andTPR (temperature buttonand nose / foreheadtouch bumper). | There was no change toany material on the outsideof the unit. The onlymaterial change wasinternal to the unit, as theanalog infrared proximitysensor was changed to adigital, infrared proximitysensor. |
| MCU | Weltrend WT5075F - Ahigh-speed, high-performance and lowpower consumption 8-bitmicro-controller, includingTurbo 8052 CPU, 64Kbytes embedded Flash,256-byte direct-or-indirect-addressingSRAM, 2K-byte indirect-addressing-only SRAM,40x4(max.) LCD driver, aTime-Base Timer, 4 multi-function timer/counters,2-channel 12-bit PWM, 1-channel divider output,serial interface (UARTand SPI), an 19-channel(15 external and 4internal) 12-bit ADconverter, 4 high-performance OPs, analogswitches and three clockgenerators (32.768kHzcrystal oscillator, high-speed crystal oscillatorand high-speed RCoscillator) on chip. | Weltrend WT5075F - Ahigh-speed, high-performance and lowpower consumption 8-bitmicro-controller, includingTurbo 8052 CPU, 64Kbytes embedded Flash,256-byte direct-or-indirect-addressingSRAM, 2K-byte indirect-addressing-only SRAM,40x4(max.) LCD driver, aTime-Base Timer, 4 multi-function timer/counters,2-channel 12-bit PWM, 1-channel divider output,serial interface (UARTand SPI), an 19-channel(15 external and 4internal) 12-bit ADconverter, 4 high-performance OPs, analogswitches and three clockgenerators (32.768kHzcrystal oscillator, high-speed crystal oscillatorand high-speed RCoscillator) on chip. | Same |
| Performance | Meets ASTM E 1965 and150 80601-2-56 | Meets ASTM E 1965 andISO 80601-2-56 | Same |
| Biocompatibility | Meets ISO 10993 andFDA Bluebook memoG95-1 | Meets ISO 10993 andFDA Bluebook memoG95-1 | Same |
| Electrical SafetyEMC | Meets IEC 60601-1Meets IEC 60601-1-2 | Meets IEC 60601-1Meets IEC 60601-1-2 | SameSame |
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:
| PerformanceStandard | Test Performed | Acceptance Criteria | Result |
|---|---|---|---|
| Touch current | 100 μA NC; 500 μA | Pass | |
| IEC 60601-1:2012:Medical electricalequipment - Part 1:General requirementsfor basic safety andessential performance | Patient leakage current | 10 μA NC; 50 μA SFC (d.c. current) | Pass |
| Patient leakage current w/mains on the F-type appliedparts | 5000 μA | Pass | |
| Shock / Drop test | 1 meter | Pass | |
| IEC 60601-1-2:2014:Medical electricalequipment - Part 1-2:General requirementsfor basic safety andessential performance- Collateral Standard:Electromagneticdisturbances -Requirements andtests | 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 GHz80 % AM at 1 kHz | Pass | |
| Proximity fields from RFwireless communicationsequipment | 9 – 28 V/m; 385 – 5785 MHzMultiple modulations | Pass | |
| Surges | ± 0,5 kV, ± 1 kV | Pass | |
| Rated power frequencymagnetic fields | 30 A/m50 Hz or 60 Hz | Pass | |
| IEC 60601-1-11:2015:Medical electricalequipment - Part 1-11:General requirementsfor basic safety andessential performance- Collateral Standard:Requirements formedical electricalequipment andmedical electricalsystems used in thehome healthcareenvironment | Ingress protection rating | IP22 per product specifications | Pass |
| Operating / storagetemperature range | -13 °F to 140 °F (-25 °C to 60 °C)per product specifications | Pass | |
| Operating / storageatmospheric pressure range | 700-1060hPA (0.7-1.06 atm)per product specifications | Pass | |
| Operating / storage relativehumidity range | 15–95% non-condensingper 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).
§ 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.