The No Touch + Forehead Thermometer (Model NTF3000US) is a non-sterile, reusable clinical thermometer intended for the intermittent determination of human body temperature in a touch and no touch on the centre of the forehead as the measurement site on people of all ages.

Device Description

The No Touch+Forehead Thermometer ( Model NTF3000US) is a hand-held, battery powered device designed to measure human body temperature. The NTF3000 is an 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 up to two (2) inches away. The NTF 3000 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 distance sensor for detection of contact or non-contact use and compensation of the temperature reading.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the KAZ USA, Inc. No Touch+ Forehead Thermometer (Model NTF3000US), based on the provided text:

Acceptance Criteria and Reported Device Performance

The primary acceptance criteria for the No Touch+ Forehead Thermometer are established by its conformance to the ASTM E1965-03 standard for clinical accuracy and repeatability. The device needed to demonstrate non-inferiority or substantial equivalence to the predicate device against a gold standard.

Acceptance Criteria (from ASTM E1965-03)	Reported Device Performance (No Touch+ Forehead Thermometer)
Bias: Clinical acceptability (less than predicate device when compared to reference)	Within clinical acceptability
Clinical Repeatability: Less than 0.3 °C (0.58 °F)	Statistically acceptable (less than 0.3 °C or 0.58 °F)

Study Details

2. Sample size used for the test set and the data provenance:

Test Set Sample Size: The document states that a comparison study was performed across four age groups: 0-12 months, 12 months- <5 years, 5 years- <18 years, and 18 years and older. However, the specific number of participants within each age group or the total number of participants in the test set is not explicitly provided in the summary. The document refers to "sections M and L for the detailed protocol and report," which would presumably contain this information.
Data Provenance: Not explicitly stated, but it's a clinical study comparing devices, suggesting prospective data collection. The location of the study is not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

The ground truth was established by another medical device, the Braun Infra Red Ear Pro 4000 Series Thermometer. Therefore, no human experts were explicitly used to establish the ground truth in the traditional sense for these temperature measurements; rather, it was a comparative study against an established, legally marketed device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Since the ground truth was established by an objective measurement device (Braun Infra Red Ear Pro 4000 Series Thermometer), no human adjudication method was required or performed for the test set's temperature readings.

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:

No, an MRMC comparative effectiveness study was not done. This device is a standalone thermometer, not an AI-assisted diagnostic tool that involves human interpretation.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

Yes, a standalone study was done. The clinical comparison study evaluated the performance of the No Touch+ Forehead Thermometer (an algorithm-driven device) directly against a reference thermometer, without human intervention in the temperature measurement process itself, beyond operating the devices. The device's measurement output is its final determination.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The ground truth was established by comparison to a legally marketed and established reference medical device: the Braun Infra Red Ear Pro 4000 Series Thermometer (K031968/K101747/K103800). This is a form of reference standard comparison.

8. The sample size for the training set:

The document does not explicitly mention a separate "training set" sample size. As this is a 510(k) submission for a medical device (thermometer), it is likely that the device's algorithms were developed and refined during product development, possibly using internal data or engineering studies, rather than a distinct, formal "training set" in the context of a machine learning model for image interpretation. The submission focuses on the validation or clinical study to demonstrate equivalence.

9. How the ground truth for the training set was established:

Not applicable/Not provided given the absence of a distinct "training set" described in the context of this submission. The device's operational principles (thermopile sensor, thermistors, parabolic mirror, infrared distance sensor, predictive algorithms) suggest engineering and calibration against known temperature standards during development.

Summary

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Section 5: 510(k) Summary K134043

1.0 Preparation Date:

December 26, 2013

2.0 Submitted By:

KAZ USA, Inc. 250 Turnpike Rd Southborough, MA 01772

Primary Contact Person/Prepared by:

Raj S Kasbekar, Global VP Regulatory Affairs

Kaz, USA, Inc 250 Turnpike Road, Southborough, MA 01772

3.0 Device Identification:

3.1 Trade Name

No Touch + Forehead Thermometer

Models:

US: NTF3000US (US Model)

International:

NTF3000CA (Canada), NTF3000WE(Western Europe), NTF3000EE(Eastern Europe), NTF3000AP (Asia Pacific), NTF3000AU(Australia), NTF3000(Korea), NTF3000CN(China)

3.2 Common Name

Contact Skin Surface Thermometer

3.3 Classification Name

Thermometer, Clinical, Electronic (21CFR 880.2910: Product code - FLL)

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4.0 Predicate Device:

Predicate	Manufacturer	DocketNumber
Safety 1st ProGrade Health No TouchThermometer	Safety 1st (Avita)	K081160

5.0 Device Description:

The NTF 3000 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 distance sensor for detection of contact or non-contact use and compensation of the temperature reading.

6.0 Intended Use:

7.0 Statement to Conform to the Consensus Standards (Verification)

The No Touch + Forehead Thermometer conforms to the following FDA recognized consensus standards and other standards that include:

ASTM E1965-2009 Infrared Thermometers for Intermittent Determination of Patient temperature and;
Clinical accuracy test requirements established in the standard of ASTM E1965-03 (Clinical part only)- Standard Specification for Infrared Thermometer for Intermittent Determination of Patient Temperature;
IEC 60601-1 30 edition: Medical Electrical Equipment: General requirements for Safety, Requirements and Tests.
IEC 60601-1-2: Medical Electrical Equipment- Part 1: General Requirements for Safety, Electromagnetic Compatibility- Requirements and Tests,
AAMI / ANSI / ISO 10993-1:2003(E), Biological evaluation of medical devices -- Part 1: Evaluation and testing- and appropriate Parts

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ISO 10993-5: Biological Evaluation of Medical Devices: Part 5: Tests for In-vitro cvtotoxicity.
ISO 10993-10: Biological Evaluation of Medical Devices: Part 10: Tests for Irritation and Sensitization.
ISO 14971:2007 2nd edition: Application of Risk Management to Medical Devices 9) EN62304:2006 Medical device software - Software life-cycle processes (IEC 62304:2006); [German version EN 62304:2006, Corrigendum to DIN EN 62304 (VDE 0750-101):2007- 03; German version CENELEC-Cor.: 2008 to EN 62304:2006]
EN60601-1-6:2009 General requirements for basic safety and essential performance - Collateral Standard: Usability
FDA compliance 510(k) - per 21CFR 807, subpart E, 21 CFR 820, clinical report per 21 CFR 812
ISO 14155:2011 Clinical investigation of medical devices for human subjects -Good Clinical Practice

Data supporting conformance with these standards is available from KAZ Inc and is attached as part of this submission.

8.0 Validation Results:

Clinical Study to show substantial equivalence:

A comparison study and clinical repeatability testing was performed on the following four age groups: 0-12 months, 12 months- <5 years, 5 years- <18 years, and 18 years and older in accordance with ASTM E1965-03 to compare the No Touch+Forehead Thermometer with the predicate Safety 1ª ProGrade Health No Touch Thermometer (K081160). The reference or the gold standard used was the Braun Infra Red Ear Pro 4000 Series Thermometer (K031968/K101747/K103800). This clinical comparison study demonstrated that the No Touch+Forehead Thermometer is as good as (noninferior or substantially equivalent to) the previously approved Safety 1st ProGrade Health No Touch Thermometer in all age groups with respect to the bias and standard deviation in comparison to the Braun Infra Red Ear Pro 4000 Series Thermometer. The temperatures obtained with the No Touch + Forehead Thermometer were highly related when compared to the predicate device, where temperatures were measured at forehead sites. The clinical bias with stated uncertainty and clinical repeatability as defined in the ASTM E1965-03 standard were within clinical acceptability (bias less than predicate device when compared to reference). The clinical repeatability of the No Touch + Forehead Thermometer was statistically acceptable (less than 0.3 deg C or 0.58 deg F). Please see sections M and L for the detailed protocol and report for the substantial equivalence study.

9.0 Conclusion:

Based on the safety and performance testing and the compliance with the acceptable voluntary consensus standards, we conclude that the No Touch+Forehead Thermometer Thermometer is substantially equivalent to its predicate device cited above and does not raise any new questions of safety and/or effectiveness.

10.0 Similiarities/Differences of the proposed candidate device when compared to the predicate:

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10.1 Intended Use

The predicate device, the Safety 18 ProGrade Health No Touch Thermometer is intended for the intermittent determination of the human's body temperature for people of all ages. The intended use and indications for use of the predicate and the Kaz No Touch + Forehead Thermometer are similar. The predicate device uses the temple area of the forehead while the Kaz "No Touch + Forehead Thermometer" uses the centre of the forehead as the measurement site.

10.2 Materials

Materials used in the manufacture of the KAZ Thermometer are similar to the predicate device. All skin contacting materials used in the new thermometer have been tested in accordance with ISO 10993-1 and FDA Blue book memo G 95-1 for both Thermometers and the corresponding test reports are included in this submission.

10.3 Design

The design of the KAZ Thermometer is technologically similar to the predicate device but uses a parabolic mirror to focus the infrared energy on the sensor.

10.4 Operational Principles

The KAZ Thermometer is a handheld device, containing an On/Off switch, sensor area, microcontroller and LCD screen to control the device and take measurements. The operating principle is based on detection of infrared energy and use of predictive algorithms to estimate the body temperature.

10.5 Technology

A technology similar to that of the predicate was used in the design of the No Touch + Forehead Thermometer is employed in the design of the predicate device. The kev difference is that the Kaz thermometer uses a parabolic mirror to focus the infrared energy collected from the forehead on the infrared sensor.

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Safety and Performance 10.6

KAZ has provided statements that its No Touch + Forehead Thermometer conforms to the following FDA recognized consensus standards and other standards that include:

Standard or Guidance Document	Data Generated	RelevantSection ofSubmission
Guidance for Industry and FDA Staff: Formatfor Traditional and Abbreviated 510(k)sFDA compliance 510(k) - per 21CFR 807,subpart E, 21 CFR 820, clinical report per 21CFR 812	SubmissionFormat	All
ASTM E1965-09- Standard Specification forInfrared Thermometer for IntermittentDetermination of Patient Temperature.	ClinicalData/Declarationof Conformity	Appendix I
IEC/ISO/EN 60601-1-1-2:2007 MedicalElectrical Equipment- Part 1 General	EMCData/Declaration	Appendix H
Requirements for Safety, ElectromagneticCompatibility-Requirements and Tests	of Conformity
IEC/ISO/EN 60601-1:2005 & -11: 2010Medical Electrical Equipment- Part 1 GeneralRequirements for Electrical Safety,Requirements and Tests	Electrical SafetyData/Declarationof Conformity	Appendix G
IEC EN60601-1-6:2010 General requirementsfor basic safety and essential performance- Collateral Standard: UsabilityFDA Human Factors Draft GuidanceDocument: Agency Expectations for HumanFactors Data in Premarket Submissions -March 21, 2012	UsabilityProtocol &Report	Appendix N
AAMI / ANSI / ISO 10993-1:2009, Biologicalevaluation of medical devices -- Part 1:Evaluation and testingAnd FDA Blue book memo G95-1 onBiocompatibility	BiocompatibilityData/Declarationof Conformity	Appendix F
AAMI / ANSI / ISO 10993-5:2009, Biologicalevaluation of medical devices -- Part 5: Testsfor In Vitro cytotoxicity	Cytotoxicity Data	Appendix F

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AAMI / ANSI / ISO 10993-10:2010,Biological evaluation of medical devices – Part10: Tests for irritationand delayed-type hypersensitivity	Irritation Data &SensitizationData	Appendix F
ISO 14971:2012Application of Risk Management to MedicalDevices	Declaration ofConformity	Appendix Q
EN62304:2006 Medical device softwareSoftware life-cycle processes (IEC62304:2006)	EN62304 Indexin Appendix J	Appendix J
21CFR 812, 50 and 56 andISO 14155:2011 Clinical investigation ofmedical devices for human subjects – GoodClinical Practice	ClinicalAgreements,IRB andInformedConsent	Appendix K,L, M

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11.0 Similarities/Differences of the proposed candidate device when compared to the predicate:

Aspects	Predicate	Candidate
Classification	21CFR 880.2910	Same
Product Code	FLL	Same
FDA Class	II	Same
Intended Use	A non-sterile, reuseable clinical thermometer intended forthe determination of the human's body temperature forpeople of all ages.	A non-sterile, re-useableclinical thermometerintended for theintermittent determinationof the human's bodytemperature for people ofall ages.
Operation	Hand held-Manually operated	Same
Sensor	Infrared	Same
Materials	Common Materials- including an impact resistant casing.Biocompatible metals and resins.	Same
StandardsMet for Benchand ClinicalPerformance	ASTM E1965-98:2009 ........ Infrared Thermometersfor Intermittent Determination of PatientTemperature. The clinical accuracy test section of ASTME1965-09- Standard Specification for InfraredThermometer for Intermittent Determination of PatientTemperature.	Same
Standardsmet for Safety	1) IEC 60601-1 3rd edition:2005 and -11: 2010 MedicalElectrical Equipment: General requirements for Safety,Requirements and Tests.2) IEC 60601-1-2:2007 Medical Electrical Equipment-Part 1: General Requirements for Safety,Electromagnetic Compatibility- Requirements and Tests.3) AAMI / ANSI / ISO 10993-1:2009, Biologicalevaluation of medical devices -- Part 1: Evaluation andtesting- and appropriate Parts4) ISO 10993-5:2009 Biological Evaluation of MedicalDevices: Part 5: Tests for In-vitro cytotoxicity.5) ISO 10993-10:2010 Biological Evaluation of MedicalDevices: Part 10: Tests for Irritation and Sensitization.6) ISO 14971:2012: Application of Risk Management toMedical Devices7) IEC EN 60601-1-6:2010 General requirements forbasic safety and essential performance- Collateral Standard: Usability8) FDA Human Factors Draft Guidance Document:Agency Expectations for Human Factors Data inPremarket Submissions -March 21, 2012	Same

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12. Conclusion:

Based on the safety and performance testing and compliance with acceptable voluntary standards, we believe that the "No Touch + Forehead" Thermometer is substantially equivalent to its predicate device cited above and does not raise any new safety and/or effectiveness issues.

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Image /page/8/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in all caps. The text is in a bold, sans-serif font. The text is centered horizontally in the image. The background of the image is white.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 21, 2014

Kaz USA, Incorporated Mr. Raj S. Kasbeker Vice President, Regulatory Affairs 250 Tumpike Road Southborough, MA 01772

Re: K134043

Trade/Device Name: NTF 3000 No Touch+ Forehead Infrared Thermometer Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical electronic thermometer Regulatory Class: Class II Product Code: FLL Dated: April 21, 2014 Received: April 24, 2014

Dear Mr. Kasbeker:

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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Page 2 - Mr. Kasbeker

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); 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" (21CFR 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 yours,

Mary S. Runner -S

Erin I. Keith, M.S. 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

510(k) Number (if known) K 134043

Device Name

NTF 3000 No Touch+ Forehead Thermometer

Indications for Use (Describe)

The No Touch + Forehead Thermometer (Model NTF3000US) is a non-sterile, reusable clinical themometer intended for the internittent determination of human body temperature in a touch mode on the centre 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)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Digitally signed by Richard C.
Chapman
Date:	2014.05.21 13:29:25 -04'00'

FORM FDA 3881 (1/14)

PSC Publishing Scrivices (JOI) 443-6740 EF

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Regulation Number and Section

§ 880.2910 Clinical electronic thermometer.

(a)
Identification. A clinical electronic thermometer is a device used to measure the body temperature of a patient by means of a transducer coupled with an electronic signal amplification, conditioning, and display unit. The transducer may be in a detachable probe with or without a disposable cover.(b)
Classification. Class II (performance standards). The device is exempt from the premarket notification procedures in part 807, subpart E of this chapter, subject to the limitations in § 880.9 and the following conditions for exemption:(1) Device is not a clinical thermometer with telethermographic functions;
(2) Device is not a clinical thermometer with continuous temperature measurement functions; and
(3) Appropriate analysis and testing (such as that outlined in the currently FDA-recognized editions, as appropriate, of ISO 80601-2-56, “Medical electrical equipment—Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement,” or ASTM E1965, “Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature,” or ASTM E1112, “Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature,” or ASTM E1104, “Standard Specification for Clinical Thermometer Probe Covers and Sheaths”) must validate specifications and performance of the device.