NO TOUCH+FOREHEAD NTF 3000 THERMOMETER

K134043 · Kaz USA, Inc (A Subsidiaryof Kaz Inc) · FLL · May 21, 2014 · General Hospital

Device Facts

• Record ID: K134043
• Device Name: NO TOUCH+FOREHEAD NTF 3000 THERMOMETER
• Applicant: Kaz USA, Inc (A Subsidiaryof Kaz Inc)
• Product Code: FLL · General Hospital
• Decision Date: May 21, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2910
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

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 Story

Hand-held, battery-powered infrared thermometer; measures human body temperature via infrared energy emitted from forehead. Uses thermopile sensor, integrated thermistor for target reading, thermistor for ambient temperature, parabolic mirror for focusing infrared energy, and infrared distance sensor for contact/non-contact detection. Device converts forehead infrared energy to oral equivalent temperature. Used in clinical or home settings by patients or clinicians. Output displayed on LCD screen. Healthcare providers use temperature readings for clinical assessment. Benefits include non-invasive, rapid temperature determination.

Clinical Evidence

Clinical comparison and repeatability study performed per ASTM E1965-03 across four age groups (0-12 months to 18+ years). Compared subject device to predicate (Safety 1st ProGrade) using Braun Pro 4000 as gold standard. Results showed subject device is substantially equivalent; clinical bias was within acceptable limits (less than predicate). Clinical repeatability was statistically acceptable (< 0.3 deg C / 0.58 deg F).

Technological Characteristics

Handheld infrared thermometer. Materials: impact-resistant casing, biocompatible metals/resins (ISO 10993 compliant). Sensing: thermopile sensor, thermistor, parabolic mirror, infrared distance sensor. Energy: battery-powered. Connectivity: none. Software: EN62304 compliant. Standards: ASTM E1965-09, IEC 60601-1, IEC 60601-1-2, ISO 14971.

Indications for Use

Indicated for intermittent determination of human body temperature in people of all ages. Measurement site is the center of the forehead. Suitable for touch and no-touch use.

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

• Safety 1st ProGrade Health No Touch Thermometer (K081160)

Reference Devices

• Braun Infra Red Ear Pro 4000 Series Thermometer (K031968/K101747/K103800)

Submission Summary (Full Text)

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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 | Docket<br>Number |
|----------------------------------------------------|--------------------|------------------|
| Safety 1st ProGrade Health No Touch<br>Thermometer | Safety 1st (Avita) | K081160 |

#### 5.0 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.

#### 6.0 Intended Use:

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.

#### 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:

1) ASTM E1965-2009 Infrared Thermometers for Intermittent Determination of Patient temperature and;

2) 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;

3) IEC 60601-1 30 edition: Medical Electrical Equipment: General requirements for Safety, Requirements and Tests.

4) IEC 60601-1-2: Medical Electrical Equipment- Part 1: General Requirements for Safety, Electromagnetic Compatibility- Requirements and Tests,

5) AAMI / ANSI / ISO 10993-1:2003(E), Biological evaluation of medical devices -- Part 1: Evaluation and testing- and appropriate Parts

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6) ISO 10993-5: Biological Evaluation of Medical Devices: Part 5: Tests for In-vitro cvtotoxicity.

7) ISO 10993-10: Biological Evaluation of Medical Devices: Part 10: Tests for Irritation and Sensitization.

8) 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]

10) EN60601-1-6:2009 General requirements for basic safety and essential performance - Collateral Standard: Usability

11) FDA compliance 510(k) - per 21CFR 807, subpart E, 21 CFR 820, clinical report per 21 CFR 812

12) 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 | Relevant<br>Section of<br>Submission |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------|--------------------------------------|
| Guidance for Industry and FDA Staff: Format<br>for Traditional and Abbreviated 510(k)s<br>FDA compliance 510(k) - per 21CFR 807,<br>subpart E, 21 CFR 820, clinical report per 21<br>CFR 812 | Submission<br>Format | All |
| ASTM E1965-09- Standard Specification for<br>Infrared Thermometer for Intermittent<br>Determination of Patient Temperature. | Clinical<br>Data/Declaration<br>of Conformity | Appendix I |
| IEC/ISO/EN 60601-1-1-2:2007 Medical<br>Electrical Equipment- Part 1 General | EMC<br>Data/Declaration | Appendix H |
| Requirements for Safety, Electromagnetic<br>Compatibility-Requirements and Tests | of Conformity | |
| IEC/ISO/EN 60601-1:2005 & -11: 2010<br>Medical Electrical Equipment- Part 1 General<br>Requirements for Electrical Safety,<br>Requirements and Tests | Electrical Safety<br>Data/Declaration<br>of Conformity | Appendix G |
| IEC EN60601-1-6:2010 General requirements<br>for basic safety and essential performance<br>- Collateral Standard: Usability<br>FDA Human Factors Draft Guidance<br>Document: Agency Expectations for Human<br>Factors Data in Premarket Submissions -<br>March 21, 2012 | Usability<br>Protocol &<br>Report | Appendix N |
| AAMI / ANSI / ISO 10993-1:2009, Biological<br>evaluation of medical devices -- Part 1:<br>Evaluation and testing<br>And FDA Blue book memo G95-1 on<br>Biocompatibility | Biocompatibility<br>Data/Declaration<br>of Conformity | Appendix F |
| AAMI / ANSI / ISO 10993-5:2009, Biological<br>evaluation of medical devices -- Part 5: Tests<br>for In Vitro cytotoxicity | Cytotoxicity Data | Appendix F |

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| AAMI / ANSI / ISO 10993-10:2010,<br>Biological evaluation of medical devices – Part<br>10: Tests for irritation<br>and delayed-type hypersensitivity | Irritation Data &<br>Sensitization<br>Data | Appendix F |
|------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------|---------------------|
| ISO 14971:2012<br>Application of Risk Management to Medical<br>Devices | Declaration of<br>Conformity | Appendix Q |
| EN62304:2006 Medical device software<br>Software life-cycle processes (IEC<br>62304:2006) | EN62304 Index<br>in Appendix J | Appendix J |
| 21CFR 812, 50 and 56 and<br>ISO 14155:2011 Clinical investigation of<br>medical devices for human subjects – Good<br>Clinical Practice | Clinical<br>Agreements,<br>IRB and<br>Informed<br>Consent | Appendix K,<br>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 for<br>the determination of the human's body temperature for<br>people of all ages. | A non-sterile, re-useable<br>clinical thermometer<br>intended for the<br>intermittent determination<br>of the human's body<br>temperature for people of<br>all ages. |
| Operation | Hand held-Manually operated | Same |
| Sensor | Infrared | Same |
| Materials | Common Materials- including an impact resistant casing.<br>Biocompatible metals and resins. | Same |
| Standards<br>Met for Bench<br>and Clinical<br>Performance | ASTM E1965-98:2009 ........ Infrared Thermometers<br>for Intermittent Determination of Patient<br>Temperature. The clinical accuracy test section of ASTM<br>E1965-09- Standard Specification for Infrared<br>Thermometer for Intermittent Determination of Patient<br>Temperature. | Same |
| Standards<br>met for Safety | 1) IEC 60601-1 3rd edition:2005 and -11: 2010 Medical<br>Electrical Equipment: General requirements for Safety,<br>Requirements and Tests.<br>2) IEC 60601-1-2:2007 Medical Electrical Equipment-<br>Part 1: General Requirements for Safety,<br>Electromagnetic Compatibility- Requirements and Tests.<br>3) AAMI / ANSI / ISO 10993-1:2009, Biological<br>evaluation of medical devices -- Part 1: Evaluation and<br>testing- and appropriate Parts<br>4) ISO 10993-5:2009 Biological Evaluation of Medical<br>Devices: Part 5: Tests for In-vitro cytotoxicity.<br>5) ISO 10993-10:2010 Biological Evaluation of Medical<br>Devices: Part 10: Tests for Irritation and Sensitization.<br>6) ISO 14971:2012: Application of Risk Management to<br>Medical Devices<br>7) IEC EN 60601-1-6:2010 General requirements for<br>basic safety and essential performance<br>- Collateral Standard: Usability<br>8) FDA Human Factors Draft Guidance Document:<br>Agency Expectations for Human Factors Data in<br>Premarket 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 [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" (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 [phone] or [phone] 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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