(141 days)
No
The device description details standard infrared thermometry components and processes, and there is no mention of AI, ML, or related concepts in the document.
No
A therapeutic device is used for treating or alleviating a medical condition. This device is a thermometer, which is used for measurement and diagnosis, not for therapy.
Yes
The device is a clinical thermometer intended for the intermittent determination of human body temperature, which is a diagnostic measurement.
No
The device description clearly outlines multiple hardware components including a thermopile sensor, thermistor, parabolic mirror, and infrared distance sensor, indicating it is a physical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Function: The No Touch + Forehead Thermometer measures body temperature by detecting infrared energy emitted from the forehead. It does not analyze any biological specimens.
Therefore, based on the provided information, the device is a clinical thermometer used for external measurement of body temperature, not an IVD.
N/A
Intended Use / Indications for 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.
Product codes
FLL
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Infrared
Anatomical Site
forehead
Indicated Patient Age Range
all ages
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
A comparison study and clinical repeatability testing was performed on the following four age groups: 0-12 months, 12 months-
§ 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.
0
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)
1
4.0 Predicate Device:
| Predicate | Manufacturer | Docket
Number |
|----------------------------------------------------|--------------------|------------------|
| Safety 1st ProGrade Health No Touch
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:
-
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
2
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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]
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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- Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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