(158 days)
No
The description mentions a "mathematical algorithm" and "heat transfer data" for temperature calculation, but there is no mention of AI, ML, or related concepts like training/test sets, image processing, or neural networks.
No.
The device is a thermometer, intended for measuring human body temperature, which is a diagnostic function, not a therapeutic one.
Yes.
Explanation: The device is a clinical thermometer intended for the intermittent determination of human body temperature, which is a diagnostic function used to assess a person's health status.
No
The device description explicitly states it is a "hand-held, battery powered device" that measures temperature by detecting heat flow on the skin, indicating it is a physical hardware device, not software only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Behind Ear Gentle Touch Thermometer measures human body temperature by detecting heat flow on the skin. This is a direct measurement of a physiological parameter on the body, not a test performed on a sample taken from the body.
Therefore, based on the provided information, the device is a clinical thermometer used for in-vivo measurement, not an in-vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Behind Ear Gentle Touch Thermometer (Models V980/BET 1000) is a non-sterile, reusable clinical thermometer intended for the intermittent determination of human body temperature using behind the earlobe as the measurement site on people of all ages.
Product codes (comma separated list FDA assigned to the subject device)
FLL
Device Description
The over-the-counter Behind Ear Gentle Touch Thermometer - Models V980/ BET 1000 is a hand-held, battery powered device designed to measure human body temperature by detecting heat flow on the skin directly behind the ear lobe as a measurement site, by using the heat conduction principal and prediction. The skin area over the posterior auricular artery passing behind the earlobe is the measurement site, which is very close to the cantharid artery. These arteries carry blood to the brain and therefore the site is the best external place to measure temperature.
The Behind Ear Gentle Touch Thermometer is designed to calculate the maximum temperature of a probe in contact with the body site by heat transfer data and mathematical algorithm. The temperature reading range is from 95.0° F to 107.6° F (35°C to 42 °C) and the time of measurement is about 1 second.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
behind the earlobe / posterior auricular artery behind the earlobe
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
A comparison study and clinical repeatability testing was performed on the following four age groups: 0-24 months, 24 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
V980/BET1000 Behind Ear Gentle Touch Thermon
JUN - 6 2011
510(k) Summary
1.0 Preparation Date:
December 15, 2010 (Revised on May 25, 2011)
2.0 Submitted By:
KAZ USA, Inc. 250 Turnpike Rd Southborough, MA 01772
Primary Contact Person/Prepared by:
Rai S Kasbekar, VP Regulatory Affairs
Kaz, USA, Inc 250 Turnpike Road, Southborough, MA 01772
3.0 Device Identification:
3.1 Trade Name
Behind Ear Gentle Touch Thermometer-Models V980(US, EU and Canada)/ BET 1000 (International)
Common Name 3.2
Contact Skin Surface Thermometer
Classification Name 3.3
Thermometer, Clinical, Electronic (21CFR 880.2910: Product code - FLL)
FDA CDRH DMC
MAY 2 7 2011 Received
1
4.0 Predicate Device:
| Predicate | Manufacturer | Docket
Number |
|-------------------------------|--------------|------------------|
| Up-Grade Forehead Thermometer | Medisim Ltd. | K032362 |
5.0 Device Description:
The over-the-counter Behind Ear Gentle Touch Thermometer - Models V980/ BET 1000 is a hand-held, battery powered device designed to measure human body temperature by detecting heat flow on the skin directly behind the ear lobe as a measurement site, by using the heat conduction principal and prediction. The skin area over the posterior auricular artery passing behind the earlobe is the measurement site, which is very close to the cantharid artery. These arteries carry blood to the brain and therefore the site is the best external place to measure temperature.
The Behind Ear Gentle Touch Thermometer is designed to calculate the maximum temperature of a probe in contact with the body site by heat transfer data and mathematical algorithm. The temperature reading range is from 95.0° F to 107.6° F (35°C to 42 °C) and the time of measurement is about 1 second.
6.0 Intended Use:
A non-sterile, reusable clinical thermometer intended for the intermittent determination of the human's body temperature using behind the patient's earlobe as the measurement site on people of all ages.
Statement to Conform to the Consensus Standards (Verification) 7.0
The Behind Ear Gentle Touch Thermometer conforms to the following FDA recognized consensus standards and other standards that include:
-
ASTM E1112-00 (Reapproved 2006)- Standard Specification for Electronic Thermometer 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: 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.
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ISO 10993-10: Biological Evaluation of Medical Devices: Part 10: Tests for Irritation and Sensitization.
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ISO 14971:2007 2nd edition: Application of Risk Management to Medical Devices
Data supporting conformance with these standards is available from KAZ Inc and is attached as part of this submission.
8.0 Validation Results:
1. Clinical Study to show substantial equivalence:
A comparison study and clinical repeatability testing was performed on the following four age groups: 0-24 months, 24 months-