(438 days)
ThermoScan Instant Thermometer, Model IR-2000, ThermoScan Instant Thermometer, Model IR-4000
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No
The summary describes a standard infrared thermometer measuring thermal radiation, with no mention of AI, ML, image processing, or data sets typically associated with AI/ML development.
No
The device is a thermometer, used for measurement and monitoring of body temperature, which is a diagnostic function, not a therapeutic one. It does not treat or alleviate any condition.
No
The device measures and monitors human body temperature, which is a physiological parameter. It does not provide a diagnosis of a disease or condition.
No
The device description clearly states it is a "hand held instrument" that measures temperature through the auditory canal, indicating it is a physical hardware device, not software only.
Based on the provided information, the Braun ThermoScan Thermometer, Model IR-6000 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 Braun ThermoScan Thermometer measures body temperature by detecting thermal radiation from the ear. This is a direct measurement of a physiological parameter within the body, not a test performed on a sample taken from the body.
- Intended Use: The intended use is for "intermittent measurement and monitoring of human body temperature," which aligns with a general medical device for physiological monitoring, not an IVD.
Therefore, the Braun ThermoScan Thermometer, Model IR-6000 falls under the category of a general medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Braun ThermoScan Thermometer, Model IR-6000 is intended for the intermittent measurement and monitoring of human body temperature in the home. It is intended for use on people of all ages.
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
The Braun ThermoScan Thermometer, Model IR-6000 is a hand held instrument that measures temperature through the opening of the auditory canal. Operation is based on measuring the natural thermal radiation emitted from the Tympanic membrane and adjacent surfaces.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
auditory canal / Tympanic membrane
Indicated Patient Age Range
All ages
Intended User / Care Setting
home
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)
Non-Clinical Results:
Accuracy Test: Passed
Consistency Test: Passed
Operating Life Test: Passed
Lens Filter Detect Switch Operating Life Test: Passed
Cleaning Test: Passed
Acoustic Noise: Passed
Test Altitude: Passed
Electrical Short Heat Measurement Test: Passed
Product performance specifications, features and software were validated.
Clinical Results:
A comparison study and clinical repeatability testing was performed on the following four age groups; 0-3 yrs, 4-10 yrs, 11-65 yrs, and >65 yrs. The comparison study demonstrated that the Braun ThermoScan Thermometer, Model IR-6000 measured ear temperature equivalently to both the IR-2000 and IR-4000 in all age groups. The clinical repeatability for each age group met ASTM standards.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Laboratory error (max):
Patient temperature range: 98.0 to 102.0°F (37.0 to 39.0°C), Error °F: ±0.2, Error °C: ±0.1
Patient temperature range: 96.4 to 102.0 to 106.0°F (>39.0 to 41.0°C), Error °F: ±0.3, Error °C: ±0.2
Patient temperature range: 106.0°F (41.0°C), Error °F: ±0.5, Error °C: ±0.3
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
ThermoScan Instant Thermometer, Model IR-2000, ThermoScan Instant Thermometer, Model IR-4000
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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
X 954523
THERMOSCANINC.
510(K) SUMMARY
DEC 1 0 1996
| DEC 10 1996 | |
|---|---|
| Submitter's Name: | Thermoscan Inc. |
| Address: | 10421 Pacific Center Court |
| San Diego, CA 92121 | |
| Phone: | (619) 550-2100 |
| Contact: | Frances E. Harrison |
| Date of Summary: | December 9, 1996 |
| Name of Device: | Braun ThermoScan Thermometer, Model IR-6000 |
| Predicate Device: | ThermoScan Instant Thermometer, Model IR-2000 |
| ThermoScan Instant Thermometer, Model IR-4000 | |
| Device Description: | The Braun ThermoScan Thermometer, Model IR-6000 |
| is a hand held instrument that measures temperature through | |
| the opening of the auditory canal. Operation is based on | |
| measuring the natural thermal radiation emitted from the | |
| Tympanic membrane and adjacent surfaces | |
| Intended Use: | The Braun ThermoScan Thermometer, Model IR-6000 |
| is intended for the intermittent measurement and monitoring | |
| of human body temperature in the home. It is intended for | |
| use on people of all ages. | |
| Technological | |
| Characteristics: | The Braun ThermoScan Thermometers, Model |
| IR-6000, IR-2000 and IR-4000 have the same general design | |
| and incorporate similar technologies, materials and | |
| components. |
The primary function of the Braun ThermoScan
Thermometer, Model IR-6000 is the same as ThermoScan
Instant Thermometer, Models IR-2000 and IR-4000 for the
measurement of body temperature and raise no new
questions of safety and effectiveness. ThermoScan Inc.
concludes that the Braun ThermoScan Thermometer,
Model IR-6000 is substantially equivalent to the
ThermoScan IR-2000 and ThermoScan IR-4000. |
:
1
004
Page 2 510(k) Summarv Braun ThermoScan Thermometer, Model IR-6000
PRODUCT SPECIFICATIONS:
| Model Number | HM3, HM3P | |
|---|---|---|
| Technical Characteristics | ||
| Displayed temperature range | 93.2-108°F (34-42.2°C) | |
| Operating ambient temperature range | 61-104°F (16.1-40°C) | |
| Display resolution | 0.1°F or C | |
| Temperature scales (user selectable) | °F or °C | |
| Operating relative humidity (max) | 80% | |
| Long term storage ranges | ||
| Temperature | -4 to 122°F (-20 to 50°C) | |
| Humidity (max) | 95% noncondensing | |
| Display modes | EAR (The displayed EAR temperature is the | |
| actual measured ear canal temperature plus | ||
| a mathematical adjustment to approximate | ||
| the familiar oral range. However, this is not | ||
| necessarily the same as an oral temperature | ||
| measured at the same time.) | ||
| Weight (without batteries) | 3.5 oz (100g) | |
| Memory recall | One previous temperature | |
| Accuracy characteristics* | ||
| Applicable patient ages | All ages | |
| Laboratory error (max) | ||
| Patient temperature range | Error °F | Error °C |
| 98.0 to 102.0°F (37.0 to 39.0°C) | ±0.2 | ±0.1 |
| 96.4 to102.0 to 106.0°F (>39.0 to 41.0°C) | ||
| 106.0°F (41.0°C) | ±0.5 | ±0.3 |
*Accuracy is determined under laboratory conditions in calibrate mode with a typical lens filter installed. See ASTM Standard "Electronic Thermometer for Intermittent Determination of Patient Temperature" E1112-86, available from ASTM, 100 Barr Harbor Dr., West Conshoken, PA 19428-2959. Tel (610) 832-9285. Consult company for calibrate mode.
The Braun ThermoScan Thermometer has been proven to be safe. It meets the laboratory accuracy requirement specified in ASTM Standard E1112 as it pertains to infrared thermometers.
2
Page 3 510(k) Summary Braun ThermoScan Thermometer, Model IR-6000
Summary of Testing:
Non-Clinical Results
| Accuracy Test | Passed |
|---|---|
| Consistency Test | ි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි හිටි හිමි කිරීම පිහිටි හිමි කිරීම පිහිටි හිමි හිමි කිරීම පිහිටි මෙම ප්රධාන බවට |
| Operating Life Test | ි පිහුළු පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහ |
| Lens Filter Detect Switch Operating Life Test | Passed |
| Cleaning Test | Passed |
| Acoustic Noise | |
| @st | Passed |
| Test | |
| Altitude | Passed |
| Electrical Short Heat Measurement Test | Passeg |
Product performance specifications, features and software were validated.
Clinical Results
A companison study and clinical repeatablify testing was performed on the following four age groups; 0-3 yrs, 4-10 yrs, 11-65 yrs, and >65 yrs. The companson study demonstrated that the Braun ThermoScan Thermometer, Model IR-8000 measured ear temperature equivalently to both the IR-2000 and IR-4000 in all age groups. The clinical repeatability for each age group met ASTM standards.