(179 days)
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No
The description focuses on standard infrared temperature measurement technology and does not mention any AI or ML components.
No.
The device is a thermometer used for measurement and monitoring, not for treating or preventing a disease or condition.
Yes
Explanation: The device is intended for "intermittent measurement and monitoring of human body temperature," which is a physiological parameter. The measurement of physiological parameters for the purpose of assessing a medical condition or disease is a diagnostic function.
No
The device description explicitly states it is a "hand held instrument" that measures temperature through the auditory canal, 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 Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The Braun ThermoScan pro-2000 Instant Thermometer measures temperature directly from the human body (specifically, the auditory canal). It does not analyze any specimens taken from the body.
Therefore, based on the provided information, the device falls under the category of a medical device used for direct physiological measurement, not an IVD.
N/A
Intended Use / Indications for Use
The Braun ThermoScan pro-2000 Instant Thermometer is intended for the intermittent measurement and monitoring of human body temperature by medical professionals. It is intended for use on people of all ages.
Product codes
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Device Description
The Braun ThermoScan pro-2000 Instant Thermometer, 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
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
tympanic membrane and adjacent surfaces (measured through the opening of the auditory canal)
Indicated Patient Age Range
all ages
Intended User / Care Setting
medical professionals
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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 pro-2000 Instant Thermometer measured ear temperature equivalently to the IR-2000 in all age groups. The clinical repeatability for each age group met ASTM standards.
Key Metrics
Accuracy: Meets American Society for Testing and Materials (ASTM) Standard E1112-86 as it pertains to IR thermometers
| Patient temperature range | Error °F | Error °C |
|---|---|---|
| 102.0 to 106.0°F (>39.0 to 41.0°C) | ±0.3 | ±0.2 |
106.0°F (>41.0°C) | ±0.5 | ±0.3
Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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510(k) SUMMARY
| Submitter's Name: | Thermoscan, Inc. MAY 16 1997 |
|---|---|
| Address: | 10421 Pacific Center Court |
| San Diego, CA 92121 | |
| Phone: | (619) 550-2100 |
| Contact: | Frances E. Harrison |
| Date of Summary: | 11/15/96 |
| Name of Device: | Braun ThermoScan pro-2000 Instant Thermometer |
| Predicate Device: | THERMOSCAN Instant Thermometer, Model IR-2000 |
| THERMOSCAN Instant Thermometer, Model IR-5000 | |
| THERMOSCAN Instant Thermometer, Model IR-6000 | |
| Device Description: | The Braun ThermoScan pro-2000 Instant Thermometer, |
| 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 pro-2000 Instant Thermometer |
| is intended for the intermittent measurement and monitoring | |
| of human body temperature by medical professionals. It is | |
| intended for use on people of all ages. | |
| Technological | |
| Characteristics: | The Braun ThermoScan Instant Thermometers, Model |
| PRO-2000, IR-2000, IR-5000 and IR-6000 have the same | |
| general design and incorporate similar technologies, | |
| materials and components. | |
| The primary function of the Braun ThermoScan pro-2000 | |
| Instant Thermometer is the same as the ThermoScan Instant | |
| Thermometer, Models IR-2000, IR-5000 and IR-6000 for the | |
| measurement of body temperature and raise no new | |
| questions of safety and effectiveness. ThermoScan Inc. | |
| concludes that the Braun ThermoScan pro-2000 | |
| Instant Thermometer, is substantially equivalent to the | |
| ThermoScan IR-2000, IR-5000 and IR-6000. |
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Page 2 510(k) Summary Braun ThermoScan pro-2000 Instant Thermometer
PRODUCT SPECIFICATIONS:
Model Number
PRO-2000
| Temperature Ranges | |
|---|---|
| Patient temperature range | 80.0 to 108.0°F (26.6 to 42.2°C) |
| Ambient temperature operating range | 60.8 to 104°F (16.0 to 40.0°C) |
| Temperature scales (user selectable) | °F or °C |
| Storage temperature range | -4.0 to 122.0°F (-20.0 to 50.0°C) |
| 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.) | |
| Humidity Range | 15 - 95% Noncondensing |
| Resolution | 0.1°F or C |
| Shock | Withstands one meter drop in thermometer |
| storage cover |
Accuracy: Meets American Society for Testing and Materials (ASTM) Standard E1112-86 as it pertains to IR thermometers
| Applicable patient ages | All ages | |
|---|---|---|
| Patient temperature range | Error °F | Error °C |
| 102.0 to 106.0°F (>39.0 to 41.0°C) | ±0.3 | ±0.2 |
| >106.0°F (>41.0°C) | ±0.5 | ±0.3 |
| Time | ||
| Measurement time | 1 second | |
| Minimum time between readings | 8 seconds | |
| Automatic "power down" | 60 seconds | |
| Weight | 7 oz (195 gm) |
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Page 3 510(k) Summary Braun ThermoScan pro-2000 Instant Thermometer
SUMMARY OF TESTING:
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 pro-2000 Instant Thermometer measured ear temperature equivalently to the IR-2000 in all age groups. The clinical repeatability for each age group met ASTM standards.