BRAUN THERMOSCAN PRO-2000 INSTANT THERMOMETER (PRO-2000)

K964605 · Thermoscan, Inc. · FLL · May 16, 1997 · General Hospital

Device Facts

• Record ID: K964605
• Device Name: BRAUN THERMOSCAN PRO-2000 INSTANT THERMOMETER (PRO-2000)
• Applicant: Thermoscan, Inc.
• Product Code: FLL · General Hospital
• Decision Date: May 16, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2910
• Device Class: Class 2
• Attributes: Pediatric

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.

Device Story

Handheld infrared thermometer; measures thermal radiation from tympanic membrane and auditory canal. Operated by medical professionals in clinical settings. Device captures infrared signal; processes data to calculate temperature; applies mathematical adjustment to measured ear canal temperature to approximate oral range. Output displayed on device screen in °F or °C. Provides rapid 1-second measurement; aids clinical decision-making regarding patient fever status and temperature monitoring.

Clinical Evidence

Clinical comparison and repeatability study conducted across four age groups (0-3, 4-10, 11-65, >65 years). Results demonstrated equivalent performance to predicate IR-2000. Clinical repeatability met ASTM E1112-86 standards for all age groups.

Technological Characteristics

Infrared tympanic thermometer. Measures natural thermal radiation. Accuracy compliant with ASTM E1112-86. Resolution 0.1°F/C. Operating range 60.8-104°F. Measurement time 1 second. Handheld form factor, 195g. No software algorithm class specified.

Indications for Use

Indicated for intermittent measurement and monitoring of human body temperature in patients of all ages by medical professionals.

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

• THERMOSCAN Instant Thermometer, Model IR-2000
• THERMOSCAN Instant Thermometer, Model IR-5000
• THERMOSCAN Instant Thermometer, Model IR-6000

Submission Summary (Full Text)

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K 964605

# 510(k) SUMMARY

Submitter's Name: Thermoscan, Inc.
MAY 16 1997

Address: 10421 Pacific Center Court
San Diego, CA 92121

Phone: [phone]

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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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 |
| <96.4°F (<35.8°C) | ±0.5 | ±0.3 |
| 96.4 to <98.0°F (35.8 to <37.0°C) | ±0.3 | ±0.2 |
| 98.0 to 102.0°F (37.0 to 39.0°C) | ±0.2 | ±0.1 |
| >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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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 &gt;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.