THERMOSCAN INSTANT THERMOMETER MODEL IR-6000

K954523 · Thermoscan, Inc. · FLL · Dec 10, 1996 · General Hospital

Device Facts

• Record ID: K954523
• Device Name: THERMOSCAN INSTANT THERMOMETER MODEL IR-6000
• Applicant: Thermoscan, Inc.
• Product Code: FLL · General Hospital
• Decision Date: Dec 10, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2910
• Device Class: Class 2
• Attributes: Pediatric

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.

Device Story

Handheld infrared thermometer; measures natural thermal radiation from tympanic membrane and adjacent auditory canal surfaces. Device converts infrared input into temperature reading; applies mathematical adjustment to measured ear canal temperature to approximate oral range. Used in home setting by patients or caregivers. Output displayed on device screen; provides single previous temperature memory recall. Assists in monitoring body temperature for clinical decision-making.

Clinical Evidence

Clinical comparison and repeatability testing performed across four age groups (0-3, 4-10, 11-65, >65 years). Demonstrated equivalent performance to IR-2000 and IR-4000. Clinical repeatability met ASTM standards.

Technological Characteristics

Infrared sensing technology; handheld form factor (100g). Temperature range 93.2-108°F. Complies with ASTM E1112-86 standard for electronic thermometers. User-selectable °F/°C scales. Battery-operated.

Indications for Use

Indicated for intermittent measurement and monitoring of human body temperature in the home for all ages.

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-4000

Submission Summary (Full Text)

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12/09/96 MON 11:34 FAX [phone] THERMOSCAN, INC. 003
X 954523
THERMOSCAN, INC.

# 510(K) SUMMARY

DEC 10 1996

| Submitter's Name: | Thermoscan Inc. |
| --- | --- |
| Address: | 10421 Pacific Center Court
San Diego, CA 92121 |
| Phone: | [phone] |
| 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.

10421 PACIFIC CENTER COURT · SAN DIEGO, CALIFORNIA 92121-4339 · [phone]

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12/09/96 MON 11:35 FAX [phone] THERMOSCAN, INC. 004

Page 2
510(k) Summary
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 to<98.0°F (35.8 to<37.0°C) | ±0.3 ±0.2 |
| >102.0 to 106.0°F (>39.0 to 41.0°C) | |
| <96.4°F (35.8°C or>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 [phone]. 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.

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12/09/96 MON 11:35 FAX [phone] THERMOSCAN, INC. 005

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510(k) Summary
Braun ThermoScan Thermometer, Model IR-6000

# SUMMARY OF TESTING:

## 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 Test | Passed |
| Altitude Test | 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 &gt;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.