BRAUN THERMOSCAN PRO3000 INFARED THERMOMETER

K992468 · Braun GmbH · FLL · Oct 20, 1999 · General Hospital

Device Facts

• Record ID: K992468
• Device Name: BRAUN THERMOSCAN PRO3000 INFARED THERMOMETER
• Applicant: Braun GmbH
• Product Code: FLL · General Hospital
• Decision Date: Oct 20, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2910
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Braun ThermoScan PRO 3000 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. Used by medical professionals in clinical settings. Device captures infrared energy; internal processing applies mathematical adjustment to measured ear temperature to approximate oral range. Output displayed on screen; provides single previous temperature memory recall. Assists clinicians in febrile status assessment; supports clinical decision-making regarding patient temperature management.

Clinical Evidence

Clinical study performed across four age groups (0-3, 4-10, 11-65, >65 years); ~39% of participants were febrile. Study demonstrated equivalent ear temperature measurement compared to predicate IR-2000(PRO-1). Clinical repeatability found statistically and clinically acceptable.

Technological Characteristics

Infrared thermometer; handheld form factor. Meets ASTM E 1965-98 standard. Operating range 68°F-108°F (20°C-42.2°C). Accuracy ±0.2°C to ±0.5°C depending on range. User-selectable °F/°C scales. Battery-operated.

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

• Braun ThermoScan IRT 3020/3520 One Second Ear Thermometer (K992468)
• ThermoScan Instant Thermometer, Model IR-2000(PRO-1) (K992468)

Submission Summary (Full Text)

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OCT 20 1999

# BRHUN K992468 Thermoscan.

10421 Pacific Center Court San Diego, CA 92121 Telephone: [phone] [phone] Telefax:

## 510(k) SUMMARY

| Submitter's Name | Braun Thermoscan |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address | 10421 Pacific Center Court<br>San Diego, CA 92121 |
| Phone | [phone] |
| Contact | Laura Guy |
| Date of Summary | July 21, 1999 |
| Name of Device | Braun ThermoScan® PRO 3000 Infrared Thermometer |
| Predicate Device | Braun ThermoScan® IRT 3020/3520 One Second Ear<br>Thermometer<br>ThermoScan® Instant Thermometer, Model<br>IR-2000(PRO-1) |
| Device Description | The Braun ThermoScan® PRO 3000 Infrared<br>Thermometer is a hand held instrument that measures<br>temperature through the opening of the auditory canal.<br>Operation is based on measuring the natural thermal<br>radiation emitted from the tympanic membrane and<br>adjacent surfaces. |
| Intended Use | The Braun ThermoScan® PRO 3000 Infrared<br>Thermometer is intended for the intermittent<br>measurement and monitoring of human body<br>temperature, by medical professionals. It is intended for<br>use on people of all ages. |
| Technological Characteristics | The Braun ThermoScan® thermometers, Models PRO<br>3000 and IRT 3020/3520 have the same general design,<br>incorporate similar materials and components, and use<br>similar technology. |
| | The primary function of the Braun ThermoScan® PRO<br>3000 Infrared Thermometer is the same as the Braun |

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ThermoScan® IRT 3020/3520 and the ThermoScan® Instant Thermometer, Model IR-2000(PRO-1). The device is to be used for the measurement of body temperature. The PRO 3000 raise no new questions of safety and effectiveness.

ThermoScan® concludes that the Braun Braun ThermoScan® PRO 3000 Infrared Thermometer is substantially equivalent to the Braun ThermoScan® 3020/3520 and the ThermoScan® Instant Thermometer, Model IR-2000(PRO-1).

#### PRODUCT SPECIFICATIONS

Model Number

3000

| Technical Characteristics | |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Displayed temperature range: | 68°F-108°F (20°C-42.2°C) |
| Operating ambient temperature range: | 50°F-104°F (10°C-40°C) |
| Display resolution: | 0.1°F or °C |
| Temperature scales (user selectable): | °F or °C |
| Long term storage ranges: | |
| Temperature | -4 to 122°F (-20 to 50°C) |
| Humidity (max) | 95% noncondensing |
| Display modes: | EAR (The displayed temperature is the actual measured ear temperature plus a mathematical adjustment to approximate the familiar oral range. However, this is not |

Weight (without batteries): Memory recall:

3.5 oz (100q) One previous temperature

temperature taken at the same time.)

necessarily

the same as an

oral

Accuracy characteristics *: Applicable patient ages: Patient temperature range 96.8°F to 102.2°F (36 to 39°C) Outside this range

All ages Error °F Error °C + 0.2 + 0.4 + 0.3 + 0.5

*ASTM laboratory accuracy requirements in the display range of 36℃ to 39℃ (96.8 to 102 °F) for IR thermometers is + 0.2°C (+ 0.4°F), whereas for mercury-in-qlass and electronic thermometers, the requirement per ASTM Standards E667-86 and E1112-86 is + 0.1ºC (+ 0.2ºF).

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This infrared thermometer meets the requirements established in ASTM Standard E 1965-98, "Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature". Full responsibility for the conformance of this Product to the standard is assumed by Braun GmbH, 61476 Kronberg, Germany.

#### SUMMARY OF TESTING

#### Non-Clinical Results

| PERFORMANCE TEST | RESULTS |
|------------------------------------------------------------------------------------------|---------|
| Five Environment Accuracy Test | Pass |
| Thermometer Operating Life Test (Reliability<br>of keys, switch and probe cover ejector) | Pass |
| Cleaning Test | Pass |
| Acoustic Noise test | Pass |
| ENVIORNMENTAL | RESULTS |
| Altitude Test | Pass |
| Electromagnetic Compatibility | Pass |

Product performance specifications, features and software were validated.

#### Clinical Results

A comparison study and clinical repeatability testing was performed on the following four ages groups; 0-3 yrs, 4-10 yrs, 11-65 yrs, and >65 yrs. Approximately 39% of the patients participating in the study were considered febrile. The comparison study demonstrated that the Braun ThermoScan® PRO-3000 Instant Thermometer measured ear temperature equivalently to the ThermoScan® IR-2000(PRO-1) in all age groups. The clinical repeatability is statistically and clinically acceptable.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 20 1999

Ms. Laura Guy Senior Regulatory Affairs Specialist Braun ThermoScan® 10421 Pacific Center Court San Diego, CA 92121

Re : K992468

> Trade Name: Braun ThermoScan® PRO 3000 Infrared Thermometer Regulatory Class: II Product Code: FLL Dated: July 22, 1999 Received: July 23, 1999

Dear Ms. Guy:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any

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Page 2 - Ms. Guy

obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the requlation entitled, "Misbranding by reference to one regaration" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Intended Use of the Braun ThermoScan Pro 3000

The Braun ThermoScan PRO 3000 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.

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