BRAUN THERMOSCAN IRT3020/3500 ONE SECONS EAR THERMOMETER, MODEL IRT3020/3520

K983295 · Braun AG · FLL · Mar 15, 1999 · General Hospital

Device Facts

• Record ID: K983295
• Device Name: BRAUN THERMOSCAN IRT3020/3500 ONE SECONS EAR THERMOMETER, MODEL IRT3020/3520
• Applicant: Braun AG
• Product Code: FLL · General Hospital
• Decision Date: Mar 15, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2910
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Braun ThermoScan IRT 3020/3520 One Second Ear Thermometer is intended for the intermittent measurement and monitoring of human body temperature by consumers in the home. It is intended for use on people of all ages.

Device Story

Handheld infrared thermometer; measures natural thermal radiation emitted from tympanic membrane and adjacent surfaces via auditory canal. Device intended for home use by consumers of all ages. Operation involves capturing infrared signals; internal processing applies mathematical adjustment to measured ear temperature to approximate oral temperature range. Output displayed on screen as temperature in °F or °C. IRT3520 model includes memory recall for up to eight temperatures; IRT3020 for one. Provides non-invasive, rapid temperature monitoring to assist in health assessment.

Clinical Evidence

Clinical comparison study and repeatability testing conducted across four age groups (0-3, 4-10, 11-65, >65 years). Results demonstrated equivalent ear temperature measurement performance compared to the IR-4000 predicate. Clinical repeatability was determined to be statistically and clinically acceptable.

Technological Characteristics

Infrared sensor technology; measures thermal radiation from tympanic membrane. Display range 93.2°F-108°F (34°C-42.2°C); resolution 0.1°F/°C. Conforms to ASTM Standard E1965-98. Handheld form factor, 3.5 oz weight. Battery-operated. Software performs mathematical adjustment of raw ear temperature to approximate oral range.

Indications for Use

Indicated for intermittent measurement and monitoring of human body temperature in patients of all ages in a home setting.

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-4000
• ThermoScan Instant Thermometer, Model IR-6000
• Genius First Temp Model 3000A

Submission Summary (Full Text)

{0}------------------------------------------------

3/15/99

K983295-

## 510(k) SUMMARY

Submitter's Name Braun Thermoscan 10421 Pacific Center Court Address: San Diego, CA 92121 [phone] Phone: Frances E. Harrison Contact: September 10, 1998 Date of Summary: Braun Thermoscan ® IRT 3020/3520 Thermometer Name of Device: ThermoScan® Instant Thermometer, Model IR-4000 Predicate Device: ThermoScan® Instant Thermometer, Model IR-6000 Genius® First Temp Model 3000A The Braun Thermoscan IRT 3020/3520 Thermometer Device Description: 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. The Braun Thermoscan IRT 3020/3520 thermometer Intended Use: 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 The Braun Thermoscan thermometers, Models IRT 3020/3520 and IR-6000 have the same general Characteristics: design and incorporate similar materials and components. The Braun Thermoscan IRT 3020/3520 has the same sensor technology as the Genius® First Temp Model 3000A. The primary function of the Braun Thermoscan thermometer, Model is the IRT3020/3520 is the same as the ThermoScan Instant Thermometer, Models IR-4000 and IR-6000 for the measurement of body temperature and raise no new questions of safety and effectiveness.

{1}------------------------------------------------

Page 2 510(k) Summary Braun Thermoscan IRT 3020/3520 Thermometer

> Braun Thermoscan concludes that the Braun Thermoscan IRT 3020/3520 is substantially equivalent to the ThermoScan IR-4000 and IR-6000.

## PRODUCT SPECIFICATIONS:

| Model Number | 3020, 3520 |
|--------------|------------|
|--------------|------------|

Technical Characteristics:

| Displayed temperature range: | 93.2°F-108°F (34°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 necessarily the same as an oral temperature taken at the same time.) |
| Weight (without batteries): | 3.5 oz (100g) |
| Memory recall: | IRT3020, One previous temperature<br>IRT3520, Up to eight temperatures |

Accuracy characteristics*:

| Applicable patient ages: | All ages |
|--------------------------|----------|
|--------------------------|----------|

| Patient temperature range<br>96.8°F to 102°F (36 to 39°C) | Error °F | Error °C |
|-----------------------------------------------------------|----------|----------|
| | ± 0.4 | ± 0.2 |
| Outside this range | ± 0.5 | ± 0.3 |

*ASTM laboratory accuracy requirements in the display range of 36℃ to 39℃ (98 to 102 °F) for IR thermometers is ± 0.2℃ (± 0.4℃), whereas for mercury-in-glass and electronic thermometers, the requirement per ASTM Standards E667-86 and E1112-86 is ± 0.1ºC (+ 0.2ºF).

{2}------------------------------------------------

Page 3 510(k) Summary Braun Thermoscan IRT 3020/3520 Thermometer

This infrared thermometer meets the requirements established in ASTM Standard E1965-98, "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 AG, 61476 Kronberg, Germany.

## SUMMARY OF TESTING:

Non-Clinical Results

】

| PERFORMANCE TEST | RESULTS |
|---------------------------------------------------------------------------------------------|---------|
| Five Environment Accuracy Test | Pass |
| Thermometer Operating Life Test<br>(Reliability of keys, switch and probe cover<br>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. The comparison study demonstrated that the BraunThermoscan IRT 3020/3520 Thermometer measured ear temperature equivalently to the IR-4000 in all age groups. The clinical repeatability is statistically and clinically acceptable.

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image is a black and white circular seal for the Department of Health & Human Services - USA. The seal features the department's name in a circular pattern around the edge. In the center of the seal is a stylized image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 5 1999

Braun AG C/O Mr. Frances E. Harrison Braun Thermoscan 10421 Pacific Center Court San Diego, California 92121

K983295 Re : Braun ThermoScan IRT 3020/3520 One Second Trade Name: Ear Thermometer Requlatory Class: II Product Code: FLL September 18, 1999 Dated: September 21, 1999 Received:

Dear Mr. Harrison

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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (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 requlation 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 obligation you might have under sections 531 through 542 of

{4}------------------------------------------------

Page 2 - Mr. Harrison

the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to beqin 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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic 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 regulation entitled, "Misbranding by reference to premarket notification" (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

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

Enclosure

{5}------------------------------------------------

Page .... of ...

510(k) Number (if known) :-

Device Name __________________________________________________________________________________________________________________________________________________________________

Indications Por Use:

The Braun ThermoScan IRT 3020/3520 One Second Ear Thermometer is intended for the intermittent measurement and monitoring of human body temperature by consumers in the home. It is intended for use on people of all ages.

.. .. ... ... ................................................................................................................................................................

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Paltina Cusente

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices

510(k) Number K483295

Prescription Use (Per 21 CFR 801.109) OR

Over-The Counter Use

(Optional Format 1-2-96)