SURETEMP PLUS

K030580 · Welch Allyn, Inc. · FLL · May 6, 2003 · General Hospital

Device Facts

• Record ID: K030580
• Device Name: SURETEMP PLUS
• Applicant: Welch Allyn, Inc.
• Product Code: FLL · General Hospital
• Decision Date: May 6, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2910
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Welch Allyn SureTemp® Plus thermometer enables the health care professional to make an accurate prediction of a febrile or hypothermic patient's oral temperature in approximately 4-6 seconds (in Normal mode). Pediatric Axillary (age 17 and younger) temperatures can be obtained in approximately 10-13 seconds. Adult Axillary temperatures (in Normal mode) can be obtained in approximately 12-15 seconds. Rectal temperatures (in Normal mode) can be obtained in approximately 10-13 seconds. Normal (predictive) mode is available for oral, rectal, and axillary use. In the Monitor mode, the instrument provides the capability of accurate, long-term monitoring of actual oral, rectal or axillary temperature, and of following the temperature whether constant, increasing, or decreasing. The SureTemp is a clinical grade thermometer intended for use by healthcare practitioners only; typically in a hospital, clinic, long- term care, or mobile health care environment. It is not intended for home use.

Device Story

SureTemp Plus is a clinical electronic thermometer; consists of elongated metal heat-conductive probe with internal thermistor connected to main body via coiled cord. Used by healthcare practitioners in hospitals, clinics, or long-term care facilities. Operation requires disposable plastic probe cover to prevent cross-contamination. Device functions in two modes: Normal (predictive) and Monitor (continuous). In Normal mode, algorithms process thermistor signals to predict final temperature within 4-15 seconds. In Monitor mode, device tracks actual temperature changes over time. Output displayed on screen; Model 692 includes backlit display, security features, and pulse timer; Model 690 is lower-cost version without these features. Provides rapid, accurate temperature assessment to assist clinical decision-making regarding patient febrile or hypothermic status.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Electronic thermometer; thermistor-based sensing; predictive and continuous monitoring modes; elongated metal probe; disposable plastic probe covers; Model 692 includes backlit display, security features, and pulse timer; Model 690 lacks these features; powered by main body unit.

Indications for Use

Indicated for healthcare professionals to measure oral, axillary, or rectal temperature in patients. Provides predictive readings (4-15 seconds) or continuous monitoring (approx. 3 minutes).

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.

Submission Summary (Full Text)

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#### 510(k) Summary Section 11:

In accordance with the Safe Medical Devices Act (SMDA) of 1990 and Title 21 of the Code of Federal Regulations Part 807 (21 CFR § 807), and in particular §807.92, the following summary of safety and effectiveness information is provided:

### Submitted By

MAY 0 6 2003

Debra L. Jackson, RAC Senior Manager, Quality Assurance & Regulatory Affairs Welch Allyn, San Diego 7420 Carroll Road San Diego, California 92121

Telephone: [phone] Contact: Dave Klementowski Date Prepared: February 21, 2003

#### Device Name

Common or usual name: Thermometer, Electronic Thermometer, Predictive Thermometer

Classification Class: Il Panel: 80 Procode: FLL - clinical electronic thermometer

## Predicate Devices

The SureTemp® Plus clinical electronic thermometer consists of an elongated metal heat-conductive probe connected to the thermometer's main body through a coiled cord. The probe contains a thermistor that conveys temperature information to the main body for calculation of patient temperature.

Prior to use, a plastic probe cover must cover the probe. This cover must not be a significant barrier to the transfer of heat from the patient to the probe body (and thermistor). In addition, the disposable nature of the probe cover prevents microbiological cross-contamination amonq patients which might occur with a reuseable probe. Calculation of patient temperature may (in the normal or predictive mode) utilize algorithms that enable accurate temperature prediction within 4 to 15 seconds of probe placement (times vary based on the temperature mode selected).

There are two model designations for the SureTemp® Plus and they are the Model 692 and 690. The Model 690 is the lower cost version of the Model 692 and does not include the backlit display and security features or pulse timer.

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# Device Description

The SureTemp® Plus clinical electronic thermometer consists of an elongated metal heat-conductive probe connected to the thermometer's main body through a coiled cord. The probe contains a thermistor that conveys temperature information to the main body for calculation of patient temperature.

Prior to use, a plastic probe cover must cover the probe. This cover must not be a significant barrier to the transfer of heat from the patient to the probe body (and thermistor). In addition, the disposable nature of the probe cover prevents microbiological cross-contamination among patients which might occur with a reuseable probe. Calculation of patient temperature may (in the normal or predictive mode) utilize algorithms that enable accurate temperature prediction within 4 to 15 seconds of probe placement (times vary based on the temperature mode selected).

There are two model designations for the SureTemp® Plus and they are the Model 692 and 690. The Model 690 is the lower cost version of the Model 692 and does not include the backlit display and security features or pulse timer.

## Intended Use

The Welch Allyn SureTemp® Plus thermometer enables the health care professional to make an accurate prediction of a febrile or hypothermic patient's oral temperature in approximately 4-6 seconds (in Normal mode). Pediatric Axillary (age 17 and younger) temperatures can be obtained in approximately 10-13 seconds. Adult Axillary temperatures (in Normal mode) can be obtained in approximately 12-15 seconds. Rectal temperatures (in Normal mode) can be obtained in approximately 10-13 seconds. Normal (predictive) mode is available for oral, rectal, and axillary use.

In the Monitor mode, the instrument provides the capability of accurate, long-term monitoring of actual oral, rectal or axillary temperature, and of following the temperature whether constant, increasing, or decreasing.

The SureTemp is a clinical grade thermometer intended for use by healthcare practitioners only; typically in a hospital, clinic, long- term care, or mobile health care environment. It is not intended for home use.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of a human figure with outstretched arms, enclosed within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 0 6 2003

Ms. Debra L. Jackson Senior Manager, QA/RA Welch Allyn, Incorporated 7420 Carroll Road San Diego, California 92121

Re: K030580

Trade/Device Name: SureTemp® Plus Regulation Number: 880.2910 Regulation Name: Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: February 21, 2002 Received: February 24, 2003

Dear Ms. Jackson:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition. FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Jackson

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Susan Punoe

Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) NUMBER (IF KNOWN): K030580

DEVICE NAME: SureTemp® Plus

INDICATIONS FOR USE:

The Welch Allyn SureTemp Plus thermometer is intended to be used by healthcave professionals,
to provide an accurate prediction of patient temperature using the oval, axillary or reastal booky sives in 4 to 15 seconds , or to provide an actual temperature reading in the continuous monitor mode about 3 minutes . 11 =

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter-Use
(Optional Format i-2-96)

Patricia Cuccente

(Division Sign-Off) Division of Anesthesiology, General I Infection Control, Dental Device

510(k) Number: K030580