MODEL 2082 TEMP PLUS III THERMOMETER/MODEL 2087 TEMP PLUS III WALL MOUNT THERMOMETER

K955846 · Y · FLL · Oct 1, 1996 · General Hospital

Device Facts

• Record ID: K955846
• Device Name: MODEL 2082 TEMP PLUS III THERMOMETER/MODEL 2087 TEMP PLUS III WALL MOUNT THERMOMETER
• Applicant: Y
• Product Code: FLL · General Hospital
• Decision Date: Oct 1, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2910
• Device Class: Class 2

Intended Use

The intended use for the IVAC Models 2082/2087 Thermometers is to measure oral, rectal and axillary temperatures in clinical practice.

Device Story

Thermistor-based electronic thermometer; measures oral, rectal, axillary temperatures. Probe tip thermistor contacts tissue; microprocessor measures circuit resistance; converts resistance to temperature; displays result. Uses NASA-developed predictive algorithm to accelerate sensor response time; reduces display time to ~10 seconds. Used in clinical settings by healthcare professionals. Output provides rapid temperature readings to assist clinical decision-making and patient monitoring.

Clinical Evidence

Bench testing only; no clinical data provided. Equivalence based on technological comparison and performance validation of the predictive algorithm.

Technological Characteristics

Thermistor-based electronic thermometer; microprocessor-controlled; predictive algorithm for accelerated response. Dimensions/form factor consistent with previous models. No specific material standards cited.

Indications for Use

Indicated for clinical measurement of oral, rectal, and axillary body temperature in patients requiring temperature monitoring.

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

• IVAC Models 2080/2085 Temp Plus II Thermometers
• Diatek SureTemp 4 Thermometer

Submission Summary (Full Text)

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K955846
Oct. 1, 1996

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

1. **SUBMITTER'S NAME:** IVAC CORPORATION
10300 Campus Point Drive
San Diego, CA 92121-1579
[phone]

**CONTACT PERSON:** Jennifer S. Hankard
Sr. Manager of Corp. QA/RA

**DATE PREPARED:** December 22, 1995

2. **DEVICE NAME:**
Proprietary Name: Model 2082/2087 Temp Plus III Thermometers
Common Name: Electronic Thermometer
Classification Name: Clinical Electronic Thermometer

3. **PREDICATE DEVICE:** IVAC Models 2080/2085 Temp Plus II Thermometers
Diatek SureTemp 4 Thermometer

4. **DEVICE DESCRIPTION:** The IVAC Models 2082/2087 Thermometers are thermistor-based electronic thermometers that are used in clinical practice for measuring oral, rectal and axillary temperature. A thermistor located at the tip of the probe is placed in contact with tissue at the desired measurement site. A microprocessor measures resistance in the circuit and converts the resistance measurement to a temperature, which is then displayed.

5. **INTENDED USE:** The intended use for the IVAC Models 2082/2087 Thermometers is to measure oral, rectal and axillary temperatures in clinical practice.

6. **TECHNOLOGICAL CHARACTERISTICS:** The new IVAC Models 2082/2087 Thermometers use a new algorithm which allows the predictive mode to display a temperature in approximately ten seconds versus the current speed of thirty seconds. There are no other significant changes being made to the existing Models 2080/2085 Thermometers. NASA developed a microprocessor and electronics package employing novel predictive technology for accelerating the response time of slowly responding sensors. The hydrogen sensor system was modified to accept input from a medical type thermistor and was tested by NASA.

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(continued)

## 6. TECHNOLOGICAL CHARACTERISTICS:

The primary function of the modified thermometers are the same as the current IVAC Models 2080/2085 Thermometers and the Diatek SureTemp 4 Thermometer: to measure oral, rectal and axillary temperatures. The technological characteristics of the devices are the same and raise no new questions of safety and effectiveness. IVAC Corporation concludes that the new IVAC Models 2082/2087 Thermometers are substantially equivalent to the original IVAC Models 2080/2085 Thermometers and the Diatek SureTemp 4 Thermometers.