(280 days)
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No
The description explicitly states the device uses a microprocessor to convert resistance to temperature, which is a standard electronic function, not AI/ML. There are no mentions of AI, ML, or related concepts.
No
The device is a thermometer used for measuring temperature, which is a diagnostic function, not a therapeutic one. It does not treat or alleviate any condition.
No
The device measures temperature, which is a symptom, but it does not diagnose a condition or disease.
No
The device description explicitly states it is a "thermistor-based electronic thermometer" with a "thermistor located at the tip of the probe," indicating it is a hardware device with embedded software, not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to measure body temperature (oral, rectal, axillary). This is a direct measurement of a physiological parameter within the body.
- Device Description: The device measures resistance in a thermistor and converts it to a temperature. This is a physical measurement, not a test performed on a sample taken from the body.
- Lack of IVD Characteristics: IVD devices typically involve testing samples (like blood, urine, tissue) in vitro (outside the body) to diagnose or monitor a condition. This device does not perform any such testing.
Therefore, the IVAC Models 2082/2087 Thermometers are considered medical devices for measuring body temperature, but not IVDs.
N/A
Intended Use / Indications for Use
The intended use for the IVAC Models 2082/2087 Thermometers is to measure oral, rectal and axillary temperatures in clinical practice.
Product codes
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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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
oral, rectal and axillary
Indicated Patient Age Range
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Intended User / Care Setting
clinical practice
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 880.2910 Clinical electronic thermometer.
(a)
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.(b)
Classification. Class II (performance standards). The device is exempt from the premarket notification procedures in part 807, subpart E of this chapter, subject to the limitations in § 880.9 and the following conditions for exemption:(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.
0
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
- IVAC CORPORATION SUBMITTER'S NAME: 1. 10300 Campus Point Drive San Diego. CA 92121-1579 (619) 458-7825
- CONTACT PERSON: Jennifer S. Hankard Sr. Manager of Corp. QA/RA
December 22, 1995 DATE PREPARED:
- Model 2082/2087 Temp Plus III DEVICE NAME: Proprietary Name: 2. Thermometers
Electronic Thermometer Common Name:
Classification Name: Clinical Electronic Thermometer
- IVAC Models 2080/2085 Temp Plus II Thermometers PREDICATE DEVICE: 3. Diatek SureTemp 4 Thermometer
- The IVAC Models 2082/2087 Thermometers are DEVICE DESCRIPTION: 4. 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.
- The intended use for the IVAC Models 2082/2087 INTENDED USE: 5. Thermometers is to measure oral, rectal and axillary temperatures in clinical practice.
6. TECHNOLOGICAL The new IVAC Models 2082/2087 Thermometers use CHARACTERISTICS: 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 emplovina 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)
TECHNOLOGICAL 6. 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.