(247 days)
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Not Found
No
The device description and performance studies indicate a standard electronic thermometer design and testing against a recognized standard (ASTM E 1112-86). There is no mention of AI, ML, image processing, or any data training/testing, which are typical indicators of AI/ML technology in medical devices.
No
A therapeutic device is one that treats or prevents a disease or condition. This device is a thermometer used for measurement, not for treatment.
Yes
The device is a thermometer, which measures body temperature. Temperature measurement is a diagnostic tool used to assess a patient's health status, especially for fever.
No
The device description explicitly states it consists of a flexible probe, connecting cord, and display unit, which are hardware components.
Based on the provided information, the Lumiscope Model 2018 Thermometer is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- The Lumiscope Model 2018 Thermometer directly measures body temperature from the oral or axillary sites. It does not analyze a specimen taken from the body.
The device description and intended use clearly indicate it's a clinical thermometer for measuring body temperature, which falls under the category of a clinical device rather than an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Lumiscope Model 2018 Thermometer has the same intended use as the predicate device. It is indicated for use in the measurement of oral and axillary temperature. It is not intended for rectal (rectum) temperature measurement. The device also provides a clock function when not in the temperature mode. The Lumiscope Model 2018 Thermometer is intended for use by adults and may be used by the infant or pediatric patient population for measurements of axillary body temperature or for measurements of oral body temperature if the child is able to hold the thermometer beneath the tongue while his mouth is closed.
Product codes
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Device Description
The Lumiscope Model 2018 Thermometer is a thermometer of standard electrical transducer design, consisting of a flexible probe, connecting cord and display unit. The probe consists of a transducer and supporting plastic tube which houses the connection between the tube and cord. The display unit houses a 1.5V DC button battery, Liquid Crystal Display (LCD), slide switches for controlling the thermometer/clock mode and °F/°C mode, hour and minute set buttons, and temperature alert beeper.
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 and axillary
Indicated Patient Age Range
adults, infant or pediatric
Intended User / Care Setting
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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)
The Lumiscope Model 2018 Thermometer meets the ASTM Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature (ASTM E 1112-86). Bench testing confirmed accuracy, precision and repeatability measurements specified in the labeling. For all body or fluid contacting materials, certification is made that the identical materials have been used in other legally marketed devices under the same use conditions.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Hanson Scale Co. Clinical Electronic Thermometer - Model 7616-10
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
JUN 21 1988
510(k) SUMMARY - Lumiscope Model 2018 Thermometer
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
Proprietary Name: Lumiscope Model 2018 Thermometer Common/Usual Name: Digital Fever Thermometer with Quartz Clock Oral and Axillary Thermometer Classification Name: Clinical Electronic Thermometer (per 21 CFR 880.2910)
Legally Marketed Device: Hanson Scale Co. Clinical Electronic Thermometer - Model 7616-10
Device Description: The Lumiscope Model 2018 Thermometer is a thermometer of standard electrical transducer design, consisting of a flexible probe, connecting cord and display unit. The probe consists of a transducer and supporting plastic tube which houses the connection between the tube and cord. The display unit houses a 1.5V DC button battery, Liquid Crystal Display (LCD), slide switches for controlling the thermometer/clock mode and °F/°C mode, hour and minute set buttons, and temperature alert beeper.
Intended Use: The Lumiscope Model 2018 Thermometer has the same intended use as the predicate device. It is indicated for use in the measurement of oral and axillary temperature. It is not intended for rectal (rectum) temperature measurement. The device also provides a clock function when not in the temperature mode. The Lumiscope Model 2018 Thermometer is intended for use by adults and may be used by the infant or pediatric patient population for measurements of axillary body temperature or for measurements of oral body temperature if the child is able to hold the thermometer beneath the tongue while his mouth is closed.
Technological Characteristics: The Lumiscope Model 2018 Thermometer has the same technological features as the predicate device: the mode of operation, physical specifications, operational, and biological specifications are identical.
Performance Data: The Lumiscope Model 2018 Thermometer meets the ASTM Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature (ASTM E 1112-86). Bench testing confirmed accuracy, precision and repeatability measurements specified in the labeling. For all body or fluid contacting materials, certification is made that the identical materials have been used in other legally marketed devices under the same use conditions.
Substantial Equivalence: The information provided demonstrates that the Lumiscope Model 2018 Thermometer is substantially equivalent to the predicate device since the devices have the same intended use, principles of operation, and teennological characteristics.
Contact Person:
UMISCOPE
Thomas C. Parnell
5/2/16
Date Prev
5/22/46
Date Prepared
E-2a