(42 days)
PolyMedica Industries, Inc's Basis® Digital Thermometer, the Becton Dickinson Flexible™ Digital Thermometer
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No
The 510(k) summary describes a standard digital thermometer and makes no mention of AI or ML.
No
The device is a digital thermometer used for temperature determination, which is a diagnostic function, not a therapeutic one. It does not treat or alleviate any condition.
No
The device is a thermometer used for measuring body temperature, which is a vital sign. While changes in body temperature can be indicative of a health issue, the thermometer itself does not diagnose a condition; it provides a measurement that a healthcare professional might use as part of a diagnostic process.
No
The device description explicitly states it is a "Flexible Tip Digital Thermometer," which is a physical hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to examine these samples outside of the body.
- Device Function: The Basis® Flexible Tip Digital Thermometer measures body temperature directly from the human body (oral, rectal, axillary). It does not analyze samples taken from the body.
Therefore, based on the provided information, the device is a clinical thermometer for direct body temperature measurement, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Basis® Flexible Tip Digital Thermometer is a clinical thermometer intended for the determination of oral, rectal and axillary body temperature determination in humans.
Product codes
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Device Description
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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 body
Indicated Patient Age Range
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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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
PolyMedica Industries, Inc's Basis® Digital Thermometer, the Becton Dickinson Flexible™ Digital Thermometer
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) Basis® Flexible Tip Digital Thermometer PolyMedica Industries, Inc.
MAY - 2 1997
510(k) Summary
| Proprietary Name: | Basis® Flexible Tip Digital Thermometer |
|---|---|
| Common Name: | Digital Thermometer with Flexible Tip |
| Classification: | Class II |
| Submitter Details: | PolyMedica Industries, Inc. |
| 581 Conference Place | |
| Golden, CO 80401 | |
| Tel: (303)271-0300 | |
| Fax: (303)271-0163 | |
| Contact: Ms. Susan Collins |
The Basis® Flexible Tip Digital Thermometer is a clinical thermometer intended for the determination of oral, rectal and axillary body temperature determination in humans.
In terms of physical requirements and operating parameters, the thermometer conforms to ASTM E1112, "Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature".
Basis® Flexible Tip Digital Thermometer is substantially equivalent to PolyMedica Industries, Inc's Basis® Digital Thermometer and the Becton Dickinson Flexible™ Digital Thermometer.
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