(42 days)
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No
The summary describes a standard digital thermometer and does not mention any AI or ML capabilities.
No.
The device is a thermometer used for measuring temperature, which is a diagnostic function, not a therapeutic one. It does not treat or prevent any condition.
Yes
The device is a clinical thermometer used for determining body temperature, which is a diagnostic measurement. While it doesn't "diagnose" a specific disease, it provides a key piece of information often used in the diagnostic process to identify fever or other temperature-related conditions.
No
The device description explicitly states it is a "Pacifier Digital Thermometer" and conforms to physical and operating parameters for electronic thermometers and safety standards for baby pacifiers, indicating it is a physical device with integrated electronics, not software only.
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® Baby-Temp Pacifier Digital Thermometer measures body temperature directly from the oral cavity of an infant or young child. It does not analyze a sample taken from the body.
The device is a clinical thermometer used for direct physiological measurement, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The Basis® Baby-Temp Pacifier Digital Thermometer is a clinical thermometer intended for the determination of oral body temperature determination in infants and young children.
Product codes (comma separated list FDA assigned to the subject device)
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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
Indicated Patient Age Range
infants and young children.
Intended User / Care Setting
clinical
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)
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". The pacifier digital thermometer also meets Safety Standards for Baby Pacifiers.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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.
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510(k) Basis® Baby-Temp Pacifier Digital Thermometer PolyMedica Industries, Inc.
510(k) Summary
Basis® Baby-Temp Pacifier Digital Thermometer Proprietary Name:
Common Name:
. ..
Unknown Classification:
Submitter Details:
- PolyMedica Industries, Inc. 581 Conference Place Golden, CO 80401 (303)271-0300 Tel: (303)271-0397 Fax: Contact: Ms. Julie Chaffee
Pacifier Digital Thermometer
The Basis® Baby-Temp Pacifier Digital Thermometer is a clinical thermometer intended for the determination of oral body temperature determination in infants and young children.
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". The pacifier digital thermometer also meets Safety Standards for Baby Pacifiers.
Basis® Baby-Temp Pacifier Digital Thermometer is substantially equivalent to Questech International, Inc. WeeCare™ Pacifier Thermometer and to Intelligent Product Limited Company Paci-Temp Pacifier with Digital Thermometer.