(91 days)
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No
The summary describes a simple, injection-molded plastic mouthpiece for aerosol medication delivery, with no mention of AI, ML, or any computational processing.
Yes
The device is described as "intended for use in providing a direct source of continuous aerosol medication," which indicates a therapeutic purpose.
No
The device is described as an "aerosol medication mouthpiece" that provides a "direct source of continuous aerosol medication," indicating a therapeutic rather than diagnostic purpose.
No
The device description explicitly states it is an injection-molded physical component made of High Density Polyethylene, which is hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "providing a direct source of continuous aerosol medication." This describes a device used for delivering medication to a patient, not for testing samples (like blood, urine, or tissue) outside the body to diagnose a condition.
- Device Description: The description focuses on the physical construction and connection to aerosol devices, which aligns with a medical device for drug delivery.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is purely for medication delivery.
N/A
Intended Use / Indications for Use
The North State Plastics Respiratory Mouthpiece is intended for use in providing a direct source of continuous aerosol medication.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
The North State Plastics Respiratory Mouthpiece is simplistic in design and easily used in multiple respiratory applications. The device is injection molded from rigid, clean, chemically inert High Density Polyethylene. The Mouthpiece is equipped with a standard 22mm OD fitting for connection to most aerosol devices.
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
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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): 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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§ 868.5620 Breathing mouthpiece.
(a)
Identification. A breathing mouthpiece is a rigid device that is inserted into a patient's mouth and that connects with diagnostic or therapeutic respiratory devices.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 868.9.
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510(K) SUMMARY OF SAFETY AND EFFECTIVENESS :
The North State Plastics Respiratory Mouthpiece has been found to be substantially equivalent to currently marketed devices (e.g. Hudson, Baxter, Marquest, Pari, Precision, and Salter).
Like the predicate devices, the North State Plastics Respiratory Mouthpiece is intended for use in providing a direct source of continuous aerosol medication. The North State Plastics device performs the same function as alternative referenced devices.
The device is injection molded from rigid, clean, chemically inert High Density Polyethylene. The Mouthpiece is equipped with a standard 22mm OD fitting for connection to most aerosol devices. Competitively marketed devices utilize essentially the same component materials.
The North State Plastics Respiratory Mouthpiece is simplistic in design and easily used in multiple respiratory applications.