(85 days)
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No
The summary describes a simple, injection-molded plastic device for delivering aerosol medications and respiratory gases. There is no mention of AI, ML, image processing, or any data-driven algorithms.
No
The device provides a conduit for aerosol medications and respiratory gases, but it does not directly treat a medical condition.
No
The device description states it is "intended for use in providing a conduit for aerosol medications and respiratory gases," which describes a delivery or management function, not a diagnostic one.
No
The device description clearly states it is an injection-molded physical component with standard fittings, indicating it is a hardware device, not software.
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 conduit for aerosol medications and respiratory gases." This describes a device used in vivo (on or within a living organism) for delivering substances, not for testing samples in vitro (outside of a living organism).
- Device Description: The description details a physical device for connecting to aerosol devices and delivering gases. It doesn't mention any components or functions related to analyzing biological samples.
- Lack of IVD Indicators: There is no mention of analyzing blood, urine, tissue, or any other biological sample. There is no mention of reagents, assays, or diagnostic purposes.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is purely for delivering respiratory substances.
N/A
Intended Use / Indications for Use
"intended for use in providing a conduit for aerosol medications and The North State Plastics device performs the respiratory gases."
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
"The device is injection molded from clear, rigid, clean, chemically inert K-Resin KRO3-NW. The Aerosol Tee is equipped with standard 18 and 22 mm OD fittings 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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§ 868.5860 Pressure tubing and accessories.
(a)
Identification. Pressure tubing and accessories are flexible or rigid devices intended to deliver pressurized medical gases.(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 the limitations in § 868.9.
0
K (55626
MAR - 6 1996
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS :
North State Plastics Aerosol Tee has been found to be The substantially equivalent to currently marketed devices (e.g. Hudson, Baxter, B & B, and Marquest).
Like the predicate devices, the North State Plastics Aerosol Tee is intended for use in providing a conduit for aerosol medications and The North State Plastics device performs the respiratory gases. same function as alternative referenced devices.
The device is injection molded from clear, rigid, clean, chemically inert K-Resin KRO3-NW. The Aerosol Tee is equipped with standard 18 and 22 mm OD fittings for connection to most aerosol devices. Competitively marketed devices utilize essentially the same component materials.
The North State Plastics Aerosol Tee is simplistic in design and easily used in multiple respiratory aerosol configurations.