(21 days)
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No
The description details a mechanical nebulizer operating on the venturi principle, with no mention of AI or ML capabilities.
Yes
Explanation: The device is used to administer aerosol treatments to patients, which is a therapeutic intervention, and its intended use is to deliver FDA-approved drugs.
No
The device description indicates that the Hsiner Nebulizer Bottle is used to "administer various aerosol treatments" and "sprays respiratory size aerosolized liquids into gasses that are delivered directly to the patient for breathing." This describes a therapeutic device, not one used for diagnosis. There is no mention of the device being used to identify, detect, or monitor a medical condition.
No
The device description clearly describes a physical nebulizer bottle that operates on a compressed gas source to aerosolize liquids, indicating it is a hardware device.
Based on the provided information, the Hsiner Nebulizer Bottle is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Hsiner Nebulizer Bottle Function: The description clearly states that the Hsiner Nebulizer Bottle is used to administer aerosol treatments (drugs) directly to the patient for breathing. It is a drug delivery device, not a device used to test or analyze biological specimens.
Therefore, the Hsiner Nebulizer Bottle falls under the category of a medical device used for drug delivery, not an IVD.
N/A
Intended Use / Indications for Use
The Hsiner Nebulizer Bottle is used to administer various aerosol treatments to adult and pediatric patients in both the homecare and hospital settings. This device is intended for use only with FDA-approved drugs upon the specific direction by a physician. Its use is indicated whenever a physician or healthcare professional administers or prescribes medical aerosol products to a patient using a Small Volume Nebulizer.
Product codes
CAF
Device Description
The Hsiner Nebulizer Bottle is used to administer various aerosol treatments in both the homecare and hospital settings. This device is intended to only be use with FDA-approved drugs upon the specific direction of a physician. This device is not used specific drug nor is it distributed with such drugs.
The nebulizer sprays respiratory size aerosolized liquids into gasses that are delivered directly to the patient for breathing. The nebulizer operates on a compressed gas source which draws liguids from a refillable Jar by the venturi principle and aerosolizes it into respirable particles by impaction and baffling.
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
adult and pediatric patients
Intended User / Care Setting
physician or healthcare professional / homecare and hospital settings
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)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 868.5630 Nebulizer.
(a)
Identification. A nebulizer is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. Heated, ultrasonic, gas, venturi, and refillable nebulizers are included in this generic type of device.(b)
Classification. Class II (performance standards).
0
Hsiner Company Modified Jet Nebulizer 510(k) Submission