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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.

The Hsiner's nebulizers are used to administer various aerosol treatments in both the homecare and hospital settings. They are intended to only be use with FDA-approved drugs upon the specific direction of a physician. These devices neither uses specific drug nor is it distributed with such drugs. These nebulizers generate respirable sized aerosols that are delivered directly to the patient for breathing. The nebulizer operates on a compressed gas source which draws liquids from a refillable Jar by the venturi principle and aerosolizes it into respirable particles by impaction ad baffling.

The provided text describes a 510(k) submission for a nebulizer bottle, but it fundamentally lacks any information about acceptance criteria or a study proving the device meets those criteria.

The document focuses on the administrative aspects of a 510(k) submission, including:

• Submitter Information: Hsiner Company, LTD.
• Device Name: Nebulizer Bottle
• Classification Information: Product Code CAF, Regulation Number 868.5630, Class 2.
• Substantial Equivalence: Listing two predicate devices (Hsiner Jet Nebulizer K052811 and Hsiner Bottle K070948).
• Device Description: General description of how nebulizers work and their intended use.
• Intended Use: Administering aerosol treatments to adult and pediatric patients with FDA-approved drugs.
• Comparison to Predicate Devices: Stating equivalence in design and performance to predicate devices.
• FDA Correspondence: The FDA's letter of substantial equivalence.
• Indications for Use Statement.

Therefore, I cannot populate the requested table or sections because the provided text does not contain any details regarding:

1. Acceptance criteria: No specific performance metrics or thresholds are mentioned.
2. Reported device performance: No data on the device's actual performance (e.g., aerosol particle size, delivery rate) is provided.
3. Study design: No mention of a study conducted to demonstrate performance.
4. Sample size: No information on test sets or training sets.
5. Data provenance: No details about the origin of any data.
6. Experts for ground truth: No mention of experts or their qualifications.
7. Adjudication method: Not applicable as no ground truth is established.
8. MRMC comparative effectiveness study: No such study is mentioned.
9. Standalone performance: No standalone algorithm performance is discussed.
10. Type of ground truth: Not applicable.
11. Training set details: No training set is mentioned.

The 510(k) summary only states that the device is "equivalent in design and performance" to the predicate devices. This implies that the performance characteristics expected would be similar to those of the predicate devices, but it does not provide the actual data or the acceptance criteria used to prove this equivalence for the new device. A 510(k) notice typically refers to detailed testing reports, which are usually not included in the public 510(k) summary document itself.

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