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The Headstar medical Small Volume Jet nebulizer creates respiratory mist out of the drug and is used to administer various aerosol treatments to adult and pediatric patients in homecare and hospital environments. It is not intended for transport use.

Based on practical measurement and comparison, Headstar Medical Small Volume Jet Nebulizer is intended for following populations:

HP-2557 Nebulizer with child face mask: 2~9 years old pediatric patients
HP-2558 Nebulizer with adult face mask: for adult patients
HP-2290 Nebulizer with mouth piece & O2 tubing: pediatric over 5 years and adult patients
HP-2291 Nebulizer with mouth/T piece & hose/O2 tubing: pediatric over 5 years and adult patients

The nebulizer operates on a compressed gas source which draws liquids from a refillable jar and aerosolizes it into respirable particles by impaction and baffling. Its use is indicated whenever a healthcare professional administers or prescribes medical aerosol products to a patient using a small volume nebulizer. It can be packaged with optional accessories; i.e .; oxygen tubing, mouthpiece, T piece, hose and face mask. Nebulizer bottle, T piece and mouthpiece are single patient re-use devices; while other accessories are single use/disposable devices. Headstar Medical small volume jet nebulizer is packed non-sterile in a polyethylene bag.

The nebulizer operates on a compressed gas source which draws liquids from a refillable jar and aerosolizes it into respirable particles by impaction and baffling. Its use is indicated whenever a healthcare professional administers or prescribes medical aerosol products to a patient using a small volume nebulizer. It can be packaged with optional accessories; i.e .; oxygen tubing, mouthpiece, T piece, hose and face mask. Nebulizer bottle, T piece and mouthpiece are single patient re-use devices; while other accessories are single use/disposable devices. Headstar Medical small volume jet nebulizer is packed non-sterile in a polyethylene bag.

{
"1. A table of acceptance criteria and the reported device performance": "The document provided is a 510(k) clearance letter for a medical device (Headstar Medical Small Volume Jet Nebulizer). It does not contain a table of acceptance criteria and reported device performance. This type of information would typically be found in the 510(k) submission itself or in a summary document, not in the FDA's clearance letter.",
"2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)": "The document does not detail any specific studies that would include sample sizes or data provenance for a test set. The clearance is based on substantial equivalence to a predicate device, implying that performance data was provided, but the specifics are not in this letter.",
"3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)": "This information is not provided in the document. The clearance letter focuses on the regulatory decision and does not include details about ground truth establishment or expert qualifications for any testing that might have been conducted.",
"4. Adjudication method (e.g. 2+1, 3+1, none) for the test set": "The document does not describe any adjudication methods related to a test set. This type of information would be part of a detailed study report, not a clearance letter.",
"5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance": "No MRMC comparative effectiveness study is mentioned, nor is there any discussion of AI assistance or its effect size. The device is a nebulizer, which does not involve AI assistance for human readers.",
"6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done": "The concept of "standalone algorithm performance" is not applicable to a small volume jet nebulizer, which is a physical device used for drug delivery, not an algorithm. Therefore, no such study was conducted or mentioned.",
"7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)": "No information regarding ground truth is presented in this document. The FDA clearance letter for a nebulizer would not typically delve into such details which are more relevant to diagnostic devices or software.",
"8. The sample size for the training set": "There is no mention of a training set or its sample size. This information would be relevant for machine learning models, which is not applicable to the device described.",
"9. How the ground truth for the training set was established": "As there is no training set mentioned or implied for this medical device, there is no discussion of how its ground truth was established."
}

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