Search Results

The Besmed Reusable Jet Nebulizer is a handheld, pneumatic nebulizer designed to aerosolize prescription drugs for inhalation by a patient. Its use is indicated whenever a healthcare professional administers or prescribes medical aerosol products to a patient using a small volume nebulizer.

The Besmed Reusable Jet Nebulizer is a handheld, pneumatic nebulizer designed to aerosolize prescription drugs for inhalation by a patient.

This document is an FDA 510(k) clearance letter for the Besmed Reusable Jet Nebulizer. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The letter primarily states that the device has been found substantially equivalent to a legally marketed predicate device and outlines regulatory responsibilities.

Therefore, I cannot provide the requested information based on the provided text. The document focuses on regulatory approval, not on the technical performance testing of the device against specific acceptance criteria.

Ask a specific question about this device

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."
}

Ask a specific question about this device

The BESMED Jet Nebulizer Bottle Set is used to administer various aerosol treatments to adult and pediatric patients in both the homecare and hospital settings. 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 MAXHEALTH Air Nebulizer is intended to spray liquid medications in aerosol fonn into gases that re directly delivered to the patient.

The information provided describes the acceptance criteria and a study to demonstrate substantial equivalence for the BESMED Jet Nebulizer Bottle Set, Model PN-1128E, as part of a 510(k) submission.

This is a device for administering aerosol treatments. The studies conducted are primarily performance and biocompatibility tests, rather than studies involving human readers or AI algorithms for diagnostic purposes. Therefore, some of the requested information (like MRMC studies, effect size of AI, number of experts for ground truth, adjudication methods, and sample sizes for training/test sets in the context of AI) is not applicable to this type of device and submission.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document doesn't explicitly list "acceptance criteria" in a quantitative table format for performance beyond what's compared with the predicate device. However, it indicates conformity to relevant standards and a comparative analysis.

Ask a specific question about this device

The Hsiner Jet Nebulizer 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 Jet Nebulizer 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. 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 and baffling.

This submission describes the Hsiner Jet Nebulizer, a device used to administer aerosol treatments. The primary evidence provided is a substantial equivalence claim based on performance testing comparing it to legally marketed predicate devices.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

The submission focuses on establishing substantial equivalence by demonstrating that the Hsiner Jet Nebulizer's performance characteristics are not significantly different from predicate devices. The specific acceptance criteria are implicitly that the performance metrics of the Hsiner Jet Nebulizer should be not significantly different from those of the predicate devices.

2. Sample size used for the test set and the data provenance

• Sample Size: Not explicitly stated as a number of devices or experimental replicates. The testing was conducted "in-vitro" and involved "any of the drugs tested," implying multiple drug types were used with the device and predicate devices.
• Data Provenance: In-vitro testing. No specific country of origin for the data is mentioned, but the submitter is from Taiwan, ROC, and the preparer of submission is from the US. The testing was conducted according to the FDA's "Reviewer Guidance for Nebulizers Metered Dose Inhalers, Spacers and Actuators (10-01-93)," which indicates a standard, controlled laboratory environment for the testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This device submission relies on objective, in-vitro physical performance measurements rather than expert human interpretation or clinical data. The "ground truth" is established by direct measurement against physical standards derived from the performance of predicate devices and industry guidance.

4. Adjudication method for the test set

Not applicable. As noted above, this submission relies on objective physical measurements, not human interpretation requiring adjudication.

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

Not applicable. This is a medical device for drug delivery, not an AI-assisted diagnostic tool requiring human reader studies.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a mechanical nebulizer, not a software algorithm. The "standalone performance" is the in-vitro performance of the device itself.

7. The type of ground truth used

The ground truth is derived from objective in-vitro performance measurements of the device and predicate devices, as specified by the "Reviewer Guidance for Nebulizers Metered Dose Inhalers, Spacers and Actuators (10-01-93)." This involves physical properties like particle size distribution (MMAD, GSD, Respirable Fraction), drug delivery capability (Respirable Mass), and operational parameters (Treatment Time, Operating pressures). The acceptance criteria are based on demonstrating that these parameters are not significantly different from those of legally marketed predicate devices.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set.

9. How the ground truth for the training set was established

Not applicable. No training set was used.

Ask a specific question about this device

The 56 Series Jet Nebulizer is a pneumatic nebulizer, which nebulizes specific drugs for inhalation by a patient.

The 56 Series Jet Nebulizer is a pneumatic nebulizer, which nebulizes specific drugs for inhalation by a patient.

The provided text is a 510(k) clearance letter for a medical device: the "56 Series Jet Nebulizer". This type of document is concerned with demonstrating substantial equivalence to a predicate device, not with detailing the results of a primary clinical study that establishes novel performance criteria for an AI or imaging device.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, ground truth establishment, MRMC studies, or standalone performance for an AI/imaging device cannot be extracted from this document.

This document primarily confirms that the device has been reviewed and found substantially equivalent to existing devices, allowing it to be marketed. It does not contain the kind of performance data or study design details that would be required to answer your specific questions, which are typically relevant for AI/imaging device submissions.

Ask a specific question about this device

Ask a specific question about this device