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510(k) Data Aggregation
(157 days)
KOO SMALL VOLUME NEBULIZER (SVN)
The Koo SVN 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 Koo SVN is intended for use with pediatric (defined by the prescribed medication) and adult patients consistent with the indications for the aerosol medication. This includes hospital/institutional settings, home care use, schools and long term care facilities.
The Koo SVN is a simple handheld small volume nebulizer powered by compressed air to nebulize the I ne Noo S V It is a simple handler shall vith a mouthpiece or standard aerosol / oxygen face mask. The SVN can be packaged with optional accessories, i.e., oxygen tubing, mouthpiece and hose, and face mask. The nebulizer and its accessories are single patient, multi-use devices.
The provided submission describes the Koo Small Volume Nebulizer (SVN). The device is a handheld, pneumatic nebulizer designed to aerosolize prescription drugs for inhalation. The study presented is a comparative performance study against a predicate device, the Miller (VixOne) nebulizer (K926055). The acceptance criteria are essentially defined by the performance of this predicate device, demonstrating substantial equivalence.
Here's the detailed breakdown:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Koo SVN are implicitly defined by performing "equivalently" to the predicate device, Miller (VixOne) K926055, across various particle characterization metrics. The study aims to show that the Koo SVN's performance falls within a similar range as the predicate.
| Metric (Drug) | Acceptance Criteria (Predicate: Miller (VixOne) K926055) | Reported Device Performance (Koo SVN) |
|---|---|---|
| Total Output (ug) | ||
| Albuterol | $1160 \pm 96$ | $1005 \pm 21$ |
| Ipratropium | $196 \pm 7$ | $184 \pm 10$ |
| Cromolyn | $4344 \pm 353$ | $4156 \pm 113$ |
| Particle Size (MMAD) (Microns) | ||
| Albuterol | $2.10 \pm 0.17$ | $1.80 \pm 0.2$ |
| Ipratropium | $1.93 \pm 0.06$ | $1.90 \pm 0.1$ |
| Cromolyn | $1.57 \pm 0.21$ | $1.53 \pm 0.06$ |
| Geometric Std. Dev. (GSD) | ||
| Albuterol | $3.00 \pm 0.25$ | $2.84 \pm 0.14$ |
| Ipratropium | $3.11 \pm 0.48$ | $2.71 \pm 0.1$ |
| Cromolyn | $2.83 \pm 0.05$ | $2.63 \pm 0.2$ |
| Respirable Fraction (% Mass 0.5-5 microns) | ||
| Albuterol | $67.3% \pm 3.2%$ | $69.0% \pm 2.0%$ |
| Ipratropium | $66.7% \pm 5.8%$ | $70.3% \pm 0.6%$ |
| Cromolyn | $68.0% \pm 2.0%$ | $71.0% \pm 3.6%$ |
| Respirable Mass (ug 0.5 - 5.0 microns) | ||
| Albuterol | $781 \pm 71$ | $693 \pm 17$ |
| Ipratropium | $131 \pm 13$ | $129 \pm 6$ |
| Cromolyn | $2949 \pm 155$ | $2953 \pm 232$ |
| Treatment Time (min) | ||
| Albuterol | $4.33 \pm 0.38$ | $4.00 \pm 0$ |
| Ipratropium | $2.92 \pm 0.38$ | $2.67 \pm 0.29$ |
| Cromolyn | $1.58 \pm 0.38$ | $1.50 \pm 0$ |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document states that the testing provided a "95% confidence level." While the exact number of samples for each specific measurement (e.g., total output, particle size for each drug) is not explicitly stated as a single number, the statistical confidence level (95%) implies a sufficient sample size was used for each test to achieve this confidence.
- Data Provenance: The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective. It is implied that the testing was conducted by the manufacturer, KOO (Shanghai) Industries Co., Ltd., as part of the 510(k) submission process, making it prospective testing for the purpose of demonstrating substantial equivalence.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of study (comparative performance of a nebulizer using physical measurements) does not involve human experts establishing "ground truth" in the way a diagnostic AI study would. The ground truth here is the measurable physical properties of aerosolized drugs, determined through standardized laboratory techniques (Cascade Impactor). Therefore, this question is not applicable to this submission.
4. Adjudication Method for the Test Set
Not applicable. As noted above, this study does not involve expert review or adjudication of results. The results are physical measurements.
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 study comparing the physical performance characteristics of a medical device (nebulizer) to a predicate device, not an AI-powered diagnostic tool involving human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Not applicable. The Koo SVN is a physical medical device, not an algorithm or software-driven device. The submission explicitly states "Software driven: No."
7. The Type of Ground Truth Used
The "ground truth" for this study is derived from objective physical measurements obtained through standardized laboratory testing, specifically "Particle Characterization per Cascade Impactor." This method directly measures key aerosol performance parameters such as Total Output, Particle Size (MMAD), Geometric Standard Deviation (GSD), Respirable Fraction, and Respirable Mass.
8. The Sample Size for the Training Set
Not applicable. As a physical medical device and not an AI or machine learning algorithm, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set for this device.
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(185 days)
SMALL VOLUME NEBULIZER
The Airlife Misty Nebulizer is a pneumatic nebulizer which nebulizes specific drugs for inhalation by a patient. The patient population includes infant, pediatric and adult patients. It's use is indicated whenever a physician or healthcare professional administers or prescribes medical aerosol products to a patient using a small volume nebulizer. This product is a single patient use, non-sterile prescriptive device and is designed to be used in either a hospital or homecare environment.
The nebulizer is a single patient use device which is filled with a fluid, typically respiratory medication, and connected to an air source via flexible tubing. The nebulizer works by having the fluid come into contact with the stream of gas. The gas shatters the liquid into small particles. These particles then impact a baffle that further reduces the size of the particles. The majority of the larger particles settle inside the nebulizer as a result of gravity and inertia, returning the mist to liquid to repeat the nebulization process. The smaller particles are then administered as the patient inhales. The treatment is completed when the majority of fluid is nebulized.
The provided text describes a 510(k) submission for the Allegiance Healthcare Corporation's Airlife® Misty Max 10™ Nebulizer. The submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and performance metrics for a novel AI or diagnostic device.
Therefore, many of the requested details, such as acceptance criteria in terms of performance metrics (sensitivity, specificity, AUC), sample sizes for test and training sets, data provenance for AI model development, expert qualifications, and adjudication methods for ground truth, are not applicable to this type of regulatory submission. The document explicitly states that the substantial equivalence is based on the same intended use and similar performance attributes to the predicate device.
However, I can extract the information that is present and explain why other requested information is not available in this document.
Acceptance Criteria and Device Performance (as interpreted for a 510(k) submission for a non-AI medical device):
| Criterion | Reported Device Performance Statement |
|---|---|
| Biocompatibility | "All materials used in the fabrication of the Airlife® Misty Max 10™ Nebulizer were evaluated through biological qualification safety tests as outlined in ISO 10993 Part-1 'Biological Evaluation of Medical Devices'." |
| Particle Size Distribution | "Comparative testing was performed using the proposed, predicate and Pari-LC with regards to particle size distribution testing." (Implied: performance comparable to predicate and industry standard) |
| General Safety/Effectiveness | "These materials also were tested in accordance with industry recognized test methods and were found to be acceptable for the intended use." (Broad statement indicating compliance with relevant standards and suitability for its purpose.) |
| Intended Use | "The intended use is the same" as the predicate device, which is "a pneumatic nebulizer which nebulizes specific drugs for inhalation by a patient." (Criterion met by matching predicate device's intended use.) |
| Performance Attributes | "The performance attributes are similar" to the predicate device. (Criterion met by demonstrating comparable functionality to the predicate nebulizer.) |
Detailed Information (as per your request, with explanations for missing data):
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A table of acceptance criteria and the reported device performance:
- See table above. The "acceptance criteria" for a 510(k) submission like this are generally demonstrating substantial equivalence by showing the new device is as safe and effective as a legally marketed predicate device, meeting relevant material safety and performance benchmarks. The performance is reported in terms of meeting those standards and being comparable to the predicate.
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Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable / Not provided. This document does not detail specific sample sizes for clinical "test sets" in the context of an AI/diagnostic algorithm testing. The testing described is primarily focused on material safety (biological compatibility) and comparative physical performance (particle size distribution) of the nebulizer hardware, not a diagnostic algorithm. Therefore, concepts like data provenance (country, retrospective/prospective) are not relevant here.
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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):
- Not applicable / Not provided. "Ground truth" in the context of expert consensus or pathology for a diagnostic algorithm is not relevant to this submission for a simple medical device (nebulizer). The "truth" here is established by standardized material and device performance tests.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable / Not provided. Adjudication methods are typically used for establishing consensus ground truth in studies involving subjective assessment (e.g., image interpretation). This is not relevant to the described testing for a nebulizer.
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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. An MRMC study is not mentioned. This is a submission for a pneumatic nebulizer, not an AI-assisted diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is not an algorithm; it is a physical medical device.
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The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- Not applicable / Not provided in these terms. The "ground truth" for this device would be established through objective, standardized test methods for material safety (ISO 10993 Part-1) and physical performance (particle size distribution), as well as comparison to the established performance of the predicate device. There is no subjective "ground truth" established by experts or pathology in this context.
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The sample size for the training set:
- Not applicable / Not provided. There is no "training set" as this is not an AI/machine learning model.
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How the ground truth for the training set was established:
- Not applicable / Not provided. As there is no training set, this question is not relevant.
In summary: The provided document is a 510(k) summary for a legacy class II medical device (nebulizer) seeking clearance based on substantial equivalence to a predicate device. It demonstrates performance through standard engineering and biocompatibility testing rather than clinical study designs focused on diagnostic accuracy or AI performance metrics. Therefore, most of the specific questions geared towards AI/diagnostic device evaluation are not applicable or answered within this type of regulatory submission.
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