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510(k) Data Aggregation
(157 days)
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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(281 days)
The Fisio Chamber Spacer is intended to be used by patients who are under the care of treatment of a licensed healthcare professional or physician. The device is intended to be used by these patients to administer aerosolized medication from pressurized Metered-Dose Inhalers, prescribed by a physician or healthcare professional.
Environments of use - Home care, nursing homes, sub-acute institutions, and hospitals
The Fisio Chamber Spacer is intended for use in the inhalation of medications delivered via an MDI and for which the medication is to be delivered to the upper and lower respiratory system. The device consists of a translucent housing and mouth piece or face mask and a one-way valve to prevent exhaling into the chamber.
The Fisio Chamber Spacer is intended to be used to inhale aerosolized drugs of approved MDIs from the following groups of active substances:
- · Corticosteroids (anti-inflammatory medications)
- · Anti-cholinergics and B2-sympathomimetics (bronchodilater medications)
- · Non-steroidal chromones (DNCG)
It is a single patient, multi-use non-sterile device.
Here's a breakdown of the acceptance criteria and study information for the Fisio Chamber Spacer, based on the provided text:
Acceptance Criteria and Device Performance
The provided document is a 510(k) Summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed acceptance criteria and performance against those criteria in a tabular format. The "acceptance criteria" here are implicitly defined by the performance of the predicate device, K070674 - Trudell AeroChamber Plus, particularly for particle characterization.
Implicit Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Criteria (Derived from Predicate) | Reported Fisio Chamber Spacer Performance (Reported as Equivalence) |
|---|---|---|
| Particle Characterization | Equivalent particle characterization to K070674 - Trudell AeroChamber Plus. | Equivalent performance via Cascade Impactor testing. |
| Mechanical Integrity | Maintain performance after mechanical testing. | "Passed or met its performance specifications." |
| Environmental Stability | Maintain performance after environmental testing. | "Passed or met its performance specifications." |
| Simulated Life Cycle/Cleaning | Maintain performance after cleaning validation. | "Passed or met its performance specifications." |
| Biocompatibility | Meet ISO 10993 testing standards. | Not explicitly stated as "passed" for Fisio, but implied by overall equivalence claim for a similar device. The predicate device (K010680 - CT Spacer) also undergoes ISO 10993 testing. |
Study Information
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated in the provided text. The comparative particle characterization testing was performed, but the number of devices or measurements is not mentioned.
- Data Provenance: The document does not specify the country of origin of the data. The study was conducted by the manufacturer, Koo (Shanghai) Industries Co., Ltd. The study appears to be a prospective test specifically designed to compare the Fisio Chamber Spacer against the predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This device is a medical device (spacer/holding chamber), not a diagnostic algorithm requiring expert-established ground truth from images or other complex data. The performance evaluation is based on objective physical and functional characteristics (e.g., particle size distribution, mechanical integrity).
4. Adjudication method for the test set:
- Not applicable. See point 3.
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. This is a physical medical device, not an AI or imaging-based diagnostic tool that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for comparative performance, particularly for particle characterization, was the established, measured performance of the predicate device (K070674 - Trudell AeroChamber Plus), specifically its particle characterization via Cascade Impactor. For other tests (mechanical, environmental, cleaning), the "ground truth" was likely predefined performance specifications that the device needed to pass.
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. See point 8.
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