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510(k) Data Aggregation
(244 days)
The Portable Nebulizer is a vibrating mesh nebulizer system designed to aerosolize liquid medications for inhalation by the patient. The device may be used with pediatic (5 years and older), defined by the prescribed medication, and adult patients in hospital/institutional settings, home care use, schools, and long term care facilities.
The Portable Nebulizer is a small, handheld, internally powered general purpose nebulizer which utilizes vibrating mesh technology to generate aerosol.
The Portable Nebulizer, a vibrating mesh nebulizer system, underwent non-clinical performance testing to demonstrate its equivalence to the predicate device, Omron NE-U22 (K062263). The assessment primarily focused on aerosol characterization, electrical safety, software verification, biocompatibility, and cleaning/disinfection validation.
Here's an overview of the acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" for each performance metric with defined thresholds. Instead, it presents a comparative analysis against the predicate device to support substantial equivalence. The reported device performance is generally considered acceptable if it is "similar" or "substantially equivalent" to the predicate, or if it meets established standards.
| Feature | Acceptance Criteria (Implied: Similar to predicate or meeting standards) | Reported Device Performance |
|---|---|---|
| Indications for Use | To aerosolize liquid medications for inhalation; pediatric (5 years and older) and adult patients in various settings. | "The indications for use are identical for the proposed device and the predicate." Pediatric population description refined but deemed substantially equivalent to predicate based on other reference nebulizers. |
| Patient Population | Pediatric (defined by prescribed medication) and adult patients. | "The patient population is similar for the proposed device and the predicate." Pediatric age range (5 years and older) considered substantially equivalent to predicate based on other reference devices. |
| Environment of Use | Hospital/institutional settings, home care, schools, long term care facilities. | "The environment of use is identical for the proposed device and the predicate." |
| Technology / Principle of Operation | Vibrating mesh nebulizer. | "The technology is identical for the proposed device as compared to the predicate." |
| Nebulization rate | ≥ 0.25 ml/min (Predicate: 0.25 ml/min to 0.9 ml/min). | Reported: ≥ 0.25 ml/min. |
| Power consumption | < 1.5 W (Predicate: 1.5 W). | Reported: < 1.5 W. |
| Electrical Safety Standards | Compliance with IEC 60601-1:2012, IEC 60601-1-2:2007, IEC 60601-1-11:2012. | "Testing established that, with respect to electrical safety, the device meets the applicable requirements of: (1) IEC 60601-1:2012; (2) IEC 60601-1-2:2007; (3) IEC 60601-1-11:2012." |
| Software Level of Concern | Moderate. | "The software for this device is of a 'moderate' level of concern." Software Verification and Validation testing conducted in accordance with FDA's Guidance 337. |
| Biocompatibility | ISO 10993-1 tests (Cytotoxicity, Sensitization, Irritation, Sub-chronic Systemic toxicity, Acute Systemic Toxicity, Leachable and Extractables with Risk Based Assessment, Gas Emission VOC plus Inorganic compounds - CO, CO2, and Ozone, PM25). | "Under the parameters of the tests it is concluded that they are biocompatible, and that there are no new issues of biocompatibility regarding their use as intended." |
| Cleaning and Disinfection Validation | Effective cleaning and disinfection by methods stated in IFU. | "All testing concluded that the nebulizer could be cleaned and disinfected effectively by use of the methods stated in the IFU." |
| Particle Size (MMAD) | Similar to predicate (ranges provided in Tables 3 & 4). | For adult flow: Albuterol 1.9–2.8*, Ipratropium 2.0–2.7, Cromolyn 2.1–2.8. For pediatric flow: Albuterol 3.31–4.95*, Ipratropium 4.34–5.72*, Cromolyn 3.68–5.38*. Overall deemed "very similar compared to that of the predicate." |
| Total Dose | Similar to predicate (ranges provided in Tables 3 & 4). | For adult flow: Albuterol 1719–2082*, Ipratropium 347–403*, Cromolyn 13372–14329*. For pediatric flow: Albuterol 2159–2592, Ipratropium 429–505, Cromolyn 17733–18426. Overall deemed "very similar compared to that of the predicate." |
| Total Respirable Dose (0.5-5 microns) | Similar to predicate (ranges provided in Tables 3 & 4). | For adult flow: Albuterol 1274–1487*, Ipratropium 237–275*, Cromolyn 8645–9954*. For pediatric flow: Albuterol 1071–1596*, Ipratropium 198–219*, Cromolyn 7925–10601*. Overall deemed "very similar compared to that of the predicate." |
| Other Particle Characteristics (GSD, Coarse, Fine, Ultra-fine Particle Dose) | Similar to predicate (ranges provided in Tables 3 & 4). | Generally shown to be within "very similar" ranges compared to the predicate. Asterisks indicate values that are higher/lower than predicate ranges, but the overall conclusion is still "substantially equivalent." |
| Shelf-life, Useful-life, Durability Testing | Not explicitly stated but implied to meet performance criteria. | Testing was performed. Specific performance not detailed in this summary. |
| Simulated Life Cycle Testing | Not explicitly stated but implied to meet performance criteria. | Testing was performed. Specific performance not detailed in this summary. |
Note: Asterisks () in the "Reported Device Performance" column for particle characterization often indicate that the device's range is different from the predicate's range. However, the overall conclusion in the document is that the results support a substantial equivalence argument.*
2. Sample Size Used for the Test Set and the Data Provenance:
The document does not explicitly state the sample sizes (number of units or test replicates) for all non-clinical tests. For the particle characterization, the tables show ranges of values for different medications (Albuterol, Ipratropium, Cromolyn), which suggests multiple tests were conducted for each.
The data provenance is not specified in terms of country of origin. The study appears to be entirely retrospective for the purpose of this 510(k) submission, utilizing pre-existing test data to demonstrate equivalence.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
This information is not provided in the document. The nature of the non-clinical tests (e.g., electrical safety, biocompatibility, particle characterization) typically relies on objective measurements and established standards, rather than expert interpretation of a "ground truth" in the way a clinical study would.
4. Adjudication Method for the Test Set:
This information is not applicable/provided for the non-clinical tests described. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies involving interpretation of data by multiple experts to establish a "ground truth" for diagnostic accuracy or similar endpoints. The tests performed here are objective engineering and material science evaluations.
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:
An MRMC study was not performed as this device is a nebulizer and not an AI-powered diagnostic device involving human readers or interpretation.
6. If a Standalone (i.e. Algorithm Only Without Human-in-the-Loop Performance) Was Done:
This is not applicable as the device is a medical device (nebulizer), not an algorithm or AI system. The "software" mentioned refers to firmware controlling the vibrating mesh, not a standalone AI diagnostic tool.
7. The Type of Ground Truth Used:
For the non-clinical tests, the "ground truth" is established by:
- Established Standards: For electrical safety (IEC 60601 series), biocompatibility (ISO 10993-1), and software verification (FDA Guidance 337).
- Objective Measurements: For particle characterization (using Cascade Impactor and laser light scattering techniques), nebulization rate, power consumption, etc.
- Comparison to Predicate Device: The performance of the Portable Nebulizer is compared directly to the legally marketed Omron NE-U22 (K062263) as key evidence for substantial equivalence.
8. The Sample Size for the Training Set:
This is not applicable as this is a traditional medical device (nebulizer) and not an AI/ML-based device that requires a "training set."
9. How the Ground Truth for the Training Set Was Established:
This is not applicable for the same reason as point 8.
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