(624 days)
The Nebulizer kit is used to aerosolize medication approved for nebulization and prescribed by a physician for delivery to the airways. The Nebulizer kit is intended for adult consistent with the indication in hospitals and sub-acute institutions.
The nebulizer kit is a small volume jet nebulizer designed to deliver aerosolized medications for inhalation to the respiratory system, the compressed air or oxygen is forced into the nebulizer through a converging nozzle, where it accelerates and emerges at a high velocity, creating a vacuum (Venturi effect), in the process the liquid medicine is converted into small droplets called aerosol by impacting upon a rigid baffle, the aerosol may be used for inhalation treatment of a physician's prescription. The nebulizer kit is single-patient, multi-use; it requires a cleaning and disinfection process before each use, and the service life is for 30 aerosol treatments.
The provided document is a 510(k) summary for a Nebulizer Kit (K192971). It focuses on demonstrating substantial equivalence to a predicate device (VixOne, K800562) rather than proving the device meets acceptance criteria for an AI/ML medical device. As such, many of the requested details, particularly regarding AI/ML related study elements (e.g., sample size for test/training sets, expert consensus for ground truth, MRMC studies, standalone algorithm performance), are not applicable or cannot be extracted from this document.
However, I can extract information related to the device's performance characteristics which were used to demonstrate equivalence to the predicate device, serving as a form of "acceptance criteria" for this type of medical device submission.
Here's how the available information aligns with your request:
Device: Nebulizer Kit (K192971)
Study Purpose: To demonstrate substantial equivalence of the proposed Nebulizer Kit to the predicate device (VixOne Nebulizer, K800562) based on performance characteristics.
1. Table of Acceptance Criteria and Reported Device Performance
For nebulizers, key performance characteristics relate to the aerosolized medication. While specific "acceptance criteria" against numerical targets aren't explicitly stated as pass/fail thresholds in a table, the document implicitly defines acceptance as "not significant statistical difference" compared to the predicate device for key aerosol characteristics.
| Performance Metric (Aerosol Characteristics) | Acceptance Criteria (Implicit) | Proposed Device Performance (Mean ± SD) @ 8L/min Flow | Predicate Device Performance (Mean ± SD) @ 8L/min Flow | Proposed Device Performance (Mean ± SD) @ 4L/min Flow | Predicate Device Performance (Mean ± SD) @ 4L/min Flow |
|---|---|---|---|---|---|
| Total Mass (µg) | No significant statistical difference from predicate device | Albuterol: 1146.80±142.12 | Albuterol: 1309.33±137.13 | Albuterol: 1031.51±113.44 | Albuterol: 1104.12±72.02 |
| Ipratropium: 228.18±12.40 | Ipratropium: 213.81±15.03 | Ipratropium: 199.78±15.60 | Ipratropium: 216.84±10.63 | ||
| Cromolyn: 6307.49±802.07 | Cromolyn: 7172.85±626.18 | Cromolyn: 5466.01±567.02 | Cromolyn: 5987.10±715.04 | ||
| Budesonide: 467.07±34.11 | Budesonide: 501.02±23.65 | Budesonide: 430.79±18.55 | Budesonide: 452.60±22.52 | ||
| Particle Size - MMAD (µm) | No significant statistical difference from predicate device | Albuterol: 2.80±0.23 | Albuterol: 2.55±0.15 | Albuterol: 4.71±0.11 | Albuterol: 4.52±0.13 |
| Ipratropium: 2.14±0.22 | Ipratropium: 2.07±0.20 | Ipratropium: 3.21±0.17 | Ipratropium: 3.19±0.24 | ||
| Cromolyn: 2.66±0.20 | Cromolyn: 2.41±0.15 | Cromolyn: 4.25±0.18 | Cromolyn: 4.09±0.10 | ||
| Budesonide: 3.32±0.18 | Budesonide: 3.11±0.18 | Budesonide: 4.97±0.14 | Budesonide: 4.84±0.15 | ||
| Geometric Standard Deviation (GSD) | No significant statistical difference from predicate device | Albuterol: 2.49±0.16 | Albuterol: 2.51±0.05 | Albuterol: 2.42±0.05 | Albuterol: 2.40±0.07 |
| Ipratropium: 2.81±0.06 | Ipratropium: 3.01±0.16 | Ipratropium: 2.76±0.16 | Ipratropium: 2.71±0.11 | ||
| Cromolyn: 2.48±0.09 | Cromolyn: 2.56±0.09 | Cromolyn: 2.52±0.01 | Cromolyn: 2.48±0.05 | ||
| Budesonide: 2.27±0.08 | Budesonide: 2.20±0.12 | Budesonide: 2.53±0.13 | Budesonide: 2.59±0.15 | ||
| Respirable Fraction (% 0.5-5µm) | No significant statistical difference from predicate device | Albuterol: 70.76±1 | Albuterol: 73.02±2 | Albuterol: 52.17±1 | Albuterol: 54.06±1 |
| Ipratropium: 71.32±3 | Ipratropium: 68.86±1 | Ipratropium: 63.63±3 | Ipratropium: 64.3±3 | ||
| Cromolyn: 72.33±3 | Cromolyn: 73.52±3 | Cromolyn: 55.96±2 | Cromolyn: 57.79±1 | ||
| Budesonide: 68.09±2 | Budesonide: 71.82±4 | Budesonide: 49.57±1 | Budesonide: 50.55±0.1 | ||
| Respirable Mass (µg 0.5-5µm) | No significant statistical difference from predicate device | Albuterol: 810.89±94.73 | Albuterol: 956.45±107.82 | Albuterol: 538.94±70.97 | Albuterol: 596.14±35.20 |
| Ipratropium: 162.63±10.34 | Ipratropium: 147.16±11.58 | Ipratropium: 126.97±10.16 | Ipratropium: 139.41±11.84 | ||
| Cromolyn: 4576.38±739.65 | Cromolyn: 5273.70±512.70 | Cromolyn: 3056.41±297.19 | Cromolyn: 3460.11±416.01 | ||
| Budesonide: 318.22±27.49 | Budesonide: 359.25±7.21 | Budesonide: 213.50±8.65 | Budesonide: 228.69±9.93 |
Overall Conclusion regarding acceptance: The document states: "the parameters of total mass, MMAD, GSD, respirable fraction and respirable Mass are analyzed and compared at a 95% confidence level, there is not significant statistical difference between the two devices." This indicates the proposed device "meets the requirements of its pre-defined acceptance criteria" by being statistically comparable to the predicate for these key characteristics.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (for performance testing): While specific numerical sample sizes for each drug and flow rate are not explicitly stated as "n=X", the phrase "For each device, four drugs... were tested respectively" implies a repeated measures design. The presence of mean and standard deviation values indicates multiple measurements were taken for each characteristic. The "variability of intra-sample and inter-sample was tested for the proposed devices," further suggesting a robust, though unspecified, sample size for these technical measurements.
- Data Provenance: The testing was conducted in accordance with relevant standards (CDRH Guidance Document, USP 40, ISO 27427:2013). The manufacturer is Excellentcare Medical (Huizhou) Ltd. in China, implying the data likely originated from their testing facilities or a contracted lab. The study is inherently prospective in the sense that controlled laboratory tests were conducted on the device for the purpose of this submission.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- Not Applicable. This is a device performance test (aerosol characteristics) for a hardware device, not an AI/ML study requiring expert annotations for ground truth.
4. Adjudication Method for the Test Set:
- Not Applicable. See point 3.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. This is not an AI/ML medical device study.
6. Standalone (Algorithm Only) Performance:
- Not Applicable. This is a hardware device, not an algorithm.
7. Type of Ground Truth Used:
- Laboratory Measurements / Defined Standards. The "ground truth" for the device's performance is established by the results of the aerosol characterization tests (e.g., measuring particle size, total mass) conducted according to recognized industry standards (USP, ISO, FDA guidance). The comparison to the predicate device validates these measurements against an already cleared product.
8. Sample Size for the Training Set:
- Not Applicable. This device does not have a "training set" in the context of AI/ML.
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable. See point 8.
Summary of what the document does provide:
The document details the physical and performance characteristics of a Nebulizer Kit and compares them to a legally marketed predicate device. The "acceptance criteria" were met by demonstrating "not significant statistical difference" in critical aerosol characteristics (Total Mass, MMAD, GSD, Respirable Fraction, Respirable Mass) at two different flow rates for four different drugs, when compared to the predicate device. This approach is standard for 510(k) submissions of non-AI/ML devices to establish substantial equivalence.
§ 868.5630 Nebulizer.
(a)
Identification. A nebulizer is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. Heated, ultrasonic, gas, venturi, and refillable nebulizers are included in this generic type of device.(b)
Classification. Class II (performance standards).