(151 days)
The NE-C802 Compressor Nebulizer System is intended to provide air to the pneumatic nebulizer in order to aerosolize medications for inhalation by the patient for respiratory disorders. The system is designed for use with pediatric (3 year old and greater) and adult patients in the home, hospital, and sub-acute settings.
The Omron Model NE-C802 is a standard nebulizer compressor system with an integral compressor and handheld, pneumatic nebulizer intended for general purpose use. It is powered by standard AC. This is a modification of the NE-C801 cleared under K110860.
Acceptance Criteria and Device Performance for Omron NE-C802 Compressor Nebulizer System
The Omron NE-C802 Compressor Nebulizer System is substantially equivalent to its predicate device, the Omron NE-C801 (K110860). The modifications made to the NE-C802, primarily involving minor changes to the nebulizer design and compressor design for smaller size and lighter weight, do not alter the intended use or fundamental scientific technology. Therefore, clinical investigation was not deemed necessary to validate these changes.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly based on demonstrating substantial equivalence to the predicate device, NE-C801 (K110860), across various performance characteristics. The reported device performance for the NE-C802 is compared directly to the NE-C801.
| Characteristic | Acceptance Criteria (Predicate NE-C801) | Reported Device Performance (NE-C802) | Notes |
|---|---|---|---|
| Compressor | Roller - 4 valves | Roller – 3 valves | Design change, but performance is viewed as substantially equivalent. |
| Power | DC 12V | DC 6V | Changed for smaller, lighter design, but performance is viewed as substantially equivalent. |
| Operating pressure & flow from compressor | 2.54 lpm | 1.2 lpm | While the flow rate is lower, the overall performance (e.g., particle size, delivery rate) is considered substantially equivalent. |
| Nebulizer Design | Standard pneumatic nebulizer | Design change to some components to improve airflow | Still pneumatic; principle of operation is the same. |
| Delivery Rate | 0.3 ml / min | 0.25 ml / min | Slightly lower, but the particle characterization results are directly compared and found substantially equivalent. |
| Particle Size (MMAD in µm) @ 15L/min | Pulmicort: 4.89; Intal: 3.33; Salbutamol: 3.38 | Pulmicort: 4.43; Intal: 3.78; Salbutamol: 3.25 | Compared across three drugs. The statistical analysis of variance and mean difference showed non-significance (p-value), indicating substantial equivalence. |
| Particle Size (MMAD in µm) @ 32L/min | Pulmicort: 4.37; Intal: 2.79; Salbutamol: 2.72 | Pulmicort: 4.08; Intal: 3.37; Salbutamol: 2.94 | Compared across three drugs. The statistical analysis of variance and mean difference showed non-significance (p-value), indicating substantial equivalence. |
| GSD @ 5 lpm | Pulmicort: 2.2; Intal: 2.4; Salbutamol: 2.7 | Pulmicort: 2.4; Intal: 2.8; Salbutamol: 2.9 | Differences in GSD were noted but deemed not to raise new questions of safety or efficacy. Statistical analysis done with 99% confidence interval. |
| GSD @ 2 lpm | Pulmicort: 2.32; Intal: 2.7; Salbutamol: 2.89 | Pulmicort: 2.55; Intal: 3.2; Salbutamol: 3.4 | Differences in GSD were noted but deemed not to raise new questions of safety or efficacy. Statistical analysis done with 99% confidence interval. |
| Total Delivered Dose (ug) @ 5 lpm | Pulmicort: 395; Intal: 13567; Salbutamol: 7650 | Pulmicort: 385; Intal: 12993; Salbutamol: 7483 | Minor differences, but comparison suggests substantial equivalence in clinical impact for drug delivery. |
| Total Delivered Dose (ug) @ 2 lpm | Pulmicort: 378; Intal: 12533; Salbutamol: 7716 | Pulmicort: 392; Intal: 12992; Salbutamol: 7494 | Minor differences, but comparison suggests substantial equivalence in clinical impact for drug delivery. |
| Total Delivered Dose Fraction (%) @ 5 lpm | Pulmicort: 80%; Intal: 69%; Salbutamol: 78% | Pulmicort: 76%; Intal: 65%; Salbutamol: 74% | Differences in delivered dose fraction were found to be substantially equivalent. |
| Total Delivered Dose Fraction (%) @ 2 lpm | Pulmicort: 81%; Intal: 64%; Salbutamol: 79% | Pulmicort: 78%; Intal: 65%; Salbutamol: 75% | Differences in delivered dose fraction were found to be substantially equivalent. |
| Respirable Fraction (0.5-5 um) (%) @ 5 lpm | Pulmicort: 55%; Intal: 59%; Salbutamol: 59% | Pulmicort: 50%; Intal: 60%; Salbutamol: 56% | Differences in respirable fraction were found to be substantially equivalent. |
| Respirable Fraction (0.5-5 um) (%) @ 2 lpm | Pulmicort: 58%; Intal: 62%; Salbutamol: 60% | Pulmicort: 54%; Intal: 64%; Salbutamol: 57% | Differences in respirable fraction were found to be substantially equivalent. |
| Total Respirable Dose (0.5-5 um) (ug) @ 5 lpm | Pulmicort: 2.17; Intal: 80.13; Salbutamol: 44.9 | Pulmicort: 1.93; Intal: 78.27; Salbutamol: 41.63 | Differences in total respirable dose were found to be substantially equivalent. |
| Total Respirable Dose (0.5-5 um) (ug) @ 2 lpm | Pulmicort: 2.39; Intal: 77.86; Salbutamol: 46.24 | Pulmicort: 2.12; Intal: 82.4; Salbutamol: 43.03 | Differences in total respirable dose were found to be substantially equivalent. |
| Dimensions | 142 mm (W) x 98 mm (H) x 72 mm (D) | 85mm (W) x 43mm (H) x 115mm (D) | Smaller and lighter, which is a stated modification, but does not impact safety or efficacy. |
| Weight (without battery) | 270 gm | 190 gm | Lighter, which is a stated modification, but does not impact safety or efficacy. |
| Reservoir Size | 7 ml | 10 ml | Increased, but does not impact safety or efficacy, potentially improving user convenience. |
| Indications for Use | Pneumatic nebulizer for respiratory disorders | Pneumatic nebulizer for respiratory disorders | Identical, with clarification for pediatric population (3 years and older). |
| Environment of Use | Home, Hospital, Sub-acute Institutions | Home, Hospital, Sub-acute Institutions | Identical. |
| Patient Population | Pediatric and adult | Pediatric (3 years and older) and adult | Identical, with clarification for pediatric population (3 years and older). |
| Contraindications | None | None | Identical. |
| Materials in Patient Contact | ABS, Polypropylene and PVC | Polypropylene and PVC | The materials in the gas and fluid pathway are identical or considered equivalent in terms of safety. The use of these materials has been determined safe by FDA. |
| Standards Met | IEC60601-1:1988 +A1:1991+A2:1995, IEC60601-1-2:2007, ISO10993-1:2009, ISO10993-5:2009, ISO10993-10:2009 | IEC 60601-1:2005, IEC 60601-1-2:2007, IEC 60601-1-11:2007, IEC 62366:2007, ISO10993-1:2009, ISO10993-5:2009, ISO10993-10:2010 | Updated to newer versions of standards where applicable, demonstrating continued compliance with relevant safety and performance requirements. |
| Operating Conditions | 10°C to 40°C, 30% to 85% RH | 10°C to 40°C, 30% to 85% RH | Identical. |
| Storage Conditions | -20°C to 60°C, 10% to 95% RH | -20°C to 60°C, 10% to 95% RH | Identical. |
| Power Source | AC | AC | Identical. |
| Nebulizer Components Cleanable | Yes | Yes | Identical. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a "test set" in the context of clinical or large-scale comparative studies. Instead, the performance testing focuses on bench testing and laboratory measurements to demonstrate substantial equivalence.
- Particle Characterization Test: This test involved 3 devices for 3 runs with 3 different drugs. This implies a total of 9 measurements per parameter.
- Data Provenance: The data is generated from bench testing conducted by Omron Healthcare, Inc. (the manufacturer). The country of origin of the data is not explicitly stated, but it is implied to be internal testing by the US-based company or its contracted labs. The data is retrospective in the sense that it was conducted for the purpose of the 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the ground truth for these types of technical performance tests (e.g., particle size, flow rates) is established by using calibrated scientific instruments and standardized testing methodologies, not by expert consensus in a clinical setting.
4. Adjudication Method for the Test Set
This is not applicable for the type of bench testing presented. Adjudication methods like 2+1 or 3+1 are used in clinical studies involving interpretation of medical images or patient outcomes, which are not part of this submission. The "adjudication" here is implied by the statistical analysis of the performance parameters demonstrating equivalence.
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 was done. This device is a mechanical nebulizer system, not an AI-assisted diagnostic or therapeutic device. Therefore, a study of human readers improving with AI assistance is irrelevant and was not conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No standalone algorithm performance study was done. This device is a physical product (compressor nebulizer), not a software algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the performance characteristics (e.g., MMAD, GSD, delivered dose) is established through objective laboratory measurements using recognized scientific instruments and methods, such as an 8-stage cascade impactor for particle characterization. It is not based on expert consensus, pathology, or outcomes data, as those are relevant to clinical efficacy and safety, which were deemed unnecessary for this 510(k) given the substantial equivalence to the predicate.
8. The Sample Size for the Training Set
Not applicable. There is no "training set" in the context of this device's evaluation. This is a hardware device, not a machine learning model.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set for a machine learning model, there is no ground truth established for one.
§ 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).