(134 days)
The NebSonic N550 Nebulizer delivers nebulized medication for patients on mechanical ventilation or for patient use independent of a ventilator. The NebSonic is indicated for adult, pediatric, and neonatal patients.
The NebSonic N550 Nebulizer is an ultrasonic nebulizer designed to deliver nebulized medication to patients being mechanically ventilated without affecting ventilator performance or patient data. It is powered by external AC (100-240 volts), allowing its use with patients on mechanical ventilation or for patient use independent of a ventilator. The NebSonic N550 Nebulizer contains piezoelectric crystal that generates ultrasonic vibrations that travel through distilled water in a vial to liquid medication in a medication cup. The vibrations convert the medication into an aerosol mist. The nebulized medication is carried to the patient by the gas traveling through the ventilator breathing circuit.
The provided text describes a 510(k) submission for the Newport NebSonic N550 Ultrasonic Nebulizer, a traditional 510(k) submission (K041082). The submission focuses on demonstrating substantial equivalence to predicate devices rather than proving a new device's efficacy through a clinical study with acceptance criteria in the typical sense.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly define specific "acceptance criteria" in terms of clinical or performance benchmarks (e.g., a specific percentage improvement in a clinical outcome, or a defined accuracy threshold for a diagnostic device). Instead, it states that:
"Testing was conducted to characterize particle size and drug mass generated by the NebSonic N550 Nebulizer in comparison to a predicate device. The combined testing and analysis of results provides assurance that the device meets its specifications and is safe and effective for its intended use."
This implies that the "acceptance criteria" were met if the device's particle size and drug mass characteristics were comparable or within an acceptable range relative to the predicate device. However, the specific numerical criteria for "comparable" are not provided.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Particle size generation comparable to predicate device. | "Characterized... in comparison to a predicate device." (Specific values not provided) |
| Drug mass generation comparable to predicate device. | "Characterized... in comparison to a predicate device." (Specific values not provided) |
| Meets specifications. | "Provides assurance that the device meets its specifications." (Specific specifications not provided) |
| Safe and effective for intended use. | "Provides assurance that the device... is safe and effective for its intended use." (Conclusion based on testing) |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "thoroughly evaluated at the unit and system level" and "comprehensive testing," but it does not specify the sample size for any test set. The data provenance is also not explicitly stated as retrospective or prospective, or country of origin. Given the nature of a medical device submission for a nebulizer, it's highly likely that this testing involved in vitro laboratory experiments on a sample of manufactured devices, rather than human subjects or a clinical study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable and not provided in the document. The "ground truth" for a nebulizer's performance typically comes from direct measurements using specialized equipment (e.g., laser diffraction for particle size, gravimetric analysis for drug mass), not expert consensus in the way a diagnostic imaging study would require.
4. Adjudication Method for the Test Set
This information is not applicable and not provided. Adjudication is relevant for subjective assessments, typically in clinical trials or diagnostic studies. For objective performance metrics like particle size and drug mass, direct measurement is performed.
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
This information is not applicable. The NebSonic N550 is an ultrasonic nebulizer, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study or assessment of human reader improvement with AI assistance is irrelevant to this device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is an ultrasonic nebulizer, a physical medical device for drug delivery, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the device's performance (particle size and drug mass) would have been established through direct experimental measurements in a laboratory setting, using standardized methodologies for nebulizer characterization. This is an objective measurement, not based on expert consensus, pathology, or outcomes data in the traditional sense of a diagnostic device.
8. The Sample Size for the Training Set
This information is not applicable and not provided. The device is a physical product directly performing its function, not a machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable. As it's not an AI/ML device, there is no training set or ground truth for such a set.
Summary of the Study:
The study described for the NebSonic N550 Nebulizer was a device performance characterization study primarily focused on demonstrating substantial equivalence to existing predicate devices. It involved:
- In vitro testing of the nebulizer's performance.
- Measured parameters: particle size and drug mass generation.
- Comparison to predicate devices (Siemens Servo Ultra Nebulizer, Models 145 and 345; Puritan-Bennett EasyNeb Nebulizer).
- Compliance with various industry recognized standards (IEC 60601-1-2:1993, CSA 22.2 No 601-1-M90, UL 2601-1, EN 55011:1998 &A1:1999) for electrical safety and electromagnetic compatibility.
The 510(k) clearance (K041082) indicates that the FDA found this testing and comparison sufficient to determine that the NebSonic N550 Nebulizer is substantially equivalent to legally marketed predicate devices and is safe and effective for its intended use. The documentation provided focuses on the regulatory submission process for a traditional medical device, not a diagnostic or AI-powered system, which would necessitate different evaluation methodologies.
§ 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).