(297 days)
The intended use of the Siemens Model 345 Ultra Nebulizer is to nebulize liquid medication for introduction into the patient's airway via an endotracheal tube. It can be used on any patient for whom the use of the Siemens Servo Ventilator 300 is indicated, in any ventilatory mode appropriate for the patient.
The Servo Ultra Nebulizer 345 (SUN 345) is an accessory to the Servo Ventilator 300 that is used to nebulize medication during ventilator treatment. An ultrasonic nebulizer similar to those commonly marketed as a component of home "medication inhaler" devices has been adapted for use in the patient circuit of the Servo Ventilator. The ultrasonic nebulizer does not add any gas volume to the circuit, so that readings and settings on the ventilator are unaffected. The SUN 345 medication cup holds 10 ml of liquid, which is nebulized at a rate of 0.3 ml/min at 0.5 1/min gas flow. The mass median diameter of particles is 4.0 um.
Acceptance Criteria and Device Performance Study for Siemens Servo Ultra Nebulizer 345
This document summarizes the acceptance criteria and the study performed for the Siemens Servo Ultra Nebulizer 345, based on the provided 510(k) summary.
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Servo Ultra Nebulizer 345 are implicitly defined by its comparison to predicate devices, focusing on key performance characteristics. The study aimed to demonstrate substantial equivalence by meeting these characteristics or performing within an acceptable range relative to the predicates.
| Acceptance Criteria | Predicate Devices (Range/Example) | Reported Device Performance (Servo Ultra Nebulizer 345) |
|---|---|---|
| Operating Principle | Ultrasonic excitation (Medisonic, Omron) | Ultrasonic excitation at 2.4 MHz |
| Particle Size (Mass Median Diameter) | 3-5 µm (Medisonic), 1-5 µm (Omron) | 4.0 µm |
| Nebulization Rate (Water) | Up to 2 ml/min (Medisonic), 0.4 ml/min (Omron) | 0.5 ml/min at 1 l/sec gas flow; 0.3 ml/min at 0.5 l/sec gas flow |
| Gas Volume Addition | Minimal/None (implicitly, as accessory to ventilator) | Does not add any gas volume to the circuit |
2. Sample Size and Data Provenance
The provided 510(k) summary does not specify the sample size used for the test set in the non-clinical tests. The tests were conducted internally by Siemens-Elema AB in Solna, Sweden. The data provenance is retrospective, as the tests were performed to support the 510(k) submission for an already developed device.
3. Number of Experts and Qualifications for Ground Truth Establishment
The 510(k) summary does not mention the use of experts to establish a "ground truth" for the non-clinical tests. The tests performed (particle size, nebulization rate) are objective measurements based on established scientific methods and instrumentation, rather than subjective interpretation by experts.
4. Adjudication Method for the Test Set
No adjudication method is described, as the tests involved objective measurements rather than subjective assessments requiring expert consensus.
5. Multi-Reader, Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was conducted or mentioned. The device is a medical accessory, and the study focused on its physical performance characteristics, not on diagnostic accuracy or interpretation requiring human readers.
6. Standalone Performance Study
Yes, a standalone performance study was conducted. The "Nonclinical Tests Used in Determination of Substantial Equivalence" section describes tests to determine particle size and nebulization rate for various medications and ventilator flow rates for the device itself. Additionally, the complete system (SUN 345 and Servo Ventilator 300) was tested for electrical safety and Electromagnetic Compatibility, which are also standalone performance aspects.
7. Type of Ground Truth Used
The ground truth used for the non-clinical tests was based on objective physical measurements using scientific instrumentation and standardized methods for determining:
- Particle size (mass median diameter)
- Nebulization rate
- Electrical safety
- Electromagnetic compatibility
8. Sample Size for the Training Set
The concept of a "training set" is not applicable here as the device is not an AI or machine learning model. The non-clinical tests involved direct performance measurements of the hardware.
9. How Ground Truth for the Training Set Was Established
As there is no training set in the context of an AI/ML model, this question is not applicable. The measurements taken for the non-clinical tests (particle size, nebulization rate, etc.) served as the direct performance data for the device.
§ 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).