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.

Device Description

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.

AI/ML Overview

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.

Summary

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K900854

510(k) Summary for Siemens Servo Ultra Nebulizer 345

DEC 23 1996

Date this summary was prepared 1.
February 28, 1996
1. Submitter's Name and Address
  Siemens-Elema AB Röntgenvägen 2 S-171 95 Solna Sweden
1. Contact Person
  Mr. Anders Lodin

Telephone	011-46 8 730 7228
Telefax	011-46 8 98 63 05

1. Device Name

Trade/Proprietary Name:	Servo Ultra Nebulizer 345
Common Name:	Ultrasonic Nebulizer Accessory to Servo Ventilator 300
Classification Names:	(1) Nebulizer(2) (Accessories to) Ventilator, Continuous (Respirator)

Predicate Devices ડ.

The legally marketed devices to which equivalence is being claimed are:

Microsonic Ultrasonic Nebulizer, marketed by Medisonic U.S.A. Inc. .
Omron NE-U07 Ultra-Air, marketed by Omron Healthcare, Inc. .
Siemens Servo Nebulizer 945 .

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6. Device Description

7. Intended Use

1. Comparison of Technological Characteristics
  The Servo Ultra Nebulizer 345 works by exciting the medication with ultrasonic energy at a frequency of 2.4 Mhz, as do the Medisonic and Omron products. The Servo -Nebulizer 945 uses the jet principal.

The SUN 345 produces particles with a mass median diameter of 4 um. The Medisonic has particle size of 3-5 um, and the Omron 1-5 um.

The SUN 345 has a nebulization rate of 0.5 ml water/min at 1 1/sec gas flow, and 0.3 ml water/min at 0.5 l/sec gas flow. This compares to up to 2 ml/min for the Medisonic and 0.4 ml/min for the Omron.

1. Nonclinical Tests Used in Determination of Substantial Equivalence
  The design of the Siemens Model 345 Ultra Nebulizer has been thoroughly validated at the unit and system level. Non-clinical tests were conducted to determine particle size and nebulization rate for various medications and ventilator flow rates. The complete system consisting of the SUN 345 and the Servo Ventilator 300 has been tested to the electrical safety requirements and the Electromagnetic Compatibility requirements of EN 60601.

2/28/96

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.0. Conclusions From Nonclinical Testing

The testing of the SUN 345 demonstrates that the performance is substantially equivalent to predicate devices cited above.

Siemens Ultra Nebulizer 345 510(k)

2/28/96

ន់នេះ

1161 2018

Regulation Number and Section

§ 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).