SIEMENS SERVO ULTRA NEBULIZER 345

K960854 · Pacesetter, Inc. · CAF · Dec 23, 1996 · Anesthesiology

Device Facts

• Record ID: K960854
• Device Name: SIEMENS SERVO ULTRA NEBULIZER 345
• Applicant: Pacesetter, Inc.
• Product Code: CAF · Anesthesiology
• Decision Date: Dec 23, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

Accessory to Servo Ventilator 300; nebulizes liquid medication for delivery into patient airway via endotracheal tube. Uses ultrasonic energy (2.4 MHz) to aerosolize 10ml medication cup contents. Nebulization rate 0.3ml/min at 0.5l/min gas flow; mass median particle diameter 4.0µm. Integrated into patient circuit; adds no gas volume, ensuring ventilator readings/settings remain unaffected. Used in clinical settings by healthcare providers. Benefits patient by enabling medication delivery during mechanical ventilation.

Clinical Evidence

Bench testing only. Validation included unit and system-level testing for particle size and nebulization rates across various medications and ventilator flow rates. Electrical safety and electromagnetic compatibility testing performed per EN 60601 standards.

Technological Characteristics

Ultrasonic nebulizer; 2.4 MHz excitation frequency; 10ml medication cup capacity; 4.0µm mass median particle diameter; 0.3ml/min nebulization rate at 0.5l/min gas flow. Designed as an accessory to the Servo Ventilator 300. Tested to EN 60601 electrical safety and EMC standards.

Indications for Use

Indicated for patients requiring nebulized liquid medication delivery via endotracheal tube during mechanical ventilation using the Siemens Servo Ventilator 300.

Regulatory Classification

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.

Predicate Devices

• Microsonic Ultrasonic Nebulizer
• Omron NE-U07 Ultra-Air
• Siemens Servo Nebulizer 945

Submission Summary (Full Text)

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K960854

510(k) Summary for Siemens Servo Ultra Nebulizer 345

DEC 23 1996

1. Date this summary was prepared

February 28, 1996

2. Submitter's Name and Address

Siemens-Elema AB

Röntgenvägen 2

S-171 95 Solna

Sweden

3. Contact Person

Mr. Anders Lodin

Telephone [phone]

Telefax 011-46 8 98 63 05

4. 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)

5. Predicate Devices

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

Siemens Ultra Nebulizer 345 510(k)

2/28/96

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# 6. 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 $10\mathrm{ml}$ of liquid, which is nebulized at a rate of $0.3\mathrm{ml/min}$ at $0.5\mathrm{l/min}$ gas flow. The mass median diameter of particles is $4.0\mu\mathrm{m}$.

# 7. Intended Use

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.

# 8. Comparison of Technological Characteristics

The Servo Ultra Nebulizer 345 works by exciting the medication with ultrasonic energy at a frequency of $2.4\mathrm{Mhz}$, 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 $4\mu\mathrm{m}$. The Medisonic has particle size of $3-5\mu\mathrm{m}$, and the Omron $1-5\mu\mathrm{m}$.

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

# 9. 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.

Siemens Ultra Nebulizer 345 510(k)
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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
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