(297 days)
Microsonic Ultrasonic Nebulizer, Omron NE-U07 Ultra-Air, Siemens Servo Nebulizer 945
Not Found
No
The description focuses on the mechanical and ultrasonic function of the nebulizer and its integration with a ventilator, with no mention of AI or ML.
Yes
The device is used to nebulize liquid medication for introduction into the patient's airway, which is a therapeutic intervention.
No
The device is a nebulizer designed to deliver medication into a patient's airway, not to detect or diagnose a medical condition.
No
The device description clearly states it is an "ultrasonic nebulizer" which is a hardware component. The testing also includes electrical safety and electromagnetic compatibility, which are relevant to hardware devices.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The Siemens Model 345 Ultra Nebulizer is used to deliver medication directly into a patient's airway. It does not perform any tests on biological samples.
- Intended Use: The intended use clearly states it's for "nebulize liquid medication for introduction into the patient's airway." This is a therapeutic function, not a diagnostic one.
Therefore, the device falls under the category of a therapeutic medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for 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.
Product codes
Not Found
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's airway
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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. The testing of the SUN 345 demonstrates that the performance is substantially equivalent to predicate devices cited above.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Microsonic Ultrasonic Nebulizer, Omron NE-U07 Ultra-Air, Siemens Servo Nebulizer 945
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
510(k) Summary for Siemens Servo Ultra Nebulizer 345
DEC 23 1996
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Date this summary was prepared 1.
February 28, 1996 -
- Submitter's Name and Address
Siemens-Elema AB Röntgenvägen 2 S-171 95 Solna Sweden
- Submitter's Name and Address
-
- Contact Person
Mr. Anders Lodin
- Contact Person
| Telephone | 011-46 8 730 7228 |
|---|---|
| Telefax | 011-46 8 98 63 05 |
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- 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 .
1
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 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.
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.
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- 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.
- Comparison of Technological Characteristics
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.
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- 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.
- Nonclinical Tests Used in Determination of Substantial Equivalence
2/28/96
2
.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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