(157 days)
No
The description focuses on the mechanical function of a nebulizer compressor and aerosol performance testing, with no mention of AI or ML.
Yes
The device is intended to aerosolize medications for inhalation by patients with respiratory disorders, which is a therapeutic purpose.
No
The device is described as a nebulizer compressor system intended to aerosolize medications for inhalation, which is a therapeutic function, not a diagnostic one.
No
The device description explicitly states it is a "standard nebulizer compressor system with an integral compressor and handheld, pneumatic nebulizer," indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "aerosolize medications for inhalation by the patient for respiratory disorders." This is a therapeutic purpose, delivering medication directly to the patient's respiratory system.
- Device Description: The description confirms it's a "nebulizer compressor system" that provides air to a nebulizer to create an aerosol for inhalation.
- IVD Definition: In Vitro Diagnostics (IVDs) 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. This device does not perform any such tests on bodily samples.
The information provided describes a device used for drug delivery, not for diagnostic testing of biological samples.
N/A
Intended Use / Indications for Use
The NE-C801 Nebulizer Compressor System is intended to provide air to the pneumatic nebulizer in order to aerosolize medications for inhalation by the patient for respiratory disorders. The system is designed for use with pediatric (defined by the prescribed medication) and adult patients in the home, hospital, and sub-acute settings.
Product codes
CAF
Device Description
The Omron NE-C801 nebulizer compressor system is a standard nebulizer compressor system with an integral compressor and handheld, pneumatic nebulizer intended for general purpose use. It is powered by standard AC. This is a modification of the NE-C28 cleared under K060811. The modifications to the device do not change the intended use of the predicate device. The modifications to the device do not alter the fundamental scientific technology. As there are no changes in hardware that will impact performance, there is no need to validate the changes through a clinical investigation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Pediatric (defined by the prescribed medication) and adult patients
Intended User / Care Setting
Home, hospital, and sub-acute settings
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)
Performance Testing:
Verification activities, as required by the risk analysis, for the modification were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met. Table 1 summarizes the comparison and Table 2 the testing.
Performance Testing:
We have performed a number of performance tests which are identical to those done with the predicate, K060811. These included:
- IEC 60601-1
- IEC 60601-1-2
- Cascade Impactor particle testing with 3 devices for 3 runs with 3 drugs resulting in a 95% confidence interval
- Compressor testing
- VOC testing per EPA TO-15
- PM2.5 testing per NIOSH NMAM 0600
- Ozone testing per OSHA method ID 214
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Total Delivered Dose (ug)
- Pulmicort - 391.1
- Intal - 12368.9
- Salbutamol - 7883.3
Total delivered Dose fraction (%)
- Pulmicort - 78.2%
- Intal - 61.8%
- Salbutamol - 77.0%
Particle size (MMAD) (Microns)
- Pulmicort - 3.88
- Intal - 2.91
- Salbutamol - 2.54
Geometric Std. Dev. (GSD)
- Pulmicort - 1.93
- Intal - 2.27
- Salbutamol - 2.62
Respirable Fraction (% Mass 0.5-5 microns)
- Pulmicort-61.9%
- Intal - 70.5%
- Salbutamol - 66.4%
Total Respirable Dose (ug 0.5 -5.0 microns)
- Pulmicort - 242.2
- Intal - 8729.5
- Salbutamol - 5335.0
Medication captured on USP Throat (ug)
- Pulmicort - 13.3
- Intal - 253.6
- Salbutamol - 144.9
Medication captured on USP Throat Fraction (%)
- Pulmicort - 3.4%
- Intal - 2.0%
- Salbutamol - 1.8%
Medication retained in Device (ug)
- Pulmicort - 96.1
- Intal - 8000.0
- Salbutamol - 2072.2
Medication Retained in Device Fraction (%)
- Pulmicort - 19.2%
- Intal - 40.0%
- Salbutamol - 41.4%
Coarse Particle (>4.7 um) Fraction (%)
- Pulmicort - 37.1%
- Intal - 27.7%
- Salbutamol - 26.6%
Fine Particle (
§ 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
SEP - 2 2011 510(k) Summary Page 4 of 6 31-Aug-11
KI10860
| Omron Healthcare, Inc. | |
|---|---|
| 1200 Lakeside Drive | Tel - 847-247-5626 |
| Bannockburn, IL 60015 USA | Fax - 847-247-5626 |
| Official Contact: | Mirna DiPano - Director, Quality & Regulatory |
| Proprietary or Trade Name: | NE-C801 Nebulizer Compressor system |
| Common/Usual Name: | Nebulizer (direct patient interface) |
| Classification Name/Code: | CAF |
| Nebulizer (direct patient interface) | |
| CFR 868.5630 | |
| Device: | NE-C801 nebulizer compressor system |
| Modified Device:Omron | - NE-C28 - K060811 |
Device Description:
The Omron NE-C801 nebulizer compressor system is a standard nebulizer compressor system with an integral compressor and handheld, pneumatic nebulizer intended for general purpose use. It is powered by standard AC. This is a modification of the NE-C28 cleared under K060811.
The modifications to the device do not change the intended use of the predicate device. The modifications to the device do not alter the fundamental scientific technology. As there are no changes in hardware that will impact performance, there is no need to validate the changes through a clinical investigation.
Indications for Use:
The NE-C801 Nebulizer Compressor System is intended to provide air to the pneumatic nebulizer in order to aerosolize medications for inhalation by the patient for respiratory disorders. The system is designed for use with pediatric (defined by the prescribed medication) and adult patients in the home, hospital, and sub-acute settings.
Patient Population:
Pediatric (defined by the prescribed medication) and adult patients
Environment of Use:
Home, hospital, and sub-acute settings
Contraindications: None
1
510(k) Summary Page 2 of 6 31-Aug-11
Summary of Modifications:
The modifications to the device do not change the intended use of thepredicate device. The modifications to the device do not alter the fundamental scientific technology. As there are no changes in hardware that will impact performance, there is no need to validate the changes through a clinical investigation.
Modifications:
- . Minor changes to nebulizer design
- Changes to physical dimensions .
- . Change to compressor design to make it smaller and lighter weight
There is no change in intended use, including patient population and environment of use. There is no change in contraindications.
Performance Testing:
Verification activities, as required by the risk analysis, for the modification were performedby the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met. Table 1 summarizes the comparison and Table 2 the testing.
Table 1 - Comparison and Equivalence of Model NE-C801 and the Predicate
| Features | New | Predicate (K060811) |
|---|---|---|
| NE-C801 | NE-C28 | |
| Indications for use | The NE-C801 Nebulizer Compressor | |
| System is intended to provide air to | ||
| the pneumatic nebulizer in order to | ||
| aerosolize medications for inhalation | ||
| by the patient for respiratory | ||
| disorders. | The Omron Compressor Nebulizer Systems | |
| include a compressor and nebulizer, Model | ||
| NE-C28 uses an AC powered compressor. | ||
| The electrically powered compressor provides | ||
| compressed air to the supplied pneumatic | ||
| nebulizer to aerosolize drugs for inhalation by | ||
| the patient. The nebulizer which when | ||
| driven by the integral air compressor, | ||
| nebulizes specific inhalable drugs for | ||
| inhalation by a patient for treatment of | ||
| respiratory disorders such as allergies, asthma, | ||
| cystic fibrous, COPD, etc. | ||
| Environment of Use | Home, Hospital, Sub-acute settings | Same |
| Patient Population | Pediatric (defined by the prescribed | |
| medication) and adult patients | Same - Pediatric and adult | |
| Contraindications | None | None |
| Principle of Operation | Pneumatic (gas powered) jet | |
| nebulizer | Pneumatic (gas powered) jet nebulizer | |
| Aerosolization | Continuous during inhalation and | |
| exhalation | Continuous during inhalation and exhalation | |
| Compressed gas source | Nebulizer compressor | |
| Wall air / oxygen with flow rate | ||
| control | Nebulizer compressor | |
| Wall air / oxygen with flow rate | ||
| control | ||
| Typical flow rate | 8 Ipm | 8 Ipm |
2
510(k) Summary Page 3 of 6
31-Aug-11
| Features | New
NE-C801 | Predicate (K060811)
NE-C28 |
|-----------------------------------------------|---------------------------------------------------------------------------|---------------------------------------------------------------------------|
| Components available in kit
with nebulizer | Mouthpiece / Hose
Face Mask
Oxygen / Delivery tubing
Aerosol tee | Mouthpiece / Hose
Face Mask
Oxygen / Delivery tubing
Aerosol tee |
| Component / Accessories
intended use | All are single patient, multi-use | All are single patient, multi-use |
| Standards met | IEC 60601-1
IEC 60601-1-2 | IEC 60601-1
IEC 60601-1-2 |
| Operating conditions | 10°C to 40°C 30% to 85% RH | 10°C to 40°C 30% to 85% RH |
| Storage conditions | -20°C to 60°C 10% to 95% RH | -20°C to 60°C 10% to 90% RH |
| Dimensions (mm) | 142(W) x 72(D) x 98(H) | 165(W) x 260(D) x 121(H) |
| Weight (kg) | 0.270 kg | 2.5 kg |
| Performance | ||
|---|---|---|
| Materials ISO 10993 | Identical to K060811 | |
| Particle Characterization per Cascade Impactor | ||
| Total Delivered Dose (ug) | ||
| Mean | Pulmicort - 391.1 | Pulmicort - 401.6 |
| Intal - 12368.9 | Intal - 12233.3 | |
| Salbutamol - 7883.3 | Salbutamol - 7972.2 | |
| Total delivered Dose fraction | ||
| (%) | Pulmicort - 78.2% | Pulmicort - 80.3% |
| Intal - 61.8% | Intal - 61.2% | |
| Salbutamol - 77.0% | Salbutamol - 79.7% | |
| Particle size (MMAD) | ||
| (Microns) | Pulmicort - 3.88 | Pulmicort - 3.73 |
| Intal - 2.91 | Intal - 2.71 | |
| Salbutamol - 2.54 | Salbutamol - 2.35 | |
| Geometric Std. Dev. | ||
| (GSD) | Pulmicort - 1.93 | Pulmicort - 2.05 |
| Intal - 2.27 | Intal - 2.29 | |
| Salbutamol - 2.62 | Salbutamol - 2.59 | |
| Respirable Fraction | ||
| (% Mass 0.5-5 microns) | Pulmicort-61.9% | Pulmicort - 62.7% |
| Intal - 70.5% | Intal - 72.8% | |
| Salbutamol - 66.4% | Salbutamol - 69.2% | |
| Total Respirable Dose (ug | ||
| 0.5 -5.0 microns) | Pulmicort - 242.2 | Pulmicort - 251.9 |
| Intal - 8729.5 | Intal - 8894.8 | |
| Salbutamol - 5335.0 | Salbutamol - 5514.4 | |
| Medication captured on USP | ||
| Throat (ug) | Pulmicort - 13.3 | Pulmicort - 14.9 |
| Intal - 253.6 | Intal - 213.4 | |
| Salbutamol - 144.9 | Salbutamol - 141.4 | |
| Medication captured on USP | ||
| Throat Fraction (%) | Pulmicort - 3.4% | Pulmicort - 3.8% |
| Intal - 2.0% | Intal - 1.7% | |
| Salbutamol - 1.8% | Salbutamol - 1.8% | |
| Medication retained in | ||
| Device (ug) | Pulmicort - 96.1 | Pulmicort - 104.4 |
| Intal - 8000.0 | Intal - 7533.3 | |
| Salbutamol - 2072.2 | Salbutamol - 1977.8 | |
| Medication Retained in | ||
| Device Fraction (%) | Pulmicort - 19.2% | Pulmicort - 20.9% |
| Intal - 40.0% | Intal - 37.7% | |
| Salbutamol - 41.4% | Salbutamol - 39.6% |
3
510(k) Summary Page 4 of 6 31-Aug-11
| Features | New
NE-C801 | Predicate (K060811)
NE-C28 |
|------------------------------------------------|--------------------------------------------------------------------------------|--------------------------------------------------------------------------------|
| Particle Characterization per Cascade Impactor | | |
| Coarse Particle (>4.7 um)
Fraction (%) | Pulmicort - 37.1%
Intal - 27.7%
Salbutamol - 26.6% | Pulmicort - 35.3%
Intal - 25.0%
Salbutamol - 24.6% |
| Fine Particle ( induction port throat. Aerosol was sampled directly from the outlet. Three (3) device samples were tested with 3 runs each, for a total of 9 sample points per each drug. Aerosol was sampled directly from the outlet. The following table is a summary of results with intervals given for a 95% confidence level.
| Mean / Std. Dev | Pulmicort
(250 ug/ml) | Intal
(10 mg/ml) | Salbutamol
(5 mg/ml) |
|---------------------------------------------------|--------------------------|---------------------|-------------------------|
| Total delivered Dose (ug) | 391.11
±16.51 | 12368.89
±269.61 | 7883.33
±116.96 |
| Total Delivered Dose Fraction (%) | 78.2%
±3.3% | 61.8%
±3.1% | 77.0%
±2.5% |
| Particle Size (MMAD) um | 3.88
±0.28 | 2.91
±0.14 | 2.54
±0.28 |
| Geometric Standard Deviation | 1.93
±0.20 | 2.27
±0.02 | 2.62
±0.03 |
| Respirable Fraction
(0.5-5 um) | 61.9%
±4.0% | 70.5%
±1.3% | 66.4%
±1.6% |
| Total Respirable Dose
(ug between 0.5-5 um) | 242.17
±18.90 | 8729.49
±497.57 | 5235.02
±233.61 |
| Medication Captured on USP
Throat | 13.34
±3.40 | 253.66
±27.42 | 144.94
±16.32 |
| Medication Captured on USP
Throat Fraction (%) | 3.4%
±0.4% | 2.0%
±0.1% | 1.8%
±0.1% |
| Medication Retained in Device | 96.11
±9.61 | 8000.00
±438.21 | 2072.22
±257.90 |
4
510(k) Summary Page 5 of 6 31-Aug-11
| Mean / Std. Dev | Pulmicort
(250 ug/ml) | Intal
(10 mg/ml) | Salbutamol
(5 mg/ml) |
|-----------------------------------------------|--------------------------|------------------------|-------------------------|
| Medication Retained in Device
Fraction (%) | 19.2%
$\u00b1$ 1.9% | 40%
$\u00b1$ 2.2% | 41.4%
$\u00b1$ 5.2% |
| Mean / Std. Dev | Pulmicort
(250 ug/ml) | Intal
(10 mg/ml) | Salbutamol
(5 mg/ml) |
| Coarse Particle Fraction (%) (>4.7 um) | 37.1%
$\u00b1$ 2.9% | 27.7%
$\u00b1$ 1.5% | 26.6%
$\u00b1$ 2.3% |
| Fine Particle Fraction (%) (