COMP A-I-R

K110860 · Omron Healthcare, Inc. · CAF · Sep 2, 2011 · Anesthesiology

Device Facts

• Record ID: K110860
• Device Name: COMP A-I-R
• Applicant: Omron Healthcare, Inc.
• Product Code: CAF · Anesthesiology
• Decision Date: Sep 2, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5630
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended 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.

Device Story

The NE-C801 is a pneumatic (gas-powered) jet nebulizer compressor system. It uses an AC-powered compressor to provide compressed air to a handheld pneumatic nebulizer, which aerosolizes liquid medications for patient inhalation. The device is intended for use in home, hospital, and sub-acute settings by pediatric and adult patients. The system includes a compressor, nebulizer, mouthpiece/hose, face mask, oxygen/delivery tubing, and aerosol tee. The device operates by continuous nebulization during both inhalation and exhalation. Healthcare providers prescribe the medication, and patients use the device to deliver the treatment for respiratory conditions. The device is a smaller, lighter-weight modification of the predicate NE-C28.

Clinical Evidence

Bench testing only. Performance was verified through cascade impactor testing using three drugs (Pulmicort, Intal, Salbutamol) across three device samples with three runs each, achieving a 95% confidence level. Additional testing included compressor performance (VOC, PM2.5, Ozone) and electrical safety (IEC 60601-1, IEC 60601-1-2). No clinical investigation was required as hardware modifications did not alter fundamental scientific technology or performance.

Technological Characteristics

Pneumatic (gas-powered) jet nebulizer system. Powered by AC. Dimensions: 142(W) x 72(D) x 98(H) mm; Weight: 0.270 kg. Flow rate: 8 lpm. Materials in gas/fluid pathway identical to K060811. Standards met: IEC 60601-1, IEC 60601-1-2. Operating conditions: 10°C to 40°C, 30% to 85% RH.

Indications for Use

Indicated for pediatric and adult patients requiring aerosolized medication for respiratory disorders. No contraindications.

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

• NE-C28 (K060811)

Submission Summary (Full Text)

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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<br>Nebulizer (direct patient interface)<br>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

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# 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<br>System is intended to provide air to<br>the pneumatic nebulizer in order to<br>aerosolize medications for inhalation<br>by the patient for respiratory<br>disorders. | The Omron Compressor Nebulizer Systems<br>include a compressor and nebulizer, Model<br>NE-C28 uses an AC powered compressor.<br>The electrically powered compressor provides<br>compressed air to the supplied pneumatic<br>nebulizer to aerosolize drugs for inhalation by<br>the patient. The nebulizer which when<br>driven by the integral air compressor,<br>nebulizes specific inhalable drugs for<br>inhalation by a patient for treatment of<br>respiratory disorders such as allergies, asthma,<br>cystic fibrous, COPD, etc. |
| Environment of Use | Home, Hospital, Sub-acute settings | Same |
| Patient Population | Pediatric (defined by the prescribed<br>medication) and adult patients | Same - Pediatric and adult |
| Contraindications | None | None |
| Principle of Operation | Pneumatic (gas powered) jet<br>nebulizer | Pneumatic (gas powered) jet nebulizer |
| Aerosolization | Continuous during inhalation and<br>exhalation | Continuous during inhalation and exhalation |
| Compressed gas source | Nebulizer compressor<br>Wall air / oxygen with flow rate<br>control | Nebulizer compressor<br>Wall air / oxygen with flow rate<br>control |
| Typical flow rate | 8 Ipm | 8 Ipm |

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# 510(k) Summary Page 3 of 6
31-Aug-11

| Features | New<br>NE-C801 | Predicate (K060811)<br>NE-C28 |
|-----------------------------------------------|---------------------------------------------------------------------------|---------------------------------------------------------------------------|
| Components available in kit<br>with nebulizer | Mouthpiece / Hose<br>Face Mask<br>Oxygen / Delivery tubing<br>Aerosol tee | Mouthpiece / Hose<br>Face Mask<br>Oxygen / Delivery tubing<br>Aerosol tee |
| Component / Accessories<br>intended use | All are single patient, multi-use | All are single patient, multi-use |
| Standards met | IEC 60601-1<br>IEC 60601-1-2 | IEC 60601-1<br>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% |

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# 510(k) Summary Page 4 of 6 31-Aug-11

| Features | New<br>NE-C801 | Predicate (K060811)<br>NE-C28 |
|------------------------------------------------|--------------------------------------------------------------------------------|--------------------------------------------------------------------------------|
| Particle Characterization per Cascade Impactor | | |
| Coarse Particle (>4.7 um)<br>Fraction (%) | Pulmicort - 37.1%<br>Intal - 27.7%<br>Salbutamol - 26.6% | Pulmicort - 35.3%<br>Intal - 25.0%<br>Salbutamol - 24.6% |
| Fine Particle (<4.7 um)<br>Fraction (%) | Pulmicort - 59.6%<br>Intal - 70.2%<br>Salbutamol - 71.6% | Pulmicort - 60.9%<br>Intal - 73.2%<br>Salbutamol - 73.7% |
| Ultra Fine Particle (um)<br>Fraction (%) | Pulmicort - 3.5%<br>Intal - 8.9%<br>Salbutamol - 16.9% | Pulmicort - 5.4%<br>Intal - 9.4%<br>Salbutamol - 0.19% |
| Nebulization rate (g/ml) | Pulmicort - 0.37<br>Intal - 0.30<br>Salbutamol - 0.37 | Pulmicort - 0.44<br>Intal - 0.35<br>Salbutamol - 0.41 |
| Confidence level of testing | The test and number of samples (3) with 3 runs provided a 95% confidence level | The test and number of samples (3) with 3 runs provided a 95% confidence level |

# Table 2 - Particle Characterization results at 95% confidence

A series of aerosol performance tests were performed using an 8 stage cascade impactor at a sampling flow rate of 15 I/min equipped with a USP <601> 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<br>(250 ug/ml) | Intal<br>(10 mg/ml) | Salbutamol<br>(5 mg/ml) |
|---------------------------------------------------|--------------------------|---------------------|-------------------------|
| Total delivered Dose (ug) | 391.11<br>±16.51 | 12368.89<br>±269.61 | 7883.33<br>±116.96 |
| Total Delivered Dose Fraction (%) | 78.2%<br>±3.3% | 61.8%<br>±3.1% | 77.0%<br>±2.5% |
| Particle Size (MMAD) um | 3.88<br>±0.28 | 2.91<br>±0.14 | 2.54<br>±0.28 |
| Geometric Standard Deviation | 1.93<br>±0.20 | 2.27<br>±0.02 | 2.62<br>±0.03 |
| Respirable Fraction<br>(0.5-5 um) | 61.9%<br>±4.0% | 70.5%<br>±1.3% | 66.4%<br>±1.6% |
| Total Respirable Dose<br>(ug between 0.5-5 um) | 242.17<br>±18.90 | 8729.49<br>±497.57 | 5235.02<br>±233.61 |
| Medication Captured on USP<br>Throat | 13.34<br>±3.40 | 253.66<br>±27.42 | 144.94<br>±16.32 |
| Medication Captured on USP<br>Throat Fraction (%) | 3.4%<br>±0.4% | 2.0%<br>±0.1% | 1.8%<br>±0.1% |
| Medication Retained in Device | 96.11<br>±9.61 | 8000.00<br>±438.21 | 2072.22<br>±257.90 |

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# 510(k) Summary Page 5 of 6 31-Aug-11

| Mean / Std. Dev | Pulmicort<br>(250 ug/ml) | Intal<br>(10 mg/ml) | Salbutamol<br>(5 mg/ml) |
|-----------------------------------------------|--------------------------|------------------------|-------------------------|
| Medication Retained in Device<br>Fraction (%) | 19.2%<br>$\u00b1$ 1.9% | 40%<br>$\u00b1$ 2.2% | 41.4%<br>$\u00b1$ 5.2% |
| Mean / Std. Dev | Pulmicort<br>(250 ug/ml) | Intal<br>(10 mg/ml) | Salbutamol<br>(5 mg/ml) |
| Coarse Particle Fraction (%) (>4.7 um) | 37.1%<br>$\u00b1$ 2.9% | 27.7%<br>$\u00b1$ 1.5% | 26.6%<br>$\u00b1$ 2.3% |
| Fine Particle Fraction (%) (<4.7 um) | 59.6%<br>$\u00b1$ 3.5% | 70.2%<br>$\u00b1$ 1.5% | 71.6%<br>$\u00b1$ 2.3% |
| Ultra-Fine Particle Fraction &<br>(<1.0 um) | 3.5%<br>$\u00b1$ 1.7% | 8.9%<br>$\u00b1$ 2.1% | 16.9%<br>$\u00b1$ 5.3% |

The differences between the proposed device and the predicates are:

- . Size
- . Slight modification to nebulizer

It is our view that these are not significant differences that affect the safety or effectiveness of the intended device as compared to the predicate device.

### Substantial Equivalence:

The NE-C801 is viewed as substantially equivalent to the predicate device because:

#### Indications for Use:

The Indications for Use are as a general purpose nebulizer and compressor system which is identical to predicate - K060811

#### Patient Population:

The patient population is pediatric and adult which is identical to predicate - K060811. The pediatric population was defined based upon the limits of the prescribed medication.

#### Environment of Use:

The environment of use is - home, hospital and sub-acute care settings which is identical to predicate -K060811

#### Technology:

The technology of the compressor is identical compressor technology to predicate- K060811

The technology of the pneumatic (jet-style) continuous flow nebulization is identical nebulizer technology to predicate - K060811

#### Materials:

The materials in the gas and fluid pathway are identical to predicate- K060811.

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# 510(k) Summary Page 6 of 6 31-Aug-11

# 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 o
- o PM2.5 testing per NIOSH NMAM 0600
- Ozone testing per OSHA method ID 214 O

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Image /page/6/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The department's name is written in a circular pattern around the symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Omron Healthcare. Incorporated C/O Mr. Paul Dryden President ProMedic, Incorporated 24301 Woodsage Drive Bonita Springs. Florida 34134

EP - 2 2001

Re: K110860

Trade/Device Name: NE-C801 Nebulizer Compressor System Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF Dated: July 12, 2011 Received: July 13, 2011

Dear Mr. Dryden:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class IH (PMA), it may be subject to additional controls. Existing major regulations affecting vour device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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## Page 2 – Mr. Dryden

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Anthony D. Watson

Anthony D. Watson. B.S.. M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

## Enclosure

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# Indications for Use Statement

Page 1 of 1

K110860 510(k) Number:

Device Name:

NE-C801 nebulizer compressor system

Indications for Use:

The NE-C801 Nebulizer Ciompressor System is intended to provide air to the pneumatic nebulizer in order to aerosolize medications for inhalation by the patient for respiratory The system is designed for use with pediatric (defined by the prescribed disorders. medication) and adult patients in the home, hospital, and sub-acute settings.

Prescription Use XX (Part 21 CFR 801 Subpart D)

or

Over-the-counter use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

L. Shult

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K110860