COMP A-I-R

K141140 · Omron Healthcare, Inc. · CAF · Sep 30, 2014 · Anesthesiology

Device Facts

• Record ID: K141140
• Device Name: COMP A-I-R
• Applicant: Omron Healthcare, Inc.
• Product Code: CAF · Anesthesiology
• Decision Date: Sep 30, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5630
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The NE-C802 Compressor Nebulizer 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 (3 year old and greater) and adult patients in the home, hospital, and sub-acute settings.

Device Story

The NE-C802 is a compressor-driven pneumatic nebulizer system for aerosolizing medications for inhalation. It consists of an AC-powered compressor unit and a handheld nebulizer. The device is operated by patients or caregivers in home, hospital, or sub-acute settings. The compressor generates airflow to the pneumatic nebulizer, which converts liquid medication into an aerosol mist for patient inhalation via a mouthpiece or mask. The device is a modification of the NE-C801 (K110860), featuring a smaller, lighter compressor design and minor nebulizer component changes to improve airflow efficiency. The output is an aerosolized medication mist; healthcare providers use this to deliver respiratory treatments. The device benefits patients by providing a portable, effective means of administering inhaled medications for respiratory conditions.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing, including aerosol performance characterization (cascade impactor testing with Pulmicort, Intal, and Salbutamol), electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), and compressor output testing (VOC, CO, CO2, ozone, and PM2.5).

Technological Characteristics

Pneumatic compressor nebulizer system. Materials: Polypropylene and PVC. Power: AC. Dimensions: 85mm x 43mm x 115mm. Weight: 190g. Standards: IEC 60601-1:2005, IEC 60601-1-2:2007, IEC 60601-1-11:2007, IEC 62366:2007, ISO 10993-1:2009, ISO 10993-5:2009, ISO 10993-10:2010. Non-software driven.

Indications for Use

Indicated for pediatric (3 years and older) and adult patients with respiratory disorders requiring aerosolized medication inhalation. 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

• Omron NE-C801 (K110860)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the United States Department of Health and Human Services. The logo features a stylized image of a human face in profile, with three overlapping profiles suggesting a sense of community and support. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.

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

September 30, 2014

Omron Healthcare, Incorporated C/O Mr. Paul Dryden ProMedic. Incorporated 24301 Woodsage Drive Bonita Springs, FL 34134-2958

Re: K141140

Trade/Device Name: Omron Compressor Nebulizer Systems -NE-C802 Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: Class II Product Code: CAF Dated: August 28, 2014 Received: August 29, 2014

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 III (PMA), it may be subject to additional controls. Existing major regulations affecting your 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.

{1}------------------------------------------------

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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

*Tejashri Purohit-Sheth, M.D.*

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known) K141140

Device Name NE-C802

### Indications for Use (Describe)

The NE-C802 Compressor Nebulizer System is intended to provide ar 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 (3 year old and greater) and adult patients in the home, hospital, and sub-acute settings.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

# PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

{3}------------------------------------------------

| 510(k) Summary |
|----------------|
| Page 1 of 6 |
| 30-Apr-14 |

| Omron Healthcare, Inc. | |
|----------------------------|--------------------------------------------------------------------|
| 1200 Lakeside Drive | Tel – 847-247-5626 |
| Bannockburn, IL 60015 USA | Fax – 847-680-6269 |
| Official Contact: | Renee Thornborough – Director, Quality & Regulatory |
| Proprietary or Trade Name: | NE-C802 |
| Common/Usual Name: | Nebulizer (direct patient interface) |
| Classification Name/Code: | CAF, Class 2, Nebulizer (direct patient interface)<br>CFR 870.1130 |
| Device: | NE-C802 |
| Modified Device: | Omron – NE-C801 – K110860 |

### Device Description:

The Omron Model NE-C802 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-C801 cleared under K110860.

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-C802 Compressor Nebulizer 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 (3 year old and greater) and adult patients in the home, hospital, and sub-acute settings.

### Contraindications:

None

### Summary of Modifications:

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.

### Modifications:

- Minor changes to nebulizer design
- Changes to physical dimensions ●
- Change to compressor design to make it smaller and lighter weight ●

{4}------------------------------------------------

# 510(k) Summary Page 2 of 6 30-Apr-14

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 performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met. Table 5.1 summarizes the difference, Table 5.2 equivalence comparison, and Table 5.3 the testing.

## Table 5.1 - Description of the modifications of the New Model NE-C802 vs. the Predicate

| Features | New model<br>NE-C802 | Predicate (K110860)<br>NE-C801 |
|---------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|
| Compressor | Roller – 3 valves | Roller - 4 valves |
| Power | DC 6V | DC 12V |
| Operating pressure and flow from compressor | < 52 Kpa<br>> 1.2 lpm | < 54 Kpa<br>> 2.54 lpm |
| Nebulizer design | Design change to some nebulizer<br>components to improve air flow<br>but still pneumatic and principle of<br>operation is the same | |
| Delivery rate | 0.25 ml / min | 0.3 ml / min |
| Particle size (MMAD) in um | @ 15L/min<br>Pulmicort - 4.43 $\mu$ m<br>Intal – 3.78 $\mu$ m<br>Salbutamol - 3.25 $\mu$ m | @ 15L/min<br>Pulmicort - 4.89 $\mu$ m<br>Intal – 3.33 $\mu$ m<br>Salbutamol - 3.38 $\mu$ m |
| | @ 32L/min<br>Pulmicort – 4.08 $\mu$ m<br>Intal - 3.37 $\mu$ m<br>Salbutamol – 2.94 $\mu$ m | @ 32L/min<br>Pulmicort - 4.37 $\mu$ m<br>Intal - 2.79 $\mu$ m<br>Salbutamol - 2.72 $\mu$ m |
| | Non-significance of Variance and mean difference (p value) | |
| Dimensions (mm) | 85mm (W) x 43mm (H) x 115mm (D) | 142 mm (W) x 98 mm (H) x 72 mm (D) |
| Weight (kg) without battery | 190 gm | 270 gm |
| Reservoir size | 10 ml | 7 ml |

{5}------------------------------------------------

# 510(k) Summary Page 3 of 6 30-Apr-14

| Features | New | Predicate (K110860) |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | NE-C802 | NE-C801 |
| Indications for use | The NE-C802 Compressor Nebulizer<br>System is intended to provide air to the<br>pneumatic nebulizer in order to aerosolize<br>medications for inhalation by the patient<br>for respiratory disorders. | The NE-C801 Compressor Nebulizer<br>System is intended to provide air to the<br>pneumatic nebulizer in order to aerosolize<br>medications for inhalation by the patient<br>for respiratory disorders. |
| Environment of Use | Home, Hospital, Sub-acute Institutions | Same |
| Patient Population | Pediatric (3 years and older) to adult | Pediatric and adult |
| Contraindications | None | None |
| Pneumatic compressor | Yes | Yes |
| Pneumatic nebulizer | Yes | Yes |
| Software driven | No | No |
| Materials in patient<br>contact | Polypropylene and PVC | ABS, Polypropylene and PVC |
| Patient Interface | Mouthpiece or mask | Mouthpiece or mask |
| Standards met | IEC 60601-1:2005 | IEC60601-1:1988 +A1:1991+A2:1995 |
| | IEC 60601-1-2:2007 | IEC60601-1-2:2007 |
| | IEC 60601-1-11:2007 | |
| | IEC 62366:2007 | ISO10993-1:2009 |
| | ISO10993-1:2009 | ISO10993-5:2009 |
| | ISO10993-5:2009 | ISO10993-10:2009 |
| | ISO10993-10:2010 | |
| Nebulizer components<br>cleanable | Yes | Yes |
| Operating conditions | 10°C to 40°C 30% to 85% RH | Same |
| Storage conditions | -20°C to 60°C 10% to 95% RH | Same |
| Power Source | AC | AC |

# Table 5.2 - Comparison and Equivalence of New Model NE-C802 and the Predicate

The differences between the proposed device and the predicates are:

- Physical size
- A 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.

# Table 5.3 - Particle Characterization results

A series of aerosol performance tests were performed using an 8 stage cascade impactor at a sampling flow rate of 15 1/min equipped with a USP <601> induction port throat. Aerosol was sampled directly from the outlet. A summary of results is listed below with intervals given for a 99% confidence level.

{6}------------------------------------------------

# Premarket Notification 510()
Section 5

| 310(k) Summary<br>Page 4 of 6<br>30-Apr-14 | | | | | | |
|------------------------------------------------|------------------------|-------------------|-----------------------|------------------------------------|-------------------|-----------------------|
| Characteristic | Device NE-C802 (NEW) | | | Predicate Device - NE-C801 K110860 | | |
| | Pulmicort<br>250 ug.ml | Intal<br>10 mg/ml | Salbutamol<br>5 mg/ml | Pulmicort<br>250 ug.ml | Intal<br>10 mg/ml | Salbutamol<br>5 mg/ml |
| MMAD (um)<br>5 lpm | 4.89 | 3.33 | 3.38 | 4.43 | 3.78 | 3.25 |
| 2 lpm | 4.37 | 3.79 | 2.72 | 4.08 | 3.37 | 2.94 |
| GSD<br>5 lpm | 2.4 | 2.8 | 2.9 | 2.2 | 2.4 | 2.7 |
| 2 lpm | 2.55 | 3.2 | 3.4 | 2.32 | 2.7 | 2.89 |
| Total Delivered Dose (ug)<br>5 lpm | 385 | 12993 | 7483 | 395 | 13567 | 7650 |
| 2 lpm | 392 | 12992 | 7494 | 378 | 12533 | 7716 |
| Total Delivered Dose Fraction (%)<br>5 lpm | 76% | 65% | 74% | 80% | 69% | 78% |
| 2 lpm | 78% | 65% | 75% | 81% | 64% | 79% |
| Respirable Fraction (0.5-5 um) (%)<br>5 lpm | 50% | 60% | 56% | 55% | 59% | 59% |
| 2 lpm | 54% | 64% | 57% | 58% | 62% | 60% |
| Total Respirable Dose (0.5-5 um) (ug)<br>5 lpm | 1.93 | 78.27 | 41.63 | 2.17 | 80.13 | 44.9 |
| 2 lpm | 2.12 | 82.4 | 43.03 | 2.39 | 77.86 | 46.24 |

510(k) Summar

ummary of result

NF-C802 was found to be substantially equivalent on all performance areas except as noted below. These differences are in GSD and Ultr
particle fraction. Neither of which

statistical analysis was done with a 99% confidence inter

{7}------------------------------------------------

# 510(k) Summary Page 5 of 6 30-Apr-14

The Model NE-C802 is viewed as substantially equivalent to the predicate device because:

### Indications -

The Indications for Use are as a general purpose nebulizer and compressor system which is identical to predicate - Omron NE-C801 (K110860).

Discussion - We have not changed the indications for use statement, only defined the pediatric population to 3 years and older, which has been a recent FDA request.

### Technology -

The technology of the compressor is identical compressor technology to predicate - Omron NE-C801 (K110860). The technology of the pneumatic nebulization is identical nebulizer technology to predicate – Omron NE-C801 (K110860).

Discussion - The modifications to compressor, smaller and lighter weight has not changed the technology. As to the nebulizer changes, this is still a pneumatic nebulizer to aerosolize medications. The changes have been for simplification and efficiency of performance. The particle characterization performance demonstrates that the 2 devices perform substantially equivalent.

### Materials -

The materials in the gas and fluid pathway are identical to predicate device, Omron NE-C801 (K110860).

Discussion - The materials are identical to our own predicate device are have the identical patient contact, exposure, and duration of use. The use of these materials has been determined to be safe by FDA under previous submission reviews.

# Environment of Use -

The environment of use is - home, hospital and sub-acute care settings which are identical to predicate - Omron NE-C801 (K110860).

Discussion - There have been no changes in the environment of use and thus the proposed device can be found substantially equivalent to the predicate.

# Patient Population -

The patient population is pediatric and adult which is identical to predicate - NE-C801 (K110860).

Discussion - We have not changed the patient population, but as requested by FDA, there are subsets of "pediatric" populations and we have added clarification of this in our indications for use. It is common practice that nebulizers may be used with patients that are 3 years and old, or can follow verbal instructions. Our added language does not alter the indications for use, but only to supports FDA's request for clarification of "pediatrics" population.

# Non-clinical Testing -

We have performed a number of performance tests which are identical to those done with the predicate, Omron NE-C801 (K110860). These included:

- IEC 60601-1 ●
- IEC 60601-1-2

{8}------------------------------------------------

# 510(k) Summary Page 6 of 6 30-Apr-14

- Cascade Impactor particle characterization testing with 3 devices for 3 runs with 3 drugs o
- Compressor testing
- VOC testing per EPA TO-15 o
- CO, CO2 testing EPA Part 60 o
- o Ozone testing per OSHA method ID 214
- PM25 testing per NIOSH NMAM 0600 O
- Cleaning
- Simulated life and age testing
- Mechanical testing ●

Discussion – The non-clinical testing demonstrated that the performance of the proposed device was equivalent to the predicate Omron NE-C801 (K110860).

# Clinical Testing -

There was no clinical testing performed.

### Substantial Equivalence Conclusion -

The proposed device has been found to be substantially equivalent to the predicate. Differences between the proposed device and the predicate do not raise new questions of safety or efficacy.