OMRON COMPRESSOR SYSTEMS, MODELS NE-C28,NE-C30

K060811 · Omron Healthcare, Inc. · CAF · May 25, 2006 · Anesthesiology

Device Facts

• Record ID: K060811
• Device Name: OMRON COMPRESSOR SYSTEMS, MODELS NE-C28,NE-C30
• Applicant: Omron Healthcare, Inc.
• Product Code: CAF · Anesthesiology
• Decision Date: May 25, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5630
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Indications for Use

The Omron Compressor Nebulizer Systems include a compressor and nebulizer, Model NE-C28 uses a DC powered compressor and Model NE-C30 can operate with AC/DC power. The electrically powered compressor provides compressed air to the supplied pneumatic nebulizer to aerosolize drugs for inhalation by the patient. The nebulizer is driven by the integral air compressor. The device may be used with pediatric and adult patients in the home, hospital, and sub-acute care settings. It is not intended for use with Pentamidine.

Device Story

Omron Compressor Systems (NE-C28, NE-C30) consist of AC/DC-powered piston-type compressor and handheld venturi-style nebulizer; converts liquid medication into fine aerosol for patient inhalation via mouthpiece or mask. Used in home, hospital, and sub-acute care settings by patients or clinicians. Compressor provides pneumatic drive to nebulizer; no software or electronic control involved. Benefits include portable, reusable drug delivery system for respiratory therapy. NE-C30 includes rechargeable battery for DC operation.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Piston-type pneumatic compressor; venturi-style nebulizer. Materials: Polypropylene. Power: AC (NE-C28/NE-C30) and DC/battery (NE-C30). Standards: IEC 60601-1, IEC 60601-1-2, UL 60601-1, FCC Part 15, ISO 14971. Non-software driven.

Indications for Use

Indicated for pediatric and adult patients requiring aerosolized drug delivery via a pneumatic nebulizer. Not intended for use with Pentamidine.

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-C09 - K914836

Submission Summary (Full Text)

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MAY 2 5 2006

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Premarket Notification 510(k) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Omron

#### 510(k) Summary

### Non-Confidential Summary of Safety and Effectiveness Page 1 of 2 19-May-06

| Omron Healthcare, Inc. | Tel - 847-247-5713 |
|-----------------------------------|----------------------------------------------|
| 1200 Lakeside Dr. | Fax - 847-680-6269 |
| Bannockburn, IL 60015 | |
| <b>Official Contact:</b> | Donna Djinovich - Regulatory Affairs Manager |
| <b>Proprietary or Trade Name:</b> | Omron Compressor Systems |
| <b>Common/Usual Name:</b> | Nebulizer Compressor Systems |
| <b>Classification Name:</b> | Nebulizer (Direct Patient Interface) |
| <b>Device:</b> | Models NE-C28 and NE-C30 |
| <b>Predicate Devices:</b> | Omron - NE-C09 - K914836 |
| <b>Device Description:</b> | |

The Oniron Compressor Systems, model NE-C28 and NE-C30, consist of a nebulizer and AC powered piston-type compressor that's generates compressed air. The Model NE-C30 also includes a rechargeable battery pack and can be connected to DC voltage.

Both units utilize the same handheld nebulizer, which is a venturi type which converts the liquid medication into a fine aerosol which is inhaled by the patient via a mouthpiece of mask. The nebulizers can be cleaned and reused.

| Indications for Use: | |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indicated Use -- | The Omron Compressor Nebulizer Systems include a compressor<br>and nebulizer, Model NE-C28 uses a DC powered compressor<br>and Model NE-C30 can operate with AC/DC power. The<br>electrically powered compressor provides compressed air to the<br>supplied pneumatic nebulizer to aerosolize drugs for inhalation<br>by the patient. |
| | The nebulizer is driven by the integral air compressor. The<br>device may be used with pediatric and adult patients in the home,<br>hospital, and sub-acute care settings. |
| | Not intended for use with Pentamidine. |
| Patient Population -- | Pediatric and adult |

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# Non-Confidential Summary of Safety and Effectiveness

Page 2 of 2 19-May-06

| Environment of Use -- | Home, hospital, and sub-acute care settings. |
|-----------------------|----------------------------------------------|
| Contraindications -- | None |

### Device Attributes:

| Features | NE-C28 | NE-C30 |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|
| Indications for use | The electrically powered compressor provides compressed<br>air to the supplied pneumatic nebulizer to aerosolize drugs<br>for inhalation by the patient.<br><br>The nebulizer is driven by the integral air compressor. | Same |
| Environment of Use | Home, Hospital, Sub-acute Institutions | Same |
| Patient Population | Pediatric and adult | Same |
| Contraindications | None | Same |
| Pneumatic compressor | Yes | Yes |
| Pneumatic nebulizer | Yes | Yes |
| Software driven | No | No |
| Materials in patient<br>contact | Polypropylene | Identical |
| Standard met | IEC 60601-1, IEC 60601-1-2, UL 60601-1, FCC Part 15<br>ISO 14971 | Same |
| Drug delivery rate | 0.35 ml/min | 0.4 ml/min |
| Reservoir size | 7 ml | 7 ml |
| 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 90% RH | Same |
| Dimensions (mm) | 168(W) x 175(D) x 100(H) | 124(W) x 98(D) x<br>51(H) |
| Weight (kg) without<br>battery | 1.7 kg | 0.4 kg |

#### Differences Between Other Legally Marketed Predicate Devices

The Models NE-C28 and NE-C30 are viewed as substantially equivalent to the following predicate device – Omron NE-C09 – K914836.

There are no significant differences that affect the safety or effectiveness of the intended device as compared to the predicate devices.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized eagle with three lines forming its body and wings, symbolizing health, services, and people. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular pattern around the eagle.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

### MAY 2 5 2006

Omron Healthcare, Incorporated C/O Mr. Paul Dryden President ProMedic, Incorporated 6329 West Waterview Court Mccordsville, Indiana 46055-9501

Re: K060811

Trade/Device Name: Omron Compressor Systems, Models NE-C28 and NE-C30 Regulation Number: 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF Dated: March 23, 2006 Received: March 24 2006

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits vour device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/industry/support/index.html.

Sincerely yours,

Chiu Lin, Ph.D.

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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Premarket Notification 510(k) - Response to e-mail of 5-May-06

# Indications for Use Statement

K060811 510(k) Number:

Models NE-C28 and NE-C30 Device Name:

The Omron Compressor Nebulizer Systems include a Indications for Use: compressor and nebulizer, Model NE-C28 uses a DC powered compressor and Model NE-C30 can operate with AC/DC power. The electrically powered compressor provides compressed air to the supplied pneumatic nebulizer to aerosolize drugs for inhalation by the patient.

> The nebulizer is driven by the integral air compressor. The device may be used with pediatric and adult patients in the home, hospital, and sub-acute care settings.

It is not intended for use with Pentamidine.

Prescription Use XX (Part 21 CFR 801 Subpart D) or

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

ﺒﺪﺃ

Omron

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Auy Sulson

ology, General Hospital,
Contact, Lerial Devices
K060811