AERONEB PROFESSIONAL NEBULIZER SYSTEM

K070642 · Aerogen (Ireland), Ltd. · CAF · May 7, 2007 · Anesthesiology

Device Facts

• Record ID: K070642
• Device Name: AERONEB PROFESSIONAL NEBULIZER SYSTEM
• Applicant: Aerogen (Ireland), Ltd.
• Product Code: CAF · Anesthesiology
• Decision Date: May 7, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.5630
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Aeroneb® Professional Nebulizer System is a portable medical device for multiple patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off ventilation or other positive pressure breathing assistance. The Aeroneb® Professional Nebulizer System is suitable for use in adult and pediatric patients as described in the Instruction Manual.

Device Story

Aeroneb Professional Nebulizer System is a portable, multi-patient device designed to aerosolize liquid medications for inhalation. It operates by converting physician-prescribed solutions into a fine mist for delivery to patients, including those receiving mechanical ventilation or positive pressure breathing support. Used in clinical settings, the device is operated by healthcare professionals. It functions as an accessory to breathing circuits or as a standalone delivery system. By enabling efficient aerosolization of prescribed drugs, it facilitates respiratory therapy for patients with various pulmonary conditions. The system is designed for reuse across multiple patients, adhering to clinical hygiene protocols.

Clinical Evidence

No clinical data provided; substantial equivalence based on bench testing and technological comparison.

Technological Characteristics

Portable nebulizer system for multi-patient use. Designed for integration with ventilation and positive pressure breathing circuits. Operates via electronic aerosolization technology. Class II device under 21 CFR 868.5630 (Product Code: CAF).

Indications for Use

Indicated for adult and pediatric patients requiring aerosolized physician-prescribed inhalation solutions, including those on or off ventilation or positive pressure breathing assistance.

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.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Frank Enright Quality Assurance/Regulatory Affairs Manager Aerogen (Ireland) Limited Galway Business Park Dangan, Galway IRELAND

MAY - 7 2007

Re: K070642

Trade/Device Name: Aeroneb® Professional Nebulizer System Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF Dated: April 6, 2007 Received: April 9, 2007

Dear Mr. Enright:

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. Enright

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 your 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.

Clive Liu, Ph.D.

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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## INDICATIONS FOR USE STATEMENT

510(K) Number (if known): K070642

Device Name: Aeroneb® Professional Nebulizer System

Indications for Use:

The Aeroneb® Professional Nebulizer System is a portable medical device for multiple patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off ventilation or other positive pressure breathing assistance. The Aeroneb® Professional Nebulizer System is suitable for use in adult and pediatric patients as described in the Instruction Manual.

Prescription Use X (Part 21 CFR 801 Subpart D)

Over the Counter Use

(21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

OR

Chletto

of Anesthesiology, General Hospital, on Control, Dental Device

*K) Number: K070642