AERONEB PROFESSIONAL NEBULIZER SYSTEM, MODEL#AG-AP6000

K021175 · Aerogen, Inc. · CAF · May 15, 2002 · Anesthesiology

Device Facts

• Record ID: K021175
• Device Name: AERONEB PROFESSIONAL NEBULIZER SYSTEM, MODEL#AG-AP6000
• Applicant: Aerogen, Inc.
• Product Code: CAF · Anesthesiology
• Decision Date: May 15, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5630
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric, 3rd-Party Reviewed

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 and other positive pressure breathing assistance. The Aeroneb Pro is suitable for use in adult and pediatric patients as described in the Instruction Manual.

Device Story

Aeroneb Professional Nebulizer System; multiple-patient reusable pulmonary drug delivery device. Uses proprietary aerosol generator technology to convert liquid medication into aerosol for inhalation. Operates without compressed gas; powered by AC/DC adapter or internal rechargeable battery. Integrates into inspiratory limb of ventilator circuits or used with mask/mouthpiece for spontaneously breathing patients. Allows refilling without interrupting ventilation; does not alter ventilatory parameters. Suitable for clinical settings and patient transport. Healthcare providers administer medication via device; output allows targeted pulmonary drug delivery. Benefits include continuous nebulization, portability, and compatibility with existing respiratory support equipment.

Clinical Evidence

Bench testing only. Performance evaluations included nebulizer delivery characterization, electrical, mechanical, and EMC safety testing based on FDA CDRH Reviewer Guidance for Nebulizers, Metered Dose Inhalers, Spacers and Actuators (1993).

Technological Characteristics

Multiple-patient reusable nebulizer; aerosol generator technology. Powered by AC/DC adapter or internal rechargeable battery. Compatible with mechanical ventilators and positive pressure breathing systems. Autoclavable. No compressed gas required.

Indications for Use

Indicated for adult and pediatric patients requiring aerosolized physician-prescribed solutions for inhalation, including patients on mechanical ventilation or other 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.

Predicate Devices

• Aeroneb® Portable Nebulizer System (K970010/ K003022)
• Siemens Servo Ultra Nebulizer (SUN), Models 354 and 145 (K960854)

Submission Summary (Full Text)

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Section 2 Aeroneb® Professional Nebulizer System 510(k) Premarket Notification

# SMDA 510(k) Summary of Safety and Effectiveness

(1) Submitter's name / Contact person:

Aerogen Inc. 1310 Orleans Drive Sunnyvale, CA 94089

Contact person:

Traci V. A. Edwards Senior Director, Quality Assurance & Regulatory Affairs Tel .: [phone] Fax: [phone]

Date prepared:

March 2002

(2) Name of device:

Trade name:

Common name: Classification name: Aeroneb® Professional Nebulizer System (Aeroneb Pro) Nebulizer Nebulizer, 21 CFR §868.5630

(3) Identification of predicate device:

| Manufacturer | Device | 510(k) Number |
|------------------|------------------------------------------------------------|------------------|
| Aerogen Inc. | Aeroneb® Portable Nebulizer System | K970010/ K003022 |
| Siemens-Elena AB | Siemens Servo Ultra Nebulizer (SUN),<br>Models 354 and 145 | K960854 |

#### (4) Description of the device:

The Aeroneb® Professional Nebulizer System is a multiple patient reusable pulmonary drug delivery system that incorporates Aerogen's proprietary aerosol generator technology for continuous nebulization of drugs to patients. The Aeroneb Pro is designed to be used with mechanical ventilators and pressurized breathing systems as well as by spontaneously breathing patients. It is intended for multiple patient use and is autoclavable. The nebulizer can be placed in the inspiratory limb of a ventilator circuit or used with a mask or mouthpiece. The Aeroneb Pro operates without changing patient ventilatory parameters, can be refilled without interrupting ventilation, and can be powered by AC/DC adapter or internal rechargeable battery. Because the Aeroneb Pro operates without compressed gas and can be battery-powered, it is also suitable for use during patient transport.

## (5) A statement of the intended use of the device:

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 and other positive pressure

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breathing assistance. The Aeroneb Pro is suitable for use in adult and pediatric patients as described in the Instruction Manual.

### (6) Predicate device comparison:

The Aeroneb Pro is substantially equivalent to similar features in the predicate devices and has the same intended use and technological characteristics as the predicate devices.

Non-clinical performance tests were conducted comparing Aeroneb Pro to the Aeroneb Portable Nebulizer System and SUN 145.

#### (7) Performance evaluations

Evaluation of performance included nebulizer delivery characterization, electrical, mechanical, and EMC safety, were based on those suggested in the FDA CDRH - REVIEWER GUIDANCE FOR NEBULIZERS, METERED DOSE INHALERS, SPACERS AND ACTUATORS issued on: October 1, 1993.

The successful tests demonstrated the device consistently performed within its design parameters, is as safe and effective, and performs as well as, or better than, the predicate devices.

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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle with three heads.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 5 2002

Aerogen, Inc. c/o Mr. Mark Job TUV America, Inc. 1775 Old Highway 8 New Brighton, MN 55112-1891

Re: K021175

Aeroneb® Professional Nebulizer System Regulation Number: 868.5630 Regulation Name: Nebulizer (Direct Patient Interface) Regulatory Class: II (two) Product Code: 73 CAF Dated: April 29, 2002 Received: April 30, 2002

Dear Mr. Job:

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. Mark Job

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours,

R. Tell

Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Section 1 Aerogen Aeroneb® Professional Nebulizer System 510(k) Premarket Notification

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

# Device Name: Aeroneb® Professional Nebulizer System

Indications for Use:

The Aeroneb® Professional Nebulizer System is a portable medical device for multiple p The Aeroned "Professional Nebalizer "System".o a prescribed solutions for inhalation to
patient use that is intended to aerosolize physician-prescribed solutions on The patient use that is mended to acrooolize prifer positive pressure breathing assistance. The patients on and on ventuation of other on adult and perficants and peditable patients as described in the Instruction Manual.

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

Cardiova iratory Des (k) Number

Prescription Use_ (Per 21 CFR 801.109) OR

Over the Counter Use_

Optional Format 1-2-96)

SK25 AN
II

0/300/нчор.

CONFIDENTIAL