AERONEB GO NEBULIZER, MODEL AG-AG2000

K032849 · Aerogen, Inc. · CAF · Nov 21, 2003 · Anesthesiology

Device Facts

• Record ID: K032849
• Device Name: AERONEB GO NEBULIZER, MODEL AG-AG2000
• Applicant: Aerogen, Inc.
• Product Code: CAF · Anesthesiology
• Decision Date: Nov 21, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5630
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric, 3rd-Party Reviewed

Intended Use

The Aeroneb Go nebulizer, for use by pediatric and adult patients, is intended to aerosolize physician-prescribed solutions for inhalation that are approved for use with a general-purpose nebulizer.

Device Story

The Aeroneb Go is a portable, silent, lightweight nebulizer for pediatric and adult patients. It utilizes the OnQ Aerosol Generator, consisting of a dome-shaped aperture plate with over 1,000 precision-formed tapered holes and a vibrational element. Upon activation, the plate vibrates at approximately 100,000 Hz, acting as a micropump to draw liquid through the apertures and generate consistently sized aerosol droplets for inhalation. The device is powered by an AC controller or a battery-powered controller using three AA batteries. It is intended for use with physician-prescribed solutions approved for general-purpose nebulizers. The device provides a portable delivery method for respiratory medications, potentially improving patient compliance and ease of use compared to traditional stationary nebulizers.

Clinical Evidence

No clinical data. Substantial equivalence was established through non-clinical performance testing, including nebulizer delivery characterization, electrical, mechanical, and EMC safety evaluations conducted in accordance with the FDA CDRH Reviewer Guidance for Nebulizers, Metered Dose Inhalers, Spacers and Actuators (1993).

Technological Characteristics

OnQ Aerosol Generator technology; dome-shaped aperture plate with >1,000 tapered holes; vibrational element operating at ~100,000 Hz; powered by AC controller or 3 AA batteries; lightweight, compact, silent form factor; non-clinical safety testing per FDA 1993 guidance.

Indications for Use

Indicated for pediatric and adult patients requiring aerosolized physician-prescribed inhalation solutions approved for general-purpose nebulizers.

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)
• Pari LC Star™ Reusable Nebulizer (K963924)
• Omron MicroAir® Portable Ultrasonic Nebulizer (K923024)

Submission Summary (Full Text)

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NOV 2 1 2003

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## SMDA Non-confidential 510(k) Summary

K032849

(1) Submitter's name / Contact person:

Aerogen, Inc. 2071 Stierlin Court Mountain View, CA 94043 USA

Contact person: Nancy E. Isaac Vice President, Regulatory Affairs and Quality Tel .: [phone] Fax: [phone]

Date prepared: August 2003

(2) Name of device:

| Trade name: | Aeroneb® Go Nebulizer |
|----------------------|-----------------------------|
| Common name: | Nebulizer |
| Classification name: | Nebulizer, 21 CFR §868.5630 |

(3) Identification of predicate device:

| Manufacturer | Device | 510(k) Number |
|------------------------|-----------------------------------------------|---------------------|
| Aerogen, Inc. | Aeroneb® Portable Nebulizer System | K970010/<br>K003022 |
| Pare Holding Co. | Pari LC Star™ Reusable Nebulizer | K963924 |
| Omron Healthcare, Inc. | Omron MicroAir® Portable Ultrasonic Nebulizer | K923024 |

### (4) Description of the device:

The Aeroneb Go nebulizer, for use by pediatric and adult patients, is intended to aerosolize physician-prescribed solutions for inhalation that are approved for use with a general-purpose nebulizer.

The Aeroneb Go nebulizer uses the OnQ™ Aerosol Generator, which is comprised of a unique dome shaped aperture plate containing over 1,000 precision-formed tapered holes surrounded by a vibrational element. When energy is applied, the aperture plate vibrates approximately 100,000 times per second. This rapid vibration causes each aperture to act as a micropump, drawing liquid through the holes to form consistently sized droplets.

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The Aeroneb Go nebulizer is lightweight, compact and silent. The device can be powered with the AC Power Controller or with the Battery Powered Controller that uses three "AA" disposable batteries.

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

The Aeroneb Go nebulizer, for use by pediatric and adult patients, is intended to aerosolize physician-prescribed solutions for inhalation that are approved for use with a general-purpose nebulizer.

#### (6) Predicate device comparison:

The Aeroneb Go nebulizer 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 Go nebulizer to the Aeroneb Portable Nebulizer System, the Pari LC Star and the Omron MicroAir. Results demonstrated that the Aeroneb Go nebulizer was substantially equivalent to the other legally marketed devices in performance.

#### (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 and is substantially equivalent to the predicate devices.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized design featuring three curved lines that resemble a human figure or a symbol representing health and well-being.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# NOV 2 1 2003

Aerogen, Incorporated C/O Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street NW Buffalo, Minnesota 55313

Re: K032849

Trade/Device Name: Aeroneb Go Nebulizer Regulation Number: 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF Dated: November 6, 2003 Received: November 7, 2003

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 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. 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 (OS) 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/dsma/dsmamain.html.

Sincerely vours.

Ches

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

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Image /page/4/Picture/0 description: The image shows the word "Aerogen" in a simple, sans-serif font. Above the word is a stylized graphic consisting of two horizontal lines that are angled upwards and converge towards the right, creating a sense of forward movement. The logo is clean and minimalist, with a focus on the company name and a symbolic representation of its brand.

Section 1 Aeroneb® Go Nebulizer Premarket Notification 510(k)

510(k) Number (if known): _K 032849

Device Name: Aeroneb® Go Nebulizer

Indications for Use:

The Aeroneb Go nebulizer, for use by pediatric and adult patients, is intended to aerosolize physician-prescribed solutions for inhalation that are approved for use with a general-purpose nebulizer.

signature

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

510(k) Number: K032847

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

OR

Over the Counter Use_

Optional Format 1-2-96)