AERONEB GO NEBULIZER

K081650 · Aerogen (Ireland), Ltd. · CAF · Oct 23, 2008 · Anesthesiology

Device Facts

• Record ID: K081650
• Device Name: AERONEB GO NEBULIZER
• Applicant: Aerogen (Ireland), Ltd.
• Product Code: CAF · Anesthesiology
• Decision Date: Oct 23, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.5630
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

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

Aeroneb® Go Nebulizer is a portable device designed to aerosolize liquid medications for inhalation. It operates by converting physician-prescribed liquid solutions into a fine mist for patient delivery. The device is intended for use by both pediatric and adult patients. It functions as a general-purpose nebulizer, allowing patients to receive prescribed respiratory treatments. The device is operated by the patient or caregiver in various settings, facilitating the administration of inhalation therapy. By aerosolizing medication, the device enables effective delivery of drugs to the respiratory tract, potentially improving patient outcomes for those requiring nebulized therapy.

Clinical Evidence

Bench testing only.

Technological Characteristics

Portable nebulizer system; utilizes vibrating mesh technology for aerosol generation; powered by battery or AC adapter; designed for pediatric and adult use; intended for delivery of physician-prescribed inhalation solutions.

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 Professional Nebulizer System (K021963)

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

OCT 2 3 2008

Re: K081650

Trade/Device Name: Aeroneb® Go Nebulizer Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF Dated: October 3, 2008 Received: October 6, 2008

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 (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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 vours.

Witmuele-Lerdinng fry

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): K081650

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.

Prescription Use X (Part 21 CFR 801 Subpart D) OR

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)

L.A.

Division Sign-Off) 'Jivision of Anesthesiology, General Hospital Infection Control, Dental Devices

K 081650 710(k) Number: