AERONEB PRO

K120939 · Aerogen, Ltd. · CAF · Apr 26, 2012 · Anesthesiology

Device Facts

• Record ID: K120939
• Device Name: AERONEB PRO
• Applicant: Aerogen, Ltd.
• Product Code: CAF · Anesthesiology
• Decision Date: Apr 26, 2012
• 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 inhulple 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.

Device Story

Portable, multiple-patient use nebulizer system; aerosolizes physician-prescribed liquid medications for inhalation. Used in clinical settings for patients on or off mechanical ventilation/positive pressure breathing assistance. Operated by healthcare professionals. Device transforms liquid medication into aerosol mist for patient delivery; facilitates respiratory therapy. Benefits include effective drug delivery to airways in both ventilated and non-ventilated patients.

Clinical Evidence

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

Technological Characteristics

Portable nebulizer system for multiple-patient use. Designed for integration with ventilation circuits or standalone use. Operates via aerosolization of liquid solutions. Class II device (21 CFR 868.5630).

Indications for Use

Indicated for adult and pediatric patients requiring aerosolized physician-prescribed solutions, both on and 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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### DEPARTMENT OF HEALTH & HUMAN SERVICES

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#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Ms. Martha Folan Regulatory Specialist Aerogen Limited Galway Business Park, Dangan Galway Ireland

APR 2 6 2012

Re: K120939

Trade/Device Name: Aeroneb Professional Nebulizer System Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF Dated: March 27, 2012 Received: March 29, 2012

Dear Ms. Folan:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Nh for

Anthony D. Watson, B.S., M.S., M.B.A. 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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#### Section 2

## Indications for Use Statement

# 510 (k) Number: 《|འ〇鸟39

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 inhulple 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.

L. Schult

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

510(k) Number: 4120939