AEROLIFE ULTRASONIC NEBULIZER, MODEL P2C

K053360 · Aerovectrx Corporation · CAF · Mar 23, 2006 · Anesthesiology

Device Facts

• Record ID: K053360
• Device Name: AEROLIFE ULTRASONIC NEBULIZER, MODEL P2C
• Applicant: Aerovectrx Corporation
• Product Code: CAF · Anesthesiology
• Decision Date: Mar 23, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

To be used to convert liquid medication into aerosol for inhalation by patients.

Device Story

AeroLife Model P2C is an ultrasonic nebulizer; converts liquid medication into aerosol mist for patient inhalation. Device operates via ultrasonic transducer to create aerosol; intended for prescription use. Healthcare providers or patients use device to administer respiratory medications; output allows direct delivery of medication to lungs. Benefits include efficient drug delivery for respiratory conditions.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Ultrasonic nebulizer; utilizes ultrasonic transducer for aerosol generation. Class II device (Regulation 868.5630, Product Code CAF).

Indications for Use

Indicated for patients requiring aerosolized liquid medication for inhalation.

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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Image /page/0/Picture/2 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

MAR 2 3 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AerovectRx Corporation C/O Mr. David Piper President Piper Medical 6224 Samoa Way Carmichael, California 95608

Re: K053360

Trade/Device Name: AeroLife Model P2C Ultrasonic Nebulizer Regulation Number: 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF Dated: February 27, 2006 Received: March 9, 2006

Dear Mr. Piper:

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. Piper

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/industry/support/index.html.

Sincerely vours.

Chiu Lin, 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

K053360 510(k) Number (if known):

Device Name: AeroLife Model P2C Ultrasonic Nebulizer

Indications For Use:

To be used to convert liquid medication into aerosol for inhalation by patients.

X Prescription Use (Part 21 CFR 801 Subpart D)

AND/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)

Cuca Intram

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

510(k) Number

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