56 SERIES AEROSOL GENERATOR

K980074 · Project Marketing · CAF · Jun 12, 1998 · Anesthesiology

Device Facts

• Record ID: K980074
• Device Name: 56 SERIES AEROSOL GENERATOR
• Applicant: Project Marketing
• Product Code: CAF · Anesthesiology
• Decision Date: Jun 12, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The 56 series Aerosol Generator is for the production of compressed air to operate a nebulizer for the production of medical aerosol for respiratory disorders. The 56 series Aerosol Generator requires a nebulizer and medication for operation. The use of the 56 series Aerosol Generator is for the sole purpose of compressed air production and requires the order of a physician for medical use.

Device Story

56 Series Aerosol Generator functions as a compressor to provide compressed air; powers a nebulizer to convert liquid medication into medical aerosol for respiratory therapy. Used in clinical or home settings; operated by patients or caregivers under physician prescription. Device output is compressed air flow; enables delivery of aerosolized medication to patient airways. Benefits include facilitating respiratory treatment for patients with diagnosed disorders.

Technological Characteristics

Electromechanical compressor; produces compressed air for nebulizer operation. Standalone device.

Indications for Use

Indicated for patients with respiratory disorders requiring medical aerosol therapy via a nebulizer. Requires physician prescription.

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 12 1998

Mr. Terry O'Brien Project Marketing 112 Caviston Way Morrisville, NC 27560

Re : K980074 56 Series Compressor Regulatory Class: II (two) Product Code: 73 CAF April 27, 1998 Dated: Received: April 30, 1998

Dear Mr. O'Brien:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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## Page 2 - Mr. Terry O'Brien

This letter will allow you to begin marketing your device as described in your 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 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Thomas J. Callahan

Thomas J. ( allahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## INTENDED USE

The 56 series Aerosol Generator is for the production of compressed air to operate a nebulizer for the production of medical aerosol for respiratory disorders. The 56 series Aerosol Generator requires a nebulizer and medication for operation. The use of the 56 series Aerosol Generator is for the sole purpose of compressed air production and requires the order of a physician for medical use.

N. Rugh

(Division Sign-Off Division of Cardiova and Neurological Devi 510(k) Number

prescriptions one