EZFLOW CONTINUOUS NEBULIZER,MODEL 1005

K990384 · Piper Medical Products · CAF · Apr 26, 1999 · Anesthesiology

Device Facts

• Record ID: K990384
• Device Name: EZFLOW CONTINUOUS NEBULIZER,MODEL 1005
• Applicant: Piper Medical Products
• Product Code: CAF · Anesthesiology
• Decision Date: Apr 26, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5630
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

To be used under proper medical supervision to deliver medicinal aerosol and diagnostic formulation.

Device Story

EZflow Continuous Nebulizer Model 1005; device delivers medicinal aerosol and diagnostic formulations to patients. Used under medical supervision in clinical settings. Operates as a continuous nebulizer system. Provides therapeutic benefit by facilitating inhalation of medications or diagnostic agents. Healthcare providers utilize the device to administer prescribed treatments to patients.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on 510(k) regulatory review.

Technological Characteristics

Continuous nebulizer system for aerosol delivery. Technical specifications and materials not detailed in the provided documentation.

Indications for Use

Indicated for patients requiring delivery of medicinal aerosol and diagnostic formulations under medical supervision.

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

APR 2 6 1999

Mr. Samuel David Piper Piper Medical Products 4007 Seaport Blvd. West Sacramento, CA 95691

Re: K990384 EZflow Continuous Nebulizer™ Model 1005 Regulatory Class: II (two) Product Code: 73 CAF February 5, 1999 Dated: Received: February 8, 1999

Dear Mr. Piper:

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 leqally 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). 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 requlations 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 Failure to comply with the GMP requlation may result in assumptions. 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. Samuel David Piper

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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic 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/dsma/dsmamain.html".

Sincerely yours,
Thomas J. Callehan

Thomas J. Callahan, 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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1990394 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

EZflow Continuous Nebulizer™ Device Name:

Indication for Use:

To be used under proper medical supervision to deliver medicinal aerosol and diagnostic formulation.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

OR

Prescription Use : (Per 21 CFR 810.109)

Over-the-Counter Use

Arth A. Garkowski.

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 10344 k T 510(k) Number .

(Optional Format 1-2-96)

INTNDUSE.DOC