EZFLOW MAX, MODEL 1007

K993558 · Piper Medical Products · CAF · Nov 12, 1999 · Anesthesiology

Device Facts

• Record ID: K993558
• Device Name: EZFLOW MAX, MODEL 1007
• Applicant: Piper Medical Products
• Product Code: CAF · Anesthesiology
• Decision Date: Nov 12, 1999
• 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 patient.

Device Story

The EZflow MAX is a medical nebulizer designed to convert liquid medication into an aerosol mist for patient inhalation. It functions by aerosolizing liquid medication, allowing the patient to inhale the therapeutic agent directly into the respiratory tract. The device is intended for use in clinical or home settings to facilitate the delivery of prescribed medications. By transforming liquid into a fine mist, it enables effective administration of respiratory treatments, potentially improving patient outcomes for those with conditions requiring inhaled therapy.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Nebulizer device for liquid-to-aerosol conversion. Mechanical operation. No software or electronic components described.

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Nov 1 2 1999

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

Re: K993558 Ezflow MAX™ Regulatory Class: II (two) Product Code: 73 CAF October 18, 1999 Dated: Received: October 20, 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 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). 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 requlation (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 regulation may result in assumptions. regulatory action. In addition, FDA may publish further announcements Please note: concerning your device in the Federal Register. 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. S. 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 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/dsma/dsmamain.html".

Sincerely yours,

fean H. Whetstone

Celia M. Witten, Ph.D., M.D. Acting Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K993558

Device Name: EZflow MAX

Indication for Use:

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

(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

foffell. hm

(Div/sion Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number_ K99358

(Optional Format 1-2-96)

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