MABIS NB-02 ULTRASONIC NEBULIZER

K990506 · Mabis Healthcare, Inc. · CAF · Mar 11, 1999 · Anesthesiology

Device Facts

• Record ID: K990506
• Device Name: MABIS NB-02 ULTRASONIC NEBULIZER
• Applicant: Mabis Healthcare, Inc.
• Product Code: CAF · Anesthesiology
• Decision Date: Mar 11, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MABIS NB-02 is an ultrasonic nebulizer intended for use in the treatment of asthma, COPD, and other respiratory ailments in which an aerosolized medication is required during therapy. It may be necessary to perform respiratory therapy at anytime and anywhere the patient needs it. The MABIS NB-02 nebulizer is not intended for use with Pentamidine. It is intended for single patient use.

Device Story

MABIS NB-02 is an ultrasonic nebulizer; converts liquid medication into aerosolized mist for inhalation therapy. Device operates via ultrasonic transducer technology to create fine particles for respiratory delivery. Used by patients for treatment of asthma, COPD, and related respiratory ailments; designed for portability to allow therapy at any location. Single-patient use device. Healthcare provider prescribes medication; patient self-administers aerosolized treatment. Benefits include convenient, on-demand respiratory therapy.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Ultrasonic nebulizer; utilizes ultrasonic transducer for aerosol generation. Single-patient use design. No specific materials or software algorithms described.

Indications for Use

Indicated for patients with asthma, COPD, or other respiratory conditions requiring aerosolized medication therapy. Contraindicated for use with Pentamidine. Intended for single-patient use.

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

MAR 1 1 1999

Mr. Steven M. Bisulca MABIS Healthcare, Inc. 28690 N. Ballard Drive Lake Forest, IL 60045

K990506 Re: MABIS NB-02 Ultrasonic Nebulizer Regulatory Class: II (two) Product Code: 73 CAF February 16, 1999 Dated: February 17, 1999 Received:

Dear Mr. Bisulca:

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 Requlation (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 regulation 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. Steven M. Bisulca

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 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,

Thomas J. Callahan

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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510(k) Number: k 990501

Device Name: MABIS NB-02 Ultrasonic Nebulizer

Indications for Use:

The MABIS NB-02 is an ultrasonic nebulizer intended for use in the treatment of asthma, COPD, and other respiratory ailments in which an aerosolized medication is required during therapy. It may be necessary to perform respiratory therapy at anytime and anywhere the patient needs it. The MABIS NB-02 nebulizer is not intended for use with Pentamidine. It is intended for single patient use.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark Kramer

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 1980506 510(k) Number_

Perscription Use***_***_
(Per 21 CFR 801.109)

OR

Over-The-Counter Use_

(Optional Format 1-2-96)