MYSTIQUE ULTRASONIC NEBULIZER

K983002 · Airsep Corp. · CAF · Oct 16, 1998 · Anesthesiology

Device Facts

• Record ID: K983002
• Device Name: MYSTIQUE ULTRASONIC NEBULIZER
• Applicant: Airsep Corp.
• Product Code: CAF · Anesthesiology
• Decision Date: Oct 16, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Airsep Mystique ultrasonic nebulizer is 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 Mystique nebulizer is not intended for use with Pentamidine. It is intended for single patient use.

Device Story

The Mystique ultrasonic nebulizer is a portable device designed for aerosolizing liquid medications for inhalation therapy. It operates by using ultrasonic energy to convert liquid medication into a fine mist for patient delivery. The device is intended for single-patient use in various settings, allowing patients to perform respiratory therapy as needed. It is operated by the patient or a caregiver. The output is an aerosolized medication mist, which the patient inhales to treat respiratory conditions like asthma or COPD. The device is not compatible with Pentamidine.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Ultrasonic nebulizer; portable form factor; intended for single-patient use. No specific materials or software algorithm details provided.

Indications for Use

Indicated for patients with asthma, COPD, or other respiratory ailments 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

OCT 16 1998

Mr. Edward Vrana AirSep Corporation 290 Creekside Drive Buffalo, NY 14228

Re: K983002 Mystique Ultrasonic Nebulizer Regulatory Class: II (two) Product Code: 73 CAF Dated: August 25, 1998 Received: August 28, 1998

Dear Mr. Vrana:

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 A substantially equivalent determination assumes compliance to 895. 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 regulation 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. Edward Vrana

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 qeneral 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. Callahon

Thomas .. 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:

K963002

Mystique ultrasonic nebulizer by Airsep Device Name:

## 3 Indications For Use:

The Airsep Mystique ultrasonic nebulizer is 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 Mystique 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)

Mr. Puf

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices

K983002 510(k) Number_

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Formal 1-2-96)