TRUMIST AIR ENTRAINED DISPOSABLE NEBULIZER

K982179 · Trudell Medical · CAF · Sep 17, 1998 · Anesthesiology

Device Facts

• Record ID: K982179
• Device Name: TRUMIST AIR ENTRAINED DISPOSABLE NEBULIZER
• Applicant: Trudell Medical
• Product Code: CAF · Anesthesiology
• Decision Date: Sep 17, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The "TruMist™ Air Entrained Disposable nitendou / intended to be used by patients who are under the care or treatment of a licensed health care professional or physician. The device troumbled to by used by these patients to administer aerosolized medication prescribed by a physician or health care professional. The intended environments for use include the home, hospitals and clinics.

Device Story

TruMist Air Entrained Disposable Nebulizer; device delivers aerosolized medication to patients. Operates via air entrainment principle to nebulize liquid medication for inhalation. Used in home, hospital, and clinical settings under physician supervision. Patient self-administers medication as prescribed. Device facilitates respiratory therapy by converting liquid medication into aerosol form for patient inhalation.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Disposable air-entrained nebulizer; designed for aerosol medication delivery. Operates via air entrainment mechanism. Intended for single-patient use in clinical or home environments.

Indications for Use

Indicated for patients under the care of a licensed healthcare professional or physician for the administration of prescribed aerosolized medication. Suitable for use in home, hospital, and clinical settings.

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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Image /page/0/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of an eagle with three stripes across its body.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 7 1998

Mr. Darryl Fischer Trudell Medical International 725 Third Street London, Ontario, CANADA N5V 5G4

Re : K982179 TruMist Air Entrained Disposable Nebulizer Regulatory Class: II (two) Product Code: 73 CAF June 17, 1998 Dated: Received: June 22, 1998

Dear Mr. Fischer:

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 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. Darryl Fischer

This letter will allow you to beqin 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 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 requlation 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. Callahon

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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| 1 | |
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| 510(k) Number (if known): | K 982179 |
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| Device Name: | AIR ENTRAINED DISPOSABLE NEBULIZER |

Indications For Use:

Intended / Indications for Use: The "TruMist™ Air Entrained Disposable nitendou / intended to be used by patients who are under the care or treatment of a licensed health care professional or physician. The device troumbled to by used by these patients to administer aerosolized medication prescribed by a physician or health care professional. The intended environments for use include the home, hospitals and clinics.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Zank

9-15-98.

Prescription Use i (Per 21 CFR 801.109) (Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

510(k) Number _

(Optional Format 1-2-96)