AEROECLIPSE II BREATH ACTUATED NEBULIZER

K053605 · Trudell Medical Intl. · CAF · Feb 27, 2006 · Anesthesiology

Device Facts

• Record ID: K053605
• Device Name: AEROECLIPSE II BREATH ACTUATED NEBULIZER
• Applicant: Trudell Medical Intl.
• Product Code: CAF · Anesthesiology
• Decision Date: Feb 27, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.5630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The AeroEclipse® II Breath Actuated Nebulizer is intended to be used by patients who are under the care or treatment of a licensed health care provider or physician. The device is intended to be 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

AeroEclipse® II is a breath-actuated nebulizer; device delivers aerosolized medication to patients. Operation triggered by patient inhalation; mechanism ensures medication delivery only during inspiratory phase, reducing waste and ambient aerosol release. Used in home, hospital, and clinic settings; operated by patients under physician supervision. Output is aerosolized drug for inhalation; assists in respiratory therapy. Device design focuses on patient-controlled delivery; enhances medication efficiency compared to continuous nebulizers.

Clinical Evidence

No clinical data provided; substantial equivalence based on device description and intended use.

Technological Characteristics

Breath-actuated nebulizer; mechanical design for aerosol delivery; intended for home, hospital, and clinic use. No electronic, software, or algorithmic components described.

Indications for Use

Indicated for patients under the care of a licensed healthcare provider requiring administration of physician-prescribed aerosolized medication. Suitable for home, hospital, and clinic 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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Public Health Service

DE

FEB 2 7 2006

Mr. John Straatman Director, Quality and Regulatory Affairs 725 Third Street London, Ontario Canada N5V 5G4

Re: K053605

Trade/Device Name: AeroEclipse® II Breath Actuated Nebulizer Regulation Number: 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF Dated: January 30,2006 Received: February 2, 2006

Dear Mr. Straatman:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting (1 will), it ind), be also of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Eederal Register.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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Page 2 – Mr. John Straatman

Please be advised that FDA's issuance of a substantial equivalence determination does not I Ticast be advisod that 1 Dr. o to the your device complies with other requirements modifine in any Federal statutes and regulations administered by other Federal agencies. of the Act of ally I outstal states requirements, including, but not limited to: registration 1 od inust comply with a 807); labeling (21 CFR Part 801); good manufacturing practice allu listing (21 CFR Part 807), mostiting systems (QS) regulation (21 CFR Part 820); and if requirences as better product radiation control provisions (Sections 531-542 of the Act);

21 CFR 1000-1050.

!

This letter will allow you to begin marketing your device as described in your Section This letter will and w Jour to begin IRDA 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), rr you desire speemo as Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the maj overni of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Susan Runoe

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital , Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number :

AeroEclipse® II Breath Actuated Nebulizer Device Name:

Indications for Use:

The AeroEclipse® II Breath Actuated Nebulizer is intended to be used by patients who are under the care or treatment of a licensed health care provider or physician. The device is intended to be 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.

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CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE) an General Hos. Over the Counter Use: _ Prescription Use: _ or

DED)

(per 21CFR 801.109)