AEROCHAMBER MAX VALVED HOLDING CHAMBER

K032972 · Trudell Medical Intl. · CAF · Jan 14, 2004 · Anesthesiology

Device Facts

• Record ID: K032972
• Device Name: AEROCHAMBER MAX VALVED HOLDING CHAMBER
• Applicant: Trudell Medical Intl.
• Product Code: CAF · Anesthesiology
• Decision Date: Jan 14, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.5630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The AeroChamber MAX™ Valved Holding Chamber is intended to be used by patients who are under the care of treatment of a licensed health care provider or physician. The device is intended to be used by these patients to administer aerosolized medication from most pressurized Metered Dose Inhalers, prescribed by a physician or health care professional. The intended environments for use include the home, hospitals and clinics.

Device Story

AeroChamber MAX is a valved holding chamber (VHC) designed to facilitate the delivery of aerosolized medication from pressurized Metered Dose Inhalers (pMDIs). The device acts as a spacer between the pMDI and the patient's airway, slowing the velocity of the aerosol plume and allowing for better coordination between actuation and inhalation. It is intended for use by patients in home, hospital, or clinical settings. The device is operated by the patient or a caregiver. By optimizing aerosol delivery, it helps ensure the medication reaches the lungs effectively, potentially improving therapeutic outcomes for patients prescribed pMDI treatments.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use.

Technological Characteristics

Valved holding chamber (VHC) for pMDI aerosol delivery. Mechanical device; no electronic components, software, or energy source. Materials and dimensions are consistent with standard VHC designs for aerosol medication administration.

Indications for Use

Indicated for patients under the care of a licensed healthcare provider or physician for the administration of aerosolized medication from pressurized Metered Dose Inhalers (pMDIs).

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

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 4 2004

Mr. Tom Holbrook Director, Regulatory Affairs Trudell Medical International 725 Third Street London, Ontario Canada, N5V 5G4

Re: K032972

Trade/Device Name: AeroChamber Max Valved Holding Chamber Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: Class II Product Code: 73 CAF Dated: December 19, 2003 Received: December 22, 2003

Dear Mr. Holbrook:

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 reguire 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 your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.

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Page 2 - Mr. Tom Holbrook

You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic 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 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), please contact the Office of 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 Division 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/dsma/dsmamain.html

Sincerely yours,

Cluls

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

Enclosure

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## Indications for Use

510(k) Number (if known): K032972

AeroChamber MAX™ Valved Holding Chamber Device Name:

Indications For Use:

The AeroChamber MAX™ Valved Holding Chamber is intended to be used by patients who are under the care of treatment of a licensed health care provider or physician. The device is intended to be used by these patients to administer aerosolized medication from most pressurized Metered Dose Inhalers, prescribed by a physician or health care professional. The intended environments for use include the home, hospitals and clinics.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

AWwh

510(k) Number: K032972

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