AEROCHAMBER PLUS ANTI-STATIC VALVED HOLDING CHAMBER WITH FLOW-VU INSPIRATORY FLOW INDICATOR

K070674 · Trudell Medical Intl. · NVP · Apr 11, 2007 · Anesthesiology

Device Facts

• Record ID: K070674
• Device Name: AEROCHAMBER PLUS ANTI-STATIC VALVED HOLDING CHAMBER WITH FLOW-VU INSPIRATORY FLOW INDICATOR
• Applicant: Trudell Medical Intl.
• Product Code: NVP · Anesthesiology
• Decision Date: Apr 11, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.5630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The AeroChamber Plus® aVHC with Flow-Vu® IFI 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 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 Plus aVHC with Flow-Vu IFI is a valved holding chamber (VHC) designed to facilitate delivery of aerosolized medication from pressurized Metered Dose Inhalers (pMDIs). The device acts as a spacer between the pMDI and the patient's airway, reducing the need for precise hand-breath coordination. It incorporates a visual indicator (Flow-Vu) to provide feedback on inhalation flow. Used by patients in home, hospital, or clinical settings under physician supervision. The device captures the aerosol plume from the pMDI, allowing the patient to inhale the medication at their own pace. The Flow-Vu indicator helps the patient or caregiver verify proper inhalation technique, potentially improving medication delivery efficiency and patient compliance.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Valved holding chamber (VHC) with integrated visual flow indicator (Flow-Vu). Mechanical design; no electronic components, software, or energy source. Materials are medical-grade plastics suitable for aerosol delivery. Dimensions and form factor designed for compatibility with standard pMDIs.

Indications for Use

Indicated for patients under the care of a licensed healthcare provider to administer aerosolized medication from pressurized Metered Dose Inhalers (pMDIs). No specific age or gender restrictions; intended for home, hospital, and clinical 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

APR 1 1 2007

Mr. John Straatman Director, Ouality & Regulatory Affairs Trudell Medical International 725 Third Street London, Ontario, CANADA N5V 5G4

Re: K070674

Trade/Device Name: AeroChamber Plus® aVHC with Flow-Vu® IFI Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: NVP Dated: March 8, 2007 Received: March 12, 2007

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 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.

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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. 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 (OS) 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/industry/support/index.html.

Sincerely yours,

Saugte Y. Michieums.

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

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510(k) Number :

076674

Device Name: AeroChamber Plus® aVHC with Flow-Vu® IFI

Indications for Use:

The AeroChamber Plus® aVHC with Flow-Vu® IFI 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 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.

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CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)

| | Chello |
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| | nt of Anocineziology, General Hospal,<br>Jon Control, Cental Devices |
| 510(k) Number: | K070674 |

| Prescription Use:<br>(per 21CFR 801.109) | or Over the Counter Use |
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