AEROCHAMBER Z-STAT PLUS VALVED HOLDING CHAMBER

K052332 · Trudell Medical Intl. · NVP · Sep 21, 2005 · Anesthesiology

Device Facts

• Record ID: K052332
• Device Name: AEROCHAMBER Z-STAT PLUS VALVED HOLDING CHAMBER
• Applicant: Trudell Medical Intl.
• Product Code: NVP · Anesthesiology
• Decision Date: Sep 21, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.5630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The AeroChamber Z-STAT Plus™ Valved Holding Chamber 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 Z-STAT Plus is a valved holding chamber (VHC) designed to facilitate delivery of aerosolized medication from pressurized Metered Dose Inhalers (pMDIs). Device acts as a spacer between pMDI and patient; reduces need for precise hand-breath coordination required for pMDI use alone. Used in home, hospital, and clinic settings by patients under physician supervision. Device captures aerosol plume from pMDI; holds medication in suspension for patient inhalation. Benefits include improved drug delivery efficiency and reduced oropharyngeal deposition. No complex electronics or software involved.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Valved holding chamber; plastic construction; one-way valve mechanism; compatible with standard pressurized Metered Dose Inhalers (pMDIs).

Indications for Use

Indicated for patients under the care of a licensed health care provider to administer aerosolized medication from pressurized Metered Dose Inhalers (pMDIs). No specific age or gender restrictions; no contraindications listed.

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)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized image of an eagle with three curved lines representing its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle.

SEP 2 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. John Straatman Director, Quality & Regulatory Affairs Traudell, Medical International 725 Third Street @ Oxford Street London Ontario N5V 5G4 CANADA

Re: K052332

Trade/Device Name: Aerochamber Z-Stat Plus Valved Holding Chamber Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: NVP Dated: August 24, 2005 Received: August 26, 2005

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 mendments, 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 approvisions 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 you casynd in the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device to rear of ther announcements concerning your device in the Federal Register.

{1}------------------------------------------------

Page 2 - Mr. Straatman

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 modified in any Federal statutes and regulations administered by other Federal agencies. or mo rice of any - 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 and fisulie (21 et read on the quality systems (QS) regulation (21 CFR Part 820); and if requirents as bettronic 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) Fins fection with and in J 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), n 95% 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,

Cure

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

{2}------------------------------------------------

510(k) Number :

K652332

AeroChamber Z-STAT Plus™ Valved Holding Device Name: Chamber

Indications for Use:

The AeroChamber Z-STAT Plus™ Valved Holding Chamber 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.

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : . NEEDED)

CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)

. ' ..

1. And 1. How to the states

Cuy Sulom
(Division Sign-Off)

Division of Aresthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: K052333

Prescription Use: (per 21CFR 801.109) Over the Counter Use