QUIXIE NEBULIZER

K112564 · Odyssey Medical Technologies · CAF · Nov 23, 2011 · Anesthesiology

Device Facts

• Record ID: K112564
• Device Name: QUIXIE NEBULIZER
• Applicant: Odyssey Medical Technologies
• Product Code: CAF · Anesthesiology
• Decision Date: Nov 23, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Quixie is intended to be used by patients who are under the care or treatment of a licensed healthcare provider or physician. The device is intended to be used by these patients to administer aerosolized medication prescribed by a physician or healthcare professional. The intended environments for use include the home, hospitals, and clinics. The Quixie is intended for multiple use by a single patient.

Device Story

Quixie Nebulizer is a device for administering aerosolized medication to patients. It operates by converting liquid medication into an aerosol mist for inhalation. Used in home, hospital, and clinic settings by patients under the guidance of a healthcare provider. Designed for multiple use by a single patient. The device facilitates the delivery of prescribed respiratory treatments, potentially improving patient compliance and therapeutic outcomes.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Nebulizer device (21 CFR 868.5630, Product Code CAF). Class II device. Designed for multiple use by a single patient. No specific materials, connectivity, or software algorithms 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. Intended for multiple use by a single patient.

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 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Mr. S. David Piper, PE President/CEO Odyssey Medical Technologies 4807 El Camino Avenue, Suite C Carmichael, California 95609

NOV 2 3 2011

Re: K112564

Trade/Device Name: Quixie Nebulizer Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF Dated: August 29, 2011 Received: September 2, 2011

Dear Mr. Piper:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Anthony D. Watson

Anthony D. Watson, B.S., M.S., M.B.A. 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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# Indications for Use

510(k) Number (if known):

Device Name: Quixie Nebulizer

### Indications For Use:

The Quixie is intended to be used by patients who are under the care or treatment of a licensed healthcare provider or physician. The device is intended to be used by these patients to administer aerosolized medication prescribed by a physician or healthcare professional. The intended environments for use include the home, hospitals, and clinics. The Quixie is intended for multiple use by a single patient.

Prescription Use X AND/OR Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 801 Subpart C)

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# Concurrence of CDRH, Office of Device Evaluation (ODE)

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L. Schultheis

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K112564