AG-PLUS, MODEL 91210

K060404 · Medel S.P.A. · CAF · Jun 22, 2006 · Anesthesiology

Device Facts

• Record ID: K060404
• Device Name: AG-PLUS, MODEL 91210
• Applicant: Medel S.P.A.
• Product Code: CAF · Anesthesiology
• Decision Date: Jun 22, 2006
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 868.5630
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The intended use of the AG PLUS is to convert liquid medication into a fine mist that can be drawn into the lungs to treat respiratory conditions for adult and pediatric patients who have been prescribed inhalation therapy or medication. The AG PLUS compressor is to be used only with specific 510(k) cleared nebulizer whose input specifications may be met by the pressure and flow characteristics of the AG PLUS compressor. The initial nebulizer distributed with the AG PLUS compressor will be the Medel Jet Pro, the performance of which is contained in this 510(k) notification. The AG PLUS is transportable equipment intended for home health care use. The AG PLUS is not intended as a life sustaining or life support device.

Device Story

AG PLUS is a transportable compressor nebulizer system for home health care. It converts liquid medication into a fine mist for inhalation into the lungs. The device operates by providing specific pressure and flow characteristics to drive a compatible 510(k) cleared nebulizer (initially the Medel Jet Pro). It is intended for use by patients prescribed inhalation therapy. The device does not provide life support or life-sustaining functions.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Compressor-based nebulizer system; transportable form factor; intended for home use; compatible with 510(k) cleared nebulizers meeting specific pressure and flow input requirements.

Indications for Use

Indicated for adult and pediatric patients prescribed inhalation therapy or medication for respiratory conditions. Not for life-sustaining or life-support 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.

Reference Devices

• Medel Jet Pro

Submission Summary (Full Text)

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 2 2006

Medel S.P.A. C/O Mr. Terrence O' Brien Official Correspondent Medel USA 112 Caviston Way Cary, North Carolina 27519

Re: K060404 Trade/Device Name: AG PLUS Regulation Number: 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF Dated: May 19, 2006 Received: May 30, 2006

Dear Mr. O' Brien:

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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Page 2 - Mr. O' Brien

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 (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/industry/support/index.html.

Sincerely yours.

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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## Indications for Use

510(k) Number (if known): K060404 Device Name: AG PLUS

Indications for Use:

The intended use of the AG PLUS is to convert liquid medication into a fine mist that can be drawn into the lungs to treat respiratory conditions for adult and pediatric patients who have been prescribed inhalation therapy or medication.

The AG PLUS compressor is to be used only with specific 510(k) cleared nebulizer whose input specifications may be met by the pressure and flow characteristics of the AG PLUS compressor. The initial nebulizer distributed with the AG PLUS compressor will be the Medel Jet Pro, the performance of which is contained in this 510(k) notification.

The AG PLUS is transportable equipment intended for home health care use. The AG PLUS is not intended as a life sustaining or life support device.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/O R

Over-The-Counter Use (21 CFR 801 Subpart C)

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Number: K0604