AEROSOL SYSTEM

K063716 · Amici, Inc. · CAF · Dec 28, 2007 · Anesthesiology

Device Facts

• Record ID: K063716
• Device Name: AEROSOL SYSTEM
• Applicant: Amici, Inc.
• Product Code: CAF · Anesthesiology
• Decision Date: Dec 28, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5630
• Device Class: Class 2

Intended Use

The AeroSol™ Radioaerosol System is intended to deliver an aerosol of diagnostic nuclear medicine to the lung for imaging. The device is intended for patients undergoing diagnostic nuclear lung ventilation imaging in a hospital or settings where nuclear medicine clinical testing is performed.

Device Story

AeroSol™ Radioaerosol System generates/administers fine droplet aerosol of diagnostic nuclear medicine to lungs for ventilation imaging. System components include injection site, nebulizer, aerosol conduit, and aerosol trapping filter. Used in hospitals or nuclear medicine clinical settings by healthcare professionals. Device transforms liquid diagnostic agent into aerosol for patient inhalation; output is inhaled radioaerosol. Healthcare providers use resulting lung images to assess ventilation. Benefits include diagnostic visualization of lung airways.

Clinical Evidence

Bench testing only. Nebulizer performance was validated using Malvern Laser Diffraction.

Technological Characteristics

Nebulizer system for radioaerosol delivery. Materials include PVC, LDPE, K-Resin, and Bromobutyl. Components include injection site, nebulizer, aerosol conduit, and aerosol trapping filter. Performance verified via Malvern Laser Diffraction. No software or electronic components described.

Indications for Use

Indicated for patients undergoing diagnostic nuclear lung ventilation imaging in hospital or clinical settings.

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.

Predicate Devices

• CIS-US (1219718) Aerotech Aerosol Delivery System (K873930)
• AMICI Xenon System (K865084)

Submission Summary (Full Text)

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K063716

Image /page/0/Picture/1 description: The image shows the word "AMICI" in a bold, sans-serif font. To the right of the word is a circular logo. Inside the circle is a square shape with a design that includes horizontal lines and three black shapes resembling triangles or wedges.

YOUR GUARANTEE OF EXCELLENCE

518 Vincent Street, Spring City, PA 19475 USA PN: [phone], FX: [phone] Internet: amici-inc.com, e-mail: [e-mail]

510(k) Summary Page 1 of 2

December 20, 2007

Owner's Name, Address, Phone and FAX: See the above letterhead

Contact Person: Michael Bono, President

510(k) Number: K063716

DEC 2 8 2007

Trade Name: AeroSol™ Radioaerosol System

Common Name: Nebulizer / Aerosolizer

Classification Name: Nebulizer (Direct Patient Interface) [21CFR868.5630]

Product Code: CAF

Predicate Device: CIS-US (1219718) Aerotech Aerosol Delivery System (K873930 licensed from Cadema Medical Products) and AMICI Xenon System (K865084)

Device Description: The AeroSol™ Radioaerosol System generates and administers a fine droplet aerosol to the breathing areas of the lungs for diagnostic imaging. It has an injection site, a nebulizer, aerosol conduit, aerosol trapping and is manufactured of materials and components used in previously cleared 510(k) devices.

Indications for Use: The AeroSol™ Radioaerosol System is intended to deliver an aerosol of diagnostic nuclear medicine to the lung for imaging.

Patient Population: For patients undergoing diagnostic nuclear lung ventilation imaging.

Environment of Use: Hospitals or settings where nuclear medicine clinical testing is performed.

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## 510(k) Summary Page 2 of 2

| Specification | Predicate<br>CIS-US AeroTech System<br>(K873930)<br>AMICI Xenon System<br>(K865084) | Proposed AeroSol™ System<br>(K063716) |
|------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | To diagnose or rule out lung<br>ventilation (airways) versus lung<br>perfusion (blood supply) diseases<br>in patients with breathing<br>difficulties. | The AeroSol™ Radioaerosol<br>System is intended to deliver an<br>aerosol of diagnostic nuclear<br>medicine to the lung for imaging. |
| Patient populations | For patients with breathing<br>difficulties suspected of airways<br>diseases. | For patients undergoing<br>diagnostic nuclear lung<br>ventilation imaging in a hospital<br>or settings where nuclear<br>medicine clinical testing is<br>performed. |
| Environment of use | Hospitals or settings where<br>nuclear medicine clinical testing<br>is performed | Hospitals or settings where<br>nuclear medicine clinical testing<br>is performed |
| Performance | Nebulize radioaerosols | Nebulize radioaerosols |
| Nebulizer Performance<br>tested via Malvern Laser<br>Diffraction | Yes | Yes |
| Circuit with conduits,<br>valves, nebulizer,<br>mouthpieces, and various<br>adapters and connectors<br>and aerosol trapping filter | Yes<br>AMICI Xenon System<br>(K865084) | Yes |
| Materials - PVC, LDPE,<br>K-Resin, Bromobutyl etc. | Yes<br>AMICI Xenon System<br>(K865084) | Yes |

Differences Between Other Legally Marketed Predicate Devices: The proposed device is viewed as substantially equivalent to the predicate devices, K873930 and K865084. There are no significant differences that affect the safety, use or effectiveness of the intended device as compared to the predicate devices.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes forming its body and wings, and the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 8 2007

Mr. Michael Bono President AMICI. Incorporated 518 Vincent Street Spring City, Pennsylvania 19475

Re: K063716

Trade/Device Name: AeroSol™ Radioaerosol System Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF Dated: December 13, 2007 Received: December 14, 2007

Dear Mr. Bono:

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 Eederal Register.

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## Page 2 - Mr. Bono

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 vours,

Dinh H. Nguyen, BS/MS, Chiu Lin, Ph.D.

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

Page 1 of 1

K063716 510(k) Number:

AeroSol™ Radioaerosol System Device Name:

Indications for Use:

The AeroSolling Radioaerosol System is intended to deliver an aerosol of diagnostic nuclear medicine to the lung for imaging. The device is intended for patients undergoing diagnostic nuclear lung ventilation imaging in a hospital or settings where nuclear medicine clinical testing is performed.

Prescription Use XX Over-The-Counter Use _ AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nul J. Dda

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

510(k) Number: K063716