AERO DV TRACHEOBRONCHIAL STENT SYSTEM

K083625 · Alveolus, Inc. · JCT · Mar 11, 2009 · General, Plastic Surgery

Device Facts

• Record ID: K083625
• Device Name: AERO DV TRACHEOBRONCHIAL STENT SYSTEM
• Applicant: Alveolus, Inc.
• Product Code: JCT · General, Plastic Surgery
• Decision Date: Mar 11, 2009
• Decision: SESU
• Submission Type: Traditional
• Regulation: 21 CFR 878.3720
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The AERO DV™ Tracheobronchial Stent System is indicated for use in the treatment of tracheobronchial strictures produced by malignant neoplasms.

Device Story

The AERO DV™ Tracheobronchial Stent System is a medical device used to treat tracheobronchial strictures caused by malignant neoplasms. It consists of a stent and a Direct Visualization (DV) delivery system. The delivery system features a larger catheter lumen, allowing a flexible bronchoscope to pass through it. This enables the physician to directly view the stent during positioning and deployment at the target site. The device is intended for use by physicians in a clinical setting. By providing direct visualization, the system assists in accurate stent placement, potentially improving treatment outcomes for patients with airway obstructions.

Clinical Evidence

Bench testing only. The device was tested in accordance with the FDA 'Guidance for the Content of Premarket Notifications for Esophageal and Tracheal Prostheses' (April 28, 1998). No clinical data was provided.

Technological Characteristics

Tracheal prosthesis (Class II). System includes a stent and a delivery catheter with an enlarged lumen for bronchoscope passage. Materials meet biocompatibility requirements per FDA guidance. Provided non-sterile for single-patient use.

Indications for Use

Indicated for patients with tracheobronchial strictures caused by malignant neoplasms.

Regulatory Classification

Identification

The tracheal prosthesis is a rigid, flexible, or expandable tubular device made of a silicone, metal, or polymeric material that is intended to be implanted to restore the structure and/or function of the trachea or trachealbronchial tree. It may be unbranched or contain one or two branches. The metal tracheal prosthesis may be uncovered or covered with a polymeric material. This device may also include a device delivery system.

Special Controls

The special control for this device is FDA's “Guidance for the Content of Premarket Notification Submissions for Esophageal and Tracheal Prostheses.”

Predicate Devices

• Alveolus AERO DV™ Tracheobronchial Stent System (K071604)
• Alveolus AERO™ Tracheobronchial Stent System (K082284)
• Rusch International Polyflex Airway Stent (K013266)

Submission Summary (Full Text)

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K083625

# MAR 1 1 2009

Image /page/0/Picture/2 description: The image shows the word "Alveollus" in a simple, sans-serif font. A curved line is drawn beneath the word, emphasizing it. The text is clear and easy to read, with a clean and minimalist design.

Alveolus, Inc. 9013 Perimeter Woods, Suite A Charlotte, NC 28216, USA

#### 510(K) SUMMARY 15

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (Per 21 CFR 807.92)

### General Company Information

| Name: | Alveolus, Inc. |
|----------|----------------------------------------|
| Contact: | Tony Alexander<br>Vice President RA/QA |

9013 Perimeter Woods, Suite A Address: Charlotte, NC 28216

| Telephone: | (704) 926 - 4837 |
|------------|------------------|
| Fax: | (704) 926 - 4838 |

# Date Prepared: December 05, 2008

#### General Device Information

AERO DV™ Tracheobronchial Stent System Product Name: Classification: "Tracheal Prosthesis." Product code: JCT 21 CFR 878.3720 - Class II

### Predicate Devices

Alveolus AERO DV™ Tracheobronchial Stent System (510(k) Number: K071604)

Alveolus AERO™ Tracheobronchial Stent System (510(k) Number: K082284)

Rusch International (owned by Boston Scientific) Polyflex Airway Stent (510(k) Number: K013266)

#### Description

CONFIDENTIAL

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AlveollUs

The Alveolus AERO DV™ Tracheobronchial Stent System described in this Notice consists of the exact same stent as the AERO™ predicate stent (K082284) but with an alternate delivery system.

The Direct Visualization (DV) delivery system of AERO DV™ allows the physician to use a bronchoscope to directly view the stent as it is being positioned and deployed at the tarqet implant site. This direct visualization is made possible with a slightly larger delivery catheter lumen that allows passage of a flexible bronchoscope through the delivery catheter.

# Intended Use (Indications)

The AERO DV™ Tracheobronchial Stent System is indicated for use in the treatment of tracheobronchial strictures produced by malignant neoplasms.

# Substantial Equivalence

This Notice supports the position that the Subject Device is substantially equivalent to AERO DV™ Tracheobronchial Stent System predicate device (K071604). The stent used with the delivery system is the exact same stent cleared under 510(k) K082284.

This 510(k) Notice contains summaries of physical test results for the delivery system as specified in the FDA "Guidance for the Content of Premarket Notifications for Esophageal and Tracheal Prostheses" document (April 28, 1998).

The data presented demonstrate that the device is suitable for its indicated use.

The single-patient-use components of the AERO DV™ Tracheobronchial Stent System are provided non-sterile.

## Conclusions

In summary, the Alveolus AERO DV™ Tracheobronchial Stent System described in this Notice has the same stent as the AERO™ predicate stent (K082284), is made of materials that have met the biocompatibility requirements of FDA "Guidance for the Content of Premarket Notifications for Esophageal and Tracheal Prostheses" document (issued on April 28, 1998), has the same indications for use, and has the same principle of operation as those of the AERO DV™ Tracheobronchial Stent System predicate device (K071604). Therefore, the AERO DV™ device does not raise any new issues regarding safety and effectiveness. Therefore, Alveolus believes that the

CONFIDENTIAL

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Image /page/2/Picture/1 description: The image shows the logo for Alveolis. The logo is in black and white and features the word "Alveolis" in a sans-serif font. Below the word is a curved line, and below that is the phrase "INSPIRING THE BREATH OF LIFE" in a smaller font. The logo is simple and modern.

system is substantially equivalent to currently marketed tracheobronchial stent systems.

The test data provided in this Notice shows that the Subject Device is substantially equivalent to the AERO DV™ Tracheobronchial Stent System predicate (K071604). The AERO DV™ Tracheobronchial Stent System has been tested in accordance with applicable FDA guidelines.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a stylized eagle or bird-like figure with three overlapping, curved shapes representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol. The text is in all caps and appears to be in a sans-serif font.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# MAR 1 1 2009

Mr. Tony Alexander Executive Vice President Alveolus, Incorporated 9013 Perimeter Woods Drive, Suite A Charlotte, North Carolina 28216

Re: K083625

Trade/Device Name: Alveolus, AERO DVTM Tracheobronchial Stent Technology System Regulation Number: 21 CFR 878.3720 Regulation Name: Tracheal Prosthesis Regulatory Class: II Product Code: JCT Dated: February 25, 2009 Received: March 2, 2009

Dear Mr. Alexander:

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). You may, therefore, market the device, subject to the general controls provisions of the Act and the limitations described below. 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.

The Office of Device Evaluation has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitation must appear in the device's labeling immediately following the Indications for Use section, and on the carton pouch labeling in a font-size that is easy to read:

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Page 3 - Mr. Alexander

If you desire specific information about the application or other labeling requirements to your device (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

Christy Youman for

Donna-Bea Tillman, Ph.D., M.P.A. Director Office of Device Evaluation Center for Devices and Radiological Health

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#### INTENDED USE STATEMENT 12

Device Name: Alveolus, AERO DV™ Tracheobronchial Stent System .

#### Indications for Use:

The AERO DV™ Tracheobronchial Stent System is indicated for use in the treatment of tracheobronchial strictures produced by malignant neoplasms.

Prescription Use_ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Turner

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

510(k) Number: K083625