AERO TRACHEOBRONCHIAL STENT SYSTEM, MODEL 90129-2XX

K062511 · Alveolus, Inc. · JCT · Jan 31, 2007 · General, Plastic Surgery

Device Facts

• Record ID: K062511
• Device Name: AERO TRACHEOBRONCHIAL STENT SYSTEM, MODEL 90129-2XX
• Applicant: Alveolus, Inc.
• Product Code: JCT · General, Plastic Surgery
• Decision Date: Jan 31, 2007
• Decision: SESU
• Submission Type: Traditional
• Regulation: 21 CFR 878.3720
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

AERO Tracheobronchial Stent System consists of a radiopaque nitinol stent and a delivery system. Stent is self-expanding; covered with biocompatible polyurethane membrane. Design features slightly larger diameters at proximal and distal ends to prevent migration; inwardly vaulted ends to minimize airway injury. Geometry maintains constant length during expansion, eliminating foreshortening. Device is used for treating tracheobronchial strictures resulting from malignant neoplasms. Stent is provided non-sterile for single-patient use.

Clinical Evidence

Safety and efficacy demonstrated via a study conducted under IDE G040202. No specific clinical metrics provided in the summary.

Technological Characteristics

Nitinol self-expanding stent; polyurethane membrane covering; radiopaque; non-sterile; designed with vaulted ends and constant-length geometry to prevent foreshortening and migration.

Indications for Use

Indicated for patients with tracheobronchial strictures caused by malignant neoplasms. Not for use in the vascular system.

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, Inc. TB-STS™ Tracheobronchial Stent System (K030947, K033053, K033990)
• Boston Scientific Corp. Inc. Ultraflex™ Tracheobronchial Stent System (K963241)
• Rusch International Polyflex Stent Kit (K013266)

Reference Devices

• Novatech S.A. Endoxane® Stent (K971509)

Submission Summary (Full Text)

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K062511
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Alveolus. Inc 9013 Perimeter Woods, Suite A Charlotte, NC 28216, USA

# 16 510(K) SUMMARY

JAN 3 1 2007

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

## General Company Information

| Name:<br>Contact: | Alveolus Inc.<br>Donald V. Canal<br>Vice President RAQA |
|--------------------|---------------------------------------------------------|
| Address: | 9013-A Perimeter Woods Drive<br>Charlotte, NC 28216 |
| Telephone:<br>Fax: | [phone]<br>[phone] |
| Date Prepared | August 15, 2006 |

### General Device Information 16.1

| Product Name: | AERO™ Tracheobronchial Stent System |
|-----------------|------------------------------------------------------------------------|
| Classification: | "Tracheal Prosthesis", Product code: JCT<br>21 CFR 878.3720 - Class II |

#### Predicate Devices 16.2

Alveolus, Inc. TB-STS™ Tracheobronchial Stent System [510(k) Numbers K030947, K033053, K033990]

Boston Scientific Corp. Inc. Ultraflex™ Tracheobronchial Stent System [501(k) Number K963241]

Rusch International Polyflex Stent Kit [510(k) Number K013266]

### 16.3 Description

The Alveolus Tracheobronchial Stent Technology System is comprised of two

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K062511
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9013 Perimeter Woods, Suite A Charlotte, NC 28216, USA

components: the radiopaque stent and the delivery system. The nitinol stent is completely covered with a biocompatible polyurethane membrane and is selfexpanding. The stent expansion results from the mechanical properties of the metal and the proprietary geometry. The stent is designed with a slightly larger diameter near the distal and proximal ends to minimize the possibility of migration. The stent ends are slightly vaulted inwardly in order to minimize possible airway injury from the stent edges. The overall stent geometry is designed to maintain a constant length over the entire range of possible diameters. As a result of this unique design the stent has virtually no foreshortening, thus facilitating the selection of the appropriate stent length.

### 16.4 Intended Use (Indications)

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

### Substantial Equivalence 16.5

This submission supports the position that the Alveolus Tracheobronchial Stent is substantially equivalent to a number of previously cleared devices, including the Boston Scientific Corp. Inc. Ultraflex™ Tracheobronchial Stent System [501(k) Number K963241], the Rusch International Polyflex Stent Kit [510(k) Number K013266] and the Novatech S.A. Endoxane® Stent [510(k) Number K971509].

The 510(k) Notice references a report of a study conducted under IDE G040202 that was completed to demonstrate safety and efficacy of the modified device.

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

## 16.6 Conclusions

Alveolus Inc. believes that the information provided establishes that similar legally marketed devices have been used for the same clinical applications as the Alveolus Tracheobronchial Stent. The materials from which the Alveolus device is fabricated have an established history of use in clinical applications, and the devices produced by Alveolus have been tested in accordance with applicable FDA guidelines.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Alveolus, Inc. % Donald V. Canal Vice President RA/QA 9013 Perimeter Woods, Suite A Charlotte, North Carolina 28216

JAN 3 1 7007

Re: K062511 Trade Name: AERO Tracheobronchial Stent System Regulation Number: 878.3720 Regulation Name: Tracheal Prosthesis Regulatory Class: II Product Code: JCT Dated: January 16, 2007 Received: January 17, 2007

Dear Mr. Canal:

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:

Warning: The safety and effectiveness of this device for use in the vascular system has not been established and can result in serious harm and/or death.

Furthermore, the indication for tracheal use must be prominently displayed in all labeling, including pouch box, and carton labels, instructions for use, and other promotional materials, in close proximity to the trade name, of a similar point size, and in bold print.

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Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.

The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification if the limitation statement described above is added to your labeling.

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.

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.

If you desire specific information about the application of 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 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,
Qatan

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

Enclosure

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K062511
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Alveollus

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

# 13 INTENDED USE STATEMENT

510(k) Number (if known): K062511

Device Name: Alveolus, AERO™ Tracheobronchial Stent System

Indications For Use:

The Alveolus AERO™ 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 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

OCETM
'1/29/07

CONFIDENTIAL

Alveolus AERO™ Premarket Notification