ALVEOLUS, TB-STS TRACHEOBRONCHIAL STENT SYSTEM

K033053 · Alveolus, Inc. · JCT · Feb 25, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K033053
• Device Name: ALVEOLUS, TB-STS TRACHEOBRONCHIAL STENT SYSTEM
• Applicant: Alveolus, Inc.
• Product Code: JCT · General, Plastic Surgery
• Decision Date: Feb 25, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3720
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Alveolus TB-STS™ Tracheobronchial Stent System is indicated for use in the treatment of tracheobronchial strictures and airway compression (stenosis) produced by malignant neoplasms. Because the device is removable it may also be used to treat conditions such as tracheo-esophageal fistula resulting from malignancies and strictures resulting from surgical anastomosis of the airway in patients with malignancies.

Device Story

Self-expanding nitinol stent covered with biocompatible polyurethane (ChronoFlex™) membrane; designed with vaulted ends to minimize airway injury and flared ends to prevent migration; maintains constant length during expansion. Delivered via specialized system to treat malignant airway obstructions. Used by clinicians in hospital settings. Stent provides mechanical support to maintain airway patency; removable design allows for temporary or permanent placement. Benefits include relief of airway compression and management of fistulas in malignancy patients.

Clinical Evidence

In vivo porcine study conducted to evaluate device performance. Study demonstrated that the completely covered stent is removable, similar to silicone stent predicates, for up to 28 days. No human clinical trial data provided.

Technological Characteristics

Nitinol self-expanding stent; polyurethane (ChronoFlex™) membrane covering; radiopaque; vaulted end geometry; constant length design. Provided sterile for single-patient use.

Indications for Use

Indicated for patients with malignant neoplasms causing tracheobronchial strictures, airway compression (stenosis), tracheo-esophageal fistula, or strictures from surgical airway anastomosis.

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)
• Rusch International Polyflex Stent Kit (K013266)
• Novatech S.A. Endoxane® Stent (K971509)

Reference Devices

• Boston Scientific Corp. Inc. Ultraflex™ Tracheobronchial Stent System (K963241)

Submission Summary (Full Text)

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NOV 3 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K033053

Trade/Device Name: Alveolus TB-STS™ Tracheobronchial Stent System Regulation Number: 21 CFR 878.3720 Regulation Name: Tracheal prosthesis Regulatory Class: II Product Code: JCT Dated: January 7, 2004 Received: January 8, 2004

Dear Mr. Canal:

This letter corrects our substantially equivalent letter of February 25, 2004.

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 (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 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

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Page 2 - Mr. Donald Canal

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 continue 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/dsma/dsmamain.html

Sincer

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

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INSPIRING THE BREATH OF LIFE

# Indications for Use

510(k) Number (if known): K033053

Device Name: Alveolus, TB-STS™ Tracheobronchial Stent System

Indications For Use:

The Alveolus TB-STS™ Tracheobronchial Stent System is indicated for use in the treatment of tracheobronchial strictures and airway compression (stenosis) produced by malignant neoplasms. Because the device is removable it may also be used to treat conditions such as tracheo-esophageal fistula resulting from malignancies and strictures resulting from surgical anastomosis of the airway in patients with malignancies.

Prescription Use_ V (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)

Res

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

**510(k) Number** k033657

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INSPIRING THE BREATH OF LIFE

# 510(k) SUMMARY (Per 21 CFR 807.92)

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of

#### General Company Information

- Alveolus, Inc. Name: Don Canal Contact:
- 9013 Perimeter Woods Dr Address: Suite A Charlotte, NC 28216
- [phone] Telephone: (704) 926 - 4895 Fax:
- February 17, 2004 Date Prepared

#### General Device Information

TB-STS™ Tracheobronchial Stent System Trade Name:

- "Tracheal Prosthesis", Product code: JCT Classification: 21 CFR 878.3720 - Class II
#### Predicate Devices

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

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

Novatech S.A. Endoxane® Stent [510(k) Number K971509]

#### Description

The Alveolus Tracheobronchial Stent Technology System is comprised of two components: the radiopaque stent and the delivery system. The nitinol stent is completely covered with a biocompatible polyurethane (ChronoFlex™) membrane and is self-expanding. 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

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Image /page/4/Picture/1 description: The image contains a text excerpt describing a stent design. The text states that the stent has virtually no foreshortening. This feature facilitates the selection of the appropriate stent length. The design is described as unique.

## Intended Use (Indications)

The Alveolus TB-STS™ Tracheobronchial Stent System is indicated for use in the treatment of tracheobronchial strictures and airway compression (stenosis) produced by malignant neoplasms. Because the device is removable it may also be used to treat conditions such as tracheo-esophageal fistula resulting from malignancies and strictures resulting from surgical anastomosis of the airway in patients with malignancies.

## Substantial Equivalence

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 contains a report of an in vivo animal (porcine) study that demonstrates that the completely covered stent is removable like the silicone stent predicates up to 28 days.

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

#### 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.