ALVEOLUS INC., TB-STS TRACHEOBRONCHIAL STENT SYSTEM

K030947 · Alveolus, Inc. · JCT · May 15, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K030947
• Device Name: ALVEOLUS INC., TB-STS TRACHEOBRONCHIAL STENT SYSTEM
• Applicant: Alveolus, Inc.
• Product Code: JCT · General, Plastic Surgery
• Decision Date: May 15, 2003
• 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 produced by malignant neoplasms.

Device Story

The Alveolus TB-STS™ Tracheobronchial Stent System is a self-expanding, radiopaque nitinol stent fully covered with a biocompatible polyurethane (ChronoFlex™) membrane. The stent features a proprietary geometry designed to maintain constant length with virtually no foreshortening during expansion; vaulted ends minimize airway injury; slightly larger diameters at proximal and distal ends reduce migration risk. The system includes the stent and a delivery system. It is intended for use by clinicians to treat tracheobronchial strictures resulting from malignant neoplasms. The device is provided sterile for single-patient use.

Clinical Evidence

Bench testing only. The submission includes summaries of physical test results and biocompatibility data as specified in the FDA Guidance Document for Testing Tracheal Stents, demonstrating the device is suitable for its indicated use.

Technological Characteristics

Materials: Nitinol (stent), polyurethane (ChronoFlex™ membrane). Principle: Self-expanding metallic stent. Form factor: Tubular with vaulted ends and flared proximal/distal diameters. Connectivity: None. Sterilization: Provided sterile.

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

• Boston Scientific Corp. Inc. Ultraflex™ Tracheobronchial Stent System (K963241)
• Vascular Architects, Inc. a Spire™ Covered Stent and CONTROLLED EXPANSION™ Delivery System (K003173 and K012544)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines representing its wings and head. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" surrounding it.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 3 2006

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

Re: K030947

.

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: March 24, 2003 Received: March 26, 2003

Dear Mr. Canal:

This letter corrects our substantially equivalent letter of May 15, 2003.

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 forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Donald Canal

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.

Sincerely vours.

Helbert Lemmens

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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Image /page/2/Picture/0 description: The image shows the logo for Alveolus. The logo consists of the word "Alveolus" in a stylized font, with a horizontal line running through the middle of the word. 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 black and white.

# Indications for Use

510(k) Number (if known): K030947

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 produced by malignant neoplasms.

**Prescription Use**
(Part 21 CFR 801 Subpart D)

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X

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)

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

510(k) Number K630947

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Alveolus.

INSPIRING THE BREATH OF LIFE

030947 p. lo f2

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

## General Company Information

- Name: Alveolus, Inc. Contact: Don Canal
Address: 9013 Perimeter Woods Dr Suite A Charlotte, NC 28216

- Telephone: (704) 926 - 4850 Fax: (704) 926 - 4895
## General Device Information

Product Name: TB-STS™ Tracheobronchial Stent System

Classification: "Tracheal Prosthesis", Product code: JCT Class II

#### Predicate Devices

Boston Scientific Corp. Inc. Ultraflex™ Tracheobronchial Stent System [510(k) Number K963241]

Vascular Architects, Inc. a Spire™ Covered Stent and CONTROLLED EXPANSION™ Delivery System [510(k) Number K003173 and K012544]

#### 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 the possible airway injury from

安

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030747 p. 2 of 2

Alveolus

the stent edges. The overall stent geometry is designed to maintain a constant length
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## Indications

The Alveolus TB-STS™ Tracheobronchial Stent System is indicated for use in the
treatment of tracheobronchial strictures produced by malignant peoples the concreation TB-STS™ Tracheobronchial Stent System is indicated for use.
treatment of tracheobronchial strictures produced by malignant neoplasms.

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# Substantial Equivalence

This submission supports the position that the Alveolus Tracheobronchial Stent is
substantially equivalent to a number of previously cleared devices including to and oublinssion supports the Alveolus Tracheobronchial Stent is
Stientificaly euports the position that the Alveolus , including the Boston
Scientific Cop. Inc. Ultraflex™ Tr Stentific Copp. Inc. Inc. Inc. Inc. Inc. Inc. Alveous Tracheoloronchial Stent
Scientific Copp. Inc. Ultraflex Tracted Created devises, including including in the United Co rent in Corp. Inc. Ultrallex™ Trached Stent System (11.1 Stiller Stein (11.1 Stenit Stein (1.6 St.
K963241), the Vascular Architects, Inc. aSpire® Covered Stent® (510(k) Numb K003173 and K012544].

The 510(K) Notice contains summanies of physical test results, and birony numbler
results as specified in the FDA Guidance Document for Testing Franches of and and

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

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

# Conclusions

Alveolus Inc. believes that the :

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