ALVEOLUS INC. TB-STS TRACHEOBRONCHIAL STENT SYSTEM

K033990 · Alveolus, Inc. · JCT · May 12, 2004 · General, Plastic Surgery

Device Facts

Record IDK033990
Device NameALVEOLUS INC. TB-STS TRACHEOBRONCHIAL STENT SYSTEM
ApplicantAlveolus, Inc.
Product CodeJCT · General, Plastic Surgery
Decision DateMay 12, 2004
DecisionSESE
Submission TypeSpecial
Regulation21 CFR 878.3720
Device ClassClass 2
AttributesTherapeutic

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; inner lumen coated with hydrophilic polymer for lubricity. Stent geometry features vaulted ends to minimize airway injury and flared proximal/distal ends to prevent migration; maintains constant length during expansion (no foreshortening). Delivered via specialized system; used by physicians in clinical settings to treat airway obstructions. Stent provides mechanical support to maintain airway patency; removable design allows for management of malignant airway conditions. Benefits include improved breathing and airway patency for patients with malignancy-related airway compromise.

Clinical Evidence

Bench testing only. No clinical data presented. Evidence consists of physical test results and biocompatibility testing conducted in accordance with FDA Guidance Document for Testing Esophageal and Tracheal Prostheses.

Technological Characteristics

Nitinol self-expanding stent; polyurethane (ChronoFlex™) membrane covering; hydrophilic polymer inner coating. Radiopaque. Designed with vaulted ends and flared diameters to prevent migration and injury. 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

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/2 description: The image is a seal for the Department of Health and Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" around the top half of the circle. The bottom half of the circle contains an image of a stylized eagle with its wings spread. 3 2006 NOV 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: K033990 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: April 9, 2004 Received: April 12, 2004 Dear Mr. Canal: This letter corrects our substantially equivalent letter of May 12, 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 {1}------------------------------------------------ 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 (240) 276-0115. 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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours, Mark N. Malkerson Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the word "Alveolus" in a stylized font, with a line drawn 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 text and lines are all in black and white. # Indications for Use 510(k) Number (if known): K033990 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) **(Division Sign-Off)** Division of General, Restorative, and Neurological Devices **510(k) Number** L033660 Page 10 of 24 {3}------------------------------------------------ Alveolus. INSPIRING THE BREATH OF LIFE ## SUMMARY OF SAFETY AND EFFECTIVENESS #### General Company Information - Alveolus, Inc. Name: Don Canal Contact: - 9013 Perimeter Woods Dr Address: Suite A Charlotte, NC 28216 Telephone: (704) 926 - 4850 Fax: (704) 926 - 4895 ## General Device Information TB-STS™ Tracheobronchial Stent System Product Name: Classification: "Tracheal Prosthesis", Product code: JCT - Class II # Predicate Devices Alveolus, Inc. TB-STS™ Tracheobronchial Stent System [510(k) Numbers K030947] Boston Scientific Corp. Inc. Ultraflex™ Tracheobronchial Stent System [501(k) Number K963241] Vascular Architects, Inc. aSpire™ 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 inner lumen of the expanded stent is coated with a hydrophilic polymer to improve lubricity. 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 {4}------------------------------------------------ Image /page/4/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 smaller letters. The logo is black and white. unique design the stent has virtually no foreshortening, thus facilitating the selection of the appropriate stent length. #### 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 Alveolus TB STS™ Tracheobronchial Stent System previously approved [510(k) K030947], the Boston Scientific Corp. Inc. Ultraflex™ Tracheobronchial Stent System [501(k) Number K963241], the Vascular Architects, Inc. aSpire® Covered Stent® [510(k) Number K003173 and K012544]. The 510(k) Notice contains summaries of physical test results, and biocompatibility test results as specified in the FDA Guidance Document for Testing Esophageal and Tracheal Prostheses (April 28, 1998). 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. 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.
Innolitics
510(k) Summary
Decision Summary
Classification Order
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