VASCULAR ARCHITECTS ASPIRE COVERED STENT AND CONTROLLED EXPANSION DELIVERY SYSTEM

K012544 · Vascular Architects, Inc. · JCT · Nov 15, 2001 · General, Plastic Surgery

Device Facts

• Record ID: K012544
• Device Name: VASCULAR ARCHITECTS ASPIRE COVERED STENT AND CONTROLLED EXPANSION DELIVERY SYSTEM
• Applicant: Vascular Architects, Inc.
• Product Code: JCT · General, Plastic Surgery
• Decision Date: Nov 15, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3720
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Vascular Architects aSpire® Covered Stent and Controlled Expansion® Delivery System are indicated for use in the treatment of tracheobronhial strictures produced by malignant neoplasms.

Device Story

The Vascular Architects aSpire® Covered Stent and Controlled Expansion® Delivery System is a tracheal prosthesis designed to maintain luminal diameter in tracheobronchial strictures caused by malignant neoplasms. The device is delivered via a catheter system to the site of the stricture. It functions as a mechanical support to keep the airway open, thereby alleviating obstruction and potentially improving patient breathing. The device is intended for use by clinicians in a medical setting. It is a mechanical device; no software or algorithmic processing is involved.

Clinical Evidence

Bench testing only. Simulated use and performance testing were conducted to evaluate mechanical integrity and device performance compared to the predicate device.

Technological Characteristics

Tracheal stent and delivery system. Materials are similar to the predicate device. Dimensions (lengths and diameters) are similar to the predicate device. Mechanical expansion mechanism. No software, electronics, or energy sources.

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

• Vascular Architects aSpire® Covered Stent and Delivery Catheter (K003173)

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 image of an eagle with its wings spread, with three human profiles incorporated into the design of the eagle's body. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular pattern around the eagle image.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 3 2006

The Wallace Enterprises, Inc. DBAVascular Architects % Mr. Kevin F. MacDonald Regulatory Consultant 229 Marvilla Circle Pacifica, California 94044

Re: K012544

K012544
Trade/Device Name: Vascular Architects aSpire® Covered Stent and Controlled Expansion® Delivery System Regulation Number: 21 CFR 878.3720 Regulation Name: Tracheal prosthesis Regulatory Class: II Product Code: JCT Dated: October 26, 2001 Received: October 31, 2001

Dear Mr. MacDonald:

This letter corrects our substantially equivalent letter of November 15, 2001.

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your because as (t) personal ally equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreations of the enactment date of the Medical Device Amendments or to conninered proc to May 20, 1978, the encordance with the provisions of the Federal Food. Drug, de vices that have been recuire approval of a premarket approval (PMA). You may, allo Cosment Act (Tech mat do not required to the general controls provisions of the Act. The general therefore, mander the act include requirements for annual registration, listing of devices, Controls provisions of are ce, 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 If your device is exassified (000 ac) Existing major regulations affecting your device can be may be subject to additions, 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 I lease oc advised that I Dr o issuants over device complies with other requirements of the Act that I Dri has made a actuations administered by other Federal agencies. You must or any I odetar batales and registments, including, but not limited to: registration and listing (21 Compry with an the 110 - 21 CFR Part 801); good manufacturing practice requirements as set

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Page 2 - Mr. Kevin F. MacDonald

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

Sincerely yours,

Holbert Lemming

- 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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Vascular Architects aSpire® Covered Stent Amendment to K012544, K030567, K031641 July 28, 2006

# Indications for Use

K012544 510(k) Number (if known): Vascular Architects aSpire® Covered Stent and Device Name: Controlled Expansion® Delivery System The Vascular Architects aSpire® Covered Stent and Indications for Use: Controlled Expansion® Delivery System are indicated for use in the treatment of tracheobronhial strictures produced by malignant neoplasms.

Prescription Use X

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Herbert Leun

(Per 21 CFR 801.109)

Optional Format 1-2-96) Division of General, Restorative, and Neurological Devices

**510(k) Number** k012544

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012544 p. lot 2

Vascular Architects aSpire® Covered Stent Amendment to K012544, K030567, K031641 July 28, 2006

## 510(k) Summary of Safety and Effectiveness

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is K012544.

### General Information

| Date Amended: | July 28, 2006 |
|----------------|------------------------------------------------------------------------------------------------|
| Classification | Class II, Tracheal Prosthesis per 21 CFR § 878.3720 |
| Product Code | JCT |
| Common Name: | Tracheal Stent |
| Trade Name | Vascular Architects aSpire® Covered Stent and<br>Controlled Expansion® Delivery System |
| Submitter | Wallace Enterprises, Inc. DBA Vascular Architects<br>1650 Elm Hill Pike<br>Nashville, TN 37210 |
| Contact | Kevin F. MacDonald<br>Regulatory Consultant<br>Tel [phone] |

#### Intended Use

The Vascular Architects aSpire® Covered Stent and Controlled Expansion® Delivery System are indicated for use in the treatment of tracheobronhial strictures produced by malignant neoplasms.

#### Predicate Devices

K003173 - Vascular Architects aSpire® Covered Stent and Delivery Catheter

#### Device Description

The Vascular Architects aSpire® Covered Stent and Controlled Expansion® Delivery I he vasound firemted the luminal diameter within tracheobronhial strictures produced by malignant neoplasms.

## Comparison To Predicate Device

The Vascular Architects aSpire® Covered Stent and Controlled Expansion® Delivery System has a similar intended use and shares the same technological characteristics as the predicate device.

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012544 p. 2 of 2

Vascular Architects aSpire® Covered Stent Amendment to K012544, K030567, K031641 July 28, 2006

The Vascular Architects aSpire® Covered Stent and Controlled Expansion® Delivery System are well-characterized materials and are suitable for this use. The materials are similar to those used to manufacture the predicate device.

The available lengths and diameters of the Vascular Architects aSpire® Covered Stent and Controlled Expansion® Delivery System are similar to the lengths and diameters available for the predicate device.

### Testing Summary

Simulated use and performance testing was conducted on the Vascular Architects aSpire® Covered Stent and Controlled Expansion® Delivery System. Results of the bench testing performed demonstrate the mechanical integrity and device performance of the subject device are substantially equivalent to that of the predicate device.