ENDOVENTIONS ALIMAXX-E ESOPHAGEAL STENT SYSTEM

K051621 · Alveolus, Inc. · ESW · Jul 11, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K051621
• Device Name: ENDOVENTIONS ALIMAXX-E ESOPHAGEAL STENT SYSTEM
• Applicant: Alveolus, Inc.
• Product Code: ESW · General, Plastic Surgery
• Decision Date: Jul 11, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3610
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Endoventions ALIMAXX-E™ Esophageal Stent System is intended for maintaining esophageal lumen patency in strictures caused by intrinsic and / or extrinsic esophageal tumors. The stent is also indicated for occlusion of esophageal fistulae.

Device Story

System consists of self-expanding nitinol stent and delivery system; stent covered with biocompatible polyurethane (ChronoFlex™) membrane. Stent features larger diameter at distal and proximal ends to maintain patency; designed to maintain constant length. Used by clinicians to treat esophageal strictures and fistulae. Device provides mechanical support to esophageal wall to maintain lumen patency; benefits patient by restoring esophageal function and managing fistulae. Single-patient-use components provided non-sterile.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing, including physical test results conducted in accordance with the FDA Guidance Document for Testing Esophageal and Tracheal Prostheses.

Technological Characteristics

Nitinol self-expanding stent; biocompatible polyurethane (ChronoFlex™) membrane covering. Features variable diameter geometry. Non-sterile delivery system. Mechanical expansion principle.

Indications for Use

Indicated for patients with esophageal strictures caused by intrinsic or extrinsic esophageal tumors and for patients with esophageal fistulae.

Regulatory Classification

Identification

An esophageal prosthesis is a rigid, flexible, or expandable tubular device made of a plastic, metal, or polymeric material that is intended to be implanted to restore the structure and/or function of the esophagus. The metal esophageal 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™ Esophageal NG Stent System (K032930)
• Rusch International Polyflex Stent for the Esophagus with Introducer / Delivery System (K030559)

Submission Summary (Full Text)

{0}------------------------------------------------

K051621
Page 1 of 2

## JUL 1 1 2005

# 15 510(k) SUMMARY

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

#### General Company Information

| Name:<br>Contact: | Endoventions<br>Don Canal<br>Vice President RA/QA |
|-------------------|---------------------------------------------------|
| Address: | 9013 Perimeter Woods, Suite |

te A Charlotte, NC 28216

| Telephone: | (704) 926 - 4837 |
|------------|------------------|
| Fax: | (704) 926 - 4838 |

### Date Prepared: June 17, 2005

#### General Device Information

| Product Name: | ALIMAXX-ETM Esophageal Stent System |
|-----------------|--------------------------------------------------------------------------|
| Classification: | "Esophageal Prosthesis", Product code: ESW<br>21 CFR 878.3610 - Class II |

#### Predicate Devices

Boston Scientific Corp. Inc. Ultraflex™ Esophageal NG Stent System [501(k) Number K032930]

Rusch International Polyflex Stent for the Esophagus with Introducer / Delivery System [510(k) Number K030559]

#### Description

The Endoventions Esophageal Stent Technology System is comprised of two components: the stent and the delivery system. The nitinol stent is completely covered with a biocompatible polyurethane (ChronoFlex™) 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 larger diameter

{1}------------------------------------------------

K051621
Page 2 of 2

near the distal and proximal ends to minimize the possibility of the possible only near the distar and proximal strace to maintain a constant length over the entire overall stent geometry lo doclynbu to this unique design the stent has range of possible diamelers. The a facilitating the selection of the appropriate stent length.

#### Intended Use (Indications)

The Endoventions ALIMAXX-E™ Esophageal Stent System is intended for The Endoventions ALMI 000 = = = == =========================================================================================================================================== haintaining CSOphagoal lamoir patt turnors. The stent is also indicated for occlusion of esophageal fistulae.

#### Substantial Equivalence

This Notice supports the position that the Endoventions Esophageal Stent is This Notice Supporte the position be of previously cleared devices, including the Substantially oqurvalorit to - Ultraflex™ Esophageal NG Stent System [501(k) Boston Scientifie Solph International Polyflex Stent for the Esophagus with Introducer / Delivery System [510(k) Number K030559].

The 510(k) Notice contains summaries of physical test results, and The STO(I) Notios ochaalite os 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 ALIMAXX-E™ Esophageal Stent System are provided non-sterile.

#### Conclusions

Endoventions believes that the information provided establishes that similar Lindoventions believes have been used for the same clinical applications as the legally manced doness notent. The materials from which the Endoventions device is fabricated have an established history of use in clinical applications, device is labhoated have an octably in occordance have been tested in accordance with applicable FDA guidelines.

{2}------------------------------------------------

Image /page/2/Picture/2 description: The image shows a black and white drawing of a bird in flight. The bird is facing left and has three lines that make up its body. There is some text in a circular pattern to the left of the bird. The text is not clear enough to read.

# JUL 1 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville -MD 20050

Mr. Donald V. Canal Vice President RA/QA Endoventions 9013 Perimeter Woods, Suite A CHARLOTTE NC 28216

K051621 Re:

Trade/Device Name: Endoventions™ ALIMAXX-E™ Esophageal Stent System Regulation Number: 21 CFR §878.3610 Regulation Name: Esophageal prosthesis Regulatory Class: II Product Code: ESW Dated: June 17, 2005 Received: June 21, 2005

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) that do not require approval of a premarket approval application (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 (Premarket Approval), it may be subject to such 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.

{3}------------------------------------------------

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and w you'ls organism of substantial equivalence of your device to a legally prematice notification - 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 If you desire speoms acries for your of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, produse note the regulation on your responsibilities under the Act from the 007.77). Tournal ourers, 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.

NITE RIDER

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

K05/621

# 12 INTENDED USE STATEMENT

Device Name: Endoventions, ALIMAXX-E™ Esophageal Stent System

Indications For Use:

The Endoventions ALIMAXX-E™ Esophageal Stent System is intended for maintaining The Endovehilons ALIMAXA-E - Esophageal strictures caused by infrinsic and / or extinsic esophageal futher patchey in occlusion of esophageal fistulae.

Prescription Use (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)

Nancye Brogdon

(Division Sign-Off)
Division of Reproducive, Abdominal,
and Radiological Devices

310(k) Number K051621