ALEOLUS/ENOVENTIONS,ALIMAXX-E DV ESOPHAGEAL STENT SYSTEM

K060239 · Alveolus, Inc. · ESW · Mar 22, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K060239
• Device Name: ALEOLUS/ENOVENTIONS,ALIMAXX-E DV ESOPHAGEAL STENT SYSTEM
• Applicant: Alveolus, Inc.
• Product Code: ESW · General, Plastic Surgery
• Decision Date: Mar 22, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3610
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Esophageal stent delivery system; features internal channel for flexible endoscope; enables direct visualization (DV) of stent placement and deployment; used by physicians in clinical settings; provides method to maintain esophageal lumen patency; benefits patients by treating malignant strictures and fistulae; implantable stent identical to predicate ALIMAXX-E.

Clinical Evidence

Bench testing only; no clinical data presented. Physical test results for the delivery device were conducted per FDA guidance.

Technological Characteristics

Esophageal stent delivery system with integrated channel for flexible endoscope; single-patient-use; non-sterile; materials have established history of clinical use.

Indications for Use

Indicated for patients with esophageal strictures caused by intrinsic or extrinsic malignant tumors and for patients requiring occlusion of 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

• Alveolus/Endoventions ALIMAXX-E Esophageal Stent System (K051621)
• Rusch International Polyflex Stent for the Esophagus with Introducer / Delivery System (K030559)

Submission Summary (Full Text)

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MAR 2 2 /006

K060239
Pacze 1 of 2

## 15 510(k) SUMMARY

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

#### General Company Information

| Name: | Alveolus, Inc. |
|----------|----------------------|
| Contact: | Don Canal |
| | Vice President RA/QA |

9013 Perimeter Woods, Suite A Address: Charlotte, NC 28216

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

#### Date Prepared: January 16, 2006

#### General Device Information

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

#### Predicate Devices

Alveolus/Endoventions ALIMAXX-E Esophageal Stent System [510(k) Number K051621]

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

#### Description

The Alveolus/Endoventions ALIMAXX-E DV Esophageal Stent System provides an alternate method to deploy the Alveolus/Endoventions Esophageal stent. The implantable stent for the Alveolus/Endoventions ALIMAXX-E and the subject device are the same. The ALIMAXX-E DV delivery device provides a direct visualization (DV) of the stent deployment by providing a channel inside of the

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K060239
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delivery device for a flexible endoscope. This channel allows the physician to directly visualize placement location, and deployment of the stent.

#### Intended Use (Indications)

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

#### Substantial Equivalence

This Notice supports the position that the Alveolus/Endoventions ALIMAXX-E DV Esophageal Stent is substantially equivalent to a number of previously cleared devices, including the Alveolus/Endoventions ALIMAXX-E Esophageal Stent System [510(k) Number K051621] and the Rusch International Polyflex Stent for the Esophagus with Introducer / Delivery System [510(k) Number K030559].

The 510(k) Notice contains summaries of physical test results for the delivery device as specified in the FDA Guidance Document for Testing Esophageal and Tracheal Prostheses (April 28, 1998).

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

The single-patient-use components of the ALIMAXX-E DV™ Esophageal Stent System are provided non-sterile.

#### Conclusions

Alveolus/Endoventions believes that the information provided establishes that similar legally marketed devices have been used for the same clinical applications as the subject device. The materials from which the Alveolus/Endoventions device is fabricated have an established history of use in clinical applications, and the devices produced by Alveolus/Endoventions have been tested in accordance with applicable FDA quidelines.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the department's name around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight. The image is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 2 2006 .

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

Re: K060239

Trade/Device Name: Alveolus/Endoventions ALIMAXX-E DV™ Esophageal Stent System Regulation Number: 21 CFR §878.3610 Regulation Name: Esophageal prosthesis Regulatory Class: II Product Code: ESW Dated: January 27, 2006 Received: January 31, 2006

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.

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This letter will allow you to begin marketing your device as described in your Section 510(k) I ins leter with anon-you to organizatial equivalence of your device of your device to a legally prematics notification: "The PDF manings" proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire speatre 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 C) (1) Also, prease note the regulation on your responsibilities under the Act from the 801:37). Tournal Manufacturers, 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.litml.

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

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# 12 INTENDED USE STATEMENT

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

Indications For Use:

The Alveolus/Endoventions ALIMAXX-E DV™ Esophageal Stent System is intended for The Aveous/Endoventions ALM/ OO L D + Loophageal strictures caused by intrinsic and / maintaining occamaged nors and for 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)

Nancy Bragdon

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Division of Reproductive, Abdominal. and Radiological Devi 510(k) Number